Pfizer

Nervous system symptom reports

Male, 26 - 39 years

Age Reported Symptoms Notes
26 2021-01-03 feeling hot his gums became discolored and turned purple/gums (both sides up and down) remain purple/discolorati... Read more
his gums became discolored and turned purple/gums (both sides up and down) remain purple/discoloration to the gums in his mouth; his mouth started hurting; feeling hot; Body aches; Fever; Pain to the gums in his mouth; muscle aches; sore throat; neck pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received the 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 to right shoulder on 24Dec2020 11:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received vaccine on 24Dec2020. He experienced body aches, fever, and feeling hot with onset of about 3-4 hours after he was administered (24Dec2020). Next day (25Dec2020), his mouth started hurting, his gums became discolored and turned purple. Gums (both sides up and down) remained purple. He will be seeing a dentist. He also reported pain and discoloration to the gums in his mouth on 25Dec2020. He had been experiencing some of the regular side effects such as muscle aches, sore throat, neck pain on an unspecified date in Dec2020. Outcome of the event gum discoloration was not recovered, of the events feeling hot, generelized aching, and fever was recovered on 26Dec2020, of the event gum pain was recovering, and of the remaining events was unknown. He reported seriousness criteria as what he thinks to be medically significant at this point; that they could be medically significant. He is scheduled to receive the second dose of the product which at this point he does not plan to change. Dose change is unknown until he determines cause of these events and on what the doctor and dentist he is going to see recommend. He believes events could be caused by the vaccine. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
26 2021-01-04 numbness Lips swelled and went numb. Hands swelled and went numb. Rash/redness covering upper body. Hives on ... Read more
Lips swelled and went numb. Hands swelled and went numb. Rash/redness covering upper body. Hives on arms. Nasal passages clogged
26 2021-01-05 weakness Fatigue, feeling drained, fever, headache.
26 2021-01-05 flushing Immediately after vaccine administration, patient reported he felt faint. Had flushed cheeks and i... Read more
Immediately after vaccine administration, patient reported he felt faint. Had flushed cheeks and increased blood pressure. Had patient recline and was monitored for 20 minutes and felt better.
26 2021-01-05 pain in extremity, cold sweat Woke up in Cold sweat the night after receiving shot. Sore arm the following day. Tested positive fo... Read more
Woke up in Cold sweat the night after receiving shot. Sore arm the following day. Tested positive for corona virus 01/06/2021
26 2021-01-08 weakness Chills, body aches, head aches, and general energy depletion
26 2021-01-09 migraine The morning after vaccination patient developed full body muscle aches, a migraine, and fatigue. Ibu... Read more
The morning after vaccination patient developed full body muscle aches, a migraine, and fatigue. Ibuprofen was taken and symptoms lessened over 6 hours, they resolved by 01/10/2021. Patient developed severe nausea the morning after vaccination (this also occurred after the first dose), and patient vomited several times with severe retching for 30 minutes. No medication was taken and symptoms subsided after 6 hours.
26 2021-01-09 tremor, hot flush Uncontrollable shaking at 2:00 am the following morning after the vaccine. Shaking lasted about an h... Read more
Uncontrollable shaking at 2:00 am the following morning after the vaccine. Shaking lasted about an hour and from 3:00am to 6:00am hot flashes and body aches. Temperature was 100 degrees.
26 2021-01-10 weakness 1 day after vaccination I experienced muscle pain, weakness, and chills. Symptoms lasted for roughly... Read more
1 day after vaccination I experienced muscle pain, weakness, and chills. Symptoms lasted for roughly 1 day.
26 2021-01-10 pain in extremity Sore Left Arm, slight muscle aches and lightheadedness that lasted 24 hours after the day the vaccin... Read more
Sore Left Arm, slight muscle aches and lightheadedness that lasted 24 hours after the day the vaccine was given.
26 2021-01-11 flushing Employee stated he did not feel well felt flush dizzy. Employee skin was diaphoretic. Walked employe... Read more
Employee stated he did not feel well felt flush dizzy. Employee skin was diaphoretic. Walked employee to EMT station, he was able to walk without assistance. Rested on stretcher, stated he was feeling better and left the facility on his own at 1450
26 2021-01-12 slurring, tingling Facial edema, glossitis, slurred speech (non-asymmetrical) onset 1/12/2021 (time unspecified). Ting... Read more
Facial edema, glossitis, slurred speech (non-asymmetrical) onset 1/12/2021 (time unspecified). Tingling sensations to lips and tongue onset 1/13/21
26 2021-01-12 tingling At 2:34pm the patient had tingling to fingers on both hands. Vitals were taken. Observed for another... Read more
At 2:34pm the patient had tingling to fingers on both hands. Vitals were taken. Observed for another 30 min and was sent home. Notes were that right side did resolve no notes about left side.
26 2021-01-14 migraine Chills, body ache, nausea, mild fever, joint pain, fatigue, and migraine like headache.
26 2021-01-14 pain in extremity fever , extreme fatigue, sore arm, headache
26 2021-01-15 burning sensation Whole body burning sensation, chills, headache, nausea, muscle aches and general exhaustion. Improve... Read more
Whole body burning sensation, chills, headache, nausea, muscle aches and general exhaustion. Improved on second day to only muscle aches, general exhaustion, headache, and nausea. On third day, only mild muscle aches, headache, and nausea. Resolved on fourth day post-vaccine.
26 2021-01-17 weakness Symptom onset approximately 24 hours after 1st dose given. Experienced sudden onset orthostatic hypo... Read more
Symptom onset approximately 24 hours after 1st dose given. Experienced sudden onset orthostatic hypotension, weakness, and nausea for 36 hours.
26 2021-01-17 flushing After receiving COVID vaccine around 1720 and being observed post vaccination pt returned at 1807 to... Read more
After receiving COVID vaccine around 1720 and being observed post vaccination pt returned at 1807 to observation area with complaints of feeling anxious, pt noted to have flushed face and sweating. BP was 160/88 and HR 108, pt observed for additional time flushing and sweating resolved, pts BP and HR decreased to 137/73 and 73. Pt declined further evaluation in ED
26 2021-01-18 feeling hot On 1/18/2021 around 1am started feeling back pain, then started feeling hot, & then the pain went al... Read more
On 1/18/2021 around 1am started feeling back pain, then started feeling hot, & then the pain went all over my body I could still move but it was just very painful. It lasted about 12hrs.
26 2021-01-18 migraine, weakness 15th Jan-1200-nausea, migraine 16th Jan-1800-nausea, fatigue, migraine, weak body, slight dizziness ... Read more
15th Jan-1200-nausea, migraine 16th Jan-1800-nausea, fatigue, migraine, weak body, slight dizziness 17th Jan-laid down all day-spotted vision, dizziness, taste was off-threw-up x times-his words 18th Jan-same as above. night slight fever@99.3 19th Jan-woke-up, low fever, gastric reflux x 2-not feeling well
26 2021-01-18 migraine Body aches, fatigue, migraine, mild cough, nausea and vomiting.
26 2021-01-18 pain in extremity Slight chills and some body aches, mild headache, all starting at night. Sore arm at injection site ... Read more
Slight chills and some body aches, mild headache, all starting at night. Sore arm at injection site reaction. Vaccine was administered around 10am. Went to sleep and woke up with more severe headache, took Naprosyn, headache resolved. Chills and body aches were gone after sleeping. Some fatigue also present after waking up.
26 2021-01-19 tingling Tingling in arm 1 minute after injection. Rapid response observed for 30 minutes. no other interven... Read more
Tingling in arm 1 minute after injection. Rapid response observed for 30 minutes. no other intervention
26 2021-01-21 pain in extremity Sore arm after 2 hours from injection. Headache upon waking up the next morning after getting the in... Read more
Sore arm after 2 hours from injection. Headache upon waking up the next morning after getting the injection in the evening. Sleepiness/fatigue the night of injection and the day following injection.
26 2021-01-25 weakness Runny nose; tachycardia; Weakness; flu like symptoms; Sore/dry throat; Sore/dry throat; nausea; This... Read more
Runny nose; tachycardia; Weakness; flu like symptoms; Sore/dry throat; Sore/dry throat; nausea; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on the left arm, first dose on 18Dec2020 (lot number: EH9899) and second dose on 08Jan2021 08:15 (lot number: EL3246), both at a single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medications were not reported. Patient did not receive other vaccines in four weeks prior to vaccination. The vaccine was given at a hospital. The patient reported sore/dry throat and nausea started Sunday (03Jan2021), weakness and flu-like symptoms on Monday (04Jan2021), then runny nose and tachycardia on Tuesday (05Jan2021). No treatment was received for the events. Patient has not been tested for COVID post-vaccination. Outcome of the events was not recovered.
26 2021-01-26 weakness Subjective fever (axillary temp 98.2F), chills, generalized weakness, malaise, headache, brain fog. ... Read more
Subjective fever (axillary temp 98.2F), chills, generalized weakness, malaise, headache, brain fog. Onset 3AM, resolved by 10PM with PO Tylenol 500mg plus PO ibuprofen 800mg taken together, as well as warm soup/tea and a nap.
26 2021-01-26 muscle spasms, tingling Shivering; muscle cramps; Extreme Neck and back pain; Extreme Neck and back pain; Left armpit pain w... Read more
Shivering; muscle cramps; Extreme Neck and back pain; Extreme Neck and back pain; Left armpit pain with tinglingly sensation down left arm; Left armpit pain with tinglingly sensation down left arm; This is a spontaneous report from a contactable nurse. A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 (brand: Pfizer, lot number: Ej1685, expiry date not reported) on 21Dec2020, intramuscular in the left arm for COVID 19 immunization. On 12Jan2021, patient experienced shivering and muscle cramps the first day; extreme neck and back pain x2 days post injection. On third day post injection, patient experienced left armpit pain with tinglingly sensation down left arm. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events shivering, muscle cramps, extreme neck and back pain and left armpit pain with tinglingly sensation down left arm was unknown.
26 2021-01-30 feeling cold I felt cold then feverish with sweats. I also had full body aches and a headache. They lasted 10-12 ... Read more
I felt cold then feverish with sweats. I also had full body aches and a headache. They lasted 10-12 hours. 1000mg of tylenol helped significantly.
26 2021-01-31 pain in extremity Extremely sore arm, very tired.
26 2021-02-02 pain in extremity Extremely sore arm for entire day after injection (painful to move and use); severe headache (mornin... Read more
Extremely sore arm for entire day after injection (painful to move and use); severe headache (morning after - present, approximately 48hrs after injection).
26 2021-02-06 numbness, tingling numbness/tingling in face for 5 - 10 minutes
26 2021-02-10 unresponsive to stimuli Patient presented with puffy eyes approximately 4 minutes after vaccination. Was alert and oriented ... Read more
Patient presented with puffy eyes approximately 4 minutes after vaccination. Was alert and oriented to time, person, and place upon questioning and was able to engage in conversation. Parent (mother) of patient was present who gave patient's medical history and reported allergy to grass with similar reaction. Blood pressure was taken and found to be 150/80. Mother reported patient had not taken his blood pressure medicine yet that day but his normal is 115/70 with medication. While nurse was assessing patient's pulse (patient's pulse was WNL at 85) and other nursing staff was obtaining medication to administer if needed after assessment, patient became unresponsive to verbal commands and his upper body became limp. At 1054, a one time, single dose of 50 mg of diphenhydramine IM was given in the left deltoid. On site EMT arrived on the scene at 1055, completed assessment, and confirmed giving diphenhydramine was the best course of action. At this time, 1055, patient became responsive to verbal commands and was oriented to time, place, and person. At 1056 O2 sat was at 97%, pulse 70, and at 1100, BP was 110/70. Patient stayed for observation 30 more minutes and remained stable. Patient and parent were educated on side effects of diphenhydramine, to watch for any returning symptoms of allergic reaction throughout the day, and if/when to head to the ER. Recommended patient not receive 2nd dose of COVID vaccination.
26 2021-02-13 bell's palsy Bell's Palsy (left sided facial droop, difficulty closing left eye lid). Outpatient treatment with o... Read more
Bell's Palsy (left sided facial droop, difficulty closing left eye lid). Outpatient treatment with oral corticosteroids, valacyclovir and topical Lacrilube (eye lubricant) prescribed by ED physician and referral to primary care for follow up.
26 2021-02-13 muscle spasms Back spasms, fatigue, dizziness when standing/moving.
26 2021-02-20 cold sweat, weakness, pain in extremity, tremor 1/28 - First dose of vaccine received. Arm felt heavy, not sore. Throughout the day, fatigue gradual... Read more
1/28 - First dose of vaccine received. Arm felt heavy, not sore. Throughout the day, fatigue gradually increased. Before bed time, had cold sweats and shakes. 1/29 - woke up feeling perfectly fine. 2/17 - Second dose of vaccine. Arm felt sore and was sore two days after. From 2/18-2/20, I noticed the effects of the Cymbalta were gradually decreasing and was experiencing side effects (shocks from toe to head every step). Turns out that even with taking my regular dose of the Cymbalta, my body after 2 hours feels like I had never taken it. 2/20 - After experiencing heavy shocks, shaking, and heart racing, I went home after coming into work 3 hours later. 2/21 - Woke up today feeling dizzy, fatigued, and weak. I know that operating a motor vehicle will not be possible for me.
26 2021-03-02 feeling hot Nausea, warmth after vaccine. Initial BP, 89/51. Final BP 111/47; blood glucose 85. Drank water.
26 2021-03-02 flushing Patient stated to RN at observation that " he wants to lay down". RN stated that "she held his head"... Read more
Patient stated to RN at observation that " he wants to lay down". RN stated that "she held his head" as he experienced a syncope event. RN notified Nurse Practitioners . EMS activated. Patients assessed and found to be alert and oriented to place and person. Patient stated that he felt dizzy. Vital signs monitored and patient found to be hypotensive, diaphoretic, and flushed. Epinephrine administered X3 with vital signs monitored in between. Vital signs stabilized and patient transferred to hospital with EMS.
26 2021-03-04 feeling hot I took notes during my wait time: -6 minutes in my throat felt weird, but different than normal alle... Read more
I took notes during my wait time: -6 minutes in my throat felt weird, but different than normal allergic reactions to foods. I prepared my Epi-Pen so I have easier access at this time. -9 minutes in the sides of my tongue were slightly itchy. -11 minutes in and I felt as though the saliva in the back of my throat was thicker and I needed to clear my throat a bit more often, similar to allergic reactions. -15 minutes in, I felt my heart pound once out of beat, but my heart rhythm returned to normal immediately. Tongue itchiness also became intermittent rather than constant. -18 minutes in, overall condition improved and I felt better. -22 minutes in, my throat felt scratchy like I would if I consumed legumes (chickpeas, green peas, soy beans, etc.) but also oddly warm, which was out of the norm. No treatments needed given mild reactions. I went to work, but notified my co-workers of my reaction, so if my condition worsens they can help administer my Epi-Pen. I am reporting this at 9:21 am on 03/05/2021, roughly an hour after my first dose.
26 2021-03-05 pain in extremity, weakness On the same day after the vaccine I had a fever and no energy. The next day my arm was still sore an... Read more
On the same day after the vaccine I had a fever and no energy. The next day my arm was still sore and I felt better until around 11pm. I had a fever again of 100.4 and fatigue and dizzy ness.
26 2021-03-07 pain in extremity very painful arm; chills; extreme fatigue; Moderate prefrontal headaches; mild nausea; This is a spo... Read more
very painful arm; chills; extreme fatigue; Moderate prefrontal headaches; mild nausea; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 26-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, via an unspecified route of administration, on 31Jan2021 12:00 pm at single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies. There are no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: EL3248) on 10Jan2021 at 08:00 am on the left arm for COVID 19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications taken with 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, 48 hours after the second dose, it was reported that the patient had very painful arm, chills, and extreme fatigue. On an unspecified date, 8 days after the second dose, the patient had moderate prefrontal headaches and mild nausea. No treatment was received for the events. The events were considered as non-serious and the events did not result in death, life-threatening condition, hospitalization, disability or congenital anomaly. The patient was tested for COVID-19 since the vaccination on 02Feb2021 via nasal swab with a negative result. The patient was vaccinated in a hospital. The outcome of the events was reported as recovering.
26 2021-03-07 pain in extremity arm very sore; her son received 6 times the amount of the vaccine dosage/overdosed 6 times the norma... Read more
arm very sore; her son received 6 times the amount of the vaccine dosage/overdosed 6 times the normal amount/over dosed him on the amount by 6 times, a huge mistake; This is a spontaneous report from a contactable consumer company CEP 2191. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 04Feb2021 via an unspecified route of administration in the arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The reporter stated her son received 6 times the amount of the vaccine dosage. The patient had not administered pfizer vaccine on same date and not had prior vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine. The patient had no AE's prior vaccinations. The patient had no any illness at time of vaccination and was not diagnosed with allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient experienced her son received 6 times the amount of the vaccine dosage/overdosed 6 times the normal amount/overdosed him on the amount by 6 times, a huge mistake on 04Feb2021 and arm very sore on an unspecified date. The patient was concerned about side effects. The patient has been feeling fine and has not mentioned any issues since the overdose. The patient had no relevant test and no had any illness. The outcome of the events was not recovered. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
26 2021-03-08 flushing, feeling of body temperature change Vision blurring, cold sweat, racing heart rate, flushing and syncope 5 minutes post-injection. EKG s... Read more
Vision blurring, cold sweat, racing heart rate, flushing and syncope 5 minutes post-injection. EKG showed ventricular arrhythmia which converted to normal sinus rhythm with regaining consciousness approximately 5 minutes later.
26 2021-03-08 numbness ten mins after shot left arm started going numb. started having chest pain, nausea, didn't feel like... Read more
ten mins after shot left arm started going numb. started having chest pain, nausea, didn't feel like himself bp started going up
26 2021-03-10 flushing, unresponsive to stimuli, feeling cold Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: COLD TO TOUCH AND SWEATING, DIFFICULTY HEARING-Mild, Systemic: Flushed / Sweating-Medium
26 2021-03-10 seizure About 30 minutes after dose he passed out and had a seizure that lasted 10 -15 seconds. This happene... Read more
About 30 minutes after dose he passed out and had a seizure that lasted 10 -15 seconds. This happened a couple times. He went to hospital had low blood pressure and oxygen. He stabilized and was released. He has a follow up appointment with his primary care doctor.
26 2021-03-10 tremor, seizure, involuntary muscle movements He began convulsing in his sleep, almost like a seizure except he woke up and became aware of what h... Read more
He began convulsing in his sleep, almost like a seizure except he woke up and became aware of what his body was doing. He could not control his body or limbs to move or stop the shaking. He did not have a fever at the time and could not determine whether or not he felt cold. The uncontrollable shaking was consistent for about ten minutes and then continued sporadically for an hour or so, though it became much more controllable. Hours later, he has more typical symptoms like a bad headache and a fever. The shaking has not come back.
26 2021-03-11 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotens... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient fainted, unfortunately did fall, however despite some bruises was ok. Waited for family to come to get him and was able to leave under his own power. Ambulance was called and he was checked, no issues found and did not leave with ambulance.
26 2021-03-12 difficulty speaking About 14 hours after the injection, pt developed difficulty breathing and hoarseness. Pt improved s... Read more
About 14 hours after the injection, pt developed difficulty breathing and hoarseness. Pt improved slightly after taking their symbacort & albuterol.
26 2021-03-15 numbness, tingling Two days after second shot Patient experienced: tingling/numbness in both hands; A rash to his face,... Read more
Two days after second shot Patient experienced: tingling/numbness in both hands; A rash to his face,chin and to both arms; Itching with bumps, swollen fingers and toes; Rash and swelling moves around body with elevated joint/bone pain; fevers on/off. 2/13/21- Went to Urgent Care, given Keflex with no change.2/15/21- Urgent Care second visit, Keflex stopped.2/17/21- Clinic, Benadryl & Tylenol PRN and labs done with no change in rash, Covid test negative. 2/18/21- Dermatology Appointment- Doxycycline 100mg BID, Hydroxyzine PRN, Zyrtec OT, Punchbx left ankle. 3/11/21 - No diagnosis made in Hospital or from follow-up visit with Dermatologist. Continue to have occasional area of transient redness and some numbness and tingling in hands.
26 2021-03-15 tremor, pain in extremity, muscle spasms, involuntary muscle movements On 2/13/2021, I began to experience both enhanced and new musculoskeletal and neurological symptoms ... Read more
On 2/13/2021, I began to experience both enhanced and new musculoskeletal and neurological symptoms that have not completely resolved still, today, 3/16/2021. While I had experienced some slight discomfort and pain of the b/l thumbs 2-3 weeks prior to 2/13, I began to experience increased pain up to the forearm in both arms on that day. In addition to pain, I had large muscular knots in the superior forearms, especially the right arm. The lower right arm felt extremely tight, and I was having difficulty raising the arm and gripping things. This continued for 2-3 weeks on the right arm. During that time, symptoms worsened on the left arm, while improving on the right arm. A week after the initial symptoms my left arm became worse, and I was struggling to lift objects as light as a sheet of paper. I was also having trouble typing at work, dialing the phone, and opening or closing my hand. Just over a week after symptoms began, I left work to determine a cause and solution for my issues. I also began to have tremors, extreme muscle spasms, and involuntary movements around this time for about 2-3 weeks. While the neurological symptoms have mostly subsided, still, today, 3/16/2021, I continue to deal with various inflammatory musculoskeletal symptoms affecting mostly my left arm, but also my right arm. Since yesterday, my left shoulder has begun to have pain as well, making raising my arm and reaching to the opposite side difficult due to pain. I have also had persistent popping of various joints in both arms since the initial symptoms began.
26 2021-03-17 grand mal seizure Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within t... Read more
Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EN5318) via an unspecified route of administration on 30Jan2021 12:45 into right arm at a single dose for COVID-19 immunisation. The patient medical history included epilepsy and cerebral palsy and known allergies is to amoxicillin. The patient had a seizure disorder, epilepsy (Lennox Gastaut Syndrome). He has an average of 1 Tonic-Clonic (Grand Mal) and 2 Series of Myoclonic Jerks a day. There is no other vaccine was administered in four weeks. There is no COVID prior to vaccination. Concomitant medications in two weeks included topiramate (TOPAMAX), lamotrigine (LAMICTAL), clobazam (ONFI), glycopyrronium bromide (CUVPOSA), potassium citrate, citric acid, calcium carbonate and colecalciferol (VITAMIN D). Within the first 24 hours(PENDING CLARIFICATION, as reported as 30Jan2021 02:45AM) of receiving the vaccine his seizure activity increased. Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks. The patient received emergency seizure medicine Klonopin. The patient did not test COVID post vaccination. The outcome of the events was recovering.
26 2021-03-18 bell's palsy Onset of Bell's Palsy two weeks post-vaccination
26 2021-03-19 numbness While in observation for 15 minute post vaccination observation period, recipient complained of dizz... Read more
While in observation for 15 minute post vaccination observation period, recipient complained of dizziness, numbness, light headed, tight chest
26 2021-03-21 pain in extremity Significant lethary, very sore arm, muscle weakness, full body achiness. Currently ongoing.
26 2021-03-22 flushing, unresponsive to stimuli Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: ANXIETY, monitored 1 hour post incident -Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Prior to injection patient fainted/syncope, and slowly made his way to the floor with assistance of RN. Pt. was \"out\" for 3-4 sec. aRevived with gentle shaking. Pt was face down taking slow breaths, patient was completely diaphoretic and lost control of his bladder. Paramedics arrived on scene with in minutes and monitored vitals. Pt reported feeling fine but embarassed and still wanted his shot. vaccine given, with paramedics present. pre-syncope rxn., due to anxiety, but fully responsive.
26 2021-03-22 seizure Patient was waiting for the 15mins post vaccine. Three minutes into waiting, patient slumps and fall... Read more
Patient was waiting for the 15mins post vaccine. Three minutes into waiting, patient slumps and falls out chair. He hit his head and turned face down, he then began to start seizing. During this time we held his head, to ensure he did not continue to hit the floor. A team was called, and the team attended to the patient. Patient's vitals were taking and he was stable. To take precaution, he was placed on oxygen to ensure he was comfortable during transfer. When picking the patient off the floor with the staff, patient began seizing once more before being transferred to the ED.
26 2021-03-23 cold sweat, feeling hot, feeling of body temperature change I have a history of insomnia, Bipolar II, and ADHD. Last night, about 10 hours after getting the vac... Read more
I have a history of insomnia, Bipolar II, and ADHD. Last night, about 10 hours after getting the vaccine, I had some insomnia. This might be unrelated, but I want to bring it up. About 18 hours after the vaccine, I started to get chills, become clammy, both hot and cold at the same time, and slight fatigue. 24 hours after my vaccine, I noticed that my headache got worse, i felt much more fatigued, and my head felt warmer.
26 2021-03-24 weakness Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Addit... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT STARTED FEELING NAUSEATED AFTER SHOT BECAME PALE ,STUNBLED HAD DIFFICULTY BREATHING AND HE LAID DOWN X 30 MINUTES . AFTER WE CALLED 911 HE SAID HE DIDNT NEED IT BECAUSE HE HAS A REACTION AFTER EVERY IMMUNIZATION
26 2021-03-24 cold sweat, feeling cold 3/24/2021 9:59 AM VACCINE AT 9:30 AM - SYNCOPE- COLD CLAMY, VASOVAGAL RESPONSE CAME TO WITH REPONSE.... Read more
3/24/2021 9:59 AM VACCINE AT 9:30 AM - SYNCOPE- COLD CLAMY, VASOVAGAL RESPONSE CAME TO WITH REPONSE. BP TAKEN NO MEDICAL PROBLEMS.
26 2021-03-24 facial paralysis Pt. reports drooping of his left eye and left lip, which lasted a few hours, one day after receiving... Read more
Pt. reports drooping of his left eye and left lip, which lasted a few hours, one day after receiving his first dose of the COVID-19 vaccine.
26 2021-03-24 feeling cold Reported lightheadedness, feeling cold and weakness in knees.
26 2021-03-25 cold sweat Client received his second dose of Pfizer vaccine and during the post-vaccination wait period in his... Read more
Client received his second dose of Pfizer vaccine and during the post-vaccination wait period in his work car, he complained of feeling nauseous. He denied any other symptoms. Vital signs: BP=116/78; Pulse=91. He was noted to be clammy. He was evaluated by the Nurse as well as the EMT Personnel on site, and declined for 911 to be called. He made arrangements for someone to give him a ride back home, and was instructed to call 911 if the nausea did not resolve. He voiced understanding and waited in his car until he was picked up.
26 2021-03-26 feeling hot This was my second dose of the Pfizer/BioNTech COVID-19 vaccine. I took some notes during my waiting... Read more
This was my second dose of the Pfizer/BioNTech COVID-19 vaccine. I took some notes during my waiting time following my injection similar to my first dose. Information from my last report can be found using Temporary VAERS E-Report No: 334845. Of note, I did prepare for my second dose by taking Benadryl 50 mg and Airborne Immune-Boost supplements the night before my second dose, so my symptoms were not as severe as last time. 6 minutes: Mild tingling around tongue. This time all around the edges of my tongue, but a lot less bothersome than the first dose. 8 minutes: Weird. Slight itchiness under left half of tongue. Still very mild but less concerning than first dose itchiness on the left and right sides of my tongue. 18 minutes: Itchy on right side slightly, only side noticeable. 20 minutes: Mild warm feeling on left side of top of my throat. Less bothersome than time. 26 minutes: Left throat warm ness resolved, but transitioned to right side of top of my throat. 31 minute: Throat warmness overall resolved, but slightly itchy on edge of right side of my tongue. 37 minutes: Top of throat on right feels weird but not itchy. Warm maybe? 39 minutes: Weird feeling on right side of throat resolved. Symptoms more or less resolved the rest of the day, especially after second dose of Flonase @ 9:00 am. 14 hours later: About to go to bed. Feeling fatigued, similar to my first dose after working out. Took airborne and two Benadryl (25 mg each) before sleeping. 24 hours later: 03/27/2021, feeling more fatigued, groggy, mild headache (mostly at back of my head), and muscle aches around my body. 25 hours later: Groggy feeling and fatigue resolved. Possibly due to Benadryl or vaccine? 32 hours later: Majority of muscle aches resolved. Headache also resolved. Feeling mostly soreness at this point. Drank Airborne @ 10:00 am and 4:00 pm. In between drank plenty of fluids (water, cranberry juice, apple juice, milk). No fever or chills.
26 2021-03-27 tremor, weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additio... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt was pale and stated that he felt as if he was going to pass out, Pt given orange juice and cool paper towel and monitored. Symptoms improved within 10 minutes and pt was able to leave store unaided.
26 2021-03-28 migraine, numbness, tingling Had onset of a headache about 2 hours after vaccination on Saturday, 20 March. On Tuesday 23 March, ... Read more
Had onset of a headache about 2 hours after vaccination on Saturday, 20 March. On Tuesday 23 March, at about 11 AM began having a migraine headache (had a past medical history of migraine headaches as a teenager). About 3:10 PM on Tuesday 23 March, began to have tingling and numbness in right hand (he is right-handed). Taken to ER where he could not remember his name. He was admitted and found to have four infarcts in three lobes of his left hemisphere (parietal, frontal and temporal). CT, MRI and cardiographic exams with contrast revealed a patent foramen ovale. Discharged on 40 mg Lipitor and ASA 81 mg, and referred to UCSF Neurology for followup.
26 2021-03-28 tingling Tunnel visioning Limited hearing Sweating Paresthesia of hands Nausea
26 2021-03-30 tingling pt. c/o headache, sweating, tingling. pt. went home after symptoms was resolved.
26 2021-03-31 cold sweat, feeling cold 26by/o male, c/o lightheaded ness, dizziness, buzzing in the ears, stated ?I think I passed out?. Pt... Read more
26by/o male, c/o lightheaded ness, dizziness, buzzing in the ears, stated ?I think I passed out?. Pt was pale, cold, clammy, diaphoretic but able to answer questions appropriately. PARAMEDICS came to check pt. V/S HR 51, BP 107/70, O2 sat 98%. NS BOLUS GIVEN, sent to HOSPITAL FOR FURTHER EVALUATION.
26 2021-03-31 migraine Migraine and inability to sleep starteing at about 6:00 am the next day, April 1, and continuing unt... Read more
Migraine and inability to sleep starteing at about 6:00 am the next day, April 1, and continuing until the submission at 4:00PM. Mild fever as well. Headaches so bad I can?t focus
26 2021-03-31 unresponsive to stimuli, seizure, tremor Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: patient was administered vaccine, was feeling well and walked to waiting area. patient \"lost balance\" and fell to floor, hitting his face and began bleeding from his nose and upper brow area. Technician retrieved an ice pack from pharmacy, and in the meantime, worker aided patient to sitting position, which was when patient began to seize. worker called EMS while holding patient's head steady. Patient regained consciousness and EMS arrived. Whole event lasted around 5 minutes.
26 2021-04-01 seizure, muscle spasms, weakness Patient got Shortness of breath, leg cramps, lost control on his body and seizures 2 hours after get... Read more
Patient got Shortness of breath, leg cramps, lost control on his body and seizures 2 hours after getting the vaccine and stayed for about 5 minutes. No medication or treatment was given. reported by his sister
26 2021-04-02 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
26 2021-04-03 night sweats Fatigue, lymph node swelling, night sweats and fever, chest tightness, muscle ache and pains (full b... Read more
Fatigue, lymph node swelling, night sweats and fever, chest tightness, muscle ache and pains (full body). All symptoms persistent and ongoing, beginning after second dose.
26 2021-04-04 unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
26 2021-04-05 tingling Temporary blindness for about 5-10 minutes. I was unable to see but was conscious and eyes were comp... Read more
Temporary blindness for about 5-10 minutes. I was unable to see but was conscious and eyes were completely dilated. As a result of the inability to see, I felt panicky and my fingers and face were tingly.
26 2021-04-06 discomfort I have developed a lump above my left collarbone causing discomfort.
26 2021-04-06 feeling cold, cold sweat C/o lightheaded ness, upon assessment pt was cold, clammy, diaphoretic. Paramedics V/S HR 73, BP 11... Read more
C/o lightheaded ness, upon assessment pt was cold, clammy, diaphoretic. Paramedics V/S HR 73, BP 118/69. pt s/s resolved, able to be discharged without s/s distress.
26 2021-04-06 seizure Patient seemed to have a seizure lasting 1 minute, hitting head as he fell out of his seat. He then... Read more
Patient seemed to have a seizure lasting 1 minute, hitting head as he fell out of his seat. He then became aware of surrounding. Paramedics came and took patient to ambulance.
26 2021-04-07 weakness Low grade fever, body chills, nauseated, no energy,
26 2021-04-07 cold sweat About 10 minutes after receiving vaccination, patient started experiencing cold sweats and he felt l... Read more
About 10 minutes after receiving vaccination, patient started experiencing cold sweats and he felt like we was about to pass out. I took him into the clinic room and allowed him to lay down and began to fan him down for him to cool off. After 1-2 minutes, we put him on his back and elevated his feet. While he was laying down, I checked his blood pressure and it was low. I let him lay down for 5 more minutes and he started to feel much better and was cooled down. I slowly got him up and allowed him to sit and checked his blood pressure again. The blood pressure began to normalize. After 5 more minutes, I told him to get up and slowly walk to another chair in the room. Once he was rested there for about 5 minutes, I checked his blood pressure a 3rd time in the opposite arm and it was normal. He no longer felt the light headed feeling and was cooled off. The patient's partner then informed me that he has a fear of needles and the last time he received a vaccination about 7 years ago, the same reaction happened.
26 2021-04-07 muscle spasms, facial paralysis Loss of taste on left side of the tongue started on Sunday 04/04. This was followed by slight muscle... Read more
Loss of taste on left side of the tongue started on Sunday 04/04. This was followed by slight muscle spasms on the left side of the face (cheek and eyelid) on 04/05. On 04/06, loss of control of left side of the face started. I cannot blink fully with the left eye, and I cannot contract my left cheek fully. My smile is asymmetric and I cannot fully lift my left eyebrow. The loss of taste on left side of the tongue persists as of today 04/08. I was prescribed prednisone 20mg twice daily by my primary physician, which I started yesterday, 04/07. No alleviation of symptoms so far.
26 2021-04-07 tingling, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mi... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient felt lighthead and almost passed out. Sweating was profuse but no fever.
26 2021-04-07 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
26 2021-04-08 flushing Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizz... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Additional Details: Patient experience Syncope
26 2021-04-08 pain in extremity, numbness WHILE PATIENT WAS WAITING 15 MINUTES, HE STARTED LOSING FEELING IN HIS ARMS AND LEGS, NEXT HE LOST A... Read more
WHILE PATIENT WAS WAITING 15 MINUTES, HE STARTED LOSING FEELING IN HIS ARMS AND LEGS, NEXT HE LOST ALL STRENGTH IN ALL EXTREMITIES, STATED PAIN IN ARM AND SIDE OF RIB CAGE, STARTED LOSING VISION TO TUNNEL VISION AND BLURINESS. LIPS APPEARED SWELLING. WRITER CALLED 911 AND GAVE PATIENT EPI SHOT. EMT TOOK TO HOSPITAL
26 2021-04-10 tremor Patient was sitting for his 15 minutes. At about 5 minutes after his vaccine he passed out and fell ... Read more
Patient was sitting for his 15 minutes. At about 5 minutes after his vaccine he passed out and fell off his chair to the floor. The Pharmacy intern noticed that the color of his skin was like a purple and he was passed out. When she started to approach him he started slowly moving his head and adjusting his eyes. He said he felt really dizzy and we had him lay down. He was very sweaty and was shaking a little bit. I took his blood pressure at 11:53 and it was approximately 124/93. He was responsive but feeling dizzy and warm and I stayed with him until the paramedics arrived at about 11:54
26 2021-04-11 tingling Vomiting, lightheadedness, tingling
26 2021-04-12 hot flush Shivers(chills) for a couple hours, low grade fever, after chills hot flashes
26 2021-04-12 muscle spasms, pain in extremity, feeling of body temperature change Soon after receiving the vaccine, heart rate increased, and sweating began. Vision then began to fad... Read more
Soon after receiving the vaccine, heart rate increased, and sweating began. Vision then began to fade to white and ears ringing. This persisted for about 15 minutes, improvement began after 5 minutes. After vaccination, patient was very tired. Sore arm for 5 days. Hot/cold flashes days 3-5. Consitent tiredness 5 days. Muscle aches and cramps days 3-5. After 5 days side effects ceased. Concerns about initial effects
26 2021-04-12 pain in extremity, tenderness Pfizer COVID-19 Vaccine EUA Patient received Pfizer COVID vaccine on 3/12/2021. Patient presented t... Read more
Pfizer COVID-19 Vaccine EUA Patient received Pfizer COVID vaccine on 3/12/2021. Patient presented to outpatient clinic on 4/8/2021 for complaints of leg pain since Monday 4/5/2021. Patient states that Monday he woke up with point tenderness in his left calf which went away after about 2 hours. Tuesday, he woke up the same pain, which is persistent to this point. Patient denies exacerbating or relieving features. Patient denies trauma, no precipitating event and denies history of similar symptoms. Patient has not presented for medical attention for this prior today. Patient had a venous doppler ultrasound which showed a clot in the posterior tibial vein. Patient started on apixaban
26 2021-04-13 bell's palsy Bell?s Palsy
26 2021-04-15 feeling cold feeling very cold; Chills; fever; severe headache; This is a spontaneous report from a contactable c... Read more
feeling very cold; Chills; fever; severe headache; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration in left arm on 09Feb2021 02:45 (at 26-years age) as single dose for COVID-19 immunisation. Medical history included arthritis. Concomitant medication(s) included meloxicam (MELOXICAM) ;amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Previously he received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration in left arm on 19Jan2021 02:45 as single dose for COVID-19 immunisation. He received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021. The patient experienced chills and feeling very cold last night and this morning severe headache and fever on 10Feb2021 12:00. Patient not tested for COVID-19 after the vaccination. No treatment received for reported adverse event. The outcome of the events was not resolved. No follow-up attempts possible. No further information expected.
26 2021-04-15 flushing Syncope, Flushing/sweating, Dizziness; provided hydration + rest
26 2021-04-15 flushing Syncope, Flushing/sweating, dizziness; BP 132/76; HR 90, SpO2 99%
26 2021-04-15 hot flush Nausea, vomiting, hot flashes
26 2021-04-16 cold sweat, feeling hot 5 MINS AFTER RECEIVING VACCINE, FELT HOT, CLAMMY, AND NAUSEA. ASSISTED TO FLOOR TO RAISE FEET BY STA... Read more
5 MINS AFTER RECEIVING VACCINE, FELT HOT, CLAMMY, AND NAUSEA. ASSISTED TO FLOOR TO RAISE FEET BY STAFF. BROUGHT BACK VIA WHEELCHAIR, S/S RESOLVED ONCE ARRIVING. EXCORTED TO EXIT WITHOUT ISSUES AT 1045. 1033 INITIAL BP 128/62 HR 56 RR 18 SATS 98% RA 1041 SITTING BP 133/80 HR 63 RR 18 SATS 98% RA 1043 STANDING BP 124/71 HR 77 RR 18 SATS 97% RA
26 2021-04-16 pain in extremity Fever, fatigue. Moderate to severe arm pain for 9 days.
26 2021-04-17 weakness Fever on set 36 hours post shot; headache; chills; sinus pressure; General soreness across body; Gro... Read more
Fever on set 36 hours post shot; headache; chills; sinus pressure; General soreness across body; Grogginess; This is a spontaneous report received from a contactable consumer (Patient) via Reference No. A 26 year old male reported for himself that he received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: ER8727; expiry date: unknown) via an unspecified route of administration in the left arm on 25-MAR-2021 at 4:00 as a single dose for COVID-19 immnunisation. The patient did not had any relevant medical history. Concomitant medications were not reported. On 27Mar2021, the patient experienced Fever on set 36 hours post shot, headache, chills, sinus pressure, general soreness across body. By 5th day, fever, chills, and soreness have subsided, all that remains is the headaches and grogginess. The patient did not have allergies to medications, food, or other products. The patient did not receive any treatment for the event. The patient did not receive any vaccine prior to vaccination. The outcome for the events headache, chills, para nasal discomfort were captured as recovering and the outcome for pyrexia and grogginess was captured as not recovered. Follow up closed. Information of lot/batch is available.
26 2021-04-17 pain in extremity Sore arm starting 30 minutes after vaccination, lasting 1.5 days. Severe headache starting 45 minut... Read more
Sore arm starting 30 minutes after vaccination, lasting 1.5 days. Severe headache starting 45 minutes after vaccination lasting 1 hour.
26 2021-04-17 unresponsive to stimuli, cold sweat Patient received vaccine at 1440. Patient eyes were opened but claimed to black out and was not resp... Read more
Patient received vaccine at 1440. Patient eyes were opened but claimed to black out and was not responsive to his name. Nurse assessed and patient was clammy and pale. Patient was alert after 1 minute and stated he was dizzy. Medics were called on scene and patients blood pressure was 84/65, heart rate was 45. Medics started an IV with normal saline. Blood pressure 96/64. Patient was transported to hospital.
26 2021-04-18 unresponsive to stimuli, seizure Patient unresponsive; presented with seizure like activity; Patient fall from chair within 15minutes... Read more
Patient unresponsive; presented with seizure like activity; Patient fall from chair within 15minutes of receiving Pfizer vaccine dose 1; pale; diaphoretic; nausea; Full body clonus; This is a spontaneous report from a contactable nurse. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 26 years of age), dose 1 intramuscular, administered in arm left on 03Apr2021 10:45 (Batch/Lot Number: ER8737) as a single dose for COVID-19 immunisation. The patient's medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient had no other vaccine prior to Covid vaccine. He was not diagnosed with COVID-19 prior to vaccination. It was unknown if patient has been tested for COVID-19 since the vaccination. It was reported that the patient fell from chair within 15 minutes of receiving Pfizer vaccine dose 1. Patient was unresponsive, pale, diaphoretic. Awakened within minutes, placed in recovery position on left side. Patient complained of nausea then presented with seizure like activity. Full body clonus. 911 notified. Patient woke within seconds able to state, name, location, date of birth accurately. He was placed on stretcher. EMS arrived. VS 154/80 HR 84, POx99% 2LO2. He continues to be pale. Family of patient notified of event at patient's request. He was transferred to ED via EMS. The events started on 03Apr2021 at 10:45 AM (as reported). Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Additional information has been requested.; Sender's Comments: Bases on the information in the case report and a strong temporal relationship, A causal relationship between adverse events Unresponsive to stimuli, Seizure and suspect product BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-04-19 feeling cold "Felt tired and a cold developing. Went away around 7pm the same day, 1/27/2021"
26 2021-04-19 flushing "Administered - 14:30, Adverse event started - 14:38. Patient had syncope, flushing/sweating, dizzin... Read more
"Administered - 14:30, Adverse event started - 14:38. Patient had syncope, flushing/sweating, dizziness. History of ""blackouts during blood draws"". BP 92/53 -- > 93/58y, HR 74 -- > 68, RR 18 -- > 18, O2 97% -- > 98%. Patient stable, released from vaccination site."
26 2021-04-19 migraine 3 weeks ago got Pfizer vaccine and has had symptoms ever since. Got pfizer vaccine #1 3/31/21, aroun... Read more
3 weeks ago got Pfizer vaccine and has had symptoms ever since. Got pfizer vaccine #1 3/31/21, around 2pm, at Site. About 90 minutes later started to have migraine HA, then exhaustion, then fever. No ST. Fever has been intermittent since the vaccine until today with spikes every day. Exhaustion and HA have almost been continuous since.
26 2021-04-19 seizure, flushing Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lig... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Seizure-Mild, Additional Details: Patient was found unresponsive on the floor by bystanders with ? siezure like activity, this RN and RN responsed. EMS called to store and was sent to the ER.
26 2021-04-19 unresponsive to stimuli Pt received vaccine and as patient began to schedule second appointment, they experienced a syncopal... Read more
Pt received vaccine and as patient began to schedule second appointment, they experienced a syncopal episode. Pt relaxed back into chair and became unresponsive. Pt was assessed immediately and EMS was called. Heartbeat was palpated and patient was breathing. Within thirty seconds of syncopal episode, pt roused and began to answer questions. Pt was moved to side of the room where they were assisted to a supine position with their legs propped up on a chair. BP 107/80 HR 70 O2 Sat 99%. EMS arrived at 1435. Pt denied feeling dizzy or faint and refused EMS services. Pt remained supine until 1445 at which time pt denied having any symptoms at all and was escorted out of the building.
26 2021-04-20 pain in extremity severe rhabdomyolysis/urinating the color of Coca-Cola and could not walk/CK level of 209,000 U/L; P... Read more
severe rhabdomyolysis/urinating the color of Coca-Cola and could not walk/CK level of 209,000 U/L; Pain in my left arm from vaccine started on Wednesday; Wednesday I worked on upper body and arm/chest/back muscle pains began/On Thursday, I worked on legs and severe quad/glute/hip muscle pain began; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:30 (Batch/Lot Number: EN6204) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included reported as none. Concomitant Therapy included multivitamin, joint suppliment. The patient was hospitalized with severe rhabdomyolysis a few days after receiving his first dose of the Pfizer vaccine. He received the vaccine Tuesday 23Mar2021 and went to the gym Wednesday 24Mar2021 and Thursday 25Mar2021. Pain in his left arm from vaccine started on Wednesday and additional muscle pain was induced post workout on both days. Wednesday he worked on upper body and arm/chest/back muscle pains began. On Thursday, he worked on legs and severe quad/glute/hip muscle pain began. Saturday (27Mar2021) he began urinating the color of Coca-Cola and could not walk. Sunday (28Mar2021) he was hospitalized with a creatine phosphokinase (CK) level of 209,000 U/L with no preexisting health conditions that would cause his CK levels to be so extreme. Adverse event severe rhabdomyolysis was started on 27Mar2021 09:00 AM and resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 7 days. Therapeutic measures were taken as a result of severe rhabdomyolysis included IV fluids. The outcome of the events was recovered.
26 2021-04-21 cold sweat Severe diarrhea (fully liquid) for 2+ days, extreme fatigue, cold sweating, fever.
26 2021-04-21 tenderness, pain in extremity BUMPS HIVES ALL OVER BODY RED ITCHY BRUISED ON INNER THIS AND ARMS SORE AND TENDER
26 2021-04-22 bell's palsy Bell's Palsy. Treatment was steroids (PredniSONE). Unknown time course.
26 2021-04-22 cold sweat Pt reported feeling a cold sweat followed by dizziness, clinical staff assisted him giving water and... Read more
Pt reported feeling a cold sweat followed by dizziness, clinical staff assisted him giving water and snack,Pt continued to feel dizzy and was assisted to the floor into recovery position until picked up by medical observartion staff. PT was transported by stretcher and monitored . Pt claims to begin feeling better and was released on his on charge at 09:50 am. Vitals as follows: 09:31 BP 109/73 HR 63 RR 20 Sp02 !00% Lying 09:38 BP 113/73 HR 62 RR 18 Spo2 100% sitting 09:46 BP 107/71 HR 58 RR 18 Sp02 100% standing
26 2021-04-23 coordination abnormal, tingling, numbness About two or three days after my second Pfizer vaccination I started to feel some immense pain in my... Read more
About two or three days after my second Pfizer vaccination I started to feel some immense pain in my right trapezius. I had difficulty moving my neck for several hours. The pain subsided later that day but I still had adverse effects. I had a numbing and tingling feeling that traveled from my right trapezius all the way down to my fingers. That sensation continued for several weeks (3 or so) until I saw my general physician. She conducted some strength tests and noticed that there was some weakness and lack of coordination on my right side. I was instructed to go get and MRI and the results showed 5 lesions in my brain and 1 in my cervical spine (C2-C3). After many other tests including blood tests and a follow up MRI the neurologist that viewed my case informed me that I showed a strong case of demylination and it looked likely that Multiple Sclerosis. The shot might have caused an immune response which allowed the MS to appear.
26 2021-04-26 weakness Situation: patient was administered 1st dose of COVID-19 (Pfizer) by certified tech. Post-administra... Read more
Situation: patient was administered 1st dose of COVID-19 (Pfizer) by certified tech. Post-administration, patient was instructed to sit for observation. Technician stated that approximately 2 min or so after patient sat down, he came up to her at the window to state that he was feeling lightheaded and weak. Consequently, while in conversation with her, patient gently collapsed onto the floor. He was alert and conscious the entire time; temp was 97; patient was noted to be pale and sweating profusely. Patient was provided water, ice pack and orange juice. Ambulance was offered and he was taken by paramedic for further evaluation.
26 2021-04-27 numbness A few days after my vaccine i was sitting in a chair and touched my calf and noticed that it was num... Read more
A few days after my vaccine i was sitting in a chair and touched my calf and noticed that it was numb. It wasnt pins and needles as if it had fallen asleep. It just had significantly decreased sensitivity. I stood up and walked around to try to fix this but the symptoms persisted for at least 36 hours before subsiding to a much lesser but still present degree of numbness. I went to my doctor and they told me that it was not an emergency aince there was no pain and it caused no weakness. This is localized to the skin on my outer left calf. He said this can be caused by crossing your legs too much but i dont ever do that. 3 weeks later and i still have muted sensations in my left calf. It mostly goes unnoticed until i go to scrub my leg in the shower or something and notice that the scrubber feels significantly different on each leg. The left side feels like "static".
26 2021-04-27 migraine Fever, migraine, fatigue
26 2021-04-27 seizure, unresponsive to stimuli Pt had generalized seizure, pupils dilated, non reactive, upper extremities contracted, diaphoretic,... Read more
Pt had generalized seizure, pupils dilated, non reactive, upper extremities contracted, diaphoretic, apneic. Seizure activity lasted approximately 30 sec. Pt attended by Rn clinic supervisor and NP.
26 2021-04-29 seizure Patient immediately felt dizzy after injection. He then passed out in his chair and we put him down ... Read more
Patient immediately felt dizzy after injection. He then passed out in his chair and we put him down on the floor. He then had a seizure lasting a couple seconds. The entire episode lasted less than a minute and he then regained consciousness and was responsive. Emergency services was contacted at the first sign of the seizure and upon arrival, they checked that he was alert and oriented x4. Patient did not go to the hospital but he did go home with a family member.
26 2021-04-29 tremor Body temperature : 100.8 Body shaking
26 2021-04-30 seizure Seizure; crashed my car.; don't remember 45 minutes of my life; This is a spontaneous report from a ... Read more
Seizure; crashed my car.; don't remember 45 minutes of my life; This is a spontaneous report from a Contactable Consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Apr2021 13:15 (Batch/Lot Number: ER8735) as SINGLE DOSE for covid-19 immunisation at a vaccine facility, at 26 years old. Medical history included known allergies: Penicillin from an unknown date. No other vaccine in four weeks. Patient did not COVID prior vaccination and has not been tested for COVID post vaccination. Concomitant medication included bupropion; and venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported. Patient waited 15 minutes and felt normal. Patient stopped for gas and soda and then patient stated to be honest he woke up surprised with EMT, police and fire just telling him he started having a seizure and crashed his car on 17Apr2021 13:30. Patient stated "that's craziest laser I don't remember 45 minutes of my life (onset 17Apr2021). Thought I would be like 140. It was 3 pm which leave a large gap. This is really scary for me and my family". The events resulted in emergency room visit for seizure and crashed his car. The patient was hospitalized for seizure and for crashed his car for 1 day. Therapeutic measures were taken as a result of seizure and crashed my car (Some things to regulate my heart rhythm). Outcome of the events seizure and crashed his car was not recovered while unknown for don't remember 45 minutes of his life.
26 2021-05-01 cold sweat 103 degree fever, cold sweats, body aches, headache
26 2021-05-01 unresponsive to stimuli, numbness Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numb... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: numbness in arms
26 2021-05-03 weakness Pfizer-BioNTech COVID-19 Vaccine The patient received the vaccine in his left arm, and 5 minutes lat... Read more
Pfizer-BioNTech COVID-19 Vaccine The patient received the vaccine in his left arm, and 5 minutes later lost consciousness/passed out for several minutes then woke up feeling weak and tired
26 2021-05-04 feeling hot, pain in extremity 1st Pfizer shot beginning of April went fine. Only a sore arm. 2nd shot this past Saturday was a dif... Read more
1st Pfizer shot beginning of April went fine. Only a sore arm. 2nd shot this past Saturday was a different story. I got the shot around 3:30 and felt great until about 7. My arm started getting very sore. It got better a little later in the day. Next morning I felt pretty fatigued but nothing I haven?t felt before. Sore arm was still there. Pretty manageable. Had to pick up groceries and that was a mistake. Had to take deep breaths and my knees were in a lot of pain as I got out of the car and walked through the store (I injured them years ago and now have Baker's cysts). Wife brought me home and I had rigors on the ride back. I got home around 11:45 or so and I put on a blanket. I felt so hot I started to get a little bit delusional and very sad/started getting teary. Took off blanket and couldn?t get off the couch or walk without help. Knees now felt like about to fall apart. Wife takes temp shows 107, makes ice bath, I get in and it goes down to 105 a few minutes later. Temp went down to 103 over the next 15-20 minutes and stayed there. Got out with her help and still couldn?t stand up or walk without help. Sat upright in bed rest of the day. Fever ranged from 98-103, mostly 101-103. Took a very cold shower later in the day but temp still stayed in the same range. All other symptoms mentions else stayed the same. I also now had no appetite and felt nauseous. Stomach felt rock hard, and I didn?t feel too with it. Finally fell asleep later at night and woke up feeling way better but still awful. Monday and Tuesday I had to take off work I felt so fatigued. Both of those days I had no fever, it went away from Sunday night into Monday. I can walk by myself now and just feel a little fatigued today. I have my appetite back now and am back to work. I should mention that I took Tylenol which didn?t help. Ibuprofen I took later in the day and that might have helped a little. Took Benadryl later and that helped with sleep.
26 2021-05-06 feeling hot Patient was sitting in chair after vaccine waiting the required 15 minutes. He states he was staring... Read more
Patient was sitting in chair after vaccine waiting the required 15 minutes. He states he was staring sown watching his phone and he felt hot and then woke up on the floor with people around him. He fainted. He felt hot and sweaty afterward. Episode seemed to pass within about 10 minutes all together. Paramedics came and checked him out since he hit his head when he fell. Patient didn't want to go to hospital and was picked up from the store by family member.
26 2021-05-07 pain in extremity Runny nose for the first hour after. Sore arm for at least two days.
26 2021-05-07 seizure seizure; Body soreness; Inability to sleep/stay asleep; Loss of memory/confusion; Loss of memory/con... Read more
seizure; Body soreness; Inability to sleep/stay asleep; Loss of memory/confusion; Loss of memory/confusion; This is a spontaneous report from a contactable consumer. A 26-yearsold male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Apr2021 13:00 (Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right as single dose for covid-19 immunization (Age at vaccination: 26 years). Medical history included High blood pressure. Concomitant medication included marijuana. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm (lot number: EW0150) on 08Apr2021, 10:00AM for covid-19 immunization (Age at vaccination: 25 years). The patient experienced seizure, body soreness, inability to sleep/stay asleep (initial insomnia), loss of memory/confusion on 30Apr2021 07:00. The events were assessed as life-threatening by the reporter. The patient was not diagnosed with COVID-19 prior vaccination and the patient has not been tested with COVID-19 since the vaccination. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
26 2021-05-09 seizure, feeling hot Pt reports that he waited for about 20 minutes after being vaccinated. During that time he felt a li... Read more
Pt reports that he waited for about 20 minutes after being vaccinated. During that time he felt a little hot and drank some water, but says he otherwise felt fine. He states that he stopped for gas after leaving the clinic and has no memories after that until he was being pulled from his car by a paramedic. He states that he was told he had a seizure and crashed his car. After the motor vehicle accident he says he was transported to the hospital, where they told him he had had a seizure, did some tests, and then released him. Pt states his heart rate and glucose were both elevated when he was at the hospital, but that his CT scan was normal. He states he was feeling fine we he got gas, and says he feels fine now (5/10/21: three weeks and two days later). He saw his primary care provider last week (5/5/21) and was referred to Neurology. He had an MRI done, which he reports was normal, and an EEG, which he says he is still waiting on results from. Pt reports no history of seizure prior to 4/17/21.
26 2021-05-10 pain in extremity Felt a little sick the day after. Significant arm pain for 2 days after. Starting 5 days after lymph... Read more
Felt a little sick the day after. Significant arm pain for 2 days after. Starting 5 days after lymph node under armpit swelled to the size of a nickel (by 4/24/21) and was very painful. Returned to normal around 4/27. At about that same time lymph nodes under jaw began to swell and were painful by 5/1. This seemed to return to normal by 5/6. Since then no other adverse affects.
26 2021-05-10 pain in extremity A male patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injectio... Read more
A male patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161 and expiration date was not reported) via an unspecified route of administration, administered in Arm Left (Left Shoulder Side of the Arm s single dose for covid-19 immunisation. Vaccination facility type was other. Reportedly, patient had no history, no other products and no investigational assessment. Patient did not have any family medical relevant history. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 evening the patient experienced left arm sore, on 17Apr2021 patient experienced fever, head pounding, Lower Half of Body was Very Sore; Muscle Aches (muscle pain). The patient states he was calling about his first dose, he got the first dose on this past Friday, 16Apr2021 and he was fine that day and then the following day, Saturday night, he had a fever and he still has a fever 4 days later. Is it normal to have a fever after 5 days. The report was not related to a study or a program. Patient took treatment Montrin. Patient did not went to emergency room or physician office, he went to urgent care. The outcome of the event pyrexia is not recovered, left arm pain recovered on 18Apr2021, muscle pain (Lower Half of Body was Very Sore; Muscle Aches) recovered on 17Apr2021 and head pounding recovered on 18Apr2021. No follow-up attempts are needed. No further information is expected.
26 2021-05-10 pain in extremity his arm is sore and tight; his arm is sore and tight; specifically soreness where the shot was.; Thi... Read more
his arm is sore and tight; his arm is sore and tight; specifically soreness where the shot was.; This is a spontaneous report from a contactable consumer reported for himself. This 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer covid 19 vaccine on 20Apr2021 and his arm was sore and tight, specifically soreness where the shot was. Event outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
26 2021-05-11 pain in extremity Pain in the left arm, headache, and fever (100 F), relieved in about 24 hours
26 2021-05-11 tingling Gradual stiffness and tightening of both shoulder joints. Reduced flexibility in knees the first nig... Read more
Gradual stiffness and tightening of both shoulder joints. Reduced flexibility in knees the first night and pain during normal range of motion. 5-minute intervals of paresthesia in both hands and wrists every couple of hours. Nausea the next day.
26 2021-05-12 tingling I am experiencing brain-fog like symptoms. My sensations are dulled, I cannot process what's going a... Read more
I am experiencing brain-fog like symptoms. My sensations are dulled, I cannot process what's going around me the way I used to be able to. For example, I am having trouble holding conversations that require a lot of thinking. I am quick to lose focus, and it is difficult to engage in cognitive activities because of it. It feels like I am "up in the clouds" as if I am experiencing a drunk-like feeling or marijuana high. It is as if I am able to feel all the sensations, but somewhere in the brain, there is a disconnect happening that I am not able to be as sensitive as I used to be. I am dull to the usual pain sensations I would normally feel (e.g. when I scratch a part of my body, or when I am in an uncomfortable position for a longer time). Just overall, my sensations are not as sensitive so everything seems duller. I do not feel like I'm 100% there in my body. I have not had any adverse side effects to other vaccines I have received in the past. I may have gotten the usual flu-like symptoms but nothing as bizarre as the symptoms I am experiencing currently.
26 2021-05-13 migraine 2 days of migraine, joint and muscle pain throughout body, low-grade fever, fatigue/drowsiness
26 2021-05-14 seizure, tremor Started violently shaking uncontrollably for 30 minutes. Nothing I did helped or stopped it, I kept ... Read more
Started violently shaking uncontrollably for 30 minutes. Nothing I did helped or stopped it, I kept biting my tongue and could not walk, my entire body was shaking very very aggressively, I stayed laid down and focused on relaxing my body, eventually it calmed down on its own and I quickly tried to fall asleep before it came back, I feel fine today, just really shaken up and frightened. I did not call anyone and have not seen any doctor about it. I thought I was having a seizure, except was conscious.
26 2021-05-15 migraine Flu like symptoms; nausea, migraines, muscle aches, chills, fever. Treated with NyQuil and Ibuprofen
26 2021-05-16 cold sweat Became pale and clammy. Felt "light-headed." He asked for water. Lied down on mat, feet elevated. Fe... Read more
Became pale and clammy. Felt "light-headed." He asked for water. Lied down on mat, feet elevated. Feeling of light-headedness passed after 5 minutes (1848). Right deltoid site benign. Monitoring changed to 30 minutes. Sat up at 1852. Color better, no longer clammy. Given water and juice. Tolerated well. Feeling better @1858. Will wait 30 minutes at next vaccination, educated & states understanding.
26 2021-05-17 discomfort I have suffered from mild tinnitus from exposure to loud sounds, mostly pronounced in my left ear, f... Read more
I have suffered from mild tinnitus from exposure to loud sounds, mostly pronounced in my left ear, for several years now. About 1 week after my second dose I noticed that my tinnitus (the ringing in my ears) got significantly worse - especially in my left ear. My perception of dynamic range for sounds was severely limited and loud sounds sounded like static and caused headaches and significant discomfort. It is now 5/18, my second dose was 4/29 and my tinnitus is still significantly worse than before I got my shot.
26 2021-05-17 pain in extremity -sore arm 2 hours after appt (4:30pm, 5/17) -extreme chills and shivering (2:00am, 5/18) -high fever... Read more
-sore arm 2 hours after appt (4:30pm, 5/17) -extreme chills and shivering (2:00am, 5/18) -high fever (speculated 104-105, 2:00am, 5/18) -delirium (2:00 am, 5/18) -continued fever (101, 10:10 am 5/18)
26 2021-05-18 weakness Woke up feeling weak and tired; Woke up feeling weak and tired; Lost consciousness/passed out for se... Read more
Woke up feeling weak and tired; Woke up feeling weak and tired; Lost consciousness/passed out for several minutes; This is a spontaneous report from a non-contactable consumer (patient). A 26 years-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0173) in the left arm, at single dose, on 04May2021, at 08:45 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, was not the patient diagnosed with COVID-19. Relevant medical history and concomitant medications were unknown. It was reported that the patient received the first dose of vaccine in left arm, then 5 minutes later, on 04May2021, lost consciousness/passed out for several minutes. Woke up feeling weak and tired on an unspecified date. Emergency Room Visit /department or urgent care required. Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected.
26 2021-05-18 tremor administered first dose of Pfizer to patient. Patient was waiting 15 minutes post vaccine and when w... Read more
administered first dose of Pfizer to patient. Patient was waiting 15 minutes post vaccine and when we went to check on him before closing for lunch, patient reported SOB and difficulty breathing. He stated he was currently a Nurse and requested administration of Epipen. administered 1 dose of EpiPen. Patient requested a second dose of Epipen but did not appear to need another dose and reported tightness lifted off chest but still SOB noted. called 911. administered patient 25 mg Benadryl liquid dose as secondary measure per protocol. Patient consumed 2 bottles of water prior to Ambulance arriving about 25 minutes after calling 911. Patient refused to lie down in supine position. He reported to EMTs that he had allergy to NSAIDs and Zoloft, so updated patient's PQCF form to reflect since patient originally reported NO to DRUG ALLERGIES. Patient left with EMTs on stretcher but reported SOB improving but still present.
26 2021-05-18 unresponsive to stimuli The patient was unresponsive, pale, and diaphoretic when I arrived at their vehicle. The patient rap... Read more
The patient was unresponsive, pale, and diaphoretic when I arrived at their vehicle. The patient rapidly regained consciousness and was alert. The patient was repositioned with legs elevated. Hydration was given. There was one episode of emesis, which resolved the patient's nausea. This was a vasovagal episode with true syncope. The patient improved rapidly with supportive care, increased monitoring, and hydration. He was returned home with his father as the driver.
26 2021-05-19 cold sweat Syncopal Episode Vital Signs: BP 92/64 HR 60 Resp 14 O2Sat 98% Skin Signs: Clammy, diaphoretic Ci... Read more
Syncopal Episode Vital Signs: BP 92/64 HR 60 Resp 14 O2Sat 98% Skin Signs: Clammy, diaphoretic Circulation: Cap refill 4-5 sec Respiratory: Breath sound clear bilaterally Initial Treatment: Patient received vaccine, fell to syncope - responsive after 5 seconds. Patient hit concrete floor with a loud sound. Patient awake after 5 seconds. A/Ox5 Patient moved to L lateral position with manual spinal check. 11:50 AM Vital Signs: BP 99/60 HR 78 Resp 18 O2Sat 97% Skin Signs: Diaphoretic Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: EMS on scene. Patient assessed by EMS. Spine cleared by EMS. Patient moved to superior posterior. Patient refused further transport to hospital. 12:00 PM Patient discharged home, escorted by EMS and significant other.
26 2021-05-19 migraine Developed chest pain, migraine and dizziness within 5 minutes of vaccination.
26 2021-05-20 bell's palsy Developed Bell?s Palsy on left side of face
26 2021-05-23 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
26 2021-05-24 pain in extremity Chills and fever started at 2:00 am almost after 11 hrs of taking the vaccine. Chills subsided afte... Read more
Chills and fever started at 2:00 am almost after 11 hrs of taking the vaccine. Chills subsided after 20-30 minutes and fever was around 100.2 F. Heart Rate slightly elevated at night but in normal rane i.e below 100 BPM. Right arm soreness constant. Extreme headache and leg pain in the morning around 9:30 am.
26 2021-05-25 weakness A 26-year-old male with no past medical history presents to the emergency department (ED) with an ac... Read more
A 26-year-old male with no past medical history presents to the emergency department (ED) with an acute episode of chest pain. He reports initially mild dull substernal chest pain for a day prior to an episode of acute sharp chest pain that radiates to his left neck and left shoulder accompanied by diaphoresis leading him to present to the ED. He had received the second dose of the Pfizer-BioNTech mRNA COVID-19 vaccine three days prior to presentation and reported myalgia and weakness beginning within 24 hours of vaccination. His blood pressure on arrival was 126/83 mmHg and pulse was 61 bpm. Electrocardiogram (ECG) on admission showed diffuse upsloping 2mm STE, no reciprocal changes, and PR elevation in aVR. Troponin-I on admission was 6.03 ng/ml prior to peaking at 21 ng/ml while initial CRP was 56.8 mg/L. Transthoracic echo (TTE) showed left ventricular ejection fraction (LVEF) of 55-60% with hypokinesis of the basal lateral wall. Cardiac magnetic resonance imaging (CMR) was consistent with myocarditis showing subepicardial late gadolinium enhancement (LGE) in the basal inferior wall, no edema on T2 sequences, and a mildly reduced left ventricular systolic function with an LVEF of 51%. He was started on colchicine, low dose beta blocker and losartan and improved symptomatically along with resolution of the EKG findings prior to being discharged with plan for close outpatient follow-up and repeat imaging. In addition, a respiratory viral PCR panel was obtained which was positive for Rhinovirus/Enterovirus on nasal swab. Although it is possible that his presentation was secondary to enteroviral myocarditis, the temporal relationship to the second dose of Pfizer-BioNTech mRNA COVID-19 vaccine suggests the possibility of myocarditis secondary to immunologic response to COVID-19 vaccine itself.
26 2021-05-25 seizure Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Seizure-Severe
26 2021-05-26 seizure like phenomena 9:05am pt had just received 1st dose Pfizer vaccine and lost consciousness at the table with seizure... Read more
9:05am pt had just received 1st dose Pfizer vaccine and lost consciousness at the table with seizure like activity. Pt was lowered to floor with assistance of several staff members. Pt very diaphoretic with decrease in skin color. Didn't hit head. Pt mother called per pt request and states him having no hx of seizures and NKA. BP 94/60 and HR 84. 9:20 am pt assisted to stretcher with heavy assist. 9:24am A&O when EMS unit arrived to transport pt to hospital for further evaluation and care.
26 2021-05-29 pain in extremity About 12-24 hours After receiving the vaccine I experienced the common side effects, sore arm, tired... Read more
About 12-24 hours After receiving the vaccine I experienced the common side effects, sore arm, tiredness, headache, nausea and lightheaded. However, I have been noticing that ever since I completed the 2 dose series I have been feeling dizzy randomly. First I thought it was normal but now is been months and I constantly feel dizzy. I check my blood pressure and heart rate thinking it may be due to that but they?re usually within normal ranges and the dizziness episodes just come and go throughout the day.
26 2021-05-30 tingling, migraine Had symptoms of tightness in chest high fever chills rapid heartbeat fluttering of heart nausea vomi... Read more
Had symptoms of tightness in chest high fever chills rapid heartbeat fluttering of heart nausea vomiting difficulty breathing lightheaded and tingling of fingers and lips severe migraine
26 2021-05-31 pain in extremity Patient received first injection left deltoid in April; 2 weeks later swelling and pain with reduced... Read more
Patient received first injection left deltoid in April; 2 weeks later swelling and pain with reduced range of motion to the left shoulder. Received second injection right deltoid in May; 2 weeks later swelling and pain with reduced range of motion to the right shoulder and worsening persistent symptoms to left shoulder. Symptoms are persistent. Not related to Sickle Cell Crisis; has been seen by specialists.
26 2021-05-31 tingling Patient had acute onset post-vaccination at 10 mins of nausea, bilateral UE and LE tingling sensatio... Read more
Patient had acute onset post-vaccination at 10 mins of nausea, bilateral UE and LE tingling sensation, no dermatological changes. Denied SOB. Patient reported last food was 30 mins prior to vaccination with bagel. Patient vitals as stated below and given OJ and gummies. VITALS: T97.7, HR 75, RR 14, O2 95%, BP 150/82 After 10 mins of snacks, symptoms were improving. After 15 mins, symptoms resolved entirely. patient left site 30 mins after onset without reoccurrence.
26 2021-06-01 night sweats Chest pain, chest tightness, difficulty breathing, all of which were worse when lying down. Soon dev... Read more
Chest pain, chest tightness, difficulty breathing, all of which were worse when lying down. Soon developed fever, chills, and night sweats, and eventually tachycardia (resting 160 bpm) with atrial flutter and then atrial fibrillation Original pain was within the week of the vaccine, but the fever came on about a month later and lasted for 2 weeks.
26 2021-06-06 pain in extremity Fever, body ache, pain in the left arm
26 2021-06-07 tingling patient reports having tingling/chills about 90 min after vaccination. No rash/hives/swelling or dif... Read more
patient reports having tingling/chills about 90 min after vaccination. No rash/hives/swelling or difficulty breathing. Some lightheadedness and feeling of blacking out. Patient did not have this reaction with the first pfizer shot. Patient was concerned since the onset was so soon after vaccination. Recommended patient rest as much as possible, drink plenty of water and eat some food. Patient may take tylenol if needed for fever/pain. Patient did have a granola bar and water for breakfast and had just recently ate lunch. Recommended no driving or any activity that requires attention/moving due to lightheadedness. Patient does have someone that will be checking in on him to see how he is doing. Advised that patient seek medical attention if condition worsens or if any trouble breathing or swelling
26 2021-06-08 muscle spasms A few hours after getting the 2nd dose, I had the following reactions (I didn't go to the doctor, I'... Read more
A few hours after getting the 2nd dose, I had the following reactions (I didn't go to the doctor, I'm just reporting what I experienced): *Slight rash consisting of pen-dot sized raised blisters which only appeared on top of a long-healed tattoo I have *Pain all throughout my right jugular (neck) *Sharp pain behind my right ear *Sleepiness *Dizziness *Muscle aches and muscle cramps Most of these lasted less than 24 hours, but the tattoo rash was progressively becoming worse, I managed to get it under control on day 4 by applying hydrocortisone directly over the immidiate area. I still see a few bumps, but it seems to be healing. I didn't do anything differently in my daily routine; nothing changed (ie: same soap, same detergent, no contact with dust or etcetera). The tattoo also contains phosphorus, which might be related to the reaction. The muscle aches and cramps are still ongoing; which is weird considering how I never get either and my daily activities haven't changed.
26 2021-06-08 pain in extremity, burning sensation Was afflicted with Severe poison Ivy on back of left leg from below glute down to mid calf. I had nu... Read more
Was afflicted with Severe poison Ivy on back of left leg from below glute down to mid calf. I had numerous smaller and less severe patches. Before getting the covid shot, I had had poision ivy for about 10 days. On the second day after receiving second shot of pfizer, I had a secondary rash occur that surrounded the poison ivy rash. There was a noticeable difference in that the covid rash appeared to come from within the body rather than the poison ivy rash that looked and felt as a more external rash. The symptoms aside from additional rash was when I would move around and generated any type of body heat the "covid rash" would begin to severely itch and irritate. Additionally, If I would go for walks, the area on my leg that still had the poison ivy rash along with the covid rash would not only itch but burn. It created the sensation that a lighter was being held to my skin. It was quite painful. The other small areas that had the mix of poison ivy and covid rash were not as painful when I was moving around/ walking like the bigger afflicted area.
26 2021-06-10 muscle twitching extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting i... Read more
extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 25May2021 at 11:00 as an unknown dose number, at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme headache resulting in fainting and twitching while unconscious on 25May2021 at 20:00. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
26 2021-06-11 numbness Severe headache numb hands and high temperature 100.5
26 2021-06-13 seizure like phenomena After patient received his 1st dose COVID vaccine, patient came to the door where nurse was statione... Read more
After patient received his 1st dose COVID vaccine, patient came to the door where nurse was stationed. Patient stated he felt like he was having a seizure and his head was hurting. Nurse notified (pharmacist) and a medical alert was called. Nurse assisted him to the chair. Patient said he felt like his eyes were heavy and head was hurting. Patient was assisted to lay on the bench. We called 911 for fire rescue, at that moment ER nurse arrived with a wheelchair. patient was transported to wheelchair and sent to the ER with another person and accompanied by ANM, security and patient's father.
26 2021-06-13 tremor, flushing 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: patient received first dose of pfizer vaccine with in 2 minutes passed out parents then told me later he has Aspergers and is very much afraid of needles has had reactions before after getting shots but none quite this severe patient was sitting and when he passed out he did not hit his head mother was beside him and helped him down called ems patient did not want to be transported to hospital left rx 20 minutes later
26 2021-06-13 unresponsive to stimuli, tremor, flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
26 2021-06-16 discomfort Left ring finger pressure sensation, immediately after injection & lasting >15 minutes after injecti... Read more
Left ring finger pressure sensation, immediately after injection & lasting >15 minutes after injection. Patient attempted to stretch the area move fingers. No improvement. Routed to Urgent Care for follow up. No new or worsening sx during monitoring.
26 2021-06-16 flushing This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient re... Read more
This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: ER2613), via an unspecified route of administration in the left arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food or other products. No medical history was reported. Concomitant medication included Emtricitabine ,Tenofovir Alafenamide (DESCOVY), Vitamin D, amphetamine salts (within two weeks of vaccination) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, patient had flushed face which was more severe on left side (same side as vaccine shot). The clinical outcome of flushed face was not recovered. No follow-up attempts are needed. No further information is expected.
26 2021-06-16 migraine Migraines; brain fog; Panic attacks; Psychosis; This is a spontaneous report from a contactable cons... Read more
Migraines; brain fog; Panic attacks; Psychosis; This is a spontaneous report from a contactable consumer, the patient. This 26-year-old male patient reported that he received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0182 59267-1000-01) via an unspecified route in the right arm on 05May2021 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to apples. Concomitant medications were not reported. 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. On 06May2021, the patient experienced migraines, brain fog, panic attacks, and psychosis; all serious for hospitalization. Patient was hospitalized for 5 days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of the events migraines, brain fog, panic attacks, and psychosis was not recovered. Since the vaccination, patient has been tested for COVID-19, result was unknown.
26 2021-06-20 feeling hot, tingling Cold sores, hives, bumps, rashes, severe itching over arms, legs, chest, and back of neck. Numbness ... Read more
Cold sores, hives, bumps, rashes, severe itching over arms, legs, chest, and back of neck. Numbness and tingling in cranial nerves. Back of neck hot, pins and needles. Severe head fog, fatigue.
26 2021-06-20 tremor Approximately 5 minutes after vaccination patient started slumping in chair. He was helped to the f... Read more
Approximately 5 minutes after vaccination patient started slumping in chair. He was helped to the floor by his companion. He had blurred vision and mild shaking and kept asking what is going on. He was asked to lay down on the floor but chose to remain sitting on the floor. He was given a cold compress for his neck and stayed seated on the floor until he felt better. He stated that he was not dizzy, lightheaded but felt really tired. He recovered and stayed for about 15 minutes after recovering. He declined any medical attention and had a ride with his companion. He was advised to seek medical attention at the ER.
26 2021-06-23 tingling PATIENT COMPLAINED OF FEELING FAINT, TINGLING TO FINGERS AND RADIAL SIDE OF HAND. HE WAS DIAPHORETI... Read more
PATIENT COMPLAINED OF FEELING FAINT, TINGLING TO FINGERS AND RADIAL SIDE OF HAND. HE WAS DIAPHORETIC. PATIENT DRANK WATER. PATIENT LAYED DOWN ON COT AND WAS OBSERVED.
26 2021-06-24 slurring Severe brain fog; difficulty concentrating, slow reaction speeds, struggling with articulation/ word... Read more
Severe brain fog; difficulty concentrating, slow reaction speeds, struggling with articulation/ word-finding, memory issues, general confusion and struggling to take in information. Inability to sleep despite fatigue. It feels like my IQ dropped 10-15 points.
26 2021-06-24 numbness, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Pt fainted a minute after recieving his vaccine. Was unresponsive for a few seconds and got up after. Bite his tongue from the fall head first. Paramedics were called and he was quickly evaluated with no vitals out of range. He went home and napped and after follow up call, feels better now 7 hours later. He confirmed had light headache,was tired so napped and also had tingling in his arm and also confirmed he did not drink water or eat anything before his visit. Now he feels fine.
26 2021-06-27 discomfort Dealing with moderate carpal tunnel symptoms, worse on non shot arm (right) mild symptoms in left ar... Read more
Dealing with moderate carpal tunnel symptoms, worse on non shot arm (right) mild symptoms in left arm. Shooting pains throughout left and right arm and hand as a result. Pressure and stiffness in right arm almost always.
26 2021-06-28 muscle twitching Muscle twitching in different muscles. Started at the left arm
26 2021-07-01 seizure The patient was given the Pfizer COVID vaccine. The patient immediately felt nausea and dizzy. The p... Read more
The patient was given the Pfizer COVID vaccine. The patient immediately felt nausea and dizzy. The patient's wife asked up to call for help and we called 9-1-1. The patient then fainted and had some seizure like activity. The patient woke up immediately after. The patient had no previous history of fainting or seizures but has almost fainted after blood tests. The EMT's came and checked his vitals which were all normal. Then the patient was taken to the hospital.
26 2021-07-02 cold sweat PATIENT STATED WHILE WAITING IN PHRMACY WAITING SEATED IN ROOM HE WAS FEELING SWEATY /CLAMMY , LI... Read more
PATIENT STATED WHILE WAITING IN PHRMACY WAITING SEATED IN ROOM HE WAS FEELING SWEATY /CLAMMY , LIGHT HEADED ABOUT 10 MINUTES AFTER 2ND DOSE OF PFIZER COVID 19 VACCINATION GIVIN AT APPROX 3PM .PATIENT THEN SAID HE STOOD UP TO GET ATTENTION FROM PHARMACY PERSONNELL AND FEINTED . BOTH PHARMACIST AND CLERK SAW PATIENT PASSING OUT AND LOWERED PATIENT TO THE FLOOR. A FEW MINUTES LATER PATIENT REGAINED CONCIOUSNESS. PARAMEDICS WERE CALLED AND WAS TAKEN TO HOSPITAL FOR CHECK UP
26 2021-07-09 unresponsive to stimuli, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted approximately 30 seconds af... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted approximately 30 seconds after receiving vaccination. Patient was seated but hit is neck on the arm of the chair. He also hit his head on the wall located next to the chair where patient was seated. Blood pressure was taken- 116/68 pulse 78
26 2021-07-10 pain in extremity Pain in right arm; mild itching all over; neck pain opposite of injection site; joint pain; This is ... Read more
Pain in right arm; mild itching all over; neck pain opposite of injection site; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via unspecified route of administration in the right arm on 27Mar2021 at 17:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight. Concomitant medications were not reported. It was unknown if the patient had any known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 at 10:00, the patient experienced pain in right arm, mild itching all over, neck pain opposite of injection site and mild joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events pain in extremity, pruritus, neck pain and arthralgia were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
26 2021-07-11 tingling Shortly after receiving the covid vaccine first shot. I began to develop symptoms that I have never ... Read more
Shortly after receiving the covid vaccine first shot. I began to develop symptoms that I have never previously felt and have sent me to the hospital in the time since. I have developed serious pins and needles sensation in my left foot, and hands. My left foot and leg constantly feel stiff. My left foot constantly feels as though it is buzzing or vibrating. I have received 3 blood test, imaging test, spent thousands of dollars trying to figure out what is wrong with me. The only thing in my life that changed was the covid vaccine. I can no longer work out due to pain in my leg. I am extremly heat intolerant. This vaccine has ruined my life.
26 2021-07-12 feeling of body temperature change, muscle spasms Immediate stomach ache, pt threw up, nausea, tachycardia, leg spasm, hot/cold, dizzy.
26 2021-07-12 unresponsive to stimuli, tremor, seizure Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Mild, Additio... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Mild, Additional Details: shortly after receiving vaccination, the patient became unconscious, fell out of his chair and to the floor, and began to seize. Body shaking lasted around 15-20 seconds. Patient then immediately became alert and concscious. Stated after this episode that he has a history of fainting and having seizures after he receives vaccinations. Patient vomited ~15-20 minutes after this episode.
26 2021-07-13 pain in extremity Erectile Dysfunction; Fatigue; Extreme Arm pain
26 2021-07-24 facial pain, migraine Initially after injection was fine. On 3/27 afternoon, experienced sinus fullness and throbbing head... Read more
Initially after injection was fine. On 3/27 afternoon, experienced sinus fullness and throbbing headache Extreme light sensitivity Felt like head was going to explode, hard to sleep. (saturday, 3/27) Went to urgent care the next day, care provider said it was a sinus migraine and prescribed antibiotics. (sunday, 3/28) Symptoms did not get better and continued to persist, headache became even worse / unable to work. (monday, 3/29 to 3/30) Stopped taking antibiotics 3/31 Went to see PCP on 4/2, was prescribed sumatriptan. Didn't seem to help. Found out a week later that covering one eye would help with the headache. Went to optometrist 4/8, confirmed that there was strabismus (left eye pointing down, right eye pointing up, prescription adjusted. Initial relief, but headaches returned a week later even with updated prescription (with prism) Had a follow-up with PCP 4/26 and got referral to a head and neck specialist. CT scan of sinus performed on 4/27, nothing weird spotted. Was prescribed verapramil. Made me extremely dizzy and did not help - stopped taking after a week. Continued to work with HNT, confirmed nothing wrong (physically) with brain after MRI. Saw specialist for strabismus - the misalignment at that point was no longer present. Continued to have on and off headaches and facial pain during this whole time period. Most recently, saw ophthalmologist who started treatment for very dry eyes.
26 2021-07-27 migraine Still experiencing severe muscle pain in right leg and left arm (arm was vax site); Severe migraine;... Read more
Still experiencing severe muscle pain in right leg and left arm (arm was vax site); Severe migraine; Flu-like symptoms; Diarrhea; Nausea; Temperature regulation issues; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7533) via an unspecified route of administration in the left arm on 04Apr2021 at 17:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Information on medical history and known allergies was not available. Information on whether the patient had received any other medications in two weeks was not available. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6203) via an unspecified route of administration in the left arm on 13Mar2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 08:00 the patient was still experiencing severe muscle pain in his right leg and left arm (arm was vax site), severe migraine, flu-like symptoms, diarrhea, nausea, and temperature regulation issues. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe muscle pain in right leg and left arm (arm was vax site), severe migraine, flu-like symptoms, diarrhea, nausea, and temperature regulation issues was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
26 2021-07-27 pain in extremity, cold sweat Cold sweats; Body aches; Dehydrated; Sore arm; Headache; This is a spontaneous report from a contact... Read more
Cold sweats; Body aches; Dehydrated; Sore arm; Headache; This is a spontaneous report from a contactable pharmacist. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient woke up in middle of the night after receiving vaccine the previous day (as reported) with cold sweats, body aches, headache all morning, sore arm and dehydrated. The adverse events were starting to subside then. The clinical outcome of the event cold sweats, body aches, headache, sore arm and dehydrated was recovering at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.
26 2021-07-27 pain in extremity experienced Flu; Joint Paint; Fever; Muscle Pain; Headache; Tiredness; Nausea; Arm Pain; Injection S... Read more
experienced Flu; Joint Paint; Fever; Muscle Pain; Headache; Tiredness; Nausea; Arm Pain; Injection Site Pain; He is feeling sick after second dose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program . A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 20May2021 (at the age of 26-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date (at the age of 26-years-old) for COVID-19 immunisation. The patient reported that he experienced Flu, Joint Paint, Fever, Muscle Pain, Headache, Tiredness, Nausea, Arm Pain and Injection Site Pain. He had his first shot of the Pfizer BioNTech Covid-19 Vaccine last day 20May2021 (as reported). Caller wanted to know if he would be allowed to take Dayquil to relieve the current side effects he was experiencing. The patient received his second dose last day (20May2021) but cannot recall exact date of 1st. He was feeling sick after second dose. His symptoms were not much different than what was on the fact sheet. He did not wish to report them at all. He just had a question. His symptoms were very typical of the flu with the usual joint pain, fever, muscle pain, headache and tiredness. He took the day off of work. He just wanted to know if he should take Dayquil tomorrow so he could function and go to work. The patient was referred to HCP. Outcome of the events was unknown. Follow-up needed. Information about batch/lot number has been requested.
26 2021-07-28 burning sensation On saturday(7/3/2021) the day after the vaccine instatted already having chest pain. Three days(7/6/... Read more
On saturday(7/3/2021) the day after the vaccine instatted already having chest pain. Three days(7/6/2021) after the chest pain I started having chest palpations and felt a ball in my chest with tightness. I went to the ER and they diagnosed me with pericarditis. I'm still dealing with it 3 weeks later and cant exercise at all. Before i was a very healthy individual and ran 15 miles a week. Now im not able to jog for 2 minutes without a burning sensation on the left side of my chest. At night i constantly get chest pains. Ive been taking the medication ibuprofin 3 times a day and cholichine 1 time a day. Its gotten slightly better in terms of pain but I am still unable to perform any physical activities that raise my heart rate.
26 2021-07-28 pain in extremity, numbness, electric shock sensation, tingling March 20 2021 (shortly after 2nd Pfizer COVID19 vaccine March 17 2021, injected into LEFT arm): woke... Read more
March 20 2021 (shortly after 2nd Pfizer COVID19 vaccine March 17 2021, injected into LEFT arm): woke up with burning, throbbing, RIGHT neck, shoulder, RIGHT arm pain for 3-4 hours -- > numbness/tingling RIGHT shoulder to fingertips; dysesthesias to extremes of temperature in RIGHT arm; RIGHT hand>arm weakness and dexterity issues; dizziness with fast lateral movements that occurred a little bit later Pain went away in a few days, but still has residual numbness and tingling (even now) Dysesthesias to temperature lasted a few weeks -- > MRI brain noncontrast March 29 2021 showed lesions c/f MS in the supra and infratentorium -March 30 2021: L'hermitte's sign (shock or vibration) from abdomen to feet when looking down -- > steroids not given initially, as sx on neuro exam felt to be mild -- > MRI C/T spine April 21 2021 with RIGHT C2-C3 nonenhancing lesion; repeat brain showed no enhancement -- > ACE slightly elevated; CT chest without LAN -- > April 23 2021 decided to order IV steroids given mild RIGHT hand weakness, given April 27-29 2021 -- helped, but still has numbness and tingling; it's getting easier to write and use a pipetter, but still some difficulty IMPRESSION: This is a 26 Y man with CIS, one neurological event mostly causing RIGHT hand weakness and sensory sx plus vertigo that happened 3 days after a 2nd COVID19 vaccine. He meets criteria for dissemination in space (spine, brainstem, and PV lesions) but does not meet dissemination in time (no contrast enhancing lesions, no change in brain lesions over 1 month of monitoring). A LP is required to finalized criteria to discriminate between CIS and RRMS. Elevated ACE and ANA are common to see in MS, and I do not think they point to further pathology.
26 2021-07-28 tingling Since receiving the vaccine, my fingertips underneath the fingernails all felt as though they had fr... Read more
Since receiving the vaccine, my fingertips underneath the fingernails all felt as though they had frostbite/tingling on and off. This has reduced in effect over time. I have developed strong chest discomfort and a cough exactly 48 hours after receiving my second dose.
27 2021-01-04 weakness Body ache, headache, body weakness, fatigue
27 2021-01-04 cold sweat Patient presented to receive COVID-19 vaccine (Pfizer) at approximately 1621. Patient waited 15 minu... Read more
Patient presented to receive COVID-19 vaccine (Pfizer) at approximately 1621. Patient waited 15 minutes when asking to leave was asked if she had any symptoms, patient reported headache. NP asked patient to lay down in stretcher and took repeat vitals which showed elevated BP. Patient reported feeling clammy had palpitations. NP made decision to call EMS. EMS arrived and transported patient to ED at 1735.
27 2021-01-06 seizure, migraine Fever as high as 101.6, body aches, severe pain at injection site, convulsions/chills, nausea, cough... Read more
Fever as high as 101.6, body aches, severe pain at injection site, convulsions/chills, nausea, cough, migraine
27 2021-01-09 tremor 104.0° fever, shaking. Started approximately 12 hours after second dose. Lasted for 6 hours then w... Read more
104.0° fever, shaking. Started approximately 12 hours after second dose. Lasted for 6 hours then went away. Following night, fever of 101.9° and slight shaking. Chest pain. Oxygen saturation still at 97%
27 2021-01-10 nerve pain, pain in extremity, concussion, weakness, mild one side paralysis Nerve pain left arm to shoulder and ring and pinky finger weakness in l hand and arm pain and heart;... Read more
Nerve pain left arm to shoulder and ring and pinky finger weakness in l hand and arm pain and heart; concussion symptoms, severe headaches, body weakness and disorientation, lights bright and sensitive. ER visit 1/9/2021 - ER referral to Ortho Spine. Continuing pain radiates to different degrees l arm to hand to include burning shoulder pain, concussion symptoms, severe headaches, body weakness and disorientation, lights bright and sensitive.
27 2021-01-11 feeling cold Began to feel really cold; Muscle pains; Joint pains; Throbbing headache; Fever of 101.7F; Shivering... Read more
Began to feel really cold; Muscle pains; Joint pains; Throbbing headache; Fever of 101.7F; Shivering chills; Second dose of BNT162b2 was given 17 days after 1st dose; This is a spontaneous report from a contactable physician, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 11:15 AM (at the age of 27-years) as a single dose (Lot Number EK9231) for COVID-19 immunization. Medical history included asthma and no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 18Dec2020 12:00 PM (at the age of 27-years) as a single dose (Lot Number EH9899) for COVID-19 immunization. The patient had not received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, approximately 10-12 hours after 2nd dose of vaccine the patient began to feel really cold, had some mild muscle pains, joint pains, and a headache. Overnight these symptoms worsened to severe muscle pains, joint pains, and a throbbing headache, shivering chills, took a temperature and had a fever of 101.7F. These symptoms did not subside until late the next morning. The headache had persisted. The patient reported taking paracetamol (TYLENOL) 1000 mg, which helped. The outcome of the events feels really cold, muscle pains, joint pains, throbbing headache, shivering chills, fever of 101.7F, were reported as recovering.
27 2021-01-12 bell's palsy R sided Bell palsy
27 2021-01-12 burning sensation, numbness, tingling A few hours after my second dose on 1/08/2021, I had some adverse reactions that worried me, includi... Read more
A few hours after my second dose on 1/08/2021, I had some adverse reactions that worried me, including arm numbness, tingling around my mouth and cheeks, a splitting headache/blurry vision, joint and muscle pain and dizziness. I called e-medicine and had a video call with a E-Medicine provider who told me to keep monitoring my symtoms and go to the ER if they got worse (fortunately they didn't); however there are some lingering effects. Currently I still am experiencing headaches (around my ears and temple area) with joint pain/body aches and occasional tingling/burning sensations in my fingers and feet.
27 2021-01-13 pain in extremity, night sweats Around 7 pm I started feeling really anxious. I checked my HR on my smart watch and it said that aro... Read more
Around 7 pm I started feeling really anxious. I checked my HR on my smart watch and it said that around 12pm my HR was 157bpm which was right after getting the vaccine when I started walking home. My resting HR is usually 47-52bpm. I am a very active person. I have been waking up in the middle of the night multiple times in night sweats and it feels like my heart is contracting very hard. I notice that my HR jumps up right when I start to be more active, but more than normal. On the 11th my average walking HR was 140. Today at work my HR was 134 at the highest around 9am and the lowest was 56bpm around 7am when I was getting ready for work. Additionally to the increased HR I have SOB when I walk and talk. I did have a sore arm as well the first day, but nothing more than any other injection I have had before.
27 2021-01-13 seizure, migraine Fever, uncontrolled convulsions, rapid cycling of body temperature for roughly 48 hours, migraine, i... Read more
Fever, uncontrolled convulsions, rapid cycling of body temperature for roughly 48 hours, migraine, intense body pain and lethargy, inability to sleep, no appetite
27 2021-01-14 tremor Fever as high as 101.6, chills and shakes lasting almost 8 hours. Currently shaking has subsided and... Read more
Fever as high as 101.6, chills and shakes lasting almost 8 hours. Currently shaking has subsided and fever/chills starting to break after some rest and Advil
27 2021-01-17 tenderness Multiple left supraclavicular lymph node enlargement. Tender to touch. Started on 01/12/2021, has ... Read more
Multiple left supraclavicular lymph node enlargement. Tender to touch. Started on 01/12/2021, has increased slightly. On 01/18/2021, felt an additional lymph node.
27 2021-01-18 weakness Symptoms began at 06:00 on 1/19/21 and included fever, chills, weakness, aches, injection site pain.... Read more
Symptoms began at 06:00 on 1/19/21 and included fever, chills, weakness, aches, injection site pain. Tylenol taken. Notified employee health at the facility.
27 2021-01-18 tingling Tingling on the face in the left side. Headache. Fatigue
27 2021-01-20 pain in extremity Chills, fatigue, body aches, left arm pain, was unable to sleep. Headaches. Symptoms lasted for abou... Read more
Chills, fatigue, body aches, left arm pain, was unable to sleep. Headaches. Symptoms lasted for about 24 hours.
27 2021-01-21 inability to speak, tremor Started shaking uncontrollably Fever got up of 105.6 Was unable to speak
27 2021-01-21 hot flush About 12 hours post-injection I began noticing hot/cold flashes and running a fever. Between 10:30pm... Read more
About 12 hours post-injection I began noticing hot/cold flashes and running a fever. Between 10:30pm and noon on January 22nd, 2021 I've experienced continued hot/cold flashes, fever, nausea, muscle aches, injection site pain, congestion, headache, and minor swelling and pain of the lymph nodes in my left axilla area. So far the fever seems to have broken with Tylenol, water, and rest. Still experiencing significant muscle aches, left axilla pain, headaches, congestion, and general fatigue.
27 2021-01-24 facial paralysis, bell's palsy Received the first COVID shot on 1-17-21 and began to feel pain in the back of my neck on the right ... Read more
Received the first COVID shot on 1-17-21 and began to feel pain in the back of my neck on the right side in the afternoon of 1-19-21. On 1-20-21 I lost part of my taste and neck started to cause headaches. On 1-21-21 symptoms continued to get worse. On 1-22-21 I began to lose control of the right side of my face. Face began to droop and eye was unable to close. I went to the ER on the evening of 1-22-21 and was diagnosed with Bell's Palsy.
27 2021-01-24 night sweats Chills, fever, body aches, headache, fatigue, night sweats. Lasted approx 24 hours after second dose... Read more
Chills, fever, body aches, headache, fatigue, night sweats. Lasted approx 24 hours after second dose.
27 2021-01-26 feeling jittery PATIENT REPORTS SYMPTOMS OF FEELING JITTERY, ELEVATED BLOOD PRESSURE 149/109 AND HR 107 AND CHEST SO... Read more
PATIENT REPORTS SYMPTOMS OF FEELING JITTERY, ELEVATED BLOOD PRESSURE 149/109 AND HR 107 AND CHEST SORENESS.
27 2021-01-26 seizure Got him up in the morning after he had gotten the vaccine the day before. Sa t him down on the toil... Read more
Got him up in the morning after he had gotten the vaccine the day before. Sa t him down on the toilet and he immediately had a major seizure. Came out of it, let him sit for 5 minutes, got him up and sat on the chair, gave some juice and water, and he was back to normal. He had diarrhea the day of the vaccination and the day before.
27 2021-01-27 bell's palsy, numbness, facial paralysis Vaccine given 01/17 R-sided neck pain 01/19 Decreased taste, tongue numbness right sided 01/20 Lip a... Read more
Vaccine given 01/17 R-sided neck pain 01/19 Decreased taste, tongue numbness right sided 01/20 Lip and facial numbness right sided 01/21 Droopy right eye and face 01/22 ED on 01/22, given 7 day course of prednisone and valtrex Ongoing right sided facial droop, right sided eyelid droop. Unable to close right eye fully. Eye dryness. Diagnosed with Bell's Palsy in ED, confirmed in clinic
27 2021-01-28 bell's palsy, facial paralysis Bells Palsy was diagnosed at hospital at the ED was prescribed steroid, antiviral, and pain medic... Read more
Bells Palsy was diagnosed at hospital at the ED was prescribed steroid, antiviral, and pain medication for up to 10 days and it has only been 5 days since then. The only improvement seen is that the head pain in the back of the ear has gone but the right side of the face being droopy is still the same.
27 2021-01-31 flushing When patient was in for his 2nd dose, reported that an hour after the first vaccination was given he... Read more
When patient was in for his 2nd dose, reported that an hour after the first vaccination was given he felt like his heart rate was high. No measurement was ever taken to confirm it was in fact high. He also became flushed. He was wearing a sweatshirt, so when he took that off he was feeling better. This episode lasted for 5 hours. No comorbidities or other heart conditions. We asked if he was possibly dehydrated or had any caffeine that day. I determined to proceed with dose 2 under the request that he came back after 1 hour and 2 hours respectively to get vitals.
27 2021-02-03 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Headache, chills, sore arm, low grade fever for 2 days followin... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Headache, chills, sore arm, low grade fever for 2 days following administration starting 12 hours after vaccine. 2.5 days later, I got upper lip angioedema that resolved within 1 day with Benadryl and Zyrtec
27 2021-02-04 discomfort Woke up middle of night sweating with 200+ BPM heart rate. Blood pressure 190/100. Weight on chest. ... Read more
Woke up middle of night sweating with 200+ BPM heart rate. Blood pressure 190/100. Weight on chest. Felt dizzy and faint. Could hardly walk. Labored breathing. Had to call ambulance for transport to hospital.
27 2021-02-07 weakness Vertigo; 101 F oral temperature; nausea; generalized weakness; rigors/ chills; generalized muscle ac... Read more
Vertigo; 101 F oral temperature; nausea; generalized weakness; rigors/ chills; generalized muscle aches; This is a spontaneous report from a non-contactable Nurse (patient). A 27 years old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 27 years old on 21Jan2021 09:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Vertigo, 101 F oral temperature, nausea, generalized weakness, chills, rigors, generalized muscle aches. Patient did not have covid prior vaccination and did not have covid tested post vaccination. The outcomes of events were unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
27 2021-02-08 feeling of body temperature change Pt received first dose Pfizer COVID 19 vaccine 26JAN21 at approx 0830. Pt reports yesterday 2330 we... Read more
Pt received first dose Pfizer COVID 19 vaccine 26JAN21 at approx 0830. Pt reports yesterday 2330 went to pee and was feeling tired. Became nauseated and then started quickly oscillating between feeling hot and cold. Sat up in bed and when he did, felt ''everything move to my toes''. Remained conscious for about 2-3 seconds and then woke up on the floor in a pool of sweat about 5 minutes later (knows the timespan based on looking at his watch when he went to the bathroom and when he woke up). Tried to get up and felt unstable so decided to lay in the floor which he did for about another 10 minutes. During this timeframe, noticed jaw pain and soreness which he attributes to clenching his jaw. At this point, able to struggle into his bed and noted that the oscillation of hot/cold had abated and he was left with a mild headache and fatigue which has slowly improved since that time. At this time, pt reports he feels about 90% of USOH but somewhat ''uneasy'' still. Denies reaction to medication or vaccine in the past other than sulfa abx for which he had skin rashes as a child.
27 2021-02-16 pain in extremity, migraine Migraine-like headache started at around noon, got worse at 2pm, slept from 3-6, still had headache.... Read more
Migraine-like headache started at around noon, got worse at 2pm, slept from 3-6, still had headache. began feeling nauseous, vomited at 8pm. Took Tylenol and slept at 11pm, feeling OK with sore arm now.
27 2021-02-21 tenderness Patient presented to Urgent Care 3 days after his second dose of Pfizer COVID-19 vaccination.. He re... Read more
Patient presented to Urgent Care 3 days after his second dose of Pfizer COVID-19 vaccination.. He reported a 10 day issue of a left axilla mass (12 cm) with new onset of tenderness.
27 2021-02-24 pain in extremity Patient verbalized "scratchy" dry throat, feeling of swelling to lips, throat, tongue. Bilateral arm... Read more
Patient verbalized "scratchy" dry throat, feeling of swelling to lips, throat, tongue. Bilateral arm soreness. Headache. Vitals taken and stable. 10mg Zyrtec given. Patient feeling less swelling to lips, and throat. Vitals before discharge BP 132/73, HR 87%, O2 99%. Discharged home ambulating and stable.
27 2021-03-04 feeling hot, unresponsive to stimuli, seizure like phenomena After vaccine pt went to observation area .He felt hot and asked staff for H2O. When staff returned ... Read more
After vaccine pt went to observation area .He felt hot and asked staff for H2O. When staff returned c H2O he stated he felt light headed. Staff concerned he was going to pass out so they assisted him from chair to ground with legs e levated . Emergency number and onsite MDcalled . Pt was unresponsive c aBormal breathing and seizure like activity . Epi 0.3mg administered in right thigh. Pt became responsive and breathing 15 RR a minute. Pt diaphoretic c rash on upper extremities. VSS. EMS arrived and transported pt to local ED for evaluation.
27 2021-03-04 numbness, pain in extremity, tingling Patient is a 27 year old male with no significant medical history presents to MC on 2/6 from Urgent ... Read more
Patient is a 27 year old male with no significant medical history presents to MC on 2/6 from Urgent Care for further evaluation of chest pain. He states that he woke up at 5:30am with abrupt onset of chest pain with present like quality in the middle of the chest. It was non-radiating with associated nausea, small amount of emesis, and dyspnea. His pain lasted for about 15 minutes and he started experiencing it again after half an hour with numbness and tingling of his bilateral distal digits and diaphoresis. He decided to seek evaluation at local Urgent Care around 7:30am. States that he was immediately send here through ambulance due to findings of EKG changes. He was given aspirin and nitroglycerin with some alleviation of pain. Currently, he feels little better although continues to have chest pressure substernally every 45 minutes lasting 5-10 minutes. His dyspnea is resolved. He does not have pleuritic chest pain, fever, chills, nausea, vomiting, abdominal pain, diarrhea, leg swelling, rash. Additionally, he has been in normal state of health until this 2/2/21 when he received second dose of COVID-19 (Pfizer) vaccine. He had extreme fatigue with left arm soreness. He reports no sick contacts, recent illness, or travel. MRI cardiac done 2/9/21 with assessment reveals Infero-lateral myocarditis. Patient remained hemodynamically stable and was discharged with ibuprofen taper for 10 days, c/w colchicine 0.6 mg QD x 3 months and pantoprazole 40 mg QD
27 2021-03-04 unresponsive to stimuli, seizure like phenomena, feeling hot After vaccine, pt went to observation area. He felt hot and asked staff for water. Staff returned wi... Read more
After vaccine, pt went to observation area. He felt hot and asked staff for water. Staff returned with water and he stated he felt light headed. Staff concerned pt might pass out so they assisted him to floor with feet elevated. 911 and onsite MD and EOA called. Pt was unresponsive with agonal breathing and seizure like activity. Epi 0.3 mg administered IM into right thigh. Pt became responsive and breathing 15 RR a minute. Pt remained diaphoretic with rash noted on upper extremities. VSS. EMS arrived and transported pt to local ED for further evaluation.
27 2021-03-05 speech disorder Cough, pale, diaphoretic, non-verbal, dry heaved. Evaluated by EMS, cleared.
27 2021-03-09 feeling hot Feeling hot; abnormal, blurred vision
27 2021-03-10 hot flush Warm flush feeling, sweating, nausea, and diarrhea starting 3 hours after vaccine lasting for 24 hou... Read more
Warm flush feeling, sweating, nausea, and diarrhea starting 3 hours after vaccine lasting for 24 hours
27 2021-03-10 seizure Immediately after he said he was dizzy. I had him remove his mask and take some deep breaths. He did... Read more
Immediately after he said he was dizzy. I had him remove his mask and take some deep breaths. He did. I called for help from other nurses in the room. He had seizure activity and fell from the chair to the floor. In the process he hit his head on the table. He had his stocking hat on. The other nurses were there immediately. Talking to him, reassuring the mom, BP, pulse oximeter, ice pack, privacy curtains in place. He was offered food and drink. Other staff removed others from the room. The ambulance was called. And arrived. The ambulance assessed him. Education and instruction were given. They asked him to go to ER. He refused. They advised him to see his Doctor. The ambulance had him sign their needed paperwork. Helped him to his feet, he refused to use their cart provided. He said, I am fine. He was strongly encouraged to follow up with his Doctor. He walked out of the room with ambulance personal and his mom.
27 2021-03-11 feeling hot Pt. was vaccinated by another pharmacist at our remote clinic at an elementary school at 11:35am 3/1... Read more
Pt. was vaccinated by another pharmacist at our remote clinic at an elementary school at 11:35am 3/11/21. Within less than 3 minutes the patient informed a student that he did not feel well. He reported: itching, feeling hot, shortness of breath, dizziness, loss of vision, and thirst. The student alerted me and I assessed the pt. He was responsive, but felt "tired". He was sitting on the floor. I told the student to call 911. I continued talking with the pt. as I was preparing the epinephrine and placing a blood pressure cuff on his arm. He became less responsive and asked me for the epinephrine. I injected him with an EpiPen 0.3mg in his outer left thigh through his pants (at 11:43am). Within approximately 30s-1min the pt. became more responsive. I then took his pulse and BP shortly before EMS arrived (11:52am) . They performed the second blood pressure reading and the pt. was transferred to their care at that point.
27 2021-03-14 muscle spasms Gi Issues, intense sharp cramps, diarrhea
27 2021-03-16 night sweats Fever (101.5 F), chills, night sweats, injection site soreness, headache
27 2021-03-17 seizure Systemic: Seizure-Severe
27 2021-03-17 unresponsive to stimuli 1242: Vaccine administered. 1255: RN called to assist with patient. Caregiver stated that the pati... Read more
1242: Vaccine administered. 1255: RN called to assist with patient. Caregiver stated that the patient reported that he "felt funny" and "feel like I can't breathe." Caregiver stated that the patient was no longer responding to questions being asked. Caregiver reported not being able to arouse the patient after shaking his leg twice an no response. Caregiver stated that excess secretions from mouth is normal. 1255: Patient responding to questions being asked. Heart rate 123 beats per minute and oxygen saturation level 99% on room air via pulse oximeter. Lungs clear to ausculation. Patient sitting power chair. 1257: Apical heart, regular with a rate 100 beats per minute. 1258: Unalbe to obtain blood pressure in left arm due to tone. 1259: Blood pressure in right arm 168/92. 1303: Blood pressure in right arm 158/98. 1309: Patient reports feeling better at this time. Patient with caregiver. Caregiver verbalized appreciation.
27 2021-03-23 tenderness Woke up this morning and my armpit on the side that I received the shot was slightly swollen and ten... Read more
Woke up this morning and my armpit on the side that I received the shot was slightly swollen and tender.
27 2021-03-24 weakness, flushing Headache, swollen muscles, dizziness, blindness, sweating, flushing, feeling dehydrated, weakness, m... Read more
Headache, swollen muscles, dizziness, blindness, sweating, flushing, feeling dehydrated, weakness, muscle fatigue, eye soreness, sore neck.
27 2021-03-24 weakness, pain in extremity The female medical employee, who was administering the vaccination. The Pfizer Vaccination. Opened ... Read more
The female medical employee, who was administering the vaccination. The Pfizer Vaccination. Opened a shot syringe. That had an empty vile. The syringe did not have the dosage of vaccine. The female medical employee, documented on my immunization card the sticker Lot number #EN6204, but the vaccine Lot Number (the syringe received) was not the Lot Number indicated on the immunization card. Why? The female medical employee, called over the military personnel whom was being the security for the vaccination site. The female military personnel was holding an open unit syringe vile dosage of the vaccine. The female medical employee showed the empty syringe vaccine to the military personnel. She said, "The dosage fell out." The female medical employee, took the open package, of the syringe vile, that contained a measured dose of the vaccine. Which is not considered the full dosage, or considered a safe dosage of the vaccine, because the package was opened. Not in front of the patient. And. Was open, when the military personnel, who was holding this vile, was walking, with the open package, around without proper medical gear. The medical employee. Quickly took out the syringe. Didn't explain which and what that syringe was, and just injected the dosage into my arm. I know, that practice was malpractice. I know I experienced malpractice. And. It's obvious the Government is going to do anything about it. This is not a petty situation. I don't know where that needle from. What has been introduced to that open syringe package. I did experience very bad side affects: headaches, muscle pains, tiredness, fatigue, weakness, low strength, dizziness, partial blindness, overwhelming stress, back pain, joint pain, spinal pain, chills, fever like symptoms, nausea, spontaneous pain, soreness in the arm, swelling throughout my body, difficulty breathing, short breaths.
27 2021-03-25 tingling Nausea Paresthesia Lightheaded Sweating 1x emesis
27 2021-03-26 flushing Flushing/sweating, light-headed. Vitals wnl. Anxious about shot.
27 2021-03-27 feeling cold Tuesday evening sour throat developed. Wednesday morning sour throat had progressed had progressed ... Read more
Tuesday evening sour throat developed. Wednesday morning sour throat had progressed had progressed and sinuses became congested. Thursday by noon severely congested, constant cough, and cold shivers (still cold and shivering under two layers of blankets, heater on, wearing pants, shirt, and jacket). Eat foods high in potassium and vitamins A and C. Take 24 hour decongestant pill. Ibuprofen for headache resulting from cough. Friday abnormal coldness gone, slightly less painful throat, slightly less congested. Eat foods high in potassium and vitamins A and C. Take 24 hour decongestant pill. Ibuprofen for headache resulting from cough. Saturday Throat less sour, less congested, and cough less persistent. Ibuprofen for headache resulting from cough. Sunday so far (as of 7:43am) same level of congestion, sourness, and cough as Saturday.
27 2021-03-30 migraine Ongoing migraine x6 days following vaccine
27 2021-03-30 seizure had a major seizure on day 8 of dose one despite nearly no history of seizures; I was tired after th... Read more
had a major seizure on day 8 of dose one despite nearly no history of seizures; I was tired after the first dose (26Feb2021) on days 2-3; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left on 26Feb2021 15:00 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization at doctor's office/urgent care. Medical history included atypical trigeminal neuralgia since 2009, complex regional pain syndrome (CRPS), attention deficit hyperactivity disorder (ADD), anxiety, depression, asthma, Epilepsy-prone and many more. The patient also had orthopedic knee surgery on 26Aug2020 which she had pain after surgery. She also had known allergies with Cephalosporins and elemental nickel. Concomitant medications included tapentadol (TAPENTADOL), amphetamine (AMPHETAMINE), and candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCTZ) all taken for unknown dates and indications. The patient stated that she was tired after the first dose (26Feb2021) on days 2-3 (Feb2021). She also had had a major seizure on day 8 of dose one (07Mar2021) despite nearly no history of seizures which require emergency room/department or urgent care visit. The seizure has been attributed to other issues by her doctor. The patient had no COVID-19 prior vaccination and was not tested post vaccination. The events were considered life threatening. The patient did not receive any treatments for the events. The patient recovered on unknown date in 2021.
27 2021-03-31 tingling, numbness patient complains of having nerve numbness and tingling from elbow down on same arm that he received... Read more
patient complains of having nerve numbness and tingling from elbow down on same arm that he received his vaccination
27 2021-04-01 pain in extremity I had very minimal symptoms after my shot, within 48 hours my slight arm pain had gone away About ... Read more
I had very minimal symptoms after my shot, within 48 hours my slight arm pain had gone away About a week later in the early morning of 4/2/21 I woke up feeling very fatigued and feverish. My symptoms continue to be a low grade fever, fatigue, headache, and sore throat.
27 2021-04-01 trigeminal neuralgia pain on the first day after the second vaccine dose was as bad as it was the first day after surgery... Read more
pain on the first day after the second vaccine dose was as bad as it was the first day after surgery; my atypical trigeminal neuralgia (had since 2009) was as bad as it has ever been; my atypical trigeminal neuralgia (had since 2009) was as bad as it has ever been; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (Pfizer/Bio-N-tech COVID vaccine), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 13:15 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunization. Medical history included major orthopedic knee surgery on 26Aug2020, atypical trigeminal neuralgia since 2009. The patient had pre-existing pain issues that also continued to be elevated on the 2nd and 3rd day after surgery but not nearly as bad as the first. The patient has known allergies to cephalosporins and elemental nickel. Other medical history: complex regional pain syndrome (CRPS), attention deficit hyperactivity disorder (ADD), anxiety, depression, asthma, epilepsy-prone, many more; rest will be provided if full list is needed. The patient was not diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. Concomitant medication included tapentadol, amphetamine and candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCTZ); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient had the 1st dose of bnt162b2 (Pfizer/Bio-N-tech COVID vaccine), via an unspecified route of administration, administered in left arm on 26Feb2021 03:00 PM (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. The patient was tired after the first dose on days 2-3, and had a major seizure on day 8 of dose one despite nearly no history of seizures but that has been attributed to other issues by his doctor. The patient had a major orthopedic knee surgery on 26Aug2020 and his pain on the first day after the second vaccine dose (after getting the dose on 19Mar2021, going to bed, and waking up the next day) was as bad in Mar2021 as it was the first day after surgery, and his atypical trigeminal neuralgia (had since 2009) was as bad in Mar2021 as it has ever been. The patient mentioned he would advise and recommend for patients to speak to their doctors before the second dose to obtain a few days of higher dose pain medication. The events resulted in: emergency room/department or urgent care and was considered serious due to life threatening illness (immediate risk of death from the event). No treatment given for events. Outcome of events recovered.
27 2021-04-02 cold sweat, flushing, seizure, tremor, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: unconscious for less than a minute.Has a history of fainting from many years ago but no incidents since.Epi pen given 4:10p and 911 called. Paramedics arrived ~4:18p.Bp was 110/80 @4:13p, 128/88 @ 4:18p, 132/86 (pulse 70) @4:21p.Was clamy, shaky, sweaty,and had a headache post.Paramedics monitored sitting and standing.Advised to followup with physician.
27 2021-04-05 cold sweat Shortly after patient received vaccine (within 5 minutes) Patient was sitting in area being monitore... Read more
Shortly after patient received vaccine (within 5 minutes) Patient was sitting in area being monitored for reaction. Patient then fell face forward and hit his face. Aid came helped immediately and patient was monitored for vitals. Patient report to feeling dizzy. He appeared pale and clammy.
27 2021-04-06 feeling hot Feeling lightheaded, very fatigued, and hot. Slight headache.
27 2021-04-06 pain in extremity Dizziness, difficult to concentrate, headache, fatigue, fear of sound and light starting 5 hours aft... Read more
Dizziness, difficult to concentrate, headache, fatigue, fear of sound and light starting 5 hours after vaccination. No treatment, went to bed as usual and symptoms were gone the next morning. Arm soreness lasted for around 1.5 days.
27 2021-04-06 tingling, feeling hot Sweating, intentional breathing, both hands, pins and needles, felt light-headed and hot. All sympt... Read more
Sweating, intentional breathing, both hands, pins and needles, felt light-headed and hot. All symptoms lasted only a few minutes (less than 5).
27 2021-04-06 seizure patient felt dizzy, was unconscious and upon awakening, patient was seizing
27 2021-04-06 tremor The patient felt uncontrollable shakes/chills at night for around 15 minutes before sleeping but rec... Read more
The patient felt uncontrollable shakes/chills at night for around 15 minutes before sleeping but recovered after rest.
27 2021-04-06 unresponsive to stimuli Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting... Read more
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pateint \"swooned\" when the observer was getting the timer. He was responsive after 2 minutes. sat upright after 5 minutes.
27 2021-04-07 cold sweat Patient reported that he "felt like he was going to pass out". Was pale and clammy. Reports hx of ... Read more
Patient reported that he "felt like he was going to pass out". Was pale and clammy. Reports hx of vasovagal response to injections. VSS. Cool air and drink applied. Within 5 minutes color returned and patient reported that he felt much better. Was able to drive self home after 20-30 minutes.
27 2021-04-07 pain in extremity Swollen lymph node in neck since March 24th 2021. I have recently been experiencing muscle fatigue/d... Read more
Swollen lymph node in neck since March 24th 2021. I have recently been experiencing muscle fatigue/dull aching in my left arm, left side of neck, left shoulder, and upper left back.
27 2021-04-07 seizure Patient received immunization and felt fine after sitting in chair for a few seconds. Pt got up and ... Read more
Patient received immunization and felt fine after sitting in chair for a few seconds. Pt got up and went to waiting area and was sitting down in chair during the 15 minute observation window. Pt passed out and slumped/fell out of chair on patients left side. I was called out by the person monitoring the waiting area to see pt in fetal position on their left side seizing. The seizing lasted for about 15 seconds and then stopped. PT was motionless for a few more seconds and then came around and said "I'm back". The pt was given a bottle of water because he said he was thirsty. In the meantime the paramedics were called and arrived. They checked his BP and Blood Glucose. After several minutes they took the pt out on a gurney for further evaluation, there was a question as to whether or not pt hit his head.
27 2021-04-07 unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild
27 2021-04-08 cold sweat Vasovagal event with lightheadedness, diaphoresis, blurry vision. No CP, SOB, palp. No s/sx anaph... Read more
Vasovagal event with lightheadedness, diaphoresis, blurry vision. No CP, SOB, palp. No s/sx anaphylaxis: no hives/rash, wheezing, stridor, throat closing, tongue swelling/itching, N/V/D. VS: BP 95/5Os, HR 50s, SaO2 99% RA, afebrile. Pt clammy, bradycardic. Lung clear, abd soft, no edema. No focal neuro deficits, A&Ox3. Pt laid down on the floor with legs elevated with improvement in symptoms, and BP up to 120s/70s, HR 70s. After ten minutes, felt well enough to sit up, repeat BP while sitting 120/70s, HR 70s. Given water/juice and a snack. After another ten minutes, felt well enough to stand, repeat BP unchanged. Pt monitored for another 30 minute without recurrence of sxs. Pt went home without issue.
27 2021-04-08 tenderness Supraclavicular lymphadenopathy following COVID-19 vaccination. Left supraclavicular lymph node is s... Read more
Supraclavicular lymphadenopathy following COVID-19 vaccination. Left supraclavicular lymph node is swollen and tender to the touch.
27 2021-04-09 speech disorder This vaccine is extremely illegal. Terroristic. I have been having such an extreme headache. Bluryne... Read more
This vaccine is extremely illegal. Terroristic. I have been having such an extreme headache. Bluryness, to the point where I have blindnesss. I am unable to think. My speech is completely off. I try to say something, but what I say is not what I was thinking. Don't you dare say I have something wrong with me, in regards to unable to articulate what I want to say, and what Is actually being said. I understand what is happening to me with this reality. Which is why this vaccine is terroristic. Im going to make it my life endeavored goal to resolve this in legal entities. For that. This is not helping anyone. Causing more pain. And. Allowing the government to lie even more. I hate this Country!
27 2021-04-10 cold sweat General fatigue after 12 hours Increased fatigue around 28 hours Nausea, cold sweats/feeling clammy,... Read more
General fatigue after 12 hours Increased fatigue around 28 hours Nausea, cold sweats/feeling clammy, and fitful sleep after 37 hours
27 2021-04-10 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Sycope episode
27 2021-04-10 pain in extremity 5 minutes after vaccine there was dizziness which passed after 10 minutes 30 minutes after vaccine... Read more
5 minutes after vaccine there was dizziness which passed after 10 minutes 30 minutes after vaccine there was headache, arm pain, muscle pain all over, fatigue, low grade fever, and sense of taste was altered. A constant metallic taste was in mouth and nothing (mints, brushing teeth, drinking water, etc.) removed it. Metallic taste resolved after 24 hours. Other symptoms lasted about 36 hours.
27 2021-04-11 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Additional Details: Patient felt ... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Additional Details: Patient felt light headness, gave patient water, he ate sour patch kids then he said hes ok but will sit for 30 minutes, but he lost consciouness for about 20 seconds, woke up then started vomitting, we called 911 and EMT came took his vital signs bp 117/91 seems ok but patient refuse to go to emergency room, Patient stayed for another 30 mins, his family came and picked him up. Patient said he will call his PCP if still nausea problem, patient said he fainted with injections before but never violently vomt
27 2021-04-12 weakness When I woke up on Sunday, April 11th, 2021 at around 9am, I have felt like my muscles have been ripp... Read more
When I woke up on Sunday, April 11th, 2021 at around 9am, I have felt like my muscles have been ripped apart, I was sweating, I had labored breathing, and I could not get up for the day. I slept all day, feeling like I had the flu, and was sleeping until 7pm that day. I called out of work when I woke up because I knew on Monday I would not be able to make it, as I felt like I was very tired, lethargic, and sore. This feeling was throughout every inch of my body. I also went to take a shower that day and I had a hard time breathing in the shower, to the point where I had to sit on the edge of the tub, just to make sure I would not pass out from lack of oxygen. This was the scariest sickness I have ever had in my entire life. I literally thought I was going to die. Monday came around and I felt even worse, my muscles were sore, I felt extremely tired, I could not do anything, and I was in bed all day. Today is Tuesday, and I have felt a little bit better, but I have missed two days of work because of the effects this vaccine has had on my body. I made a virtual appointment with a doctor on the app on phone and met with Doctor who basically told me that the only thing I could do for myself is take Ibuprofen every 8 hours for the pain and swelling that might occur and drink plenty of gatorade. It is Tuesday, April 13th, 2021 at 11:29pm at night and I still feel the same as Monday, very weak, tired, and sore all over my body. I have never had this with a vaccine before, until I got the COVID-19 one. I have taken the Flu Vaccine, Hep A, Tantnius, Chicken Pox and never felt like I was so tired I could not get out of bed from these vaccines.
27 2021-04-12 involuntary muscle movements, seizure, muscle twitching Patient walked to waiting area and when he sat down he fainted, hit his head, and started having sei... Read more
Patient walked to waiting area and when he sat down he fainted, hit his head, and started having seizure-like activity (jerky, twitchy). Patient was down about 15 seconds and when he sat back down his blood pressure was 74/48 and his vision was black. Called EMT, patient refused to go with EMT, because he felt better after 30 minutes of sitting
27 2021-04-12 seizure Patient fainted and exhibited seizure-like activity within 15 minutes of vaccination. Patient was t... Read more
Patient fainted and exhibited seizure-like activity within 15 minutes of vaccination. Patient was transported to ER by EMS.
27 2021-04-13 seizure like phenomena Syncope with seizure like activity. Bradycardia and hypotension, HR 30-40 BMP
27 2021-04-13 tenderness, burning sensation Approximately 6 days after my second dose, I began getting red splotchy bumps on my left forearm. 7 ... Read more
Approximately 6 days after my second dose, I began getting red splotchy bumps on my left forearm. 7 days after the 2nd dose these spots had spread up my arm and were appearing on my left Tricep area and shoulder. The lesions are tender to the touch with a mild burning sensation, they are mildly itchy.
27 2021-04-14 bell's palsy, facial paralysis 4/10/2021 experienced some right side facial paralysis upon waking. Called urgent care who directed... Read more
4/10/2021 experienced some right side facial paralysis upon waking. Called urgent care who directed me to go to a hospital as soon as possible and asked about all events leading up to this, noting that the vaccine may potentially have this side effect, as written in the medical journal. Went to the ER, they put me in stroke protocol, did CAT scan, negative results, blood tests (including for Lyme), MRI to look for tumors after the CAT scan was negative, and an echocardiogram as they detected a new heart murmur never present before. MRI showed Bell's palsey in one facial nerve, all other tests are negative, including for Lyme's disease, a common cause. I am still experiencing it, and am on Valtrex (anti viral) and Prednisone, but the symptoms still exist. There is no other change in my life or health, the only thing I've done differently is have the vaccine (for which we are grateful).
27 2021-04-14 bell's palsy Bell's palsy, took prednisone and acyclovir
27 2021-04-14 feeling hot Patient states feeling lightheaded, hot, and nauseous while waiting 15 minutes at the waiting area p... Read more
Patient states feeling lightheaded, hot, and nauseous while waiting 15 minutes at the waiting area post vaccination. Upon being assessed by EMS, patient did vomit.
27 2021-04-14 seizure Seizure. Lasted approximately 5 minutes. Outcome was positive and no lingering effects.
27 2021-04-15 discomfort NOTE: Taking Tylenol, Ibuprofen, Diphenhydramine HCL, Clear Eyes Eye drops. Have secere bruising o... Read more
NOTE: Taking Tylenol, Ibuprofen, Diphenhydramine HCL, Clear Eyes Eye drops. Have secere bruising of the eyes. Shortness of breath. Muscle Aches. Joint Aches. Congestion. Mucus buildup. Headaches. Brain noble unstable pressure, and heaviness. Unbalanced and unstable proprioception.
27 2021-04-15 tingling Systemic: Tingling on feet-Medium
27 2021-04-18 weakness Chills, fever, body aches, dizzy, weak
27 2021-04-18 feeling hot, pain in extremity On day 3 following, 2nd dose of Pfizer vaccine, he had right sided calf pain. Initially thought to b... Read more
On day 3 following, 2nd dose of Pfizer vaccine, he had right sided calf pain. Initially thought to be recurence of strain injury, although no history of trauma or obvious trigger. Pain conitnued to worsen and had different characteristics than original strain symptoms. Continued to worsen to point wher eunable to weight bear and swollen, hot and red. Saw orthopedist who refered to vascular surgeon, and on day 13 was officially diagnosed with large DVT extending form tibeal & peroneal, popliteal up to the femoral veins. Has no known clotting defects. Currently under evaluation with hematologist who recommended anticoagulants for remainder of his life.
27 2021-04-18 tingling, speech disorder Client began to complain of feeling dizzy and experiencing tunnel vision right after receiving the v... Read more
Client began to complain of feeling dizzy and experiencing tunnel vision right after receiving the vaccine. Ice pack was applied to back of client's neck. About 5min after receiving the shot the client stated he thought he was going to pass out. 2 RN's walked client to a safe place to lie down. Client began to pass out while walking and was carefully lowered to the floor. Total time unconscious was about 30 seconds. Client began talking though mumbled. About 3 min later client stated he was feeling better. Another 3 min and client moved from laying on the ground to sitting in a chair. He stated he was less dizzy but his arms felt tingly. Client eating crackers and drinking water. Vitals remained stable throughout incident. Client was released to personal vehicle at 1:41pm, walked out of building on his own, gait was steady. Educated pt to request to lie down for 2nd vaccine.
27 2021-04-19 flushing Patient had syncope, dizziness, flushing/sweating, seizure, urinary incontinence. BP 119/79 -- > 103... Read more
Patient had syncope, dizziness, flushing/sweating, seizure, urinary incontinence. BP 119/79 -- > 103/53 -- > 108/50, HR 47 -- > 38 -- > 37 -- > 64 -- > 62, RR 16, O2 100%, Temp 97.3F. EMS called at 17:06, arrived at 17:13.
27 2021-04-19 pain in extremity PATIENT BROUGHT WITH RAPID RESPONSE TO ED FROM VACCINATION ROOM; SYNCOPE IMMEDIATELY AFTER VACCINE S... Read more
PATIENT BROUGHT WITH RAPID RESPONSE TO ED FROM VACCINATION ROOM; SYNCOPE IMMEDIATELY AFTER VACCINE SHOT; PATIENT FELL FROM STANDING AND HIT HEAD ON TABLE; C-COLLAR IN PLACE; PATIENT REPORTS LOSS OF CONSCIENTIOUSNESS; PATIENT STATES HE HAD PAIN TO LEFT SIDE OF HIS ARM; NO SIGNS OF SOFT TISSUE INJURY
27 2021-04-20 pain in extremity Tinnitus Sore arm
27 2021-04-21 weakness Day of shot (4/9), experienced a potential vasovagal reaction and bleeding in the arm. 10 days after... Read more
Day of shot (4/9), experienced a potential vasovagal reaction and bleeding in the arm. 10 days after shot, on 4/19, began to feel very weak and faint, and movement became effortful, along with chills and muscle aches and soreness. This continued into 4/20. Vitals were checked and found to be normal, and by 4/21 symptoms mostly subsided, except for remaining occasional chills and muscle-aches.
27 2021-04-21 numbness 10mins into his observation Client reported feeling itchiness on collarbone and numbness on his ri... Read more
10mins into his observation Client reported feeling itchiness on collarbone and numbness on his right side arm where he had received his vaccine. Client then proceeded to taking his own allergy med that he carries in his bag. Claritin 1 tab 10-15mg. Vitals signs at 3:15pm BP 109/60 HR 60 Respirations 18. He states he is allergic to sulfa, cucumber, avocado, banana which causes him to have an anaphylaxis response. Pt stated he hadn't had anything to eat and a granola bar was provided for him, as well as water. Vital signs BP 130/70 HR 70 RR 18, 3:27pm BP 125/75 HR 71 RR 18. After third set of vitals were taken client reported feeling much better. 3:34pm BP 130/70 HR 70 RR 18 02 97%. Client reported itchiness had gone away. Client was in no respiratory distress and denied having any closing of throat. Client was informed to follow up with his Primary care provider, and emergency precautions were given. He left site in no apparent distress.
27 2021-04-22 cold sweat Post vaccine patient stated his vision began to be blurry and he felt clammy, sweaty and like he w... Read more
Post vaccine patient stated his vision began to be blurry and he felt clammy, sweaty and like he wanted to pass out. Pt was transferred to the observation area. Pt laid down on the stretcher and was given some graham crackers and water. Shortly after the patient stated he was feeling better . Vitals as follows: 1120 SITTING BP 109/74 HR 71 RR 71 SpO2 99; 1124 LYING BP 110/72 HR 74 RR 20 SpO2 99; 1128 BP 104/71 HR 76 RR 20 SpO2 100; 1135 standing BP 107/63 HR 71 RR 18 SpO2 98
27 2021-04-23 pain in extremity Sore arm, Full body aches, fatigue
27 2021-04-23 seizure Systemic: convulsed immediately after getting shot, less than 10 sec, came to in less than 10 sec-Mi... Read more
Systemic: convulsed immediately after getting shot, less than 10 sec, came to in less than 10 sec-Mild, Systemic: Seizure-Mild, Additional Details: he covulsed immediately after injection, staff got him on floor, he awoke in less than 10 sec and was completely aware, knew his name, where he was, and relatively the current time. We had him lay on floor with feet up, he said he felt fine, had normal blood pressure 142/88 hr 89, when emt arrived he felt lightheaded so they took him to hospital, He said no history of seizures, but said does pass out and do this after injections.
27 2021-04-26 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium
27 2021-04-27 seizure Pt had Pfizer vaccine, lost consciousness briefly and had seizure and lost control of bladder. EMS w... Read more
Pt had Pfizer vaccine, lost consciousness briefly and had seizure and lost control of bladder. EMS was called, pt declined to go to ED. Documents were signed and since pt had seizure and lost consciousness, report was filed. Pt was informed. Pt's friend picked up patient. Pt was urged to followed up with PCP and go to ED.
27 2021-04-28 tremor, flushing POST VACCINE, BEGAN TO FEEL FLUSHED, LIGHT HEADED, AND HAD PRE-SYNCOPAL EPISODE, ASSISTED TO FLOOR; ... Read more
POST VACCINE, BEGAN TO FEEL FLUSHED, LIGHT HEADED, AND HAD PRE-SYNCOPAL EPISODE, ASSISTED TO FLOOR; SYNCOPAL TREMORS NOTED BRIEFLY. SPONTANEOUS RECOVERY WITH NO S/S UPON ARRIVAL TO OBS VIA STRETCHER. VSS. ESCORTED TO EXIT WITH NO ISSUES ONCE S/S RESOLVED AT 1700. 1631 BP 160/88 HR 70 RR 12 SATS 100% RA 1653 STANDING BP 144/90 HR 80 RR 16 SATS 98% RA
27 2021-04-28 unresponsive to stimuli Vasovagal syncope Pt fell face first out of the chair approximately 10 minutes post covid vaccine. P... Read more
Vasovagal syncope Pt fell face first out of the chair approximately 10 minutes post covid vaccine. Pt became pale,diaphortic , pupils dilated and non-responsive. No chest rise/fall noted. Nurse could not palpate a pulse. Epi pen administered in right thigh. Pt responded to epi pen and sat up on his own . Emergency alert called overhead on the PA System. ED staff responded and transported pt via stretcher to ED. Pt discharged to home.
27 2021-04-29 weakness, tremor Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Med... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
27 2021-04-29 migraine Migraine Minor body ache Fever 101F
27 2021-04-30 bell's palsy lower right side of his face drooping and unable to move it/ Bell's Palsy; This is a spontaneous rep... Read more
lower right side of his face drooping and unable to move it/ Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8733) via an unspecified route of administration, administered on the left arm on 29Mar2021 11:30 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. On 10Apr2021 09:00 AM, patient woke up with lower right side of his face drooping and unable to move it. Urgent care advised going to ER, he was put in a stroke protocol, MRI proved it to be Bell's Palsy; ruled out stroke, brain tumors, all blood work normal, echocardiogram normal. No Lyme. No other events or health issues, only change was taking the vaccine. The event resulted in emergency room/department or urgent care visit and hospitalization for 1 day. Therapeutic measures were taken as a result of the event which included valaciclovir (VALTREX) and prednisone (and lots of tests). COVID test post vaccination on 10Apr2021: nasal swab negative. The facility where the vaccine was administered was in a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Outcome of the event was not recovered.
27 2021-04-30 numbness Patient Received his 2nd dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1000 on 4/30/21. Patient ... Read more
Patient Received his 2nd dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1000 on 4/30/21. Patient alerted EMT. Patient stated that he felt that both hands felt numb at around 1032. EMT asked patient to stay extra 30 minutes. EMT reassessed patient at 1107 and patient no longer felt any symptoms. Patient requested for his vital signs to be taken. EMT took vital signs at 1108. BP: 152/92, pulse: 82, O2: 96%. Patient was educated on signs and symptoms of hypertensive crisis and recommended to make appointment to PCP. Patient agreed. Patient left vaccination site unassisted with a steady gait.
27 2021-04-30 migraine, cold sweat Severe migraine, muscle aches, cough, fever, cold sweats and muscle fatigue.
27 2021-04-30 tremor Headache, chills, dizziness, nausea, hands shaking
27 2021-04-30 unresponsive to stimuli Systemic: Fainting/Unresponsive-Severe. Additional Details: Patient had a syncope episode post vacci... Read more
Systemic: Fainting/Unresponsive-Severe. Additional Details: Patient had a syncope episode post vaccine administration. Unresponsive for about 5 minutes. Paramedics were called, patient had recovered from his episode quickly.
27 2021-05-01 weakness Within 5 minutes, I was very sweaty, nauseous and felt like I might pass-out. I was weak. I was told... Read more
Within 5 minutes, I was very sweaty, nauseous and felt like I might pass-out. I was weak. I was told my blood pressure was low. Approximately 15 minutes from the start of symptoms, I rapidly recovered. Within 20 minutes since the shot, I mostly felt normal. The next day and later that evening I felt fine.
27 2021-05-01 pain in extremity, cold sweat Tunnel vision, vomiting, chills, cold sweats, and very close to fainting. These effects occurred at ... Read more
Tunnel vision, vomiting, chills, cold sweats, and very close to fainting. These effects occurred at 3AM the morning after the second dose was administered. Nausea, lack of appetite, arm soreness and fatigue continued through the day. Fatigue continued the day after but the effects seem to be wearing off.
27 2021-05-03 muscle spasms, pain in extremity 1. Sharp Pain in left leg behind knee. Felt similar to nerve pain when leg cramps. Pain occurred ran... Read more
1. Sharp Pain in left leg behind knee. Felt similar to nerve pain when leg cramps. Pain occurred randomly off and on throughout the day. 2. Nausea. Occurred 2-3 times throughout the day. 3. Nose bleed. Occurred 2x on 5/2 and again on 5/4.
27 2021-05-04 cold sweat Fatigue, chills, cold sweats. Low grade fever. Lasted around 15 hours
27 2021-05-04 pain in extremity Left Arm pain starting around 4pm intensifying until plateauing at midnight, May 3rd going into May ... Read more
Left Arm pain starting around 4pm intensifying until plateauing at midnight, May 3rd going into May 4th. Left Arm pain became much more mild by early morning May 4th before resolving completely sometime overnight between May 4th and May 5th. Stiffness and feeling feverish starting around 11pm May 3rd lasting until around 4am May 4th. Slight nausea while standing up starting around 3am May 4th and lasting until around noon May 4th. All symptoms managed at home.
27 2021-05-04 unresponsive to stimuli lost my vision; lost my vision and hearing; essentially unresponsive; feel light-headed; This is a s... Read more
lost my vision; lost my vision and hearing; essentially unresponsive; feel light-headed; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0161), dose 1 via an unspecified route of administration, administered in the left arm on 16Apr2021 at 14:30 as SINGLE DOSE (at the age of 27 years-old) for covid-19 immunisation. Medical history included coarctation of the aorta from an unknown date and unknown if ongoing coarctation of aorta (age: 3 months), only requires bi-annual cardiologist visits, loss of consciousness from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient had no know allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient lost his vision and hearing, essentially unresponsive and light-headed on 16Apr2021 at 14:30. Circulation issues leading to a black out. Within 60 seconds of getting the shot, he began to feel light-headed. Within 30 seconds of that, he knew he needed help, so alerted the emergency medical technicians (EMTs) via car horn/flashers. By the time they arrived (120 seconds from the initial shot), he lost his vision and hearing and was essentially unresponsive. They woke him enough to unlock my car door, at which point they had him lay back to improve his circulation. That ultimately worked and got him back to normal within about 5 minutes. The patient had issues like this before relating to a coarctation of his aorta which he had done at 3 months of age. Over the years, he has "blacked out" like this from weight lifting and other high exertion things. This was the first time it was induced without him overexerting himself, and the onset of the "blackout" was much quicker than what he had experienced from weightlifting. Normally, he could tell 1-3 minutes in advance that he would black out. This time, it was about 30 seconds. Therapeutic measures were taken as a result of lost vision and hearing, essentially unresponsive and feel light-headed. EMTs did an electrocardiogram (EKG) and blood glucose check. The outcome of lost his vision and hearing, essentially unresponsive and light-headed was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
27 2021-05-05 night sweats He received the 1st dose of the Pfizer COVID vaccine on 4/22/21 and within 5 minutes, developed coug... Read more
He received the 1st dose of the Pfizer COVID vaccine on 4/22/21 and within 5 minutes, developed coughing, sneezing, and rhinorrhea. Within 2-3 hours, symptoms progressed into pt having swollen and red cheeks and red eyes. Denies any sob, tongue or lip swelling, hives, abd pain, dizziness. His BP was his normal, O2 was normal and he was sent home. He did not take any Benadryl or use epinephrine. That night he had subjective fever and night sweats. The symptoms lasted for 2 days and pt used Tylenol for symptomatic relief. Sx resolved by the 3rd day
27 2021-05-05 unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Fainting / Unres... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received vaccine, sat in observation chair for about 3 min speaking on his phone, patient leans forward and passes out, falling out of the chair and hitting the floor. The patient was unconscious for about 10-15secs. Pharmacist administering vaccine, immediately went to his aid and had his sit. I was called over and offered medical care, which he declined. Patient was given water and an ice pack for the abrasions received.
27 2021-05-07 pain in extremity Thought that I was in the clear of any side effects. First vaccine only resulted in a minor sore arm... Read more
Thought that I was in the clear of any side effects. First vaccine only resulted in a minor sore arm. Got second Phizer vaccine at 10:40 a.m. on 5/6 and went all day with nothing. Woke up at 2 a.m. the next morning (15.5 hours after vaccine) with sore arm at point of injection, chills, fever, aches, and a headache. Symptoms lasted all day. Woke up the next morning (46 hours after vaccine, 30 hours after symptoms started) with no lasting effects.
27 2021-05-08 pain in extremity Swelling and pain around arm, redness, sleepy
27 2021-05-09 migraine Migraine (2PM - 8PM) Fatigue (2PM - 8PM) Nausea (2PM - 8PM)
27 2021-05-09 seizure In the 15 minute waiting area patient begin to have seizure activity, then slumped into steering whe... Read more
In the 15 minute waiting area patient begin to have seizure activity, then slumped into steering wheel and then went rigid again with seizure like activity. Each one lasted approx. 15 -20 seconds. No medical hx of seizures per patients.
27 2021-05-10 feeling hot I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, h... Read more
I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; I received the first dose of the Pfizer vaccine. During the 15 minute evaluation, i felt nauseous, hot/sweaty and my vision got blurred to the point i passed out on the floor. After I regained conscio; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 at 15:00 (Batch/Lot Number: EW0158) at 27-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient's medical history was reported as none. There were no concomitant medications received within the two weeks of vaccination. The patient experienced: "I received the first dose of the Pfizer vaccine. During the 15-minute evaluation, I felt nauseous, hot/sweaty and my vision got blurred to the point I passed out on the floor. After I regained consciousness (medically significant, hospitalization) on 10Apr2021 at 15:00. Reported Event: The patient received the first dose of the Pfizer vaccine. During the 15-minute evaluation, the patient felt nauseous, hot/sweaty and their vision got blurred to the point where the patient passed out on the floor. After, the patient regained consciousness with the assistance from the doctors and nurses there. The patient passed out again within minutes. After the second time, the patient was placed on a stretcher and sent to the emergency room for further testing. The patient reported that he had no history of medical conditions. The patient stated "all because of my vaccine hospitalization, I acquired a (some amount) medical bill. I would like to discuss assistance for handling this. I have all of the paperwork as proof. It's very unfortunate to pay this amount due a shot." Pfizer received an adverse event letter from withheld directed to Department, on 03May2021. Customer Verbatim: "On Saturday, 10April2021, I received the first dose of the Pfizer vaccine. During the 5-minute evaluation, I passed out on the floor. After I regained consciousness, I passed out again within minutes. After this, I was taken to the emergency room. I have no history of medical conditions. All because of my vaccine hospitalization, I acquired a (some amount) medical bill. I would like to discuss assistance for handling this. I have all of the paperwork as proof. " It was reported that the events required an emergency room visit and physician office visit. The patient was hospitalized due to the events from 10Apr2021 to an unknown date for 1 day (as reported). It was reported that no therapeutic measures were taken. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
27 2021-05-10 feeling hot Starting 10 mins after vaccination, patient complains of blurry vision and feeling hot. Instructed t... Read more
Starting 10 mins after vaccination, patient complains of blurry vision and feeling hot. Instructed to turn on AC in car and patient reports he had not eaten much today. OJ given. At 15:15 episode of emesis x 1. Nausea relieved after emesis. Water given and vision returned back to baseline. Vitals 15:16 T975., HR 74, RR 16, O2 97% RA, BP 102/82. Patient remained at site for about 10 mins and symptoms entirely resolved.
27 2021-05-10 unresponsive to stimuli, grand mal seizure, seizure Patient appeared to have 45-60 second seizure following first dose of Pfizer COVID-19 vaccine. Appea... Read more
Patient appeared to have 45-60 second seizure following first dose of Pfizer COVID-19 vaccine. Appeared to experience a tonic/clonic seizure. He was sitting in a chair, scheduling an appointment to receive his second COVID-19 vaccine and became unresponsive and stiff. Staff responded, patient was lowered to the floor for safety. Patient was turned on his side to maintain airway. O2 was take 97-99% on RA. Once rigidity had resolved, O2 was applies at 3L NC as a precaution once stiffness resolved. BP was taken, 83/59 and pulse 105 side laying. 5 min later, BP 109/73, pulse 106 supine. EMS was called, patient transferred to ambulance. Patient was alert and oriented.
27 2021-05-12 speech disorder PT FAINTED AFTER VACCINATION. AFTER HE WOKE UP WE HE STILL SEEMED LETHARGIC AND WAS MUMBLING. HIS BP... Read more
PT FAINTED AFTER VACCINATION. AFTER HE WOKE UP WE HE STILL SEEMED LETHARGIC AND WAS MUMBLING. HIS BP WAS 68/40 SO WE CALLED EMS. WE PUT PT ON THE FLOOR AND RAISED HIS LEGS. EMS EVALUATED PT AND TRANSPORTED HIM TO HOSPITAL FOR FURTHER EVALUATION
27 2021-05-13 pain in extremity, feeling hot Body aches, headaches, chills, body very hot, lots of soreness in arm of injected site, arm ache on ... Read more
Body aches, headaches, chills, body very hot, lots of soreness in arm of injected site, arm ache on other arm after a day as well
27 2021-05-14 limb paralysis Began to have pain in hip that progressed to severe pain and parlaying leg and foot; Unable at 2 nd ... Read more
Began to have pain in hip that progressed to severe pain and parlaying leg and foot; Unable at 2 nd week to stand or walk; Unable at 2 nd week to stand or walk; Began to have pain in hip that progressed to severe pain and parlaying leg and foot; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 30Apr2021 at 15:30 (at the age of 27 years) as unknown dose, single for COVID-19 immunization. Medical history included obesity and mental illness. Concomitant medications included aripiprazole (ABLIFY), sertraline hydrochloride (ZOLOFT), metformin, bupropion hydrochloride (WELLBUTRIN), simvastatin and lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient was tested for COVID-19. The patient was hospitalized on 27Apr2021 for an unknown reason and began to have pain in hip that progressed to severe pain and parlaying leg and foot on 03May2021. Unable at the second week to stand or walk. These adverse events result in emergency room (ER) or department or urgent care. The patient's hospitalization was prolonged and the patient was disability as a result of these events. It was unknown if the treatment was received by the patient due to these events. It was reported that the duration of hospitalization was 10 days discharged on 07May2021 (also reported as continued, CLARIFICATION PENDING). The outcome of all these events was not recovered at the time of report. Information on the lot/batch number has been requested.
27 2021-05-14 muscle spasms High fever, chills, shorten breathe, dizziness, fatigue, muscle spasms, joint pain
27 2021-05-14 unresponsive to stimuli Patient was administered the Pfizer vaccine and was asked to wait around the pharmacy for 15 minutes... Read more
Patient was administered the Pfizer vaccine and was asked to wait around the pharmacy for 15 minutes post vaccination. After 5 minutes, patient started feeling dizzy and started to faint. He was accompanied by his parents, father tried waking patient up a few times but he was unresponsive to wake and started to tilt his head backwards and falling over. We called the paramedics and administered the epipen. Father did notify us that patient is fine and was discharged from the ER on the same day.
27 2021-05-15 cold sweat Chills, cold sweats, throbbing headache, and hives
27 2021-05-15 feeling hot Severe fever and chills overnight, unmeasured but body noticeably hot to touch. Fever still 99.8 dur... Read more
Severe fever and chills overnight, unmeasured but body noticeably hot to touch. Fever still 99.8 during next day after several hours when thermometer was acquired, but had significantly broken by that point
27 2021-05-17 involuntary muscle movements Pt DOB 1/4/1994. Pt had his first dose of Pfizer and was sitting in post observation. Per post obser... Read more
Pt DOB 1/4/1994. Pt had his first dose of Pfizer and was sitting in post observation. Per post observation staff to this writer: Pt began to jerk and slumped to his right side. Pt became diaphoretic, eyes were fixed but was able to answer all questions. Pt was laid onto cot feet elevated until Aid arrived. Guest reports he came from the gym and has not eaten today. Pt back to baseline and cleared to d/c home. Pt mother came to drive Pt home.
27 2021-05-17 numbness, pain in extremity fainted; lost consciousness for a couple of seconds; burning pain that felt like needles on his shou... Read more
fainted; lost consciousness for a couple of seconds; burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/He had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn; felt like he could not stand and had to go to the floor, struggled to get up; arms were numb; thought he was having a heart attack; left arm weak; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left side of face is swollen; left side of face is swollen was reported as worsened.; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left arm pain; This is a spontaneous report from contactable consumers (patient reported for himself, patient's mother). A 27-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 01May2021 12:00 noon (Batch/Lot Number: EW0170; Expiration Date: 31Aug2021) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunization, at the age at vaccination of 27 years old. The patient's medical history and concomitant medications were not reported. The patient experienced thought he was having a heart attack(medically significant) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (medically significant) on 03May2021 with outcome of not recovered, fainted (medically significant) on an unspecified date with outcome of unknown, lost consciousness for a couple of seconds (medically significant) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/he had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn (non-serious) on 03May2021 01:00 with outcome of unknown, felt like he could not stand and had to go to the floor, struggled to get up (non-serious) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, arms were numb (non-serious) on 03May2021 01:00 with outcome of recovering, left arm pain (non-serious) on 03May2021 with outcome of not recovered, left arm weak (non-serious) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 01:00 with outcome of not recovered, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 with outcome of not recovered, left side of face is swollen (non-serious) on 03May2021 01:00 with outcome of not recovered , left side of face is swollen was reported as worsened (non-serious) on 03May2021 with outcome of not recovered. The patient underwent lab tests which included computerised tomogram (brain CT): no results, electrocardiogram (EKG): no results, both on unknown date. Reported patient was in pain and his mom and dad didn't know what to do. He had sharp pains. No bruises. He remember lowering myself to fall. He didn't fall. It was a strange thing. When he went to the ER they didn't fine anything. He was still in the same amount of pain. Caller stated her son took the vaccine on Saturday. Thirty six hours later around 1:00am he started getting extremely, burning pains across his back.The patient stated he was coming out of the bathroom and felt like he couldn't stand and he had to go to the floor. He lost consciousness for a couple of seconds. Both arms were numb. He struggled to get up. He sat on the couch and then went upstairs after being in the basement. He had a burning pain that felt like needles on his shoulder, left arm and a little on right side. His skin was sensitive. The back of his neck feels like he has a third degree burn. This morning he went to the hospital. Initially said he fainted but clarified that he was speaking about losing consciousness. He had left arm pain. He thought he was having a hard attack. While at the emergency room today he had labs, a brain CT scan and an EKG. He does not have results to provide. Caller added that his skin was hypersensitive. It was like if he moves the hair on his arm it hurts. His parents noticed he has swelling on the left side of his face. The events require a visit to Emergency Room. No Prior Vaccinations (within 4 weeks). Information on Lot/Batch number was available. Additional information has been requested.
27 2021-05-17 migraine dry cough, runny nose, migraine, dizziness, trouble sleeping, stiffness, weakness in left arm, sore ... Read more
dry cough, runny nose, migraine, dizziness, trouble sleeping, stiffness, weakness in left arm, sore throat,...
27 2021-05-17 unresponsive to stimuli Pt feeling lightheaded, BP 102/71; HR 79; RR 18. At assessment in observation pt hard to initiate a ... Read more
Pt feeling lightheaded, BP 102/71; HR 79; RR 18. At assessment in observation pt hard to initiate a response, blankly staring & unresponsive to questions. Eventually responded after 1 min & stated "I'm dizzy." Wheeled to bay, VS stable, AOx4, dizziness subsided per pt. Water given, BP 120/71 sitting, feels good to walk on own.
27 2021-05-19 tingling Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in both arms and fingers
27 2021-05-19 seizure Almost immediately after patient received the second dose of vaccine he stood up and passed out to t... Read more
Almost immediately after patient received the second dose of vaccine he stood up and passed out to the floor. He slightly seized for a few seconds until it stopped. When patient came to he stated that his knee hurt but he didnt believe he hit his head and he felt a bit light headed. Patient laid down for a while with us until he started to feel better. His BP was 102/58, but normally runs low. He said that he has passed out before and has been under a lot of stress, also had not eaten that morning before getting vaccinated. His significant other was with him and was planning to drive home. Patient was offered a call to EMS but refused.
27 2021-05-21 numbness, pain in extremity, tingling Initial symptom was tingling then loss of feeling in both lower legs. Happened a few times over seve... Read more
Initial symptom was tingling then loss of feeling in both lower legs. Happened a few times over several days. Lasted for several minutes each episode. Also had involuntary muscle tightness and pain in left upper thigh (quads) and left biceps. These episodes also happened several times, but not concurrently.
27 2021-05-22 bell's palsy Bell's Palsy on the right side of my face; muscle weakness around the right corner of my mouth, chee... Read more
Bell's Palsy on the right side of my face; muscle weakness around the right corner of my mouth, cheek, and eye.
27 2021-05-22 tremor, flushing, unresponsive to stimuli Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Letha... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild, Additional Details: Patient passed out about 5 minutes after receiving immunization. He came to fairly quickly but was confused, shaky and sweaty. After laying on the floor for a while he became nauseous but did not physically vomit while in my care. As the paramedics arrived the patient passed out a second time and was taken to the ER after evaluation.
27 2021-05-22 tremor, flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-M... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
27 2021-05-23 seizure Roughly 5 minutes after vaccine patient lost awareness, became red in the face, eyes rolled to back,... Read more
Roughly 5 minutes after vaccine patient lost awareness, became red in the face, eyes rolled to back, seizure like activity for about 1 to 2 minutes. 911 was called and the patient was assessed and released.
27 2021-05-24 discomfort Moderate aches experienced on the day following vaccination (5/23) beginning in the morning. Two dos... Read more
Moderate aches experienced on the day following vaccination (5/23) beginning in the morning. Two doses of ibuprofen taken in the morning and afternoon. Mild pain experienced in left front armpit, nearly on the left pectoral, on the night following vaccination. On the following morning (5/24), moderate swelling was noticed in the left armpit, extending from underneath the armpit down to the upper lat muscles and up along the left pectoral nearly to the nipple up to just below the left collarbone. Mild pain experienced in the left front armpit as well as on the lymph node under the armpit. No inhibition of arm motion or pain when using arm, but some feeling of discomfort and pressure. Tele-med help was sought which did not recommend any course of action. By the afternoon, moderate swelling was noticed on the left arm, on the bicep and tricep down to the elbow. Ibuprofen was taken at ~3pm with no effect. Medical advice was sought at 7pm and it was recommended to head to urgent care, but all providers in the area were closed. By this morning (5/25), the swelling has reduced significantly and localized to the left front armpit. Mild pain remains, now more localized to the lymph node under the left armpit.
27 2021-05-25 pain in extremity 27-year-old gentleman with history of mild intermittent asthma, anxiety, presented with complaints o... Read more
27-year-old gentleman with history of mild intermittent asthma, anxiety, presented with complaints of fever of 99.8 °F on 5/22/2021 associated to fatigue and body aches and then chest pain, generalized with radiation to left arm since afternoon of 5/23/2021, which got worse on 5/24/2021 and he was admitted for further evaluation with initial troponin of 472. Had an NSTEMI; chest tightness, pain in left arm, lightheadedness, dizziness, presyncope. Discharge diagnosis - probable myocarditis; clinical picture most consistent with viral myocarditis.
27 2021-05-25 pain in extremity Very sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 27-year... Read more
Very sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm right, on 19Feb2021 at 08:30 AM (Lot Number: EN6203), as single dose, for COVID-19 immunisation. The patient's medical history was none. Patient had no known allergies. Patient did not have COVID-19 prior to vaccination. Concomitant medications included loratadine (unknown manufacturer), vitamin d3 (unknown manufacturer) and men multivitamin 1x/day. The patient experienced very sore arm (non-serious) in Feb2021 at 12:00 PM with outcome of unknown and nausea (non-serious) in Feb2021 at 12:00 PM with outcome of unknown. Patient has not been tested for COVID-19 post vaccination. Follow-up attempts are completed. No further information is expected.
27 2021-05-25 cold extremities Patient started to feel dizzy , skin color getting pale , cold hands , sweat , and was about to f... Read more
Patient started to feel dizzy , skin color getting pale , cold hands , sweat , and was about to faint 5 minutes after administering the vaccine . pharmacist on duty grabbed the Epipen and blood pressure machine . patient blood pressure was 65/40 , patient started to feel better for couple minutes then he start to feel dizzy and to get same symptoms again , at this moment pharmacist injected the patient with Epipen as he stated he iwas fainting .patient denied to have any allergies , fear for needles or any health conditions . pharmacist kept watching and monitoring the patient till his blood pressure came back to 118/69. patient family came to pick him up .
27 2021-05-25 sciatica, nerve pain Flared up my chronic lower back pain, which flared up my nerve/sciatic pain. At its worse, it was so... Read more
Flared up my chronic lower back pain, which flared up my nerve/sciatic pain. At its worse, it was so bad I couldn?t walk.
27 2021-05-26 seizure Employee have a history of a seizure disorder received vaccine 1030 seizure started at 1047
27 2021-05-27 feeling hot Pfizer was given as second dose of which patient received moderna for the first one. Patient experi... Read more
Pfizer was given as second dose of which patient received moderna for the first one. Patient experienced a warm feeling in the arm. It continued but by the afternoon 3 o'clock he was feeling better
27 2021-05-27 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Se... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Medium
27 2021-05-27 numbness, tingling After first Pfizer dose, I was just feeling really tired. After the second dose, around that afterno... Read more
After first Pfizer dose, I was just feeling really tired. After the second dose, around that afternoon/evening I started feeling my mouth feeling weird. The next day I saw blisters filled with yellow/whiteish puss in my tongue. I went to the ER later i felt a lump under left shoulder while showering. On 28 MAY 3 AM I suddenly felt my face feeling numb and tingly along with my legs. Mind you I have been in the field emplacing howizters for the past few days in a field exercise. I also jammed my finger on an 80 lb metal bar on 26 MAY and got my finger poked with a hot device that also drained the blood after getting an xray. I called medical ER at 242 and spoke to Dr.(?) Doctor did not give me his name spelling after I asked for the spelling and he told me that I could always come in to the ER. I told him whether the finger pricking and blooding draining could cause the left facial numbness and legs tingleness. He said no so i am now assuming it is an adverse side effect. I am a smart guy have bachelors in journalism but right now I cannot concentrate and filling out htis form hastily just i case the effects get worse and I have to go to hospital er. Talking to the Dr. (?) was harder than normal and he asked if my breathing was normal, I said i am breathing heavily, which I did not have much control over. He said breathe normally and I will be better from the tingliness. I can write well I am a journalism major but this is hard to write for me . I am also feeling chills and I am also not feeling well. I was able to get this link from my local online meeting and I am glad I can contribute to the research and science in general. I wish the doctor had tested me for possible problems when I had an adverse effect from the first vaccine but the doctor told me to come back if the "viral infection" gets worse after I breathe normal. I did take a PT test and my 2 mile run time increased and it was much harder to run than the 2 mile run. Time went up by at least 3 minutes.
27 2021-05-28 weakness Swollen lips; Swollen tongue; Swollen face; Itchy throat; Lightheaded; weak; feeling Sore on right a... Read more
Swollen lips; Swollen tongue; Swollen face; Itchy throat; Lightheaded; weak; feeling Sore on right arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EN 6204) via an unspecified route of administration in right arm on 12Mar2021 at 08:45 AM (at the age of 27-years) as a single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 12Mar2021, post the vaccination, the patient felt soreness on the right arm. On 13Mar2021 at 12.00 PM, he started to become very weak, and light headed. On 14Mar2021, he woke up and his entire face was swollen including his tongue and his throat was itchy and on 17Mar2021, his lips and tongue were still swollen. Therapeutic measures included treatment with methylprednisolone acetate (DEPO-MEDROL) 40 mg/ml injection. The clinical outcome of the events vaccination site pain, weakness, light headedness, swollen face, swollen tongue, swollen lips, and itchy throat was reported as not resolved. No follow-up attempts are needed. No further information is expected.
27 2021-06-01 numbness felt numb and emotionless; felt numb and emotionless; felt sick to my stomach; Food does not take go... Read more
felt numb and emotionless; felt numb and emotionless; felt sick to my stomach; Food does not take good anymore and I have to force myself to eat; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 11May2021 16:30 (Batch/Lot Number: EW0173) (at the age of 27-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included known allergies nickel. Concomitant medications included none (did not receive other medications the patient received within 2 weeks of vaccination). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 administered in Arm Right on 20Apr2021 17:30 (Batch/Lot Number: EW0170) for covid-19 immunisation and had no adverse event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021 09:30, the patient experienced felt numb and emotionless, felt sick to my stomach and food does not take good anymore and i have to force myself to eat. Seriousness criteria reported as non-serious. No treatment was given for the events. The outcome of the events was not recovered.
27 2021-06-05 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: PAIENT GOT PANIC ATTACK AND FAINT BUT ... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: PAIENT GOT PANIC ATTACK AND FAINT BUT RECOVER WITH IN 3-4 M INUTES, CALLED 911, PARAMEDIC HELPED HIM
27 2021-06-08 pain in extremity I CALLED THIS PATIENT AND HE SAID HE FELT NAUSEOUS LAST NIGHT. HE SAID IT MAY HAVE BEEN DUE TO WHAT ... Read more
I CALLED THIS PATIENT AND HE SAID HE FELT NAUSEOUS LAST NIGHT. HE SAID IT MAY HAVE BEEN DUE TO WHAT HE ATE. BUT OTHER THAN THAT, JUST A SORE ARM TODAY.
27 2021-06-09 night sweats Headache; Fever; Chills; Sweating all night; This is a spontaneous report received from a contactabl... Read more
Headache; Fever; Chills; Sweating all night; This is a spontaneous report received from a contactable consumer (patient's parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202), on 04Mar2021 (at the age of 27-year-old) as unknown, single dose for COVID-19 immunisation. Vaccine facility type was reported as workplace clinic. The patient's medical history included known allergies: seasonal allergies, mold, dust, and mites. No COVID prior vaccination was reported. No concomitant medications in two weeks were reported. Patient did not receive other vaccines in four weeks. On 05Mar2021 the patient had headache, fever, chills and sweating all night. Patient was treated due to the events with paracetamol (TYLENOL). Patient was not tested for COVID post vaccination. The outcome of the events was recovered with sequel (reported as recovered with lasting effect). No follow-up attempts are needed. No further information is expected.
27 2021-06-09 seizure The patient was given Pfizer Covid vaccine and was the 1st dose in series. The patient walked to obs... Read more
The patient was given Pfizer Covid vaccine and was the 1st dose in series. The patient walked to observation chair after receiving vaccine. He fell from chair to the floor and appeared to have a seizure with arm movements and became aware soon after. Ems was called. Patient had some water and disclosed that he had not eaten yet. He then had OJ while awaiting EMS. He did not go with EMS.
27 2021-06-10 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
27 2021-06-12 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient was sitting in chair and rested head on arms. Then he fell out of chair onto floor. Immediately woke up after rph-on-duty went to him. He sat on floor for approximately 3 minutes and then was feeling well enough to sit in chair. Patient was able to communicate and sit in chair again. Patient stayed at pharmacy for approximately 30 minutes and was well enough to walk on own. No other issues reported by patient.
27 2021-06-13 numbness, feeling cold 3:00- 2nd dose Pfizer covid-19 vaccine placed to left arm. 3:05- reports ?saw shooting stars? pt pal... Read more
3:00- 2nd dose Pfizer covid-19 vaccine placed to left arm. 3:05- reports ?saw shooting stars? pt pale, laid him down immediately BP 122/82, HR 62, 100% on RA. 3:15 Pt reports facial numbness in lower face. Reports numbness to left arm. Pt report he feels cold. +Nausea. Brief neuro exam, equal facial symmetry, equal grips, Eye tracking normally, speech clear, normal and equal strength in all extremities. 145/80, HR 100 sat 100%. 3:28 Numbness to left arm resolved. Numbness to cheeks and lips continues. Nausea persisting. Pale. Pt reports he felt lower facial numbness 4 hours after first dose of Pfizer covid-19 vaccine, he did not seek medical care and reports the symptoms resolved. Pt in seated position, Pt given juice, tolerating well. BP 122/75, HR 104 98% on RA. 3:43 + emesis, HR 95-105, 98% on RA. PT states he feel better after episode of emesis. States lower facial numbness improving. PT pale. PT states he feels well enough to leave. Pt encouraged to stay to be monitored. Pt reports that his daily food intake consisted of 1 breakfast Danish during the morning, did not eat during the day. Pt reports he smokes 1 pack of cigarettes per day. 3:50- Pt given small sips of water and crackers. Pt tolerating well. Pt no loner pale. Pt denies facial numbness, Vitals WNL. 3:59-Ambulation trial with PT and Nurse. Pt tolerating well. 4:15- Pt Alert and oriented. Pt expressed that he feels well and would like to leave. PT edu given to contact PCP. Pt advised to contact EMS or ER if symptoms return or if new symptoms arise. PT aware of risks. Pt escorted to Car by staff.
27 2021-06-13 tremor, cold sweat cold skin, headaches, dizzy, throwing up blood, shaking, heart rate was elevated, hard time breathin... Read more
cold skin, headaches, dizzy, throwing up blood, shaking, heart rate was elevated, hard time breathing
27 2021-06-16 tingling Pt c/o Left hand/finger tingling 15min after receiving his first dose. BP 130/76, HR 63, RR 16, 98%... Read more
Pt c/o Left hand/finger tingling 15min after receiving his first dose. BP 130/76, HR 63, RR 16, 98% on RA. Pt mentating well and speaks in full sentences. No CP, SOB, DIB, N/V. NP monitored pt and pt stated that his condition is improving. Pt stated that he was on his computer all day. Possible carpal tunnel. Wrist brace encouraged. Stop repetitive movements until tingling subsides. Pt stable and released from vaccination site. Recommended that the pt follow up with their healthcare provider, follow up instructions provided.
27 2021-06-17 facial paralysis, bell's palsy Bell?s Palsy Paralysis and swelling on the left side of the face Prednisone for treatment
27 2021-06-17 pain in extremity Around 2 weeks after my first dose, I started having heart palpitations. The palpitations were on an... Read more
Around 2 weeks after my first dose, I started having heart palpitations. The palpitations were on and off for a week and I didn't think of it much. A week after the palpitations started it started happening more frequently and I was feeling light headed and I went to ER. I was diagnosed with SVT and put on metoprolol to control my heart rate. 1 week after I was on metoprolol, I took my second dose. I was feeling a little dizzy after my second dose but it improved after like 10 minutes. I started getting very fatigued and difficult to concentrate after my second dose. I spoke to my doctor and we thought it was because of metoprolol. My cardiologist took me off metoprolol but the fatigue didn't stop and I started having aches in shoulders, arms, neck and back. The aches and fatigue was more severe in the morning. After a week of being off metoprolol I started waking up with chest pain. One day the pain was severe and I had aches in shoulders, arms, neck and back and my heart rate was around 140 so I went to ER. The doctors put me on carvedilol and my heart rate has been controlled but my body aches and fatigue has been going on. The cardiologist and my PCP aren't sure if SVT or the medication is causing my body aches and fatigue. The only other thing I could think of was the vaccine so I wanted to send this report.
27 2021-06-18 pain in extremity Headache; diarrhea; chills; sweating; sore arm; This is a spontaneous report from a contactable cons... Read more
Headache; diarrhea; chills; sweating; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: unknown), via an unspecified route of administration, in his left arm on 17Mar2021 (at the age of 27-years-old) for COVID-19 immunisation. The patient had no medical history and had no known allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The concomitant medications included cephalexin (MANUFACTURER UNKNOWN) for an unknown indication. On 18Mar2021 at 03:15 am, the patient experienced headache, diarrhea, chills, sweating and sore arm. No therapeutic measures were taken for these events. The clinical outcome of the events headache, diarrhea, chills, sweating and sore arm was unknown at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
27 2021-06-20 tension headache 27 yo M presents to the ICC c/o a headache and dizziness. States that he has neck muscle stiffness a... Read more
27 yo M presents to the ICC c/o a headache and dizziness. States that he has neck muscle stiffness and a squeezing, pressure-type headache that is affecting the top of his head and both sides of his forehead. The lights are bothering him and he is nauseated. Received COVID vaccination 4 days ago. Had a headache yesterday, which was worse than the one he has today. Has not taken any medications for symptom relief because he did not want to mess with the vaccine. Symptom duration == 5 hours. Not worsening. Diagnosed with a tension headache. Treated with acetaminophen 1000 mg. Rated 8-9/10 before taking acetaminophen and 3-4/10 after acetaminophen.
27 2021-06-24 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
27 2021-06-27 hot flush I am experiencing hot flashes, cold shivers, fever, full-body muscle soreness, headache, and vomitin... Read more
I am experiencing hot flashes, cold shivers, fever, full-body muscle soreness, headache, and vomiting. Vomiting only happened once during a really bad hot flash. Onset of event was roughly 12 hours after receiving second dose, and has continued through for almost 48+ hours on and off.
27 2021-06-30 feeling hot, pain in extremity Headache; injection site is at hurts a little bit.; he is feeling warm, is not sure if it's due to t... Read more
Headache; injection site is at hurts a little bit.; he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know; arm hurts; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 22Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced headache, injection site is at hurts a little bit, he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know and arm hurts on an unspecified date in 2021. Patient asked if it's alright to take Aspirin or place an ice pack on the injection site. Outcome of all the events was unknown. Information about Lot/batch number is requested.
27 2021-07-05 tremor temporary loss of vision; sweating; pale skin; shacking; This is a spontaneous report from a non-con... Read more
temporary loss of vision; sweating; pale skin; shacking; This is a spontaneous report from a non-contactable pharmacist. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), intramuscularly, administered in left deltoid on 20Jun2021 15:00 (at 27-year-old) as dose 1, single, for COVID-19 immunization. The patient had no medical history. No unknown allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cannabis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jun2021 at 15:00, the patient experienced temporary loss of vision, sweating, pale skin, and shacking. The events resulted in emergency room/department or urgent care. It was unknown whether treatment was received. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on the temporal relation, the association between the event blindness and vaccination cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
27 2021-07-07 discomfort Starting on Wednesday morning, couldn't hear in left ear and over the day both ears starting to lose... Read more
Starting on Wednesday morning, couldn't hear in left ear and over the day both ears starting to lose hearing. Thursday both ears felt like they were clogged and continued to get worse and felt pain and have a fever up until today. Patient also experienced ringing in the ear and discomfort. Pt would not use phone. Also experience dizziness. Patient was seen at urgent care on 7/7/21 and was diagnosed as a double ear infection and was prescribed cefdinir.
27 2021-07-07 seizure Observation RN noted a "30 second seizure" less than 15 minutes post vaccination. Initial steps tak... Read more
Observation RN noted a "30 second seizure" less than 15 minutes post vaccination. Initial steps taken by staff on duty, including calling EMS, which arrived shortly. Pt transported to local ED. Pt's SO states this has happened a few times previously associated with blood or needles. Pt was in a drive-thru vaccination/observation facility without AC on a nearly 100 degree day.
27 2021-07-08 weakness Within less than 5 min after administration, the patient looked pale, temporary lost of vision, and... Read more
Within less than 5 min after administration, the patient looked pale, temporary lost of vision, and weak to sit up straight. After asking more questions about his health and mediations, he informed about taking cannabis before the vaccination. By the paramedics came, he looked better and his vision came back. He was communicating and able to walk around.
27 2021-07-08 migraine Long lasting headache, migraine, vertigo, nauseous, unable to concentrate, brain fog, insomnia, stif... Read more
Long lasting headache, migraine, vertigo, nauseous, unable to concentrate, brain fog, insomnia, stiff neck, head sinus. Has been ongoing for 2 weeks
27 2021-07-08 tingling, pain in extremity About 4 hours post injection ring finger nerves became painful at tip with pins and needles feeling.... Read more
About 4 hours post injection ring finger nerves became painful at tip with pins and needles feeling. Still present, but not as painful. About 1 week post injection, began getting chest pains, difficulty breathing, and dizziness/lightheadedness. We to urgent care 1 week after symptoms started to appear as they got worse. EKG ran showing potential heart attach in past, but I don't think I've had one before. Was noted and told might have been due to crutches. Symptoms got worse next day so went to urgent care at different facility. Brought to ER for x-ray, blood , and EKG. Told no myocarditis, but potentially pericarditis.
27 2021-07-12 pain in extremity Very brief period of nausea; Slight drowsiness lingering; Soreness in arm on side that received inje... Read more
Very brief period of nausea; Slight drowsiness lingering; Soreness in arm on side that received injection; Soreness in shoulder; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included men daily multivitamin (MANUFACTURER UNKNOWN) and daily fiber supplement (MANUFACTURER UNKNOWN); both taken for unknown indication from unknown date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 12:15, the patient experienced very brief period of nausea, some slight drowsiness lingering to about 2-3 hours after injection and soreness in shoulder/arm on side that received injection which lasted till approximately 21 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events nausea, drowsiness pain in arm and shoulder pain was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
27 2021-07-14 bell's palsy I got Bell?s Palsy, 2 weeks after I received the shot.
27 2021-07-17 night sweats Fever; Chills; Night sweats; This is a spontaneous report from a contactable other healthcare profes... Read more
Fever; Chills; Night sweats; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 13:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 22Feb2021 at 13:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. On 16Mar2021 at 00:00 the patient experienced fevers, chills and night sweats for two days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the fever, chills and night sweats was recovered on 18Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
27 2021-07-17 pain in extremity sore left arm; also had diarrhea from Saturday to Tuesday and my stool was bright yellow.; This is a... Read more
sore left arm; also had diarrhea from Saturday to Tuesday and my stool was bright yellow.; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in the left arm on 13Mar2021 (at the age of 27-year-old) at 15:00 as a single dose for COVID-19 immunization. Medical history included asthma and COVID-19. The patient had no known allergies. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 21:00, the patient experienced a sore left arm, diarrhoea from Saturday to Tuesday and his stool was bright yellow, which was not too serious. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of sore left arm was recovered on 15Mar2021, while that of diarrhoea was recovered on 16Mar2021 at the time of this report. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Prior to vaccination, was the patient diagnosed with COVID-19? Yes, added as Relevant Med History and vaccination Facility Country added.
27 2021-07-18 limb paralysis Within a few minutes of receiving the Pfizer Covid vaccine the patient passed out. He fell to the fl... Read more
Within a few minutes of receiving the Pfizer Covid vaccine the patient passed out. He fell to the floor. Person standing near said it looked like he hit his head on the sign he was next to but when he came to said his head did not hurt just his back and his arm which appeared to have carpet burn/scratch. He said he did not remember passing out only feeling nauseous. After a few more minutes he passed out once more. Firefighter checked vitals and said they were all fine. Patient declined transfer to a medical facility but did have someone come to pick him up. It was recommended to him to be checked at a medical facility but it is unknown if he did.
27 2021-07-20 tingling, numbness About one week after the second dose, I started to experience a persistent numbness throughout my le... Read more
About one week after the second dose, I started to experience a persistent numbness throughout my left arm. It is a "pins and needles" like feeling, mostly occurring in the left hand. However, if I use my arm for strenuous activity or let it sit the wrong way, the numbness persists in my arm as well. Soft and light movements generally ease the feeling, however it is not fully going away.
27 2021-07-21 pain in extremity Heart inflammation, fever, headache, arm ache, chest pain, shortness of breath, pulsing pain through... Read more
Heart inflammation, fever, headache, arm ache, chest pain, shortness of breath, pulsing pain throughout body, extreme pain at injection site, injection site was very hot to the touch, redness at injection site, swelling at injection site
27 2021-07-24 unresponsive to stimuli after giving imz., i went over adverse effects then after total of a few minutes i went to catch ph... Read more
after giving imz., i went over adverse effects then after total of a few minutes i went to catch phone and counsel. patient was fine in room. my assistant(who is a retired nurse) walked by and said patient was slumped and pale. i went into room immediately patient was fainting. eyes fluttered and closed still breathing. no response from voice or slight shaking. we put patients legs on other chair to elevate, (patient too heavy to move) He revived after a few minutes and we had him lay on ground with legs elevated. bp was 116/61 and he had eaten only a cliff bar after working the night shift. I gave him glucose. after 15 minutes or so he felt fine and called his sister to pick him up, while waiting i gave him pop tarts and cold water (his stomach was growling). He left with his sister and will return in 21 days for 2nd shot. I will call and check on him 24-48 hours from now.
27 2021-07-25 numbness and pain in extremities Neuropathy started in both feet and have radiated up towards knee. Started end of May, still ongoing... Read more
Neuropathy started in both feet and have radiated up towards knee. Started end of May, still ongoing. Also headaches, fatigue, dizziness.
27 2021-07-28 bell's palsy I got Bell's Palsy.; dose 1 on 27Apr2021, dose 2 on 27Apr2021; This is a spontaneous report from a ... Read more
I got Bell's Palsy.; dose 1 on 27Apr2021, dose 2 on 27Apr2021; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 27 year old male patient (age at vaccination 27 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0171) as dose 1, single dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0185) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. The patient was no prior to vaccination, was the patient diagnosed with COVID-19 and the patient not had the patient been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient experienced Bell's palsy, on 02Jun2021. The outcome of the event was not recovered. Upon follow-up on 22Jul2021 the follow-up attempts are completed. No further information is expected.
27 2021-07-28 numbness Within the first 5 minutes of injection: heart palpitations, shortness of breath, dizziness, extreme... Read more
Within the first 5 minutes of injection: heart palpitations, shortness of breath, dizziness, extreme thirst, and facial numbness.
27 2021-07-28 numbness Numbing and dead arm feeling; arm discomfort; This is a spontaneous report from a contactable consum... Read more
Numbing and dead arm feeling; arm discomfort; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 18:00 (at the age of 27-year-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 26Mar2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 the patient experienced some numbing and discomfort around just the upper left arm area after the first shot, but not nearly as significant as the second shot, and it never came back like it was now (at the time of this report). After receiving the second dose, on 26Mar2021 at 18:00, the patient experienced numbing and dead arm feeling in upper left arm, extending into the armpit area and side of upper left chest area immediately, it went away after 1-2 hours and dead arm/discomfort returned 8-11 days later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 22Mar2021, the patient underwent COVID-19 PCR test (nasal swab) and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the event numbing and dead arm feeling and arm discomfort was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
28 2021-01-03 burning sensation Woke up to a burning sensation all over my face that quickly spread to my upper torso. I stumbled in... Read more
Woke up to a burning sensation all over my face that quickly spread to my upper torso. I stumbled into the bathroom and removed my pajama shirt to relieve the heat I was experiencing. I ran my hands under luke warm water and the sensation suddenly disappeared as quickly as it came. Later that same day I experienced fatigue and loss of appetite that lasted about 24 hours.
28 2021-01-04 tingling, flushing Pt. states that he received covid Pzifzer vaccine at 11:17 am on 01/05/2021 to left deltoid IM. Arou... Read more
Pt. states that he received covid Pzifzer vaccine at 11:17 am on 01/05/2021 to left deltoid IM. Around six to seven minutes at 11:23 am post vaccination patient started having burning sensation at site, felt flushed, diaphoretic, light-headed, nauseated, and now he is experiencing tingling to bilateral feet. Pt. states that earlier post vaccination he was feeling anxious, but he is no longer feeling anxious. Pt. denies feeling this way post vaccination with other vaccines. Pt. states that he is still having bilateral feet tingling up to both calves right greater than left.
28 2021-01-05 pain in extremity Arm pain, muscle aches, headache, chills. Started with arm pain a 6 hours after shot. Developed rest... Read more
Arm pain, muscle aches, headache, chills. Started with arm pain a 6 hours after shot. Developed rest of symptoms overnight.
28 2021-01-05 pain in extremity Patient returned about 2 hours after receiving vaccine complaining of chest tightness, shortness of ... Read more
Patient returned about 2 hours after receiving vaccine complaining of chest tightness, shortness of breath and arm and chest pain. Patient declined rapidly and could not breath. Called 911 and administered 1 dose of Epipen 0.3mg. Patient's breathing improved immediately. Patient went to ER for further workup.
28 2021-01-06 night sweats Fever and myalgias started approximately 36hrs after administration. Fever, myalgias, headache, dren... Read more
Fever and myalgias started approximately 36hrs after administration. Fever, myalgias, headache, drenching night sweats continued for over 24hrs until approximately 72hrs post administration.
28 2021-01-07 pain in extremity Congestion; Nostrils are really like dry inside; back was hurting; Body ache; Muscle ache; Sweats; B... Read more
Congestion; Nostrils are really like dry inside; back was hurting; Body ache; Muscle ache; Sweats; Body fatigue; Sore in arm; This is a spontaneous report from a contactable nurse. A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included antidepressant therapy. Concomitant medication included sertraline hydrochloride (ZOLOFT) as an antidepressant therapy. On 28Dec2020, patient was sore in her arm. On 29Dec2020, the next day patient woke up, she had body fatigue and muscle aches and had the sweats and was fine the next day. On 30Dec2020, Wednesday, the patient's back was hurting and has a body ache. And on 01Jan2021, patient stated she was like super congested. There was no back ache or anything but just has a really bad congestion and stated her nostrils were like really dry inside. Therapeutic measures were taken as a result of congestion, nostrils were like dry inside with spray nose with normal saline and the use of a humidifier. The patient recovered from the event, back pain; has not recovered from the events, congested and nostrils were like really dry; and outcome of all other events was unknown.
28 2021-01-10 hot flush Awakened 4 times shivering, Headache- relieved with 1 gram of Tylenol. dizziness- resolved 3-4 hour... Read more
Awakened 4 times shivering, Headache- relieved with 1 gram of Tylenol. dizziness- resolved 3-4 hours after waking. Fatigue- slept for 13 hours after working Body aches (mainly lower extremities)- worsened above movement. Dull ache while at rest. resolved with time. Hot flashes- random hot flash with sweating. Still experiencing almost 48 hours after immunization.
28 2021-01-11 feeling hot Patient was feeling hot and appeared to be diaphoretic Pulse was 68 BPM, Respirations 12/minute Oxyg... Read more
Patient was feeling hot and appeared to be diaphoretic Pulse was 68 BPM, Respirations 12/minute Oxygen saturation 98% room air No c/o SOB and no difficulties breathing or swallowing Was given 250ml Orange juice and 200ml Water then another 150ml of soya milk within a one hour period Patient monitored closely with oversight by ARNP Patient felt improved and able to leave area approximately 2 hours later and was access last by ARNP
28 2021-01-11 night sweats Fever/chills/night sweats for 1 day, body aches, injection site pain, nausea for 3 days, headache fo... Read more
Fever/chills/night sweats for 1 day, body aches, injection site pain, nausea for 3 days, headache for 3 days, all resolved. Two doses of 1000 mg acetaminophen needed to resolve fever.
28 2021-01-12 cold sweat, tingling Patient asked to remain in observation area x15 minutes. Approximately 5 min into observation compl... Read more
Patient asked to remain in observation area x15 minutes. Approximately 5 min into observation complained of dizziness, tingling in fingers, sweating. Pulse 110, skin clammy. Requested patient move from chair to floor, remove jacket, instructed purse-lipped breathing, drank 2 bottles of water patient compliant and tolerated well. Pulse reduced to 79 at 1309, finger tingling resolved, asked patient to wait until 1:30 to leave, pt agreed. Symptoms resolved quickly and completely.
28 2021-01-13 tremor Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Minor Ras... Read more
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Minor Rash/Itching/Shakiness on left side, followed by trouble breathing; symptoms lasted 1 day
28 2021-01-13 unresponsive to stimuli On day due for 2nd dose, Patient was found unresponsive at work in the hospital. Patient pupils wer... Read more
On day due for 2nd dose, Patient was found unresponsive at work in the hospital. Patient pupils were fixed and dilated. Full ACLS was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was intubated. Patient continued into V. Fib arrest and was shocked multiple times.
28 2021-01-14 weakness, numbness, migraine, pain in extremity Symptoms of 2nd Covid vaccine lot EL 1284: numbness in feet, legs throbbing, muscle weakness in legs... Read more
Symptoms of 2nd Covid vaccine lot EL 1284: numbness in feet, legs throbbing, muscle weakness in legs, overall tiredness I received my second Pfizer vaccine on 1/12/21 at 12:15 pm. After several hours, I felt weak and tired. By 7:00 pm, I had a migraine that wouldn?t go away and I had muscle ache in my feet and legs. On 1/13/21 I felt some numbness in my feet and my legs were throbbing. By 10:00 pm, both of my feet were completely numb and my legs were throbbing/radiating heat. It felt as if circulation was cut off from my feet entirely. On 1/14/21 I went into work where I?m constantly on my feet. I felt intense muscle weakness in my legs and thighs to point where I could barely stand up. I immediately went to an urgent care where they started me on an Sodium Chloride 0.9% intravenous IV solution drip. They ran blood tests and urine tests to rule out any other causes to my symptoms. All results came back negative. I was told to rest, hydrate, and recover for the next several days. If my symptoms did not subside within the next couple days, I was instructed to go to the ER for further examination.
28 2021-01-19 tingling postural dizziness; dyspnea; paresthesia; This is a spontaneous report from a contactable Physician.... Read more
postural dizziness; dyspnea; paresthesia; This is a spontaneous report from a contactable Physician. This Physician reported for a 28-year-old male patient received 2nd dose of BNT162B2 Intramuscular on 10Jan2021 07:30 on Left arm for covid-19 immunization. Medical history and concomitant drug were not reported. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Historical Vaccine was first dose of BNT162B2 on an unspecific date. Patient experienced Moderate reaction: postural dizziness, dyspnea, and paresthesia on 10Jan2021 09:00 AM that resolved with H1 and H2 antagonists and IV hydration. AE-resulted-in Emergency room/department or urgent care. Outcome of the event was recovered. No covid-prior-vaccination. No covid-tested-post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
28 2021-01-20 pain in extremity, weakness strong pulsating heartbeat; severe arm pain; fever with temperature of 102 [units unspecified]; abdo... Read more
strong pulsating heartbeat; severe arm pain; fever with temperature of 102 [units unspecified]; abdominal pain; general weakness; unquenchable thirst; very bad headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 10Jan2021 10:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he did not experience any symptoms yesterday (unspecified date) and a few hours ago, he started to experience severe arm pain, fever with of 102 [units unspecified], abdominal pain, general weakness, unquenchable thirst, very bad headache, tiredness and strong pulsating heartbeat. The outcome of the events was unknown. Information about lot/batch has been requested.
28 2021-01-21 migraine, hot flush Migraine began at 01:00pm following hot flashes, diarrhea, vomiting and nausea at about 2:30pm. Migr... Read more
Migraine began at 01:00pm following hot flashes, diarrhea, vomiting and nausea at about 2:30pm. Migraine became more pronounce when under light. Sweating began at 8:30pm when I notified charge nurse of side effects and requested to leave. I?ve taken 500mg of Tylenol at 1:00pm which helped until 3:00pm when I took 500mg again which lasted until 11:00pm when effects of medicine started to wear off.
28 2021-01-21 tingling Tenderness at injection site lasting ~36 hours Noted weakness and loss in dexterity in hand Feeling ... Read more
Tenderness at injection site lasting ~36 hours Noted weakness and loss in dexterity in hand Feeling of swelling in hand Pins and needles sensation in full arm and extending through fingers
28 2021-01-24 discomfort, feeling hot 1st shot of Pfizer-BioNTech: 12/29/2020, left shoulder: marginal shoulder pain from 12/29 to 12/31, ... Read more
1st shot of Pfizer-BioNTech: 12/29/2020, left shoulder: marginal shoulder pain from 12/29 to 12/31, no further swellings (ek9231) 2nd shot of Pfizer-BioNTech: 01/22/2020, also left shoulder (el3247): less shoulder pain throughout; feeling that it "spreads" from injection side to left side of the neck in the following hour; on the 01/24 in the morning, palpable swollen lymph node with accompanying calor and dolor right on top of the left clavicular bone; 01/25 swelling reduced, calor and dolor mostly gone but lymph node still palpable No additional drugs taken and on a scale of 0 to 10 maybe a 2/10 causing discomfort
28 2021-01-28 feeling hot tired; dizzy/dizziness/lightheaded; chills; he is warm all of a sudden; a history of vertigo, so he ... Read more
tired; dizzy/dizziness/lightheaded; chills; he is warm all of a sudden; a history of vertigo, so he thought he was having a vertigo attack; super sick on the 8th after his second dose; Fever; This is a spontaneous report from a contactable nurse (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 07Jan2021 at single dose on the left arm for COVID-19 immunization. Medical history included vertigo from Aug2019. There were no concomitant medications. The patient received the vaccine through the facility where he works (not a military facility). Patient received his first dose on 17Dec2020 (lot number: EL0140). Patient said that the symptoms started Monday, he was super sick Friday after first dose. Patient clarified to super sick on 08Jan2021 after his second dose. On 08Jan2021 after his second dose, patient had a fever of unknown temperature which he slept through it. He was tired the whole day on Monday (11Jan2021) and really dizzy and had chills from then to now, which is not stopping, he means the dizziness is not better, the chills come and go. He clarifies that he did take Tylenol to treat the fever and the next day he had no fever. He says that the dizzy, he still has it. Patient took 500mg once by mouth of the Tylenol. Patient stated that he also has a history of vertigo, so he thought he was having a vertigo attack, but he took his medicine and it did not help him. Patient stated that these were not serious for him, he just feels dizzy and lightheaded. He has no loss of balance. The patient reported that he had both doses of the COVID vaccine on the left arm. Patient had the second dose on 07Jan2021, and until now he has been dizzy, it started 3 days ago (11Jan2021), he has had chills and then after he was warm all of a sudden, he was concerned. Patient has had no new medications or other vaccinations recently. He last saw his doctor six months ago and he plans to see her tomorrow (15Jan2021). The events were assessed as non-serious by the reporter. Outcome of the event dizzy/dizziness vertigo attack, and chills was not recovered (ongoing), for fever was recovered on 09Jan2021 while for other events was unknown.
28 2021-01-28 pain in extremity Fever (100.7 F), Chills, Sore arm, Fatigue
28 2021-02-01 weakness I was feeling fine for most of the day. The next day I woke up in sweats and chills but I didn?t thi... Read more
I was feeling fine for most of the day. The next day I woke up in sweats and chills but I didn?t think much of it. As I was standing up I notice all of the following- headaches, body pain, fever, low energy (although this one went away fast). I also felt like puking most of the day. I woke up at 7am and After work I took a nap. I woke up at 7pm feeling a lot better. I still had some minor headache but it went away with Advil.
28 2021-02-01 burning sensation, feeling hot initial exposure to coronavirus; COVID-19 PCR test positive; COVID-19 PCR test positive; when he wok... Read more
initial exposure to coronavirus; COVID-19 PCR test positive; COVID-19 PCR test positive; when he woke up the next morning he had a 5 minute interval of indescribable burning sensation on the face and upper torso/being hot; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. A 28-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly on 31Dec2020 in arm at a single dose to prevent COVID. There were no medical history or no concomitant medications. He confirmed he is the physician and the primary doctor for the patient. The patient is a pharmacist and he received the first dose of the Pfizer COVID vaccine on 31Dec2020. The next day (01Jan2021), he woke up with a 5-minute interval of indiscernible burning sensation on his face and upper torso that went away after about 5 minutes. The patient reported being hot for a few seconds after taking the Pfizer COVID vaccine. The patient came in to contact with some with coronavirus and then the patient tested positive for coronavirus on 17Jan2021 with a PCR test. He had no symptoms since a week after his initial exposure to coronavirus. No adverse reactions but turned up with infection. The outcome of event burning sensation on the face and upper torso was recovered on 01Jan2021, outcome of the other events was unknown. Reporter assessed seriousness for burning sensation on face and upper torso: Medically significant. Causality between burning sensation on face and upper torso and bnt162b2 was related by Primary Source Reporter per Global Introspection. Information on the batch number/lot number has been requested.; Sender's Comments: Based on the current available information , Exposure to SARS-CoV-2 is most likely related to an intercurrent condition which is not related to the suspected drug. Based on the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of other events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-02-01 tremor Mild fatigue/extreme fatigue (difficulty standing); strong chest/abdominal tightness (described simi... Read more
Mild fatigue/extreme fatigue (difficulty standing); strong chest/abdominal tightness (described similar to indigestion); strong chest/abdominal tightness (described similar to indigestion); chills (severe shaking/trembling); chills (severe shaking/trembling); deep breathing; Mild fatigue/extreme fatigue (difficultly standing); elevated temperature (99.3-7); sensitivity to cold for 24-48 hours; This is a spontaneous report from a non-contactable consumer. A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL3246) via an unspecified route of administration at right arm on 14Jan2021, at 10:00 AM at a single dose for COVID-19 immunization. Age at vaccination was 28-year-old. Medical history included blood pressure. No other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as 2 - blood pressure (identity not disclosed). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL0140) at right arm on 23Dec2020 at a single dose for COVID-19 immunization and no symptoms reported. Facility where the most recent COVID-19 vaccine was administered at hospital. It was reported mild fatigue within first few hours for second dose. Around 12 hours after injection (11:30 PM) had rapid onset of strong chest/abdominal tightness (described similar to indigestion), extreme fatigue (difficultly standing), chills (severe shaking/trembling), and deep breathing. These strong symptoms lasted for around 15 minutes. Over next few hours elevated temperature (99.3-7) and sensitivity to cold for 24-48 hours. Symptoms resolved. Events with start date on 14Jan2021 at 11:30 PM. The outcome of events was resolved in Jan2021. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
28 2021-02-04 pain in extremity Hives from neck down to elbow on left side. Wet cough, chest pain over sternum and on left side llq... Read more
Hives from neck down to elbow on left side. Wet cough, chest pain over sternum and on left side llq on coughing. Fatigue, arm pain, localized swelling/inflammation.
28 2021-02-09 pain in extremity, numbness Sore arm near injection site and throughout arm; minor numbness in elbow and fingers; Sore arm near ... Read more
Sore arm near injection site and throughout arm; minor numbness in elbow and fingers; Sore arm near injection site and throughout arm; This is a spontaneous report from a contactable consumer reported for himself. A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration in left arm on 25Jan2021 14:15 at first single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. No other medical history. No 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 experienced sore arm near injection site and throughout arm including minor numbness in elbow and fingers. Adverse event start date: 25Jan2021 04:30 PM. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
28 2021-02-09 seizure like phenomena Immediately after I administered the vaccine, the patient passed out. He fell onto the floor and we... Read more
Immediately after I administered the vaccine, the patient passed out. He fell onto the floor and we witnessed some oral seizure like type movement . The patient was unconscious for approximately 1.5-2 minutes. Our Chief Medical Officer was on site and walking into the room as the patient fell. We immediately placed him on his left side, protected his head, and stayed with him. We called 911 immediately due to the uncertainty of health issues. Once conscious, the patient explained to us that he experiences such every time he receives a vaccine. He was assessed by the CMO as well as the EMTs that arrived on scene. His vitals were taken. He was moved into a comfortable position and monitored. He was alert and orientated x 3. We requested he have someone pick him up instead of him driving himself home which he did. This gentleman is also an employee and we were able to see him and verify all was well in the following days. We also recommended he tell all vaccinators that he experiences LOC post vaccination. When he receives his second dose we plan to have him lying down and our CMO will be present. We recommended he follow-up with his PCP.
28 2021-02-15 feeling hot Started to feel warm and light headed. VS @ 15:15 HR 72, RR 16, BP 112/68, S02 98%
28 2021-02-16 tremor Body/head/muscle aches, nausea, dizziness, chills, mild shaking, poor attention/concentration.
28 2021-02-19 pain in extremity, feeling hot, numbness, tingling After about an hour following my second COVID-19 Injection I began feeling warm. My forehead felt w... Read more
After about an hour following my second COVID-19 Injection I began feeling warm. My forehead felt warmer so I figure I may have had a slight fever at that point. I received a metallic (Note I say metallic but I know it wasn't actually metal but that's simply the best way I can describe the taste I experienced) following the injection about 5 minutes after. My arm remained sore following and still remains sore as of this report. I experienced a decline in mental acuity following about an hour after injection. I began to feel lightheaded and exhausted to the point I was experiencing severe disorientation and confusion. I was having trouble putting sentences together and experienced a ringing sensation in the ears. I felt like I wasn't even present anymore. I couldn't comprehend things around me and apparently had conversations I don't even remember having. Note that at that point I had gotten home but don't even remember getting home. I just know that this did not begin to wear off until around 8:45pm when it was like someone flipped a switch and I suddenly was coherent again. It was an odd sensation to experience. The arm remained sore and the metallic taste returned briefly after this experience. I experienced a similar feeling from the HPV injection years ago, but just like this it was a temporary thing that resulted in no long term issues. However, I cannot tell you fully what we did the rest of the day until around 845-9 pm. I also remember becoming partly agitated after the injection like my body just all of a sudden took notice of something and shot into action. I had received my allergy injections this same day about two hours earlier as well and none of these reactions ever occur with those for me. I continued to drink liquid as far as I know as there were a few empty bottles of water next to me. I have no recollection of getting them. It's odd. There's just this brief moment in time that is just missing from my memory with a few short bits and pieces that are there like a puzzle with some missing pieces. I feel I became so fatigued I could not function. My emotions I remember were off and hard to control during this period too. I felt like I was having some random mood swings. I feel ok now though aside from the upset stomach occasionally and the fatigue and arm pain (but even the arm pain has partly decreased now). It all ceased. I have a number of health issues outside of this but have not experienced this long of a period of almost intermittent amnesia and incoherency following an injection before. I believe it made me that much more tired or reacted with one of my many conditions or genetic variants that perhaps may have been part of this. I'm happy to provide anything I can to help with this. I am greatly appreciative of all the CDC has done to get us this vaccine and continues to do to ensure our safety both before and after injection. It is commendable. I did fill out my survey through the V-Safe portal as well and will continue to follow up there should I have any changes. I have not sought medical care following this event as the coherency and such have seemed to resolve in regards to the vaccine injection. Only thing left are known side effects at this point besides an occasional increase in numbness and tingling that I already experience in my legs and feet. My absolute best guess for the cause is my immune system which already has some issues regulating (doesn't always like to learn everything it should and we are currently searching for an undiagnosed autoimmune disorder currently going on as well in me) on top of allergy shots today. it was perhaps just a bit too much demand on it all at once. But it seems to be balancing out again now.
28 2021-02-21 weakness, pain in extremity Left arm pain, headache, weakness on date of vaccination. 2 Extra strength Tylenol taken. Symptoms i... Read more
Left arm pain, headache, weakness on date of vaccination. 2 Extra strength Tylenol taken. Symptoms improved next morning.
28 2021-02-24 pain in extremity Soreness at the injection site/tenderness of arm; Soreness at the injection site/tenderness of arm; ... Read more
Soreness at the injection site/tenderness of arm; Soreness at the injection site/tenderness of arm; This is a spontaneous report from a contactable consumer (patient). This 28 -year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 11Feb2021 (at 15:45) at a single dose on right arm for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history and concomitant medications were provided. No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 before vaccine. On 11Feb2021 (at 22:00), the patient had soreness at the injection site/tenderness of arm. The events were reported as non-serious. Post vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
28 2021-02-24 tremor Uncontrollable shivering and shaking, lasting 45 minutes, relieved about 30 minutes after taking 1g ... Read more
Uncontrollable shivering and shaking, lasting 45 minutes, relieved about 30 minutes after taking 1g Tylenol
28 2021-03-02 pain in extremity Chills and Muscle aches in neck, shoulders, and arms.
28 2021-03-02 pain in extremity Had severe chest pains and pain radiating down left arm three (3) days; Had severe chest pains and p... Read more
Had severe chest pains and pain radiating down left arm three (3) days; Had severe chest pains and pain radiating down left arm three (3) days; I was diagnosed with myopericarditis (inflammation of both the lining of the heart and the heart muscle); This is a spontaneous report from a contactable consumer. This 28-year-old male consumer reported that: Report about Covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Adult (18-64 Years) Current age: 28 Current age unit: Years Gender: Male Patient occupation: None of the above Covid vaccine details: (product=COVID 19, brand=Pfizer, lot number=EL3246, lot unknown= False, administration date=18Jan2021, administration time= 04:00 PM, vaccine location= Right arm, dose number= 2), (product= COVID 19, brand=Pfizer, lot number= EJ1685, lot unknown= False, administration date= 29Dec2020, administration time=11:00 AM, vaccine location= Right arm, dose number=1) Facility type vaccine: Hospital If other vaccine in fourweeks: No Other medications in twoweeks: No Adverse event: Had severe chest pains and pain radiating down left arm three (3) days (Thursday 21Jan2021) after receiving the second Pfizer COVID vaccine (lot:EL3246) on Monday 18Jan2021. I was admitted to the hospital the same day, and was discharged on Saturday 23Jan2021. I was diagnosed with myopericarditis (inflammation of both the lining of the heart and the heart muscle). I was given a 90 day prescription of colchicine 0.6mg and I am still currently taking the medication twice daily with 1g of Tylenol (acetaminophen) once daily. Adverse event start date: 21Jan2021 Adverse event start time: 03:00 AM AE resulted in: [Emergency room/department or urgent care, Hospitalization] No days hospitalization: 3 If patient recovered: Recovered If treatment AE: Yes AE treatment: Colchicine 0.6 mg tablet (twice daily) If Covid prior vaccination: No If Covid tested post vaccination: Yes Covid test post vaccination: (covid test type post vaccination=Nasal Swab, covid test date=21Jan2021, covid test result=Negative) Known allergies: Penicillin/Amoxicillin Other medical history: No
28 2021-03-04 migraine, mild one side paralysis 18 days after Covid Vaccine Dose 1, patient started to present with symptoms of a frontal lobe migra... Read more
18 days after Covid Vaccine Dose 1, patient started to present with symptoms of a frontal lobe migraine along with nausea, dizziness, and L Sided Weakness. As time continued to pass while en route to local hospital, patient began to stutter harshly, saying every other word in a sentence, complained of a stiff jaw, and began to panic.
28 2021-03-06 flushing 7-10 minutes after vaccine patient becae flushed, diaphoretic , nauseated and started vomiting. Mild... Read more
7-10 minutes after vaccine patient becae flushed, diaphoretic , nauseated and started vomiting. Mildly hypotensive BP 101/60. Symptoms resolved after 30 min with IM dose Benadryl and promethazine. BP on discharge 122/70
28 2021-03-10 weakness I had dermatitis reaction. My body was full of itchy and painful rash followed by weakness and body ... Read more
I had dermatitis reaction. My body was full of itchy and painful rash followed by weakness and body aches. Treatment: Benadryl 1 tablet single dose.
28 2021-03-11 unresponsive to stimuli Pt fell out of his chair landing on the right side of his body. Unresponsive 2-3 seconds. He was ... Read more
Pt fell out of his chair landing on the right side of his body. Unresponsive 2-3 seconds. He was able to respond verbally immediately p initial unresponsive episode asking "how long was I out for?" Pt is alert and oriented to person, place time situation "highlight headed. He did not eat breakfast. 0935AM HR 67, SpO2 98%, RR 22, BP 152/94. At 1950 AM HR 84, SpO2 97%, RR 22, BP 136/84. At 1015AM 8 oz water, granola bar snack, Capri-sun, consumed and he felt better. No injuries noted from falling out of chair. At 1026AM called -made it to work.
28 2021-03-14 unresponsive to stimuli 4:07 pm Vaccinating nurse said client was unresponsive to verbal stimuli, breathing even and unlabor... Read more
4:07 pm Vaccinating nurse said client was unresponsive to verbal stimuli, breathing even and unlabored. 4:08 pm client alert and orientated. According to patient, "I usually faint when I receive any vaccine of by blood pressure taken." 4:10 pm Client evaluated by onsite Paramedics. 4:12 pm client able to ambulate without any difficulties. 4:15 pm client expressed a phobia of needles. 4:40 pm client placed on 30 mins. of additional observation. 4:55 pm no additional symptoms observed and paramedics released to go home. 5:00 pm client released.
28 2021-03-15 numbness prolonged numbness in left pinky finger and occasionally the adjacent finger/first noticed this on l... Read more
prolonged numbness in left pinky finger and occasionally the adjacent finger/first noticed this on left shoulder/numbness radiated to shoulder maybe once or twice, but has been more prolonged in pinky finger; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on 26Jan2021 at 15:45 pm (at the age of 28-years-old) on left arm at single dose for covid-19 immunisation. Medical history was none. No Known allergies. Allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included linoleic acid (CLA), l-carnitine [levocarnitine] (L-CARNITINE [LEVOCARNITINE]), cocos nucifera oil (MCT OIL [COCOS NUCIFERA OIL]) as dietary supplements. The patient reported that, I noticed mild numbness on my left side the same night I had received the vaccine on 26Jan2021 at 20:00 PM. This has quickly faded over the course of the next day, however a week later (about 2 days prior this submission) I noticed prolonged numbness in my left pinky / sometimes adjacent finger. On occasion (once or twice) I have felt slight pain in my left shoulder and left foot. Pinky finger is currently still numb. I am unsure if I pulled a nerve while exercising or if this is an adverse reaction to the Pfizer Covid vaccine. He will be scheduling a checkup with his PCP to get a diagnosis, but informed me as his manager and I'm hereby reporting it as an adverse event. The event was considered as non-serious. 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. No treatment was received for the adverse event. The patient was not recovered from the event. Information about lot/batch number has been requested.
28 2021-03-15 tingling Full body rash, itchy, pins and needle feeling all over the body. Some joint pain. Noticed the day a... Read more
Full body rash, itchy, pins and needle feeling all over the body. Some joint pain. Noticed the day after the second shot. Got progressively worse over the next day. I Saw PCP Doctor Friday and Dermatologist On Monday. The treatment has been bed rest, 4mg MethlPREDNISolone and Clobetasol 0.05%. Some of the rash is clearing up.
28 2021-03-15 tremor Patient got vaccine and went to restroom once given despite being told to wiat 15mins before going. ... Read more
Patient got vaccine and went to restroom once given despite being told to wiat 15mins before going. After 10mins of being vaccinated patient stated not feeling well. His face became pale and bacame shaky and sweaty. We laid him on the ground and elevated his ffet and called 911. Patient felt batter and was sitting in chair when parmedics arrived. Once the paramedics arrived patient had another episode as previouse and threw up. After a while patient states he had 2 beers before coming for the vaccine and had it on an empty stomach. Pstient was taken by paramedic to hospital for evaluation.
28 2021-03-18 migraine, cold sweat migraine; Fever; mild chills/uncontrollable heavy shivering; cold sweats; Mild muscle pain at inject... Read more
migraine; Fever; mild chills/uncontrollable heavy shivering; cold sweats; Mild muscle pain at injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration in the left arm on 14Feb2021 07:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: ADHD (attention deficit hyperactivity disorder), severe migraine, unknown vestibular event in June-Jul2020 attributed to vestibular migraines based on normal CT, MRI, and EEG. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), amitriptyline, caffeine/ paracetamol (EXCEDRIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL4262), via an unspecified route of administration in the left arm on 26Jan2021 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Feb2021, the patient experienced mild muscle pain at injection site onset 1 hour after injection (at 08:30) lasted about 24 hours. At 01:20 on 15Feb2021, also reported as 17 hours 10 minutes post-injection, the patient woke up with mild chills, temperature (oral thermometer) was 97.6°F. Chills and cold sweats progressed rapidly, with severe chills and uncontrollable heavy shivering and sweating present within 10-15 minutes (on 15Feb2021). Temperature at 02:00 15Feb2021 was 103.0°F. Fever slowly waned without medication. By 04:30, fever at 101.2°F, chills mild, sweating persisted. At 07:00 15Feb2021, the patient started to develop early stages of migraine (preexisting condition), took EXCEDRIN 565 mg tablet x 2. At 08:00 15Feb2021, the temperature was 98.2°F. By 10:00 15Feb2021, the fever resolved, temperature 97.6 (individual baseline) and chills had resolved. Sweating has improved to be more mild, but persistent now at 16:30 15Feb2021. Treatment was received for migraine. No treatment was received for the other events. The clinical outcome of mild muscle pain at injection site was recovered on 15Feb2021 08:30, chills and fever both recovered on 15Feb2021 10:00. The clinical outcome of cold sweats and migraine was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
28 2021-03-18 seizure Aggressive convulsions, in 5 minute spurts, with pauses between, for roughly 3 hours 11:00pm to 2:00... Read more
Aggressive convulsions, in 5 minute spurts, with pauses between, for roughly 3 hours 11:00pm to 2:00am.
28 2021-03-18 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
28 2021-03-19 cold sweat Patient received vaccine at 12:30pm, at 12:35 pm, patient felt dizzy and felt like he had a lump in ... Read more
Patient received vaccine at 12:30pm, at 12:35 pm, patient felt dizzy and felt like he had a lump in his throat that made it hard to swallow. Upon assessment, patient had constricted pupils, skin was cold and clammy. Patient respirations were rapid but unlabored. Nurse administered 25mg of benadryl and had patient drink Pepsi while waiting for an ambulance. Ambulance arrived at 12:52 and assessed patient. At 13:09, patient refused vital signs by squad and refused to be evaluated at hospital, stating he was feeling much better and thinks he just had an anxiety attack due to witnessing another patient have a reaction. Patient stayed onsite with nurse until 14:00, when he called someone to come drive him home. Patient texted nurse at 15:40 stating he arrived home safely and felt fine.
28 2021-03-22 tremor Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: shaking-Mild, Systemic: Shakines... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: shaking-Mild, Systemic: Shakiness-Mild
28 2021-03-24 migraine deathly sick; deathly sick; high fever; throwing up; massive migraine; dehydration; This is a sponta... Read more
deathly sick; deathly sick; high fever; throwing up; massive migraine; dehydration; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the parent, reported that a 28-year-old male patient (son) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 vaccination. Medical history included Crohns disease (caller concerned because HUMIRA causes immunosuppression). Concomitant medication included adalimumab (HUMIRA) for Crohns disease. After the first dose, the patient became "deathly sick" with the following: high fever, throwing up, massive migraine. These symptoms occurred approximately 5-7 days post vaccination. The patient went to ER (emergency room) and was given IV fluid for dehydration, no other diagnosis, but was told it could be related to the dose of vaccine. The outcome of the events deathly sick, high fever, throwing up, massive migraine and dehydration was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
28 2021-03-25 pain in extremity 24 hours following administration patient developed body aches, fever (101), sore throat and nausea.... Read more
24 hours following administration patient developed body aches, fever (101), sore throat and nausea. 72 hours after receiving the shot he developed sudden onset substernal chest pain described as sharp and burning with radiation to his bilateral arms.
28 2021-03-26 pain in extremity Extremely sore arm, beginning only several minutes after injection, persisting at least several seve... Read more
Extremely sore arm, beginning only several minutes after injection, persisting at least several several hours and days, painful to move, difficult to use for normal tasks Fatigue, sleepiness,
28 2021-03-28 cold sweat Patient is a 28 year old male who has completed a 45-minute observation period with the following si... Read more
Patient is a 28 year old male who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: other - syncopal episode. COVID-19 vaccine # 1 in series administered. Patient complaints of syncopal episode witnessed by other patients after received 1st dose of Covid vaccine. Patient states that he developed clammy skin, lightheadedness 10 minutes after he received his Covid vaccine, patient tried to get out of chair when he had a syncope episode and fell on the floor face down witnessed by other patient in the Covid vaccine lobby area. Denies any head or facial injury. Patient states that he has needle phobia and he forgot to tell the nurse about his needle phobia. Treatment provided/action Taken: Vital sign @ 1325: blood pressure 114/44, heart rate: 71. SPO2: 98%, respiration : 16; Vital sign @ 1335: blood pressure 104/62, heart rate: 82. SPO2: 95%, respiration : 16; Vital sign @ 1352: blood pressure 102/68, heart rate: 90. SPO2: 99%, respiration : 16; Patient states that he didn't eat breakfast or lunch today, able to tolerated fluid and intake well, eating chocolates. Action taken: Transferred to higher level of care ( urgent care ); Patient advised to discuss second dose considerations with a clinician.
28 2021-03-29 hot flush Fatigue, body aches, headaches, hot flashes (no fever), chills, decreased concentration, heart rate ... Read more
Fatigue, body aches, headaches, hot flashes (no fever), chills, decreased concentration, heart rate spikes, mild nausea, malaise. Effects lasted through the evening of vaccination date and the following two days.
28 2021-03-30 weakness Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium... Read more
Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: symptoms occured 30-45 minutes after vaccination -Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Said he felt dizzy when he got up (about 10 minutes post) to go to restroom. He said he sat for an additional 30 minutes then left. While driving he felt lightheaded and pulled over. He also reported stomach cramps at that time. He felt better and drove back to the store. NP looked at him and checked bp and O2 sat level. Bp was little low. Advised have someone pick him up and he felt any worse to go to urgent care. After 15 minutes pt said he felt much better and left. Unable to reach f/u.
28 2021-04-01 numbness, tingling Tingling sensation throughout body 1 hour after vaccination, followed by numbness. 1 hour and 20 m... Read more
Tingling sensation throughout body 1 hour after vaccination, followed by numbness. 1 hour and 20 minutes after the vaccination my face started swelling.
28 2021-04-01 migraine I initially got a bad migraine three days after the first vaccine. Since then I?ve experienced dizzi... Read more
I initially got a bad migraine three days after the first vaccine. Since then I?ve experienced dizziness, anxiety, blurred vision, headache, and constant tinnitus. I decided to have my second shot which I had today.
28 2021-04-01 muscle twitching Constant twitching in right eye, and above left ear.
28 2021-04-04 flushing Mother called to report information for son. All information documented was information obtained. Lu... Read more
Mother called to report information for son. All information documented was information obtained. Luanne counseled to have son contact PCP for further recommendation. 04/02/2021, symptom of nausea, headache and feeling flushed instantly after receiving the vaccine. Client did not report symptoms or wait 15 minutes prior to leaving mass clinic. Symptoms on 04/02/2021 were resolved by morning of 04/03/2021. On 04/04/2021, client woke with swollen eyes and red blotches to face. Client took 50mg of Benadryl, 3 times on 04/04/2021. Symptoms improved over the day, but did not resolve.
28 2021-04-04 flushing Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported chill... Read more
Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported chills and sweat
28 2021-04-05 feeling hot, weakness Light headed, faint, weak, hot, sweating. Complained about throat tight and difficulty breathing. Pr... Read more
Light headed, faint, weak, hot, sweating. Complained about throat tight and difficulty breathing. Provided patient with ice pack for back of neck and wrist. Due to patient complaining of difficulty breathing, 911 was called and he was assessed by EMS personnel.
28 2021-04-05 tingling RNs x 2 responded to pt's vehicle c/o nausea, left arm tingling. RN reported pt was visibly "panick... Read more
RNs x 2 responded to pt's vehicle c/o nausea, left arm tingling. RN reported pt was visibly "panicked " and self-reports he "passed out twice:" after seeing blood after getting vaccine. RN reported pt had small of blood on bandaid. Reports history of anxiety, especially r/l blood needles
28 2021-04-05 unresponsive to stimuli Patient received Pfizer vaccine as IM into left arm at approximately 10:05am on Tuesday 4/6/2021. Pa... Read more
Patient received Pfizer vaccine as IM into left arm at approximately 10:05am on Tuesday 4/6/2021. Patient had a vasovagal response at 10:20am on Tuesday 4/6/2021. Patient fell out of chair, face down onto gym floor. This RN went over to patient. Patient noted to be unresponsive, however after 30 seconds woke up and was alert and oriented x 4. Patient log rolled onto back and noted to be pale and diaphoretic. EMS called by RN at 10:20. Initial set of vital signs BP 132/80, SpO2 98% on room air, HR 90 and RR 20. Legs elevated onto chair and patient remained lying flat on his back until EMS responded. EMS initial arrival at 10:49 am ... EMS response time 33 minutes with arrival onsite at 10:53am. Patient taken to hospital by EMS.
28 2021-04-06 pain in extremity . Pfizer dose 1 on 3/30. Just had sore arm. Symptoms dizziness began on 4/3. Otherwise feeling well.... Read more
. Pfizer dose 1 on 3/30. Just had sore arm. Symptoms dizziness began on 4/3. Otherwise feeling well. Labs drawn 4/5 which revealed pancytopenia, rechecked today and numbers are worsening. Working to get him into hematology now. 28 yo male s/p Covid-19 Vaccine (Pfizer) on 3/30 with lightheadedness only when bending down and coming up returns for follow up today for pancytopenia found on labs obtained 4/5. He denies any recent viral symptoms. He did not have any episodes in past that made him question that he may have had Covid-19 viral illness. He is able to tolerate his normal daily exercise and bike without any symptoms. He has no dietary restrictions, eats dairy, meat, lots of vegetables/fruits, pastas and some breads/cereals. He drinks alcohol once per week. He abstains from ETOH every April. He has used edible THC in past, only once per month at most. He has not been tested for HIV in past. His girlfriend, in last semester of school advised him to ask about HIV testing. He denies any chest pain, SOB, HA. Upon review of his lab results yesterday, I called the hematology fellow, Dr. through program at hospital and he recommended the labs to be obtained and rechecking labs in one week. He felt the student was not exhibiting any emergent symptoms requiring emergent evaluation. Patient and I spoke on phone after this call with fell at 1557 4/6 and I advised him to seek emergent medical eval in ED for any CP, SOB, HA or any neurologic symptoms. Patient has not had any of those symptoms. He exercised this morning without difficulty. He notes raised papules on legs which he has had in past. They have currently been present for a few days. He believes it to be related to biking in sweatpants. He has been in a hot tub recently, but after the bumps were present. They do not itch. He has had them in past, more in winter months with heavier clothing. He also notices slight left arm pain today. This was site of his vaccine. He denies any swollen lymph nodes. He is notices only with arm movement. He denies any FH of blood disorder/ blood cancers/MDS. He denies bruising, bleeding or dark stools. He states he likely has not had a blood draw in past, unless one visit to ER, for HA/concussion in high school (9+yrs ago) resulted in any blood test.
28 2021-04-06 seizure Pt started to faint and then had a seizure. The patient awoke from seizure and 1 minute later had an... Read more
Pt started to faint and then had a seizure. The patient awoke from seizure and 1 minute later had another seizure. EMS arrived and took the patient to a hospital facility.
28 2021-04-07 migraine migraine; nausea; nausea followed by vommiting; mild headache; This is a spontaneous report from a c... Read more
migraine; nausea; nausea followed by vommiting; mild headache; This is a spontaneous report from a contactable consumer (Patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9262) via unspecified route of administration on 11Feb2021 10:00 AM at single dose for covid-19 immunization. Medical history included Psoriasis - Take Stelara every 12 weeks for it. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included multivitamins in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on 22Jan2021 10:00 AM at left arm single dose for Covid-19 immunization (Lot number: EN6201). It was stated on 13Feb2021 at 06:00 PM, 50-60 hours after injection- migraine that lasted for about 6 hours , nausea followed by vomiting, no fever even after 3-4 days still mild headache. No therapeutic measures were received for all the events. The outcome of the events were recovering.
28 2021-04-07 unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Mild, Additional Details: Patient passed out hit his head while dropping to the ground. Paramedic was called and came. He was fine after, but called a ride to get him to be on the safe side.
28 2021-04-08 grand mal seizure Generalized tonic clonic seizure with post-ictal state, 1 minute after the shot, 2 episodes, each l... Read more
Generalized tonic clonic seizure with post-ictal state, 1 minute after the shot, 2 episodes, each lasting about 15 seconds. -stable vital signs, patient has no prior h/o seizure disorder, no h/o allergies to food, vaccine or meds, -patient was not on any meds at the time. -patient was stabilized and transferred to the ER for further evaluation.
28 2021-04-08 unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted due t... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted due to fear of needles-Medium, Additional Details: Patient has fear of needles and passed out after administration- EMS called to assess him and he was cleared to go home. No pain at injection site, no adverse effects from vaccine
28 2021-04-09 pain in extremity First day I only had a sore arm Second day, typical malaise, flu-like symptoms Third day I saw impro... Read more
First day I only had a sore arm Second day, typical malaise, flu-like symptoms Third day I saw improvement but still malaise. I tried a 500mg tumeric curcumin suppliment which was new for me ~5 hours later I noticed brain fog and my vision was not as clear. Over the next 3-4 days my brain stem/back brain started to throb/vibrate occasionally, and I got very bad tinnitus.
28 2021-04-09 tremor Mother and patient reports directly after injection patient experienced chills and shaking. That res... Read more
Mother and patient reports directly after injection patient experienced chills and shaking. That resolved within 3-4 hours. The next morning he woke up with a sore throat that felt swollen that persisted through today 4/10/21.
28 2021-04-10 feeling hot Feeling hot, Dizzy and Nauseous
28 2021-04-11 pain in extremity Slight fever and sore arm. Went away not long after and fine now! Took some Tylenol.
28 2021-04-12 tingling, numbness Swelling; Numbness; Tingling; received the most recent COVID-19 vaccine subcutaneously; This is a sp... Read more
Swelling; Numbness; Tingling; received the most recent COVID-19 vaccine subcutaneously; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 subcutaneously administered in left arm on 29Mar2021 12:45 (Lot Number: 1239921-00) as a single dose for covid-19 immunisation. Medical history included type 1 diabetes and allergic to tempeh (it's a food). The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included amoxicillin (AMOXICILLIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine subcutaneously in a pharmacy or drug store. On 29Mar2021 14:00, the experienced swelling, numbness and tingling which was considered serious since the patient was hospitalized (unspecified date in 2021) for 1 day (unspecified date in 2021). The adverse event required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events required treatment which included Benadryl. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovered on an unspecified date in 2021 with sequel.
28 2021-04-12 seizure I got the Covid 19 Vaccine Pfizer at the pharmacy. After I got the Vaccine I was waiting in the wait... Read more
I got the Covid 19 Vaccine Pfizer at the pharmacy. After I got the Vaccine I was waiting in the waiting room for 15 minutes but before my time was up and it was my time to leave I felt really dizzy & light headed as I was sitting down on a chair. Then I just felt some one tell me to wake up because I had fainted, fell face down to the floor & convulsed for 5 seconds.
28 2021-04-12 tremor Almost immediately after receiving the vaccine, I started having really bad blepharospasms which I h... Read more
Almost immediately after receiving the vaccine, I started having really bad blepharospasms which I had not had for about a month and started having general shaking throughout, but especially in my legs. Much of these side-effects began to subside upon the self-administration of clonezepam, but not completely There is a still a lot of pain at the injection site as well as fatigue
28 2021-04-13 weakness, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: sweating-Severe, Systemic: Flushed / Sweating-... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: sweating-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Weakness-Mild
28 2021-04-13 pain in extremity Client fell out of chair and hit his head. Began to seizure Left arm pain after pfizer injection. EM... Read more
Client fell out of chair and hit his head. Began to seizure Left arm pain after pfizer injection. EMS called
28 2021-04-14 feeling hot Pt vaccinated and immediately felt, hot, sweaty, faint. Hx of having similar reaction to vaccines in... Read more
Pt vaccinated and immediately felt, hot, sweaty, faint. Hx of having similar reaction to vaccines in the past. No medical problems. No medications. Ate a "snack" this AM. Drank fluids this AM. Pt wheeled without incident to triage area. Feeling a little better after drinking 16 oz water. Appears A & O X 3, no distress, diaphoretic, skin warm and moist to touch Mood and affect normal Initial vitals 10:30 am - P78 PO2 95% RA BP 113/62 Repeat vitals 1040 am P71 PO2 97% BP 104/56 Repeat vitals 1046 am P76 PO2 97% BP 100/57 Repeat vitals 1048 am P76 BP 102/61 Reports feeling better after water and Gatorade. Pt advised hydration. Advised immediate medical attention should symptoms persist or worsen Hypotension , Hypotension
28 2021-04-14 hot flush Hot flashes, fatigue(lasting 24 hours), drowsiness (slept for 18 hours the next day), lower back pai... Read more
Hot flashes, fatigue(lasting 24 hours), drowsiness (slept for 18 hours the next day), lower back pain,
28 2021-04-15 weakness Approximately 10 minutes after receiving the COVID vaccine (second dose) pt. Experienced a fainting ... Read more
Approximately 10 minutes after receiving the COVID vaccine (second dose) pt. Experienced a fainting episode, with the possibility of loosing his pulse for approximately 30 seconds according to RN. Pt. Was in his vehicle in the monitoring area. When RN arrived after approximately 1 minute, the patient had a strong carotid pulse of around 80. Airway was maintained until patient woke up. Pt stated that he had not eaten before coming. BP's follow: 1230:99/64, P-48-Sat 94% 1243:109/74,P-67,Sat-97% 1248: 102/63,P-73,Sat-95% 1253-106/72,P-68, Sat-93& 1258-105/64,P-66, Sat-94% 1305-106/73,P-63,Sat 95%. 1311-112/74,P-59,Sat 94% 1316-99/68,P-59, Sat 92% 1322-112/73,P59, Sat 94% Pt remained weak and nauseous for approximately 45 minutes. It was decided at that time he would need to go to the ER and EMS was called. At approximately 1330 Pt. Was assisted to the stretcher and transported to ER for further evaluation. ED physician determined that patient had a vasovagal reaction to the vaccine and was discharged home.
28 2021-04-15 flushing Patient experienced flushing and sweating. BP 98/53 P86 RR18. No signs of respiratory distress, vita... Read more
Patient experienced flushing and sweating. BP 98/53 P86 RR18. No signs of respiratory distress, vitals stable. Patient given orange juice and crackers, felt better, possible lower blood sugar episode. Did not eat for more than 6hrs prior to vaccination. Discharged in stable condition.
28 2021-04-15 muscle twitching, seizure patient sitting in post-vaccination area has a witnessed seizure at 1525, patient had twitching, LO... Read more
patient sitting in post-vaccination area has a witnessed seizure at 1525, patient had twitching, LOC and eye rolling. EMT and RN were there and observed. Patient returned to consciousness, and moved behind curtin. Patient had another witnessed seizure @ 1532 lasting 10 seconds, with LOC, twitching, eyerolling and vomiting. Patient came to and placed on floor, alert and awake, able to answer questions but feeling foggy. EMS was called during 1st seizure. EMS arrived and took patient to hospital @ 1558.
28 2021-04-15 tingling Soreness at the place of injection beginning around 12:10 pm, stomach ache beginning around 7:00 pm,... Read more
Soreness at the place of injection beginning around 12:10 pm, stomach ache beginning around 7:00 pm, followed almost immediately by tingly feeling in arms and legs. Lost movement below the elbow for 3-5 minutes around 7:15 pm. By loss of movement, I mean my fingers tensed up, fully extended, and I was unable to relax or move them at all.
28 2021-04-17 involuntary muscle movements 4/18/2021 , 11:15 - Upon getting his First dose of Pfizer Vaccine, Patient seen in his chair having ... Read more
4/18/2021 , 11:15 - Upon getting his First dose of Pfizer Vaccine, Patient seen in his chair having generalized jerking movements, arms and legs were extended, both eyes were rolling. 911 called and EMS came. Patient refused to be taken to the hospital.
28 2021-04-17 feeling hot IMMEDIATELY AFTER VACCINE PT EXPERIENCED A "HOT FEELING" AND LIGHTHEADEDNESS. PT WAS TRASNPORTED TO ... Read more
IMMEDIATELY AFTER VACCINE PT EXPERIENCED A "HOT FEELING" AND LIGHTHEADEDNESS. PT WAS TRASNPORTED TO OBS VIA WC AT 1032. PT REPORTS HE IS FEELING BETTER ALREADY. WATER AND SNACKS GIVEN. VSS. PT RELEASED BY SELF AT 1043. PT ESCORTED BY STAFF TO EXIT WITH NO FURTHER ISSUES. VITALS AS FOLLOWS: 1036 SITTING BP 122/81 HR 86 SPO2 98 1042 STANDING BP 116/73 HR 72 SPO2 98
28 2021-04-18 feeling hot The patient received the vaccine on 4/18/21 at 12:56pm. As he was waiting 15-minute post-administrat... Read more
The patient received the vaccine on 4/18/21 at 12:56pm. As he was waiting 15-minute post-administration, he walked to the front, (~1 minute post-administration) and fainted. He was caught by his girlfriend and brought down to the floor, where he remained sitting. No injuries reported, reported no nausea, was oriented, held a normal conversation, reported being hot, temp was 95.5F. Paper towel soaked in cold water was applied to forehead, and gave him water to drink. Declined juice. The patient mentioned he had a reaction to a flu vaccine in the past where he was very ill after. He expressed a fear of needles, and he has fainted after bloodwork previously. EMS evaluated, patient declined hospital visit.
28 2021-04-18 muscle twitching About 24 hours after patient got his second dose of the Pfizer Covid-19 vaccine, he started to get m... Read more
About 24 hours after patient got his second dose of the Pfizer Covid-19 vaccine, he started to get muscle twitches throughout the entire body. This lasted for 24 hours, and then reduced to legs only. He now has leg twitches, chills and flu-ish symptoms that have continued to today, Monday April 19, 5 days after the second dose.
28 2021-04-19 pain in extremity right arm axilla lymph node swelling, fatigue, headache and right arm pain
28 2021-04-19 pain in extremity Soreness in the left arm from 3 hours after shot. Headache and elevated temperature in the late afte... Read more
Soreness in the left arm from 3 hours after shot. Headache and elevated temperature in the late afternoon and evening. Fever and chills in the evening. Headache continued in the morning of April 20th. Took 200 mg ibuprofen, 50mg zinc and 2 tbsp elderberry.
28 2021-04-20 muscle spasms, weakness, tremor, seizure, discomfort seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; ... Read more
seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.
28 2021-04-20 tremor Whole body aches and trembling, fever, lightheaded, nauseated, vomiting
28 2021-04-20 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted for a few seconds while sitting in observation for 15 minutes. almost 15 minutes had lapsed and fell to the floor. bumped head mildly on the groud. immediate response. a little disorientated. gave water and granola bar. pt did not drink or eat anything all day . sat for 30 extra minutes and felt better. advised to check with md.
28 2021-04-21 numbness, tingling Pt contacted health clinic on Apr 22 at approximately 0900 stating he was experiencing numbness and ... Read more
Pt contacted health clinic on Apr 22 at approximately 0900 stating he was experiencing numbness and tingling in his right arm/hand, no other symptoms/side effects stated. Pt indicated that symptoms started yesterday morning, Apr 21 and got worse this morning when he woke up which prompted him to contact the clinic. Pt was instructed to f/u at urgent care/er to rule out other medical conditions.
28 2021-04-22 weakness Headache, body ache, tiredness, lack of energy.
28 2021-04-22 bell's palsy Bells palsy came into effect 1 week after the first Pfizer shot
28 2021-04-23 seizure Patient at pharmacy and sitting in chair after receiving vaccine. Patient slumped in his chair and ... Read more
Patient at pharmacy and sitting in chair after receiving vaccine. Patient slumped in his chair and had seizure x 2, incontinent of urine. Patient to ER and neurology consult.. Neurology diagnosed convulsive syncope. No further treatment. Patient discharged home.
28 2021-04-24 cold sweat Patient became for clammy, dizzy, low pulse rate, low blood pressure, blue lips, somewhat incoherent
28 2021-04-24 pain in extremity Received the vaccine at 10:;15 am on 4/14/2021 and had fatigue, slight chills, and a sore arm. By ... Read more
Received the vaccine at 10:;15 am on 4/14/2021 and had fatigue, slight chills, and a sore arm. By 4/16/2021 I felt normal until approx. 10pm when my right ear blocked up and I lost hearing in my right ear. On 4/17/2021 I treated it as a congestion issue with neti pot and decongestions but the ear remained blocked. After sleeping for approx 1 hour on 4/17/2021 I woke up at approx. 11pm with severe vertigo and nausea and vomited consistently for approx 1 hour. I could not get off of the floor and the right side of my face was fixated to the floor. Paramedics were called and I was taken to the ER where I was treated with anti-nausea medications and valium to reduce vertigo. A non contrast CT, blood panel, and stroke assessment were all normal with no sign of ear infection. I was release from the hospital at 10am on 4/19/2021. On 4/21/2021 I saw an ENT who performed a hearing exam revealing my right ear is completely deaf with normal left ear function. The ENT prescribed prednisone 10mg (63 tablets over 10 days). As of today (4/25/2021) I no longer have vertigo and nausea, but I still have no hearing in my right ear and have significant vestibular challenges and cannot walk safely unassisted without getting dizzy.
28 2021-04-24 tension headache, weakness afraid to take second dose of Pfizer COVID-19 vaccine due to the events; brain fog every single day;... Read more
afraid to take second dose of Pfizer COVID-19 vaccine due to the events; brain fog every single day; kind of off and uneasy; body aches; slight dizziness not like he was going to fall over, but cant stand still without lean a little/felt immediate rush to the head and feeling of fainting; very weird like an out of body experience this was almost like an anxiety attack/anxiety attacks for every 30 minutes or so; tension headaches; Chills; tunnel vision/tunneled, it was like tunnel vision and a very very weird like an out of body experience this was almost like an anxiety attack; it was extremely intense; pain at the injection; insane rush from the bottom of his feet to the top of head, felt like he was going to pass out; weakness; This is a spontaneous report from a contactable consumer (Patient). A 28-year-old male patient received first dose of BNT162B2 (Pfizer COVID Vaccine, solution for injection, Lot Number: ER8733; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 28Mar2021 at 17:00 (at the age of 28 years-old) as single dose for COVID-19 immunization. Medical history included ongoing asthma, anxiety experienced years and years ago when he was about 19-20 years old and it has been under control, he hasn't had this happen in years. The patient mother suffers from slight anxiety at times; dad currently has high blood pressure. Concomitant medication included albuterol sulfate taken for asthma (in inhalation (90mcg per actuation 200 metered inhalations: 2 puffs as needed) and liquid form (0.083% 2.5 mg out of 3ml as needed) for nebulizer since he was born). Patient did not have COVID prior vaccination. Patient did not want to contract COVID-19 because he has asthma. On 28Mar2021 at 17:00 (within 5 minutes of vaccination), patient experienced Tunnel Vision, chills, weakness, insane rush from the bottom of his feet to the top of head, felt like he was going to pass out (which was recovered same day with lasting effects), weakness, hasn't felt the same; feels like something is off every day; not himself, very weird like an out of body experience this was almost like an anxiety attack/anxiety attacks for every 30 minutes or so, tension headaches, dizziness and felt immediate rush to the head and feeling of fainting, at 8PM or 9PM, he felt pain at the injection and body aches. The patient visited physician room as a result of Insane tension headaches, and anxiety. On 29Mar2021, he didn't really feel too anxious, but he felt out of place, kind of off and uneasy. The chills and body aches, kind of off and uneasy were disappeared on 30Mar2021. On 31Mar2021, brain fog and slight dizziness does not like he was going to fall over but cant stand still without lean a little/felt immediate rush to the head and feeling of fainting. On 02Apr2021, injection site pain was gradually faded away. The patient states that these events started after the Pfizer COVID 19 vaccine. Therapeutic measures were taken as a result of events included Tylenol. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): Pending on 06Apr2021. The patient did not take any other vaccinations four weeks prior to vaccination. The patient was afraid to take second dose of Pfizer COVID-19 vaccine due to the events. Patient felt very hard to work with these symptoms and to get through everyday life, it is very tough. Patient knows plenty of people that died from COVID-19 and he does not want to have to make changes and fix things in his life that he did not cause and worries this will stick around for the rest of his life all because he took a vaccine. The patient had physician office and Emergency room visit. The outcome of the events insane rush from the bottom of his feet to the top of head, felt like he was going to pass out, pain at the injection, chills and body aches were recovered, while for tension headaches, anxiety attacks, dizziness, weakness, brain fog, hasn't felt the same; feels like something is off every day; not himself was not recovered, and for tunnel vision it was unknown. Information on the lot/batch number has been requested.
28 2021-04-25 hot flush, feeling cold, cold sweat PATIENT EXPERIENCED A "HOT FLASH' AND TIGHT THROAT AT ITHE 15 MIN MARK, COLD AND CLAMMY FOREHEAD, 1... Read more
PATIENT EXPERIENCED A "HOT FLASH' AND TIGHT THROAT AT ITHE 15 MIN MARK, COLD AND CLAMMY FOREHEAD, 121/79 89, 100 % GIVEN COLD WATER TO SIP, REPORTS NO DIFFICULTY SWALLOWING AND IMPROVED TIGHTNESS WITH SIPS. 0935 SIDE EFFECTS RESOLVED DISCHARGED AT 945 TOLD PO'S NOT THROAT TIGHTNESS. PATIENT EDUCATED TO REPORT SIDE EFFECT TO VACINATOR AT SECOND DOSE APPOINTMENT PRIOR TO ADMINISTRATION. PATIENT VERBALIZED UNDERSTANDING OF PATIENT CARE PLAN.
28 2021-04-25 numbness, bell's palsy Bell's Palsy. Feel numbness on the right side of face for about 10 days.
28 2021-04-25 migraine with aura Below symptoms noticeably worse - Vertigo - Migraine visual aura - Tinnitus Onset 4 days after Pfiz... Read more
Below symptoms noticeably worse - Vertigo - Migraine visual aura - Tinnitus Onset 4 days after Pfizer dose # 1. Symptoms still not much improved as of 12 days after vaccination
28 2021-04-26 flushing Patient had flushing/sweating, dizziness, lightheaded, diaphoretic, lips tingling, slight blurred vi... Read more
Patient had flushing/sweating, dizziness, lightheaded, diaphoretic, lips tingling, slight blurred vision, anxious. Given water, juice, graham crackers. Symptoms improved, stable, patient released from vaccination site.
28 2021-04-26 seizure, tremor, unresponsive to stimuli, muscle twitching Systemic: Fainting / Unresponsive-Medium, Systemic: pt had seizure-like twitching, fell off his chai... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: pt had seizure-like twitching, fell off his chair face first. He cut his face.-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Pt told me he gets lightheaded after vaccines. I told him I'd help him get to a chair near vaccination area so I could monitor him. He agreed. I didn't even have time to apply the bandage when he started twiching & basically jumped out of his chair. He twisted 180 degrees and fell on his face. He got cut in at least 2 facial areas. Pharmacist cleaned him up. He never lost consciousness. EMS came and treated him. He refused to go to hospital at first, but eventually they took him.
28 2021-04-27 feeling of body temperature change, flushing Pain on left lower side of stomach around at random times, this is the second day in a row. Feeling ... Read more
Pain on left lower side of stomach around at random times, this is the second day in a row. Feeling exhausted and sore the second day after the vaccine. Feeling hot and flushed and then cold at times Headache
28 2021-04-28 pain in extremity Chills, injection arm ache, back ache, headache - symptoms disappeared overnight but lasted roughly ... Read more
Chills, injection arm ache, back ache, headache - symptoms disappeared overnight but lasted roughly 16 hours or so
28 2021-04-28 pain in extremity Received COVID vaccine (Pfizer) 3 days prior to admission which was followed by subjective fevers an... Read more
Received COVID vaccine (Pfizer) 3 days prior to admission which was followed by subjective fevers and chills x 2 days but no longer endorses this. Had a headache one day prior to admission that resolved with tylenol. Reports that he has hx HTN but home BPs (which he takes infrequently) have been 140s-150s systolic in the past. Has never been on meds for blood pressure. Chest pain was substernal 5/10 lasted 2 hours and believes it relieved with his blood pressure coming down. Does not describe any other alleviating factors. It was nonradiating, just happens for have left arm pain after vaccine that was present prior to chest pain.
28 2021-04-28 seizure PATIENT HAD SEIZURE ABOUT 5 MINUTES AFTER VACCINATION. THE SEIZURE LASTED ABOUT 5 SECONDS.
28 2021-04-28 tenderness A day after the vaccine I noticed pain in my armpit. I looked at my arm and I have roughly a golf b... Read more
A day after the vaccine I noticed pain in my armpit. I looked at my arm and I have roughly a golf ball sized lump in my armpit. It's pretty tender when I touch or move my arm abruptly. From what I've researched it seems like a fairly normal reaction, but I still want to report it. I've taken ibuprofen and tried icing it to help with the swelling.
28 2021-04-29 tenderness Notmal injection. Days later large lumps formed on my under arm and rib cage that appear to be lypno... Read more
Notmal injection. Days later large lumps formed on my under arm and rib cage that appear to be lypnodes or something similar. Painful to the touch and persistent over a few days
28 2021-05-01 feeling hot headache, fever (100 F), chills. Symptoms started at about midnight. The chills lasted for a few ho... Read more
headache, fever (100 F), chills. Symptoms started at about midnight. The chills lasted for a few hours throughout the night but were gone after a few hours (2-6). I took 325 mg of aspirin in the morning at about 10 am. I did not remeasure my temperature, but my head still felt warm. I took 500 mg of acetaminophen 1-3 hours afterwards. The fever went away and I felt normal again by the time I went to bed (11 pm).
28 2021-05-03 discomfort Two lumps above clavicle suspected to be swollen lymph nodes on the left side (same side of vaccine ... Read more
Two lumps above clavicle suspected to be swollen lymph nodes on the left side (same side of vaccine injection). One lump is soft and moveable, and one is pea sized and it is firm and also moveable. Both lumps are painless. Discomfort and tension on the side of the neck where the swollen lymph nodes are. I noticed the lumps about two weeks after the first vaccine dose. The day after the second dose, the lumps swelled a bit more and neck tension increased.
28 2021-05-03 flushing Patient reports dizziness, nausea, flushed and visual changes. Patient reports going running before... Read more
Patient reports dizziness, nausea, flushed and visual changes. Patient reports going running before vaccine and didn't eat or drink. After patient spent some time lying down and drinking some water, patient reports symptoms resolved.
28 2021-05-03 pain in extremity Aside from the expected soreness in the arm and short lived fevers, I started to develop painful swe... Read more
Aside from the expected soreness in the arm and short lived fevers, I started to develop painful swelling and hard lumps in my lymph of the same armpit as my injection site. It was quite painful and broke out into a puss-tipped rash and continued to get worse. It has been over 20 days now and instead of getting better, it has spread to my other armpit now. I went to the local advanced urgent care clinic who ran some bloodwork and said my white cell count is normal and non-indicative of lymphoma, so I was put on prednisone and doxycycline. The medication has done next to nothing and I was told that there was nothing else they could do. The pain in the arm varies per day but there are some days where it is too painful to use my arms at all.
28 2021-05-04 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
28 2021-05-05 feeling hot Post vaccine pt felt warm a light headed. Pt laid down independently and symptoms went away but retu... Read more
Post vaccine pt felt warm a light headed. Pt laid down independently and symptoms went away but returned upon standing up. Pt laid down again until brought to Medical Observation. Vitals obtained and monitors. Water and food provided 1626 LYING BP 125/75 HR 93 Sp02 100% 1631 LYING BP 126/69 HR 93 RR 16 Sp02 98% 1636 LYING BP 128/85 HR 89 RR 14 Sp02 100% 1648 STANDING BP 150/81 HR 94 RR 14 Sp02 98% 1650 STANDING BP 128/74 HR 93 Sp02 99%
28 2021-05-05 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
28 2021-05-05 tingling Patient is a 28 year old male in the observation area presents tingling sensation from right hand th... Read more
Patient is a 28 year old male in the observation area presents tingling sensation from right hand that jumped to left arm then to left leg then resolved after 2-3 minutes. Endorsed had the same No CP, SOB, angioedema, blurry vision, slurry of speech, facial droop. Physical exam unremarkable. Vital signs stable. Neuro intact. Given ED precautions for CP, SOB, angioedema, sudden focal weakness. Sent home stable with resolved symptoms.
28 2021-05-06 cold sweat Cold sweats, nausea, flu symptoms
28 2021-05-06 feeling cold Last weekend on Sunday morning (April 25th), I received my second shot of Pfizer vaccine at 9am. My... Read more
Last weekend on Sunday morning (April 25th), I received my second shot of Pfizer vaccine at 9am. My body started to show some side effects on the evening of Sunday. I felt super cold around 10 pm and at the same time, I had a fever, too. I went to bed early that night (around 10:30 pm) and since I was super cold, I had 3-4 blankets on me when I was on my bed. Suddenly, at 1 am, I woke up due to a very strange noise in my head (a very low-volume noise of knocking on the door every 10 seconds!! I think it was only something in my mind). Since I couldn't sleep because of that low artificial noise, I decided to go to the bathroom at around 1:10 am (My bode was also in lots of pain at that time). When I started to walk, I realized that something is wrong with my body. When I peed and stood up to get back to my bed, I noticed that I'm losing control! Therefore, I hit the bathroom door to wake up my girlfriend, and then I fainted! (I can't remember anything for about 30 seconds here). My girlfriend told me that when I fainted, one of my eyeballs was upward and the other was downward (like zombies!!). She started to freak out and called her mom, but once they started talking, I woke up. My body was soaking wet when I woke up and I was in lots of pain. I asked her to help me to lay down on the ground. After 10 minutes, that my sweats were gone, I started feeling cold and asked her to give me a blanket. I couldn't sleep for about 2-3 hours after I fainted, but I was feeling better (I was much better than the time before fainting). On Monday afternoon, I called the health center and told them my side effects. They strongly recommended visiting ER ASAP since the symptoms that I described were severe side effects of Pfizer. Therefore, I went to ER on Monday (April 26th) to see what?s the issue. Hopefully, after spending 3-4 hours there, and passing some tests, the results did not show anything wrong with my body, but just the side effects of the vaccine.
28 2021-05-07 weakness, inability to speak, tingling Shortness of breath, rapid heartbeat, tiredness and weakness, tingling in the face and extremities, ... Read more
Shortness of breath, rapid heartbeat, tiredness and weakness, tingling in the face and extremities, could not articulate, swelling on the right side of the face.
28 2021-05-08 cold sweat, numbness Immediately after the patient received the vaccination he stated that his arm felt numb. This seemed... Read more
Immediately after the patient received the vaccination he stated that his arm felt numb. This seemed to concern him greatly although I reassured him that this reaction had been reported to me on other occasions and it was transient. I checked his blood pressure and pulse, both of which were normal, and he waited for about 20 minutes before returning to work where he received the shot. He returned to the pharmacy approximately 15 minutes later and stated that he felt dizzy, nauseous, and had blurry vision. His forehead felt cold and clammy to the touch and he was sweating. I had him sit, and checked his pulse again (still normal). He stated that his chest felt "cold and tired" but he was not having difficulty breathing. After observing him for some minutes I gave him a 50mg dose of Benadryl in case the reaction was allergic in nature. I observed him for at least 15 more minutes were he seemed calm and was able to speak on his cellphone to family so they could come and pick him up. In my opinion he seemed improved by the time he left but I counseled him to seek medical attention if his adverse feeling worsened. The patient was able to walk out of the Walmart without assistance. I called him at home around 5:20 pm and he sounded very sleepy but he had not yet had to seek further medical attention.
28 2021-05-09 cold sweat 5 min after receiving vaccine felt clammy and nauseous vomited small amt undigested food brought b... Read more
5 min after receiving vaccine felt clammy and nauseous vomited small amt undigested food brought back to OBS 1 via wheelchair upon arriving to OBS area pt pale in color transferred self without difficulty to stretcher, VS as noted pt feeling better once laying on stretcher, awake and alert pt states has anxiety related to needles pt given snack and water, tolerated well. denies further symptoms color improved. pt repositioned self to dangle at side of bed then standing with no further issues. discharged to exit. VS 0925 hr 66 po 100 bp 134/82 0930 hr 71 po 99 bp 138/73 0935 dangle hr 63 po98 bp 121/74 0940 standing hr 79 po 98bp 124/76
28 2021-05-09 pain in extremity woke up 3 AM Friday was sore, ache, chills, the small blister noted that Friday evening injection si... Read more
woke up 3 AM Friday was sore, ache, chills, the small blister noted that Friday evening injection site bump small blemish- scratched and it "popped" similar to a sunburn, it's flat now but a little itchy. Sore arm, body ache, chills - this is resolved 5/4-Placed follow-up call, pt reports that on the left arm the bump went down and not as raised as before, and it is not spreading and not painful. Pt reports took Tylenol ES and drank a lot of powerade and that helped. Pfizer 1st dose 4/8/2021 @ 1630 LOT#: EW0153. Recommend that if it gets itchy or red an apply topical otc anti-itch cream as needed.
28 2021-05-10 bell's palsy Bells palsy on the right
28 2021-05-10 migraine Within 15 minutes, light headed and slight nausea, deeveloping small rash on right arm Within 60 min... Read more
Within 15 minutes, light headed and slight nausea, deeveloping small rash on right arm Within 60 minutes, migraine, nausea, slight chest pain, HBP, fever Within 8 hours, migraines, nausea, body aches, fatigue, fever With 24 hours, migraines, nausea, body aches, fatigue,on/off fever
28 2021-05-10 tingling Dizzines, nausea, tingling in fingers, vasovagal reaction. Pt reports that has needle phobia and has... Read more
Dizzines, nausea, tingling in fingers, vasovagal reaction. Pt reports that has needle phobia and has not had blood draw or any vaccination for a long time. Pt reported nausea, but no vomiting, feeling dizzy, and tingling of fingers. Pt was transported via wheelchair and transferred to bed. Pt reported doing well after 5 minutes, water, crackers and juice was given. Pt reported doing well and was asymptomatic. Pt was observed for a period 20 minutes. BP: 110/69, HR: 62, R: 16, O2 sat: 98 to 100% room air. Pt was discharged in stable condition.
28 2021-05-13 speech disorder, paralysis, numbness, weakness, burning sensation, coordination abnormal he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experienc... Read more
he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having a hard time to get a sentence out (felt like his motor skills were affected); having a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021. Information about lot/batch number has been requested.
28 2021-05-16 electric shock sensation, pain in extremity, burning sensation, nerve pain, tingling Cognitive -- severe symptoms began ~3 days after Pfizer 2nd dose. Extreme disorientation and confus... Read more
Cognitive -- severe symptoms began ~3 days after Pfizer 2nd dose. Extreme disorientation and confusion (transient), memory loss (longterm), extreme lethargy - unable to move, intermittant psychosis (mild, esp. when going to sleep), and anxiety (transient but very extreme, unlike anything I've felt before, not improved by diazepam) (continued for 10 days then began to improve dramatically followed by alternating relapse on a daily basis for 4 weeks, up to present -- dramatically and stably improved by steroid treatment, returned after discontinuing) Nerve pain -- began ~1 week after Pfizer second dose. -- tingling, burning throughout extremities, especially fingertips, toes, hips; transient (usually 5 seconds or less). Progressively became more frequent (20+ / day), longer lasting (up to 20 seconds) and more severe (like stabbing or electric shock). Gradually resolved after course of dexamethasone beginning 3 weeks after vaccination. Sharp inner ear pain -- (both ears) began ~1 week after Pfizer second dose. Rare events (~5x / day), very transient (1-2 seconds) but extremely painful. Continues up to present, (4 weeks after Pfizer second dose). Also constant popping of both ears beginning week 2 to present, feels like fluid inside. Adenopathy -- On 4/28/21 noticed massive swelling on left pectoral muscle (contralateral to vaccine injection site), diagnosed as lymphadenopathy, moderately painful. Continued to get worse for 1 week, began dexamethasone on 5/7/21. Dramatically improved, however swelling returned after discontinuing steroid and spread to all lymph nodes, including neck and others. Became extremely painful on 5/14/21, unable to walk due to swelling in inguinal lymph nodes. Again dramatically improved after steroid injection on 5/16/21.
28 2021-05-17 bell's palsy Bell's Palsy
28 2021-05-18 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Chills roughly 12 hours after administration. Resolved by the n... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Chills roughly 12 hours after administration. Resolved by the next morning Headache began 15May21 resolved 16May21 Left Hip pain from 16May21-17May21 Pain in outer left thigh 19May21 - ongoing (no redness or swelling) Fatigue: 14May-15May21
28 2021-05-18 tingling Patient reported tingling sensations all over body, heavy sweating, and *feeling like fainting* 5 mi... Read more
Patient reported tingling sensations all over body, heavy sweating, and *feeling like fainting* 5 minutes after injection during observation period. One dose of epipen was administered and patient immediately started feeling better after 2 minutes
28 2021-05-19 facial paralysis Patient reports approximately 1 week after vaccination noticing tingling sensation to right upper li... Read more
Patient reports approximately 1 week after vaccination noticing tingling sensation to right upper lip. This was mild and persisted for a few days. He noticed a few days later that when he went to drink water it drippled down his right cheek, as if he could not close his lips completely on the right side. This continued for 1 day, then improved and has now resolved. Never had any other facial paralysis and was able to completely close his right eye. He did not seek medical attention for this. He went for his follow up vaccination dose and was turned away when he brought up these symptoms, and made appointment with myself at his PCP office.
28 2021-05-20 weakness After shot. I was sitting down for the advised 15 minutes. I got up to pass the time and look at an ... Read more
After shot. I was sitting down for the advised 15 minutes. I got up to pass the time and look at an aisle in the store. All of a sudden everything went white and my head got light headed and I had to go down on my knees, I was then weak and advised to stay seated. Eventually it passed but I am shaken up.
28 2021-05-21 cold sweat PT ADMINISTERED 1ST DOSE OF COVID PFIZER VACCINE. WAS TOLD TO SIT FOR 15 MINUTES. AFTER ABOUT 5 MINU... Read more
PT ADMINISTERED 1ST DOSE OF COVID PFIZER VACCINE. WAS TOLD TO SIT FOR 15 MINUTES. AFTER ABOUT 5 MINUTES, WIFE NOTIFIED PHARMACY STAFF OF PT PASSED OUT IN CHAIR (SLUMPED OVER). AFTER PHARMACIST ATTEMPTED TO GET ATTENTION, HE REGAINED CONSCIOUS BUT WAS CLAMMY AND SWEATY. PT ASKED FOR A GLASS OF WATER. AFTER A FEW MINUTES, HE STATED HIS CHEST WAS HEAVY AND VISION BLURRY. 1 DOSE OF AN ADULT EPIPEN WAS ADMINISTERED WITH PT CONSENT. HE STATED HE FELT BETTER. WIFE REQUESTED EMS BE CONTACTED. EMS DISPATCHED AND PT LEFT PHARMACY CONSCIOUS IN A STRETCHER.
28 2021-05-21 feeling hot Patient observed at 1442 sliding down in his observation chair. Observation nurse helped lower patie... Read more
Patient observed at 1442 sliding down in his observation chair. Observation nurse helped lower patient to the floor. Patient had a syncopal episode for a few seconds. Patient woke up, assisted into wheelchair, and taken to private room for further assessment. Full set of vitals obtained as follows: O2 sat 99% RA, HR 66, BP 138/80, RR 18. Patient stated he was feeling fine and that he previously was outside today and was very hot before receiving his vaccine. Patient also stated he had a historyof syncopal episodes from being over heated. Monitored pt for another 10 minutes and took another set of vitals at 1452 as follows: O2 sat 99% RA, HR 83, BP 135/85, RR 17. Assessed patient vitals 10 minutes later at 1502...
28 2021-05-23 nerve pain, pain in extremity On May 13 (3 Weeks after first covid vaccine shot), I started to feel skin pain on the area above ri... Read more
On May 13 (3 Weeks after first covid vaccine shot), I started to feel skin pain on the area above right kneecap. Then I felt nerve pain on the same side of leg. May 14 I couldn't sit down as I felt occasional lumbar pain. I even went to orthopedics and they said no trouble found. Skin pain spread through the whole body. May 15 I had second shot of pfizer, still back pain and thigh pain. Skin pain spread through whole body. May 16 I saw red spots begin to surface on the thigh. Skin pain spread through whole body. May 17 red spot became bigger I thought it was rash, pain persists. May 18 the red spots looks out of control, I scheduled the next available appointment for primary care (2days later!) May 19 Just bigger red spots every time I take off my pants. May 20 black bubbles appeared in the morning, and I got to finally go to appointment at noon, diagnosed as shingles.
28 2021-05-23 unresponsive to stimuli Syncopal episode with fall from chair. Unresponsive approx 30 seconds. Pt was GCS 15 within 60 seco... Read more
Syncopal episode with fall from chair. Unresponsive approx 30 seconds. Pt was GCS 15 within 60 seconds after syncope. EMS was called because the pt hit his head on the ground but did not sustain any life threatening or injuries. No signs of trauma to note. Pt was AOx4 and GCS 15 by the time he was dismissed from the clinic.
28 2021-05-25 pain in extremity Chest pain, dizzy, light headed, leg and arm pain, short of breath, tired, spaced out mentally/unabl... Read more
Chest pain, dizzy, light headed, leg and arm pain, short of breath, tired, spaced out mentally/unable to focus. No treatment at this time.
28 2021-05-30 unresponsive to stimuli, flushing Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
28 2021-06-01 feeling hot Patient complained of feeling warm all over, sweating, feeling shaky. Denies shortness of breath, fa... Read more
Patient complained of feeling warm all over, sweating, feeling shaky. Denies shortness of breath, facial swelling or itching. Patient transferred to gurney from wheelchair. Patient put in Trendelenburg position and legs elevated, cold compress to forehead, ice pack to back of neck. After a few minutes, patient stated he "feels much better". Blood pressure 154/88 at first, 8 minutes later 138/81 (lying). Tried sitting. Apple juice given. Patient vomited x 1. After a few minutes he felt okay sitting with feet dangling. Tried ambulating. Denied dizziness. Patient wanted to go home. Discharged with mother.
28 2021-06-01 pain in extremity Fever; Headache; sore arm; very tired; This is a spontaneous report from a contactable consumer (pat... Read more
Fever; Headache; sore arm; very tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0150) in the left arm, on 24Apr2021, at 12:15 PM, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. On 02May2021, at 06:00 AM, the patient experienced fever, headache, sore arm and he was very tired. No treatment was received. Post the vaccination, the patient has not been tested for COVID-19. The patient did not recover from the events at time of this report. The case was assessed as non-serious. Then, on 15May2021, at 09:45 AM, the patient received the second dose of BNT162B2 (COMIRNATY, Lot. EW0179) in the left arm, at single dose, for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.
28 2021-06-01 tremor Patient reports having tremors lasting 1 hour straight which were on and off for the first day and a... Read more
Patient reports having tremors lasting 1 hour straight which were on and off for the first day and a half. Had a gradient body temperature from warm to cold from lateral side to lateral side of body.
28 2021-06-02 flushing VIIS ID: 41412; Pfizer COVID-19 Vaccine Vaccine Lot Number: Ew0178 2nd dose; vagal faint after vacc... Read more
VIIS ID: 41412; Pfizer COVID-19 Vaccine Vaccine Lot Number: Ew0178 2nd dose; vagal faint after vaccine#2 pfizer, hx of anxiety and vagal reaction, + 10-15 secs LOC no fall, no trauma, no neck pain/stiffness. increase oral hydration. Apprehension, flushing and/or skin edema, moderate ETOH night before. faints with vaccinations and tattoos. 540pm 140/88, P-70, R-20 POX 99%; 5:50 147/80, p-66, r-20, Pox-99%. Pt d/c home-friend driving him home.
28 2021-06-02 numbness, tingling Tingling, numbness in left arm and heart area; shortness of breath; abnormal heartbeat all on a dail... Read more
Tingling, numbness in left arm and heart area; shortness of breath; abnormal heartbeat all on a daily basis since about a week or 2 after the second vaccination shot.
28 2021-06-02 muscle twitching Patient reports twitching in left arm throughout day at vaccine site in tricep each day since first ... Read more
Patient reports twitching in left arm throughout day at vaccine site in tricep each day since first covid Pfizer vaccine. Patient reports twitching is getting better.
28 2021-06-02 pain in extremity Patient received the Jansen vaccine in April then came to our facility informing us that he had not ... Read more
Patient received the Jansen vaccine in April then came to our facility informing us that he had not been vaccinated and we went ahead and administered the Pfizer vaccine serues
28 2021-06-02 unresponsive to stimuli 28 year old male presented for initial dose of Phizer-BioNtech at 1100 AM on 6/3/21. Pre-assessment... Read more
28 year old male presented for initial dose of Phizer-BioNtech at 1100 AM on 6/3/21. Pre-assessment form was filled out and reviewed with nursing student administering the vaccine. The client stated no known allergies to medications, food, venom, or environmental elements. He also stated no allergic reactions to previous vaccines. The client also stated that he had no known health issues. After administration the patient stated he was dizzy and then immediately became unresponsive, diaphoretic, eyes rolled back, and head hyperextended. Family was present and we asked if he had any seizure history and his family declined. At this time the patient and family informed us that after vaccines in the past he does faint but didn't inform staff before this vaccine was administered. The patient remained unresponsive for 45 seconds. Then his feet were elevated and he asked to lay down. At 11:11 AM his HR was 60 and O2 was 97% on pulse oximetry. He felt hot and was still diaphoretic and felt very fatigued. Once he started feeling better we sat him back up and his HR was 89 and O2 was 99%. We gave him 2 bottles of water and crackers. He remained in our care for 45 minutes. He then waited an additional 30 minutes in the post vaccine area. His family stated they were going to drive him home and get some food. The patient is expected to return June 24, 2021 for his second dose of the Phizer vaccine. We provided additional discharge instructions
28 2021-06-03 inability to speak 28 yold male previously healthy who presented with recurrent loss of speech and motor function witho... Read more
28 yold male previously healthy who presented with recurrent loss of speech and motor function without loss of consciousness beginning 5/8/2021. Pt received his 2nd Pfizer COVID MRNA vaccination on 5/7/2021
28 2021-06-03 numbness, tingling It was the patients first COVID-19 Pfizer vaccine dose and he was sitting in the waiting room after ... Read more
It was the patients first COVID-19 Pfizer vaccine dose and he was sitting in the waiting room after his vaccination and came to get me to tell me that he did not feel well. He was sweating and then proceeded to vomit. We had him sit in the other exam room and gave him some water. After that he started saying his arms were tingling and going numb, when that happened I discussed with him calling EMS and instructed the PCT to call EMS. When EMS came the pt said he was feeling better and signed a refusal to go with them to the ER. The pt had a friend who was in the store with him that was going to drive him home. He was able to sit for about 30 minuets when he stated that he was feeling better and was wanting to go home. PCT walked him to the car. He was instructed that if at any time he started having symptoms again that he needed to go to the ER.
28 2021-06-06 weakness Pt was brought to the triage area with c/o chest tightness, weakness, and mild SOB. No CP, non-radia... Read more
Pt was brought to the triage area with c/o chest tightness, weakness, and mild SOB. No CP, non-radiating. VS taken: (1:47 PM) BP 141/97, HR 108, Resp 20, O2 sat 100 on R; (1:52 PM) BP 147/98, HR 106, Resp 18, O2 sat 100% on RA. Pt no in apparent distress, speaks in full sentences, mentating well. Nurse manager and attending MD at triage area to monitor pt. Advised pt to go to ED but pt refused. Pt stated that he will be fine and just need to go home and rest. ED precautions discussed. Pt verbalized understanding and signed AMA form. Pt left the triage area with no assistance, ambulating well, with steady gait.
28 2021-06-06 pain in extremity Patient presented for his second dose and noted lingering arm pain and difficulty raising left arm t... Read more
Patient presented for his second dose and noted lingering arm pain and difficulty raising left arm to shoulder height.
28 2021-06-06 tremor Per LVN patient was nervous and shaking some prior to the vaccine. LVN offered patient to decline or... Read more
Per LVN patient was nervous and shaking some prior to the vaccine. LVN offered patient to decline or return another date. Patient reported he has to get it for the University. Immediately after the vaccine which was given at 0950, patient reported nausea. LVN notified RN. 0958 Patient sitting up in chair with an emesis bucket. Patient is pale and has light tremors, and reports nausea. Vital sigs taken Pulse 91, respirations 20, blood pressure 91/54, and 02 sat 100%. Patient reports he is thirsty. Reports he ate a bagel and had coffee this morning. Gave patient sips of water. Had patient take a few deep breaths. 1003 Assisted to gurney. Vital signs rechecked and ice pack applied to back of head and neck. Pulse 65, blood pressure 110/74, 02 100%. Patient reports he is feeling better. Patient transported with LVN and RN via gurney to nurse treatment room per protocol. Report given to LVN ad RN. Patient is stable.
28 2021-06-07 pain in extremity, feeling hot arm sore; got a little warm; got a little headache; This is a spontaneous report from a contactable ... Read more
arm sore; got a little warm; got a little headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration in arm left, on 22Apr2021 (Lot Number: EW0171) and on 14May2021 (Lot Number: EW0182), (at the age of 28-years-old) respectively, both as single doses for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that his second shot was scheduled at the location where he got his first dose, but he could not go to that location, so he rescheduled the second dose at different location. Further he added that, the guy at the second location did not know he was going to get the second shot hence, the patient was afraid if he might get the first shot twice and wanted to know if he should be concerned about this. On an unspecified date in May2021, the patient had arm sore, got a little warm and headache. The patient experienced the same side effects as he did with the first dose and stated that the symptoms started the next day after each dose and lasted about two days (exact dates were unknown). The outcome of the events was unknown. Additional information is requested.
28 2021-06-08 tingling Patient felt tingling in the arm after administration & informed vaccinator that he felt like he was... Read more
Patient felt tingling in the arm after administration & informed vaccinator that he felt like he was going to pass out. He started to lose consciousness shortly after & EMS was called to clear before he was allowed to leave. Patient was out for only a couple of seconds before regaining consciousness. He remembered feeling dizzy & like he was falling during the episode.
28 2021-06-10 flushing, unresponsive to stimuli, weakness Patient started perspiring profusely, became weak and flush, and appeared to pass out and become unr... Read more
Patient started perspiring profusely, became weak and flush, and appeared to pass out and become unresponsive while sitting in the chair. Patient was given water and ice to cool down while 911 was contacted. After a few minutes, the patient returned to normal mental status and was ready to leave. Patient refused care when arrived and he was released from the site.
28 2021-06-10 seizure R56.9 - Unspecified convulsions SEIZURES
28 2021-06-10 tremor His eyes rolled in the back of his head , became stiff , and was shaking. It lasted approximately 1 ... Read more
His eyes rolled in the back of his head , became stiff , and was shaking. It lasted approximately 1 minute. EMS was called to check out.
28 2021-06-11 flushing, unresponsive to stimuli 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: Hyperventilation-Mild, Additional Details: Pt fainted about 8 minutes after vaccine. He had been given cold water and candy. Blood pressure was normal, but he was sweating and continued dizzy. He admitted to vaping earlier. He wanted us to call 911. 911 said he was hyperventilating and said it was from anxiety. He was checked out and fine. Called him later and he was fine.
28 2021-06-15 pain in extremity Developed left lower leg pain the follow day after receiving his second COVID vaccine. Still persis... Read more
Developed left lower leg pain the follow day after receiving his second COVID vaccine. Still persistent to date.
28 2021-06-16 numbness, face paralysis Patient is a 28 year old male who developed left side facial weakness and numbness a day after his s... Read more
Patient is a 28 year old male who developed left side facial weakness and numbness a day after his second COVID-19 vaccination. His physical exam was notable for left sided forehead and mouth weakness, with loss of left side blink although forced eye closure intact on the left side.
28 2021-06-16 migraine Fever with sweats and chills, migraine. Happened overnight, about 12 hours of intensity and 12 hours... Read more
Fever with sweats and chills, migraine. Happened overnight, about 12 hours of intensity and 12 hours lingering.
28 2021-06-18 numbness, tingling right shoulder felt numb/ the numbness spread to the rest of the right arm, hand, shoulder, side of ... Read more
right shoulder felt numb/ the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face.; I feel intense tingling sensations throughout the day; lose of control of my right arm and leg; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). This 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 08Apr2021 07:00 AM (Lot Number: EP7533) at the age of 28-year-old as single dose for covid-19 immunisation. The patient medical history was none. No known allergies or other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the evening of the first day after getting the vaccine, on 08Apr2021 at 04:00 PM, patient right shoulder felt numb. Over the course of the next few days, the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face. At this point, he went to the ER and then they admitted him to hospital for 3 days, gave him steroids, did an MRI of his neck and a CT of head. After discharged, in Apr2021, patient felt intense tingling sensations throughout the day making him dizzy, nauseous, and loss of control of his right arm and leg. Patient has had regular visits with the recommended neurologist where they did an EKG test, and patient is now waiting on a lumbar puncture test. Event numbness resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for three days. Since the vaccination, the patient had not been tested for COVID-19. Treatment received for the adverse event numbness as steroids. Outcome of the events was not recovered.
28 2021-06-19 tingling Within a few minutes after receiving my first COVID vaccine I started feeling lightheaded/nausea and... Read more
Within a few minutes after receiving my first COVID vaccine I started feeling lightheaded/nausea and then lost consciousness. My wife was with me during this time and stated that I lost consciousness for about a minute. My wife stated that my eyes rolled back in my head, my back arched, and I became rigid. Upon waking up my ears were muffled and my wife stated my lips were blue and my face/arms/legs were very pale in color. Both of my legs and both of my hands were also tingling upon waking up. 911 was called by my wife.
28 2021-06-21 pain in extremity, weakness Hand pain, no appetite, weak, fever, severe headaches.
28 2021-06-21 seizure Patient has seizure disorder and was well controlled for 1.5 years prior to 1st Pfizer vaccine. Pat... Read more
Patient has seizure disorder and was well controlled for 1.5 years prior to 1st Pfizer vaccine. Patient experienced a seizure within 8 hours after receiving dose. No report of fever.
28 2021-06-23 feeling cold Patient got really dizzy and was sweating profusely about 3 minutes after receiving his vaccine. Th... Read more
Patient got really dizzy and was sweating profusely about 3 minutes after receiving his vaccine. This lasted about 15 minutes. He then felt cold and had the chills once he stopped sweating. He was soaked with sweat. I made him stay for another 15 minutes to observe him. He felt normal once he left.
28 2021-06-24 tingling Lightheaded(mild); Fatigue(mild); muscle pain at injection site(moderate); tingling in fingertips(mi... Read more
Lightheaded(mild); Fatigue(mild); muscle pain at injection site(moderate); tingling in fingertips(mild); This is a spontaneous report from a contactable consumer or other non HCP (Patient, reported for self) A 28-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:15 as single dose for covid-19 immunization. (vaccination Facility: Other). Medical history was not reported. The patient concomitant medications were not reported. patient did not took any other vaccine in four weeks. Patient did not experience COVID prior to vaccination. No known allergies. Patient had no known allergies. Other medical history: None. On 05Feb2021 at 10:45 AM patient experienced Lightheaded(mild), Fatigue(mild) muscle pain at injection site(moderate) and tingling in fingertips(mild). Patient did not receive any treatment for the adverse events. Patient was not tested for COVID post vaccination. Outcome for the events was reported as Recovering. Follow-up attempts are completed. No further information is expected.
28 2021-06-27 tingling 10 TO 15 MINUTES AFTER RECIEVING 1ST DOSE OF PFIZER COVID VACCINE PATIENT STATED HIS ARM FELT LIKE ... Read more
10 TO 15 MINUTES AFTER RECIEVING 1ST DOSE OF PFIZER COVID VACCINE PATIENT STATED HIS ARM FELT LIKE IT WAS TINGLING AND IT RADIATED TO HIS CHEST. HE STATES HE DID NOT HAVE CHEST PAIN BUT IT FELT STRANGE. PATIENT STATED HE HAD NOT HAD ANY PO FLUIDS SINCE 4:30 THAT MORNING. HE WAS GIVEN WATER TO DRINK AND OBSERVED. PATIENT'S SYMPTOMS WERE RESOLVED BEFORE LEAVING FACILITY. FOLLOW UP CALL ON 6/28/21 PATIENT STATED HE CONTINUED TO BE ASYMPTOMATIC OVER THE WEEKEND AND WAS BACK AT WORK TODAY.
28 2021-06-29 migraine, tremor The morning after the first inoculation I woke up at 7:30 am with severe chest pain . It would hurt ... Read more
The morning after the first inoculation I woke up at 7:30 am with severe chest pain . It would hurt to inhale and exhale and I was short of breath, possibly due to the not being able to inhale without pain. Breathing was shallow as to not cause pain. I administered hydrocodone 15 mg PO q6h for pain. I told my pulmonologist who stated it sounded like pleuritis. He stated I should go to the hospital if the pain comes back . I admit I did not follow this order as I felt the pain med resolved it and did not want to go to an ER if it wasn?t critical. The chest pain lasted 96 hours and then resolved . The pain was severe enough to wake me from my sleep multiple times. That was the only AE associated with the first shot . The second shot had many more side effects , Severe nausea , emesis , diarrhea , migraine headache , high fever , shaking , and sinus discharge. The chest pain also came back and I did the same regiment of pain meds to treat the severe pain. These side effects lasted 7 days and then resolved .
28 2021-06-30 pain in extremity Sore arm, fever of 100.7.
28 2021-06-30 tingling, numbness, weakness I started having intermittent numbness, tingling, pain and weakness in my left arm down to my hand a... Read more
I started having intermittent numbness, tingling, pain and weakness in my left arm down to my hand about a week after my second Pfizer Covid vaccination. Over several months it progressively was getting worse. I am a nurse in a hospital and after speaking with several colleagues (other nurses and doctors) about what was going on, I went to my PCP. After seeing my PCP, I was referred to a Hand to Shoulder Center. The doctor declared it as cubital tunnel syndrome in which I had an Ulnar Nerve Release Surgery on June 8th. Approximately a week and a half to two weeks after the surgery I started noticing intermittent numbness and tingling to the left side of my lips and left side of my face. Until I started having issues with my face, I didn't even consider the possible correlation with my problems and the COVID vaccines. It it just ironic that I received both vaccines in my left arm and I am having issues with my left arm and the left side of my face. I am still having numbness, tingling and some weakness to my left arm as well as the intermittent numbness and tingling to the left side of my face. Now I was advised by the surgeon that it could take up to a couple of months for my issues with my arm to resolve but when I contacted my PCP regarding an update on my arm as well as to inform her about the concerns with my face, and questioning the possible correlation with the COVID vaccines, she advised me to file a report through VAERS.
28 2021-07-05 tingling lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, ... Read more
lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; Face/arms/legs were pale in color; My lips were blue; My hearing was muffled; Tingling in both of my legs and hands; Mouth was also extremely dry; This is a spontaneous report received from a contactable consumer or other non hcp. A 28-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in arm left on 19Jun2021 17:15 as dose 1, single for covid-19 immunization. Medical history included cat hair allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ascorbic acid (VIT C) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ergocalciferol (VIT D) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. 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 not has been tested for covid-19 since the vaccination. On 19Jun2021 17:15, the patient experienced lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. Therapeutic measures were taken as a result of lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. The outcome of the events was recovering. Information on the lot/batch has been requested.
28 2021-07-07 difficulty speaking Lip swelling and altered voice.
28 2021-07-08 pain in extremity on 7/8/21 , patient noticed soreness in his right arm when he moved his arm in a certain direction o... Read more
on 7/8/21 , patient noticed soreness in his right arm when he moved his arm in a certain direction or position. he stated after vaccine administration on 6/18/21 his arm was sore for 2 days (he stated he experienced average soreness like with any vaccine). Soreness went away completely and had no complaints, but noticed soreness again on 7/8/21 ,around area of injection site on and also sometimes when lifting or rotating arm. He stated he did lift some boxes/totes recently at home and it's possible the soreness could be from that; however, the soreness seems to be in similar area where he received the vaccine 3 weeks ago.
28 2021-07-09 pain in extremity, numbness Heart inflammation, shortness of breath, numbness of left arm, sharp pains in left arm, tightness in... Read more
Heart inflammation, shortness of breath, numbness of left arm, sharp pains in left arm, tightness in chest.
28 2021-07-12 numbness dizziness, sweating, headache, numbness in arms. given 25mg diphenhydramine liquid and water. he d... Read more
dizziness, sweating, headache, numbness in arms. given 25mg diphenhydramine liquid and water. he did not pass out but felt as if he might. he rested in the waiting area until he felt he could leave safely on his own (about 30 minutes).
28 2021-07-14 weakness, migraine sore throat, body aches, weakness, nausea, headache/migraine
28 2021-07-14 feeling hot PATIENT GOT HIS VACCINE AND THEN WATCHED HIS GIRLFRIEND GET HER SHOT, PATIENT STATED HE SAW ME WITH ... Read more
PATIENT GOT HIS VACCINE AND THEN WATCHED HIS GIRLFRIEND GET HER SHOT, PATIENT STATED HE SAW ME WITH THE NEEDLE AND GIVE IT TO HER AND THEN HE GOT SICK FEELING. PATIENT SAT ON FLOOR AND GOT HOT AND TURNED A GREENISH COLOR BEFORE PASSING OUT, PATIENT WAS IN AND OUT FOR ABOUT 2 MINUTES. PATIENT CAME TO AND JOKED ABOUT IT AND SAID THIS HAS HAPPENED BEFORE. PATIENT WANTED TO WALK OFF AND LEAVE, WE HAD HIM SET DOWN AND HIS GIRLFRIEND WENT TO GET WATER AND A SNACK FOR HIM. BEFORE SHE RETURNED HE FAINTED AGAIN AND I HELD HIM UP IN THE CHAIR. HE CAME TO AND STARTED FEELING BETTER. EMS ARRIVED AND CHECKED HIM OUT, PATIENT WAS TAKEN TO AMBULANCE TO BE CHECKED OUT MORE. GIRLFRIEND SAID THEY WOULD RELEASE HIM AFTER WATCHING HIM FOR 30 MINUTES.
28 2021-07-17 feeling of insects crawling on skin Itching.; Random red rash appears on numerous parts of the body; feel headcrawling; This is a spon... Read more
Itching.; Random red rash appears on numerous parts of the body; feel headcrawling; This is a spontaneous report from contactable healthcare professional. A 28-year-old male patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3249) via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE: Lot number: EL0140) via an unspecified route of administration in the left arm on 23Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 12Jan2021 the patient experienced itching, red rash and crawling sensation. The patient had itching, a random red rash appeared on numerous parts of the body one month after receiving the second dose of the vaccine. The patient also felt head crawling. The event resulted in a doctor or other healthcare professional office/clinic visit. On an unknown date, post-vaccination, the patient underwent a COVID-19 virus test (nasal swab test) and resulted negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itching, red rash and crawling sensation were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
28 2021-07-17 tingling Patient developed paresthesia of the left arm; Patient developed paresthesia of the left arm and lef... Read more
Patient developed paresthesia of the left arm; Patient developed paresthesia of the left arm and left side of face.; This is a spontaneous report received from a contactable healthcare professional, the physician. A 28-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left deltoid on 26Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included herniated disc of lumbosacral spine. It was unknown if the patient had any allergies to food, medications, or other products. It was unknown if the patient received any medication within two weeks prior to the COVID-19 vaccine. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced paraesthesia of the left arm and left side of face and neg (negative) weakness was reported. The adverse events resulted in a visit to the doctor's or other healthcare professional office/clinic visit. The clinical outcome of the events paraesthesia of the left arm, left side of face was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
28 2021-07-18 weakness Intermittent dizziness, palptiations, and feeling lightheaded since administration. Feel much better... Read more
Intermittent dizziness, palptiations, and feeling lightheaded since administration. Feel much better but still feels weak. Had similar episode today (4/20/2021) around 3pm with accompanied by 3 episodes of diarrhea. Seen on 4/10/2021.
28 2021-07-18 feeling hot On June 25th, 2021 at around 4 A.M. I started feeling itchiness and warmth on my face, neck and arms... Read more
On June 25th, 2021 at around 4 A.M. I started feeling itchiness and warmth on my face, neck and arms. Shortly after I noticed red spots on my face, neck, elbows, and hands. Some of the red spots on my face and elbows were raised bumps that were itchy and other red spots were not raised or itchy. On the same day around 10 A.M., the spots on my face faded but others appeared around my knees that were warm to the touch and were raised and itchy. I took allergy medicine (Zyrtec) and applied anti-itch cream (Gold Bond) to the spots which helped with the itchiness and raised bumps but the red spots remained. The following day some of the spots faded on my neck and elbows but some had appeared on my legs, feet and chest. I continued taking the allergy medicine and cream until they completely faded away on like the 4th day, June 28th, 2021.
28 2021-07-21 pain in extremity, seizure First day had sore arm Second day-4th day after injection I could barely life my arm at all. After t... Read more
First day had sore arm Second day-4th day after injection I could barely life my arm at all. After the first dose 7 days later I had a medical episode in my sleep that drs are trying to say was seziure.I have absolutely no family history of epilepsy,no major brain trauma in my life and was in perfect health prior to shot. Prior to the shot I didn't feel sick,I didn't have any kind of medical issues whatsoever.
28 2021-07-21 unresponsive to stimuli The patient was given the first dose of Pfizer COVID-19 vaccine and was instructed to wait in the wa... Read more
The patient was given the first dose of Pfizer COVID-19 vaccine and was instructed to wait in the waiting area for 15 minutes. After waiting for about 15 minutes, he tried to exit the waiting area, but ended up collapsing. When I went out to examine him, his eyes were open and he was breathing normally, but he was not immediately responsive. I had to ask him if he was OK several times before I was able to get an answer. He appeared to be disoriented, but otherwise appeared fine. My technician helped him to a chair. He was coming in and out of non-responsive/limp state several times before he asked us for a glass of water. I had contacted 911. They came in and examined him. One of the paramedics told me that he appeared to be fine, but they were going to take him to ER. The patient walked to the stretcher outside the pharmacy.
28 2021-07-22 pain in extremity The aches have moved into hands; Chills; Headache; Bad body aches; This is a spontaneous report from... Read more
The aches have moved into hands; Chills; Headache; Bad body aches; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the right arm on 31Mar2021 at 08:45 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included crohns, IBD, fibromyalgia, sleep apnea, rheumatoid arthritis and juvenile idiopathic arthritis (jia). Concomitant medications included vedolizumab (ENTYVIO), duloxetine (MANUFACTURER UNKNOWN), pregabalin (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN) and nifedipine (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient previously took humira and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 14:00, the patient experienced chills along with bad body aches. The chills went away but still having body aches and a headache every hour. On an unknown date in Apr2021, the aches have moved into hands. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event chills was recovered. The clinical outcome of the event bad body aches, headache and the aches have moved into hands were recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
28 2021-07-22 tingling Sore neck; dizziness; pins and needles feeling while standing; Pressure feeling behind eyes; This is... Read more
Sore neck; dizziness; pins and needles feeling while standing; Pressure feeling behind eyes; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 02Apr2021 at 14:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and COVID-19. Concomitant medications included valproate semisodium (DEPAKOTE ER) from an unknown date, for an unknown indication. The patient previously took Lamictal and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 03:00 the patient experienced sore neck, dizziness, pins and needles feeling while standing and pressure feeling behind eyes. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events of sore neck, dizziness, pins and needles feeling while standing and pressure feeling behind eyes was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
28 2021-07-22 seizure PT HAD A SEIZURE SHORTLY AFTER VACCINATIONI LASTING ABOUT 1 MINUTE - WAS ALERT AND ORIENTED AFTERWAR... Read more
PT HAD A SEIZURE SHORTLY AFTER VACCINATIONI LASTING ABOUT 1 MINUTE - WAS ALERT AND ORIENTED AFTERWARD - PT CALLED HIS MOM TO PICK HIM UP AND SHE SAID SHE'D STAY WITH HIM TODAY. PT DOES NOT CURRENTLY HAVE A PRIMARY CARE MD BUT WILL LOOK FOR ONE NOW.
28 2021-07-26 seizure After receiving his 1 dose of the shot, patient did not wait as requested for 15 minutes. He went to... Read more
After receiving his 1 dose of the shot, patient did not wait as requested for 15 minutes. He went to the gas station next to the pharmacy , and while he was about to pump for gas he had a seizure attack. Patient came to the pharmacy to inform me of the incident. Patient sustained minor cuts and bruises on his chin, leg and hands. I was able to dress his cut by applying band aid after wiping with alcohol wipes. I did follow up with patient today and he's doing well.
28 2021-07-27 cold sweat six minutes after receiving vaccine patient complained of feeling as if his throat was closing up. P... Read more
six minutes after receiving vaccine patient complained of feeling as if his throat was closing up. Pt appeared pale and clammy. Vital signs BP 150/100, Heart rate 142, PO2 99. 2 doses of EPI given, EMS called. Pt was transported to Hospital.
28 2021-07-27 grand mal seizure Grand mal seizure
28 2021-07-27 numbness, pain in extremity, weakness from a contactable nurse (patient mother). A 28-year-old male patient (reporter son) received first ... Read more
from a contactable nurse (patient mother). A 28-year-old male patient (reporter son) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: ER8731, Expiration Date: 31Jul2021), via an unspecified route of administration on 19Apr2021 (at the age of 28-years-old) as dose 1, 0.3ml single for COVID-19 immunisation. The patient medical history included blood cholesterol increased. The reporter stated that she called for her son. She have a concern he had his first shot on 19Apr and that was Monday, last Monday and then Sunday he felt some symptoms and Sunday and Monday but he did not tell her until today. On the second day, on Monday a lot of fatigue, no energy, a little bit of nausea and he just slept it off and yesterday when he told her the symptoms he experienced. Its just because of the vaccine of the, she know its like less more than, less than a week 6 days after he said he felt some numbness on his left leg both legs but most in the left leg. He had some tingling pins and needles like on his mouth like numb on the left side of his body. She don't know if its related to the shot, it was 6 days after but she was concerned. He said, than he did not tell her he just let it go but he was like scared and then Monday in the evening, in the afternoon same thing happened like he just went to bed because he was not feeling well and he did not tell her he just said all he was just tired in his head its hurting and laid down and today is when he told her symptoms that he felt like he said mom like mom I read it looks like a TIA(Further not clarified hence not captured in tab). So, Sunday he felt like pain on both legs but most on the left leg. He felt like paralysis on the left side like numb on the left side and then he had some headache too, blurred vision and confusion. He had a shot on Sunday, on Monday it had some proximity. The reporter states that, she don't know if its related we had a shot on the 19, He do not have numbness or anything now. 25th he felt like he was sitting down himself. He said his left leg is paralysed. He said a little bit little for a short time he had blurry vision. He could not focus. He did not tell any of us about any of the symptoms. She guess he just went to sleep, it lasted 15 minutes. He just told her yesterday that his cholesterol was high according to his primary physician. she have not really called to find out exactly what the numbers are but he told her his cholesterol was high but he is not being treated for anything. He is not on any medication except for the vitamins that he takes every morning. That was January. She think its the usual CBC and CMT. she did not get a chance to see his results. She thinks he just did virtual, he just talk to the doctor and they talked about vital signs, she was not sure. She just corelated it because he just have it for almost a week that is why she was like could it be related, that is her concern and he is going to get his second dose in May 10. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
29 2021-01-03 numbness, facial paralysis Bell?s palsy, right side of face is numb, with difficulty closing eyes, smiling, raising eyebrows, e... Read more
Bell?s palsy, right side of face is numb, with difficulty closing eyes, smiling, raising eyebrows, eating, drinking, swallowing.
29 2021-01-03 numbness, speech disorder, involuntary muscle movements, inability to speak, mild one side paralysis, tingling left sided weakness; it has weakened his heart; stutter; severe stroke like symptoms; Ventricular ta... Read more
left sided weakness; it has weakened his heart; stutter; severe stroke like symptoms; Ventricular tachycardia/help keep his heart rate at bay; Loss of balance; extreme numbness and tingling in left hand and foot; tingling in left hand and foot; oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily; Issues finding words and trouble speaking; Issues finding words and trouble speaking; Ejection fraction down to 25%; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other healthcare professional (HCP). A 29-years-old male patient received bnt162b2 (lot number: EJ1685), intramuscular (deltoid left) on 21Dec2020 at 05:30 at 0.3 mL single (first dose) for Covid. Medical history was reported as "none". Concomitant medications were not reported. The patient previously received Flu vaccine in Oct2020 for immunization. The patient is an Occupational Therapist, and he called to report an adverse event that he experienced with the first dose of the COVID Vaccine. He received the vaccine last Monday, 21Dec2020 at 5:30AM before his shift at work, then 20 minutes later, he was having severe stroke like symptoms. He experienced severe left sided weakness, loss of balance, extreme numbness and tingling in his left hand and foot, he had issues finding his words and he couldn't speak, and he had an oral motor impairment where his mouth was weak and not coordinated. The staff at the hospital did a neurological exam on him, and he failed, so he had to go to the emergency room (ER). The patient added that he was already in the hospital when this happened, and the ER doctors suspected that he had a CVA, and they gave him TPA to prevent any permanent brain damage and it worked. The patient then added that due to the shock of this whole event, from everything that happened, it has weakened his heart. Reportedly, he is a healthy 29 year old man, with no preexisting conditions, and he works out, and he has no heart conditions, but he had to get a cardiology follow up a few days after he got the vaccine, because he started going in to Ventricular Tachycardia, which he had never had in his life. So, the doctors at the hospital went ahead and did an Echocardiogram and an EKG, and he was told that his Ejection Fraction is down to 25%. He stated his heart is so weak, that he cannot work right now, but the structure of his heart is fine and has not had any damage. The hospital staff thought that maybe the patient had a chronic heart issue that he just did not know about, and that the stress of this event maybe made it kick into overdrive, but he states that the cardiologist said that was not the case, because the structure of his heart is fine, and the only thing they can see is that the heart is pumping weak. One physician even suggested that due to the shock of the event, he might have Takotsubo Cardiomyopathy, which is a broken heart, but because the structure of his heart is okay, it should be reversible. He stated that he is hoping he will heal up good, because he is young and has no pre-existing conditions. He added that his heart is in such a state right now; he has to wear an external defibrillator. The patient stated that all these happened about 20 minutes after he received the vaccine, and he was admitted to the hospital from 21Dec2020 to 25Dec2020. His neurological symptoms have resolved except that he has a stutter that he did not have before and his mouth is fatigued easily, so he has to slow down when he is eating, but now he can eat regular for the most part. The patient confirmed that he was not specifically prescribed the product; it was administered to him at his place of work, but it was optional. He stated he considered how he is working with COVID patients every day, and given the circumstance, he thought that it would be a best practice for him to get the vaccine. He had not gone to his primary care doctor in a while because he had been fine and healthy, but he called them and found out that his primary care had retired, so he has to find a new one now. Regarding the issues finding words and trouble speaking, he stated that he has improved, but it is still ongoing, he is just stuck in a plateau zone. With the Ventricular Tachycardia, he stated that this is an ongoing issue, as he has to wear the life vest even though he has no need to activate it yet. He did have one minor bought of the VTach, but because he is a therapist, he knows how to take care of it with relaxation techniques, he knows how to manage it. He had one bought of VTach the evening prior, but he was able to get it under control. The doctors have him on medication to help keep his heart rate at bay. He has never had to use medication before and is on the following medications to help keep his heart rate at bay: Metoprolol 25mg one tablet once daily by mouth and Lisinopril 5mg one tablet once daily by mouth. The VTach has improved, it was good enough he was able to discharge home, but it is still a concern. His cardiologist said that, basically his hope, is that once his body recover from the whole shock of everything, then his ejection fraction will heal, and his heart will heal. He again stated that the doctor told him that the structure of his heart is perfectly fine; he has thick walls in his heart, no leaking valves, and the heart was not conducting any abnormal signals. The doctor just said that right now, his heart is super weak and that it is an acute problem. With the Takotsubo Cardiomyopathy, he states that two doctors mentioned this diagnosis, but he confirmed that he was not actually diagnosed with this issue, he was just diagnosed with Ventricular Tachycardia. The outcome of the ejection fraction down to 25% was unknown to the patient at this time as he has not had another EKG or echocardiogram, but the cardiologist told him that the cardiologist expects that this will not be resolved quickly anyway. The patient confirmed that he did not receive any other vaccines on the same day he received the COVID vaccine. The only other vaccine he had this year was the flu vaccine which he got back in Oct2020. He has gone on to his online portal and there are the bloodwork results and all the imaging results on there from his CTs and MRIs, but he did not see the EKG or Echocardiogram results yet. He does not have this pulled up at this time, but he does have access to this stuff and can provide it later, if requested. He is curious about the next steps from here to how his case is processed. He is also curious if this information would help Pfizer make modifications to the vaccine if it is found that a lot of people are having the same reaction as he did. He is also wondering, given his situation, that probably he is not going to get the second dose, for his safety, but he is wondering what percentage of effectiveness the first dose does having just covered. The events left sided weakness, loss of balance, extreme numbness and tingling in left hand and foot resolved on 25Dec2020; severe stroke like symptoms and oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily resolved in 2020. The events ventricular tachycardia/help keep his heart rate at bay and issues finding words and trouble speaking were resolving, stutter had not resolved while the outcome of the events it has weakened his heart, and ejection fraction down to 25% was unknown.; Sender's Comments: The reported information is unclear and does not allowa meaningful assessment of the case. It will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
29 2021-01-04 tingling Nausea; Chills; Injection site pain; Tingling in his arm; This is a spontaneous report from a non-co... Read more
Nausea; Chills; Injection site pain; Tingling in his arm; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via intramuscular, on 28Dec2020 at 13:15, at single dose for COVID-19 immunisation. Vaccine location was left arm. No relevant medical history and concomitant medications were provided. The patient was vaccinated at workplace clinic, age at vaccination was 29-year-old. No other vaccine was received in four weeks. On 29Dec2020, the patient reported normal side effects of nausea, chills, injection site pain. Patient also reported that he was experiencing tingling in his arm. No therapeutic measures were taken as result of the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.
29 2021-01-05 pain in extremity 12/17 vaccination 12/20 Wen to use restroom. Reddish hue in urine. Went to urgent care. UTI was neg... Read more
12/17 vaccination 12/20 Wen to use restroom. Reddish hue in urine. Went to urgent care. UTI was negative. Positive for blood in urine. Next day, urine back to normal. Arm soreness
29 2021-01-06 weakness, unresponsive to stimuli Pfizer-BioNTech COVID-19 Vaccine EUA Injection given at 1420. He was watched for 15 minutes follow... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection given at 1420. He was watched for 15 minutes following vaccine administration without incident. Returned endorsing dizziness and nausea at 1455. Was tachycardic with HR in 130s with elevated BP with systolic in 150s. Given hydration and vitals monitored for about 45-55 minutes. Vitals downtrended and began to normalize. Stood to leave and became diaphoretic and weak. Placed in wheelchair for transfer down the hall to the ER and became unresponsive on the way. Was given epinephrine 0.3 mg to L thigh. Given IV fluids and acetaminophen. Returned to usual state of health and was discharged home.
29 2021-01-07 pain in extremity Normal after the inj. 8 hours later, arm pain, fatigue. Next day at noon, felt anxious, heart rate 1... Read more
Normal after the inj. 8 hours later, arm pain, fatigue. Next day at noon, felt anxious, heart rate 140's, extreme back pain, tachycardia. Lasted 12 hours 140 at rest. Movement 160 rate. Had chest pain. High fever 102-103.
29 2021-01-10 feeling cold The night of vaccine administration, I developed headached which progressed into the next day. For r... Read more
The night of vaccine administration, I developed headached which progressed into the next day. For roughly 24 hours I had fever, chills, total body aches, and headache. Symptoms completely resolved by 5am 1/10/21
29 2021-01-10 feeling jittery 0700- Vaccine 0800 -2200- Clear urine, 1-2 times per hour, 300-500ml each time 2200-2300 sleep 230... Read more
0700- Vaccine 0800 -2200- Clear urine, 1-2 times per hour, 300-500ml each time 2200-2300 sleep 2300 - woke up, felt jittery, provided car for emergent surgical case 0100 - felt like headed, drank 50oz water, felt better after 20 minutes 0400 - 0700 - sleep. Woke up 3 -5 times and urinated 300-500 each time clear urine 0800- 0900 - drove home 0900-1000- Urinated 3 times while attempting to fall asleep, each time 500ml if clear urine. Massive 10/10 right sided headache 1000-1300 sleep 1300- present- woke up. Felt ok, able to eat and drink, felt ?normal? by the following morning
29 2021-01-10 pain in extremity, weakness Received around 7-8pm on 12/22. Woke up 12/23 feeling okay, just L arm soreness however as day went ... Read more
Received around 7-8pm on 12/22. Woke up 12/23 feeling okay, just L arm soreness however as day went on progressively worsening chills, myalgias, malaise, headache, and extreme weakness/fatigue. Lasted 24-48 hours, peaking around 24-36 hours. Necessitated sick call out from work. Of note I had Covid in March and had antibodies prior to vaccination.
29 2021-01-11 flushing pt reported feeling flush, dizzy immediately after vaccine administration. It quickly resolved, VS W... Read more
pt reported feeling flush, dizzy immediately after vaccine administration. It quickly resolved, VS WNL. Observed for 30 mins pt reported initial symptoms resolved and no new ones have developed.
29 2021-01-11 flushing Red flushing over the arms and face (upper). No treatment administered. Duration of event: (1 hr app... Read more
Red flushing over the arms and face (upper). No treatment administered. Duration of event: (1 hr approx.)
29 2021-01-11 pain in extremity Dose 1 (12/16/20 9:30 am): L arm pain, malaise, fatigue, myalgias lasting 48 hours Dose 2 (1/06/21 ... Read more
Dose 1 (12/16/20 9:30 am): L arm pain, malaise, fatigue, myalgias lasting 48 hours Dose 2 (1/06/21 9:30am): L arm pain, malaise, fatigue, myalgias, severe rigors starting at 2am and lasting 3 hours
29 2021-01-13 muscle spasms, feeling cold, numbness, weakness, tingling Severe chills the evening of vaccination. Uncontrollable chills lasting 10pm 1/5 to 2:30am 1/6. Gene... Read more
Severe chills the evening of vaccination. Uncontrollable chills lasting 10pm 1/5 to 2:30am 1/6. General fatigue and weakness 1/6. Severe muscle spasms 1/7. Ongoing headaches, head pressure, mental ?fog? noticed 1/8 and continuing through when report was filed. Fog makes simple tasks seem very difficult. Seems always present, but sometimes much worse than others. Some facial numbness/tingling when head pressure is severe.
29 2021-01-13 pain in extremity, weakness At around 1:30 in the morning, i became really weak, achey, had the chills, some nausea, a minor hea... Read more
At around 1:30 in the morning, i became really weak, achey, had the chills, some nausea, a minor headache, a slight sore throat, and minor eye pain like they were dry. Though i I felt terrible, the most concerning side effect was that my skin felt like it was extremely raw in patches all over my body where if my sheets lightly touched one of those ?patches?, it would be very painful. However, there was no rash or discoloration from what I could tell. I also had strange painful sensations at the ends of my toes but were different in quality relative to the hypersensitive/raw painful sensations on my skin. The adverse events kept me awake for hours but when I finally got to sleep and woke up the next morning. I only had chills, weakness, and acheyness which were much less in severity than those early morning hours. It is now 4:45 pm and the only adverse effect I am still feeling is the fatigue. Also, I forgot to mention it on the medication portion but I had taken 400 mg of ibuprofen about 15 minutes before receiving that second dose.
29 2021-01-13 pain in extremity Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache b... Read more
Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache body and headache for 12 hours.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration at the left arm on 29Dec2020 18:45 at a single dose for COVID-19 immunization. Medical history included anxiety, asthma, seasonal allergies, known_allergies: PCN and dairy allergy. Concomitant medication included celecoxib (CELEXA, 40 mg) and cetirizine hydrochloride (ZYRTEC, 10 mg). On 30Dec2020, the patient experienced sore left arm for 24 hours. Additionally, she had ache body and headache for 12 hours. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Nasal Swabs for COVID-19 on 05Jan2021 and 06Jan2021, both results were negative. The outcome of the events was recovered on an unspecified date in Dec2020.
29 2021-01-14 weakness I was having like sore throat but not very severe almost like a tight throat; I was having like sore... Read more
I was having like sore throat but not very severe almost like a tight throat; I was having like sore throat but not very severe almost like a tight throat; Difficulty swallowing; I began to have a stuffy nose; Sleep restless; Upon swallowing I had increased amount of mucus going down; Since getting the second dose, I have been breathing more shallow; I have had tiredness, body aches, just not feeling well; I have had tiredness, body aches, just not feeling well; I have had tiredness, body aches, just not feeling well; I noticed my heart rate, it seems to be irregular; I feel like mine is like speeding up and just an irregular; Weakness, I have been super weak, I have not been able to do much physically/I have just been sleeping, just resting, my body is getting weak from that; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3246), via an unspecified route of administration, on 05Jan2021 at 9:40 am at single dose for COVID-19 immunisation. Age at vaccination was 29-years-old. Medical history was none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Dec2020. Concomitant medications included multivitamins. He is a very health conscious individual. He is very healthy. On same day of getting the vaccine, 05Jan2021, on that evening the patient began to have a stuffy nose and then he had a very restless sleep. He woke up the very next day. On 06Jan2021, with difficulty swallowing. He was having like sore throat but not very severe almost like a tight throat. He noticed that he had, upon swallowing he had increased amount of mucus going down and then he noticed yesterday and today as well, it was like not difficulty breathing but very shallow breathing. He is typically a deep abdominal breather. Since getting the second dose, he has been breathing more shallow. He has noticed increased amount of tiredness. He has body aches, he is not sure about body aches because he has just been sleeping, just resting, his body is getting weak from that. He is not sure but he has had tiredness, body aches, just not feeling well. He is still able to eat and he is still able to drink. he noticed his heart rate, it seems to be irregular, not alarming but it was like, he is not sure if you are a coffee drinker but sometimes when you take caffeine your heart rate speeds up. He feels like his is like speeding up and just an irregular. Also, weakness, he has been super weak, he has not been able to do much physically. Outcome was unknown.
29 2021-01-14 hot flush Chills, Malaise, Hot Flashes - All symptoms waxing and waning in severity, present from 0230 - 2230 ... Read more
Chills, Malaise, Hot Flashes - All symptoms waxing and waning in severity, present from 0230 - 2230 on 01/14.
29 2021-01-15 muscle spasms, night sweats Fever (max 101.3), body aches, body chills, muscle cramps, night sweats, hives on face
29 2021-01-18 feeling jittery Abnormal diuresis from 8am to 10pm; Urinating 1-2 time per hour; woke up for midnight trauma/woke up... Read more
Abnormal diuresis from 8am to 10pm; Urinating 1-2 time per hour; woke up for midnight trauma/woke up 4 times in between; woke up for midnight trauma; Felt very jittery, although HR was 75.; extremely nauseous; lightheaded; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0140), intramuscular at left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included 1 kidney stone in 2019. No known allergies to medications, food, or other products. There were no concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1685), intramuscular at left arm on 18Dec2020 07:15 for COVID-19 immunization at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. It was reported that the patient was vaccinated at 07:15. The events started on 08Jan2021 08:00. Detailed clinical course was reported das follows. Abnormal diuresis from 08:00 to 10:00. Urinating 1-2 time per hour, 300-500 ml per time. He went to sleep from 22:00 to 23:30, woke up for midnight trauma. He felt very jittery, although heart rate (HR) was 75. In the middle of surgical case, he became extremely nauseous and lightheaded. He left the operating room (OR) for 20 minutes and drank 50 oz of water and felt slightly better. He finished case at "an". He slept from 04:00 to 07:00. He woke up 4 times in between and urinated 300 500ml each time. He drove home from 07:00-08:00, felt nauseous. Laid in bed from 08:00 to 09:00 and urinated 3 times 300-500 ml each time. Slept from 09:00 to noon, felt better, urinating every 4-6 hours, appears back to normal routine. Treatment for the events included fluids. The outcome of the events was unknown. The reporter consider the events as non-serious.
29 2021-01-18 night sweats Fever, night sweat, fatigue, and diarrhea. Feel a little tired, but not extremely tired.
29 2021-01-18 night sweats Fever, chills, night sweats, muscle aches, joint aches all started approximately 14 hours after the ... Read more
Fever, chills, night sweats, muscle aches, joint aches all started approximately 14 hours after the vaccine (2100, 1/17,2021) and continued for approximately 6 hours (0300). Joint and muscle aches and pains however continued for approximately 24 hours (until 2100, 1/18/2021). Treatment was acetaminophen 1000mg q6-8h with little to no relief of symptoms.
29 2021-01-18 pain in extremity At midnight 1/17/2021I developed severe muscle aches, shivering, chills, and a temperature of 100 F.... Read more
At midnight 1/17/2021I developed severe muscle aches, shivering, chills, and a temperature of 100 F. The pain in my left arm was so severe I could barely move it. This all persisted to the morning of 1/18/2021 after which it resolved. I was unable to sleep at all the nights of 1/16/2021 or 1/18/2021.
29 2021-01-18 pain in extremity Beginning 1/17/2021 at midnight I developed shivering, chills, a temperature of 100 F, and severe mu... Read more
Beginning 1/17/2021 at midnight I developed shivering, chills, a temperature of 100 F, and severe muscle aches. My left arm was so painful I could barely move it. This persisted until the morning of 1/18/2021 and resolved. I also could not sleep at all the nights of 1/16/2021 or 1/18/2021.
29 2021-01-18 tingling Patient received Pfizer COVID vaccine at approximately 0850. Patient instructed to wait 15 minutes a... Read more
Patient received Pfizer COVID vaccine at approximately 0850. Patient instructed to wait 15 minutes after receiving vaccine. Observer reported to administering RN that patient was having symptoms of a reaction. RN immediately spoke with patient regarding statements. Patient stated he had tingling in his neck and then tightness along his mediastinum immediately following tingling. Vitals taken by RN at 0905. BP 164/84, P 108 and O2 98%. Tightness began to subside after approximately 5 minutes. Patient asked to stay an additional 30 minutes for observation. Vitals taken again at 0920. BP 144/82, P85 and O2 sat 99%. Patient stated he was no longer experiencing tightness of tingling at that time. Patient discharged from clinic and advised to contact his PCP before receiving second dose of Pfizer COVID vaccine.
29 2021-01-22 muscle spasms Uncontrollable shivers for about 20 min, with muscle spasms, and the tempature of 92°F lasting for... Read more
Uncontrollable shivers for about 20 min, with muscle spasms, and the tempature of 92°F lasting for about 30-45min.
29 2021-01-24 numbness Numbness to both legs; This is a spontaneous report from a contactable Other Health Professional (pa... Read more
Numbness to both legs; This is a spontaneous report from a contactable Other Health Professional (patient). This 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EL1283), intramuscular, on 13Jan2021 at single dose for COVID-19 immunisation. Vaccine location was right arm. Age at vaccination was 29-years-old. No other vaccine was received in four weeks. Medical history and concomitant medications were none. On 13Jan2021 at 09:00 PM, the patient experienced numbness to both legs, went to sleep and when he woke up both legs were completely numb. This had never happened to him before, so he assumes it's attributable to the vaccine. The event was reported as non-serious. No treatment was received for the event. Outcome was not recovered.
29 2021-01-26 migraine * 01/14/21 - Received first Pfizer COVID Vaccine. Felt really strange for first 10 mins after vaccin... Read more
* 01/14/21 - Received first Pfizer COVID Vaccine. Felt really strange for first 10 mins after vaccine. * 01/17/21 - Noticed my heart rate was at 120 bpm and I was extremely tired. * 01/24/21 - I noticed that I?ve started getting headaches more frequently. I rarely got headaches before (maybe 3-4 per year) * 1/25/21 - Had one of the worst migraines I?ve ever had. Blurred vision. * 1/26/21 - Went to the E.R. to get my heart checked because my heart rate was high and I was extremely tired. Also had a minor headache. * 1/27/21 - I still do not feel right. My heart flutters. Come and go headache. Very sleepy, though I had good sleep the night before.
29 2021-01-27 pain in extremity 8:00am-5:00pm. Headache, nausea, sore arm, lack of appetite.
29 2021-01-27 pain in extremity Headache; fatigue; irritable bowels; diarrhea; nausea; stomach cramps/stomach pain; arm soreness; ki... Read more
Headache; fatigue; irritable bowels; diarrhea; nausea; stomach cramps/stomach pain; arm soreness; kidney pain; the first dose of BNT162B2 was administered in the left leg; This is a spontaneous report from a non-contactable pharmacist, the patient. A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left leg on 23Dec2020 at 13:00 (at the age of 29-years old) as a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 15:00, the patient experienced headache, fatigue, irritable bowels, diarrhea, nausea, stomach cramps/stomach pain, arm soreness, and kidney pain. The patient took lopearmde (MANUFACTURER UNKNOWN), sucralafate (MANUFACTURER UNKNOWN), and calcium carbonate (TUMS) as treatment. The clinical outcomes of the headache, fatigue, irritable bowels, diarrhea, nausea, stomach cramps/stomach pain, arm soreness, and kidney pain were not recovered. It was reported that the patient received the second dose of the BNT162B2 on 11Jan2021 (at the age of 29-years old; Lot Number: EL3302) in the right arm. No follow-up attempts are possible. No further information is expected.
29 2021-01-27 tremor Sweating; 38 degrees fever; Feverish chill; Shaking; This is a spontaneous report from a contactable... Read more
Sweating; 38 degrees fever; Feverish chill; Shaking; This is a spontaneous report from a contactable pharmacist (patient). A 29-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 11Jan2021 16:45 at a single dose for COVID-19 immunization. The patient has no medical history and concomitant medications. Previously, the patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the right arm on 23Dec2020 14:45 for COVID-19 immunization. It was reported that approximately starting 10 hours after the patient received the vaccine (reported as 12Jan2021 03:00) he woke up in the middle of the night feeling feverish chill, but had no fever at the moment. Took Tylenol 1000 mg and slept, but still shaking. Starting around 11:00, he had 38 degrees fever, chill, and sweating for next 18 hours, where Tylenol 1000 mg q (every) 6h briefly dropped temperature to 37 degrees but spiked again when drug is excreted out. Then he maintained with 37 degrees for 12 more hours, then came back to normal. The patient reported that it looks like he had hyperimmune reactions. The events recovered on an unspecified date in Jan2021.
29 2021-01-28 weakness 1407: Patient c/o extreme dizziness and weakness stating "feels like all of the energy left my body"... Read more
1407: Patient c/o extreme dizziness and weakness stating "feels like all of the energy left my body", BP 150/80, P121, O2 99, denies hx of hypertension and post injection reactions, nurse offered juice and will increase monitor time. 1420: BP 160/84, P 118, dizziness persisted and c/o heaviness in tongue lasting about 4 seconds. 1430: BP 164/82, P 122, O2 98, nurse encouraged patient to go to ER for further evaluation, patient refused ambulance and stated "I have to call my supervisor". 1447: Supervisor arrived, patient still c/o dizziness and "feeling weird" 1503: Supervisor and nurse escorted patient to security vehicle for safety, patient will go to ER. Cormier, Markus, RN 1/29/2021 08:37:21 AM > Contacted patie
29 2021-01-28 pain in extremity, feeling of insects crawling on skin, numbness He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his l... Read more
He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating; he fell flat on the floor; felt really tired; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; He couldn't hardly move it sore; tingling, kind of like ants crawling up his leg; This is a spontaneous from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via intramuscular route of administration on 13Jan2021 at 19:05 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Hepatitis B vaccine that is supposed to last for 10 years (which was administered for about three years ago) and flu vaccine. On 13Jan2021, patient received the vaccine and felt really tired, his arm feels like it was punched by a gorilla, it was sore. He couldn't hardly move it sore, like a muscle sore, so he went to bed. His arm was really, really sore, he's just kind of avoided using his arm. He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating. He didn't know his legs were numb until he literally got out of bed, and he fell flat on the floor because he could not feel them. He went to bed again and woke up at 7:20. On an unspecified date in Jan2021, he feels the tingling, kind of like ants crawling up his leg. It's not as bad as it was, it's like a feeling one gets when sitting on top of your legs. He wanted to know could these be side effects of the vaccine. The patient took Advil for arm feels like it was punched by a gorilla/his arm was sore/muscle sore. The patient underwent lab test which included COVID-19 PCR test with negative result on 10Jan2021. The outcome of the events arm feels like it was punched by a gorilla/his arm was sore/muscle sore, he couldn't hardly move it sore, numbness in leg was not recovered; sweating was recovered on an unspecified date, while unknown for the other events.
29 2021-01-31 discomfort, pain in extremity, feeling hot, feeling cold General body aches, compressed feeling. chills, second day big headache , cold and hot feeling , pa... Read more
General body aches, compressed feeling. chills, second day big headache , cold and hot feeling , pain in lower neck and spine, today minor headache and tired. sore arm all days.
29 2021-02-01 discomfort, pain in extremity 12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Disc... Read more
12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Discomfort is a 6/10; gradual onset of soreness raidiating from lymphnodes in neck; gradual onset of soreness in chest/ soreness in bronchi; gradual onset of soreness in back; gradual onset of soreness in hips; gradual onset of soreness in legs; gradual onset of soreness in glutes; soreness in upper lungs; soreness in upper respiratory system; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on the left arm from 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included major depression, anxiety; increased airway sensitivity due to being former smoker from an unknown date and unknown if ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD), loratadine (LORATADINE), theanine (THEANINE). The patient previously received the first dose on 28Dec2020 (Lot number=EK3730). There were no noticable effects after the first dose but 12hrs after second dose (19Jan2021), the patient experienced increased pain at injection site, but no swelling or redness. There was gradual onset of soreness raidiating from lymphnodes in neck, chest, back, hips/glutes, and legs; headache; soreness in upper lungs/bronchii (they are hypersensitive and usually sometimes get sore in reaction to irritants in the air), as well as upper respiratory system, but no difficulty breathing. Discomfort was at 6/10 on 19Jan2021. The outcome of the events was not recovered.
29 2021-02-05 muscle spasms Constipation, lethargic 24-72 hours onset after vaccine administered. Vomiting, diarrhea, nausea, c... Read more
Constipation, lethargic 24-72 hours onset after vaccine administered. Vomiting, diarrhea, nausea, cramping, bodyaches onset 72 hours to present time.
29 2021-02-06 feeling of insects crawling on skin, speech disorder Causing symptoms of SSRI withdrawal. Skin crawling, brain feels like electricity is running through ... Read more
Causing symptoms of SSRI withdrawal. Skin crawling, brain feels like electricity is running through it, racing mind, stumbling over my words and I'm taking my medication as directed.
29 2021-02-13 numbness, feeling cold, pain in extremity Approx. 8 hours following injection, on Friday, 2/5 at 3:45 p.m., began experiencing the following... Read more
Approx. 8 hours following injection, on Friday, 2/5 at 3:45 p.m., began experiencing the following symptoms: low grade fever (99.1 F); Left arm numbness and pain from deltoid to fingers; severe joint pain in L thumb, Index, and middle fingers; headache; chills; systemic muscular weakness; dizziness/nausea; extreme fatigue. Symptoms began to abate on Sunday 2/7 at approx. 8 p.m., and had completely abated by Monday 2/8 at 6 a.m.
29 2021-02-14 tingling, pain in extremity Within 5 minutes following administration: - Paresthesia and pain in left upper extremity extending ... Read more
Within 5 minutes following administration: - Paresthesia and pain in left upper extremity extending from shoulder to hand Within 48 hours following administration: - Progressive pain in left upper extremity - Greatly reduced range of motion in left upper extremity - Inability to bear any weight in left upper extremity - Large ecchymotic lesion at head of left humerus After 48 hours to current presentation: - Pain in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Painful spasticity in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Pain-restricted impaired range of motion of the neck including flexion, extension, lateral rotation, medial rotation, and lateral bending - Pain restricted impaired range of motion of the left upper arm including flexion, extension, lateral rotation, medial rotation, and abduction - Painful left-sided dysphagia at the level of the cricoid cartilage - Use of left arm impaired versus baseline with no signs of improvement
29 2021-02-20 pain in extremity Sore arm
29 2021-02-24 feeling hot 29M hx HTN who obtained his first COVID vaccine. Few minutes after receiving the vaccine, he reporte... Read more
29M hx HTN who obtained his first COVID vaccine. Few minutes after receiving the vaccine, he reported to provider that he felt warm and dizzy. He was immediately brought to the enclosed first responder area where he mentioned additional sx of nausea. Vasovagal response, Dizziness, Hypotension, nausea
29 2021-03-02 cold sweat Chills, anxiety, cold, clammy, chest tightness, SOB
29 2021-03-02 feeling hot blacked out and loss consciousness twice; hit head and make a gauche on eyebrow needing stiches; hit... Read more
blacked out and loss consciousness twice; hit head and make a gauche on eyebrow needing stiches; hit head and make a gauche on eyebrow needing stiches; whole body was feverishly hot; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 13Feb2021 10:30 (at 29-years-old) at single dose (Left arm) for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), on 23Jan2021 03:30 PM (at 29-years-old) on Left arm for COVID-19 immunization. Facility type vaccine was reported as Other. There were no other vaccine administered in four weeks. There were no other medications in two weeks. Approximately 12-24 hours after second dose, whole body was feverishly hot, blacked out and loss consciousness twice within 30mins of each other waking up on the floor from standing position, causing to hit head and make a gauche on eyebrow needing stiches. Events started on 14Feb2021 04:00. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of hit head and make a gauche on eyebrow needing stiches. The outcome of the events was recovering. No follow-up attempts are possible. No further information expected.
29 2021-03-04 cold sweat, migraine Migraine Muscle aches Fatigue Severe Nausea Fever Cold Sweat
29 2021-03-12 pain in extremity Received vaccination on 03/12/2021 at 4:04PM. Symptom onset 03/13/2021 around 10:00AM: soreness at i... Read more
Received vaccination on 03/12/2021 at 4:04PM. Symptom onset 03/13/2021 around 10:00AM: soreness at injection site (left deltoid muscle), soreness in leg muscles, fatigue, nausea, chills, dizziness, runny nose, cough, and worry. Axillary temperature: 98.6F.
29 2021-03-15 tingling, pain in extremity Both Arm soreness, both hands soreness/ tingling, Dizziness, Nausea, Tingling of lips, large patches... Read more
Both Arm soreness, both hands soreness/ tingling, Dizziness, Nausea, Tingling of lips, large patches of painful itchy welts covering body including arms, torso, groin area. Took benedryl for two days, welts subsided, soreness remained. Sought out medical attention from physician on 3/16 and was given a steroid injection and prescribed a steroid pack and OTC pepsid as well as continuing the use of benedryl.
29 2021-03-19 weakness Patient reported fast heartbeat, sweating. Patient was pale, HR 112, O2Sat 96%, BP 108/60, reported... Read more
Patient reported fast heartbeat, sweating. Patient was pale, HR 112, O2Sat 96%, BP 108/60, reported feeling dizzy, vision changes, had brief moment of syncope, then aroused, Oxygen applied at 2l via NC, patient continued with sweating, HR now 78, EMS called, patient continued with sweating and feeling weak gradual improvement, EMS arrived, patient evaluated and did not want to go to ER for eval. Vitals rechecked and patient ambulated to private vehicle with no further difficulty.
29 2021-03-20 tremor, cold sweat patient received their first dose of the Pfizer covid immunization. during observation, the patient ... Read more
patient received their first dose of the Pfizer covid immunization. during observation, the patient got extremely red and lost consciousness. upon waking up, the patient began having cold sweats and lost color in this face, the patient then lost consciousness again and began shaking. 911 was called. the patient was moved to the ground with the help of a fellow team member. blood pressure was taken and was 106/62. heart rate was around 60. patient began getting color back but remained on the floor until the paramedics came.
29 2021-03-22 tingling Light headedness, tingling feeling all over body and excessive vomiting (in this progressive order).... Read more
Light headedness, tingling feeling all over body and excessive vomiting (in this progressive order). All of this occurred within 2 hours of receiving the vaccine.
29 2021-03-23 bell's palsy, facial paralysis Bell's Palsy/ facial droop
29 2021-03-25 discomfort, pain in extremity I felt soreness and pressure build up in my arm starting a few hours after the receiving the dose. T... Read more
I felt soreness and pressure build up in my arm starting a few hours after the receiving the dose. The soreness and pressure got progressively worse over the course of two days. It wasn't unbearable, just uncomfortable. The second day after the vaccine I had stretched my arm pretty good for minute, when I released the stretch I felt a rush of something for from my arm into my torso. I got really dizzy and passed out, my wife was in the room at the time and said I never closed my eyes; but I had completely blacked out. My wife had woken me up and I wasn't sure what had happened, it took me about 30 seconds to realize I had passed out after stretching that arm. My arm had felt better after waking up from passing out, and soreness had passed a couple days later. I didn't get checked out, after I woke up I started feeling fine. I'm honestly not sure if it's directly related to the vaccine or not, I just thought I should let someone know just in case.
29 2021-03-25 feeling hot, tingling Sweaty Warm Anxious Parasthesia
29 2021-03-28 burning sensation, weakness Intermittent Chest Pain, Palpitations, burning sensation in the area of the heart, weakness, hyperve... Read more
Intermittent Chest Pain, Palpitations, burning sensation in the area of the heart, weakness, hyperventilation due to pain, inability to sleep, and chronic cough while standing or sitting but not while laying prone. Seen at Atrium Health Urgent Care Clinic Shelby NC on 14 Mar 2021. Then at the Emergency Room CaroMont Regional Medical Center Gastonia NC on 17 Mar 2021. Seen by PA-C on 19 Mar 2021 at Novant Health Family Physicians of Gastonia. Then seen again at the Emergency Room CaroMont Regional Medical Center Gastonia NC on 20 Mar 2021. Symptoms have begun to subside as of the date 28 Mar 2021 with the exception of the chronic cough.
29 2021-03-28 tingling difficulty, swallowing and breathing. Rapid heart beat, tingling in the throat and cheeks
29 2021-03-30 flushing The patient had a syncopal event, followed by flushing and vomitting. He received the vaccine at 9:3... Read more
The patient had a syncopal event, followed by flushing and vomitting. He received the vaccine at 9:30am and the event occurred at 9:32am and lasted 30 seconds. He then became extremely flushed and dizzy. He was given a cool compress and bottle of water. I observed him for 7 minutes and then he began to vomit. After vomiting, I observed him for 15 more minutes, personally, and then had him wait in our waiting area for 15 additional minutes.
29 2021-03-31 hot flush I started feeling a headache around 9:00 P.M. Eventually around 11-12:00; I started experiencing bod... Read more
I started feeling a headache around 9:00 P.M. Eventually around 11-12:00; I started experiencing body aches and chills. Eventually in between the hours of 12:00 A.M. to 4:00 A.M. I started a fever. I dealt with varying degrees of the previous stated symptoms throughout the day with varying effectiveness with OTC Tylenol. On Friday, most of the symptoms had dissipated, however I did experience random bouts of hot flashes.
29 2021-04-01 pain in extremity Soreness of injection site, sympathy pains in other arm
29 2021-04-01 unresponsive to stimuli Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pa... Read more
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had a vasovagal reaction. He states he has had this occur previously. Orthostatic vitals: lying 176/81 HR 81, sitting 129/86 HR 82 standing BP 119/82 HR 83, Pulse OX 99%
29 2021-04-02 tingling, numbness 28 y/O male immediately post-vaccined reported feeling faint and lightheaded. The patient was assis... Read more
28 y/O male immediately post-vaccined reported feeling faint and lightheaded. The patient was assisted to a wheelchair and taken for observation. He reports no known h/o vasovagal symptoms. He did however admitted he had not eaten. He was placed in Trendelenburg position for recovery and later sat up after being offered crackers and a drink. Vitals 151/76 HR, 65 O2 sat 98%. The patient was unable to complete the snack and started to experience chills, fatigue, chest pressure with palpitation and numbness and tingling down his left arm. EMS was called. The patient was observed for additional time, the chills resolved but but the chest pressure and lightheadedness persisted,
29 2021-04-03 numbness Dry mouth 10-15 mins after shot Swollen throat/discomfort swallowing about 45 mins after shot Numbne... Read more
Dry mouth 10-15 mins after shot Swollen throat/discomfort swallowing about 45 mins after shot Numbness feeling in face about 1 hour after shot
29 2021-04-04 feeling cold Injection site tenderness, pain, and bleeding; headache, sweating, chills, full-body muscle and join... Read more
Injection site tenderness, pain, and bleeding; headache, sweating, chills, full-body muscle and joint aches, lethargy, malaise, runny/stuffy nose. Started a couple hours after the dose and continued for two days after.
29 2021-04-06 tingling The patient developed lightheadedness, tightness in his chest, and tingling of his hands about two m... Read more
The patient developed lightheadedness, tightness in his chest, and tingling of his hands about two minutes after receiving the vaccination. He said that he felt anxious that something was happening. He was hyperventilating. During the event, his heart rate was normal (in the 70s-80s), his blood pressure was normal (SBP in the 130s to 140s), and his oxygen saturation was 100%. He was able to communicate without difficulty, he did not have any weakness, chest pain, diplopia, dysarthria, dysphagia, trouble with walking/balance, bowel/bladder dysfunction, or pain elsewhere in his body. He had a bottle of water. His symptoms lasted about 30 minutes, and then resolved completely.
29 2021-04-08 feeling cold, cold sweat Client had a vasovagal response, became diaphoretic, cool and clammy. Lips were pale. Client never... Read more
Client had a vasovagal response, became diaphoretic, cool and clammy. Lips were pale. Client never lost consciousness. Client recovered within 15 minutes. Administered ammonia inhalant. Pt. was bradycardic which resolved within 10 minutes. Client movd to holding/observation.
29 2021-04-08 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe
29 2021-04-09 feeling cold patient stated was sitting in the chair after receiving the vaccine 10 minutes later he started expe... Read more
patient stated was sitting in the chair after receiving the vaccine 10 minutes later he started experiencing dizziness and light headiness then he started feeling cold and feverish at one time like he was about to pass outpatient was evaluated and assessed the vitals are as followed 2:44p b/p 112/65 p 98 r 18 sat 98% 3:00p b/p 117/73 p 93 r 18 sat 93% 3:10p b/p 120/74 p 83 r 18 sat 98% patient stated he was feeling better patient was wheeled to the front entrance patient was encouraged to go to the nearest ER was to reoccur. Patient was released home.
29 2021-04-09 pain in extremity Soreness in arm
29 2021-04-09 throat numbness, numbness throat numb; Numb lips; face started to feel numb; Feel asthmatic; My head felt cloudy; This is a sp... Read more
throat numb; Numb lips; face started to feel numb; Feel asthmatic; My head felt cloudy; This is a spontaneous report received from a contactable consumer (patient). A 29 years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EP7533 and Expiration Date unknown) via an unspecified route of administration on 03Apr2021 01:30 PM (vaccine location: Left arm, vaccination age:29 years old) at single dose for COVID-19 immunisation. The patient's medical history included peanut allergy and asthma. The patient was not diagnosed with COVID-19 prior to vaccination. The concomitant medications included Loratadine, Montelukast, salbutamol (ALBUTEROL HFA), ciclesonide (ALVESCO). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Around 30-40 minutes afterwards after vaccine (reported as 03Apr2021 02:00 PM), patient experienced lips, throat, and face started to feel numb. Additionally, patient started to feel asthmatic and head felt cloudy. Seriousness criteria was provided as life-threatening for events. Treatment received for event included Benadryl. The outcome of event was recovered in Apr2021. No follow-up attempts are possible. No further information is expected.
29 2021-04-09 tenderness Left axillary lymph node inflamed, red, and tender. 4.5 cm x 2.0 cm. Difficulty moving left arm due... Read more
Left axillary lymph node inflamed, red, and tender. 4.5 cm x 2.0 cm. Difficulty moving left arm due to pain. Patient has taken Ibuprofen and Tylenol PRN. He also did warm heating pad. No improvement.
29 2021-04-09 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe
29 2021-04-10 tingling Pt called c/o tingling on bilateral hand , foot and face after 20 minutes of receiving Pfizer vaccin... Read more
Pt called c/o tingling on bilateral hand , foot and face after 20 minutes of receiving Pfizer vaccine. Pt advised to come back to the clinic pt monitored for 45 minutes. Pt reports that she does not have tingling in her foot any more. Pt denies any SOB, any fast heart beat, swelling of face or throat, rash , dizziness or weakness. Spoke with the pt on 4/11/2021 10AM . Pt reports that she does not have any more tingling sensation.
29 2021-04-11 hot flush, feeling cold The day after I got my 2nd dose I woke up with a mild fever of 99.9 which came and went throughout t... Read more
The day after I got my 2nd dose I woke up with a mild fever of 99.9 which came and went throughout the day and continued on and off for 3 days. During those 3 days, I had severe body aches and fatigue. I slept 16-18 hour nights and struggled to stay awake. I had hot and cold flashes throughout the evenings from the night of the vaccine and the 2 nights following that (3 nights total). I had a loss of appetite during those 3 days and on day 4 finally started to feel normal.
29 2021-04-11 pain in extremity Arm pain all the way down
29 2021-04-11 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted in store after receiving... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted in store after receiving first dose of Pfizer Covid vaccine. Patient regained consciousness within a minute and reported no other injuries. Patient was guided by pharmacist on duty to lie down with feet propped up. Patient remained in room for approximately 30 minutes after which patient confirmed that he was feeling fine. Patient will call pharmacy if any new symptoms develop
29 2021-04-12 numbness After 10 minutes of receiving vaccine, patient reported that his left side of face felt a little num... Read more
After 10 minutes of receiving vaccine, patient reported that his left side of face felt a little numb. He also complained of feeling dizzy. Patient was brought to exam room. BP was elevated 160s/90s. Stroke ruled out, no drooping noted in face. Patient able to move upper extremities fully and symmetrically. Patient was observed for 15 minutes. BP rechecked. BP decreased to 131/80. Patient observed for 15 more minutes. Patient reports cessation of numbness and dizziness. Patient was able to walk out of clinic alert and without assistance. Patient encouraged to make appointment with PCP to check for undiagnosed HTN. Patient denied having a PCP. Encouraged to find PCP or sign up at clinic.
29 2021-04-12 pain in extremity, seizure Patient had a seizure on the day of the Pfizer vaccine as well as arm & leg pain due to fall
29 2021-04-14 flushing, tremor, weakness Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Sy... Read more
Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
29 2021-04-15 seizure This patient had received vaccination and was scheduling next appt in observation area. Medical aler... Read more
This patient had received vaccination and was scheduling next appt in observation area. Medical alert called overhead. RN responded to alert. Pt conscious, but per RN, in observation area, she stated he had a loss of consciousness and although she tried to break his fall, he did hit his head on the wall. Pt was sitting in chair, vitals attempted to be assessed, no reading, but patient alert. Before vitals were repeated,16:18 pt eyes drifted left and closing, another loss of consciousness, followed by convulsions and gasping sounds from the throat. Pt convulsed and left leg /foot turned inward torsion. Pt was removed from chair by 3 RN's to floor safely. approximately 15-30seconds of convulsion. pt regained consciousness AOX4. Pt remained laying, head propped on cushion. vitals taken 16:24 BP 108/69 86bpm, 100%O2Sat. MD assessed and pt stable. MD provided recommendation for pt to be evaluated at ED for further evaluation due to the convulsions. Pt accompanied by friend, friend agreed to drive pt to ED. Blood Glucose 90, which was taken at 1630. Wheelchair was provided for patient, RN rolled pt out to car and friend designated driver.
29 2021-04-15 seizure <10 minutes after vaccination, patient had syncope episode, fall broken by another person, slight bu... Read more
<10 minutes after vaccination, patient had syncope episode, fall broken by another person, slight bump to head. Patient became conscious, was seated on a chair, and then had second syncope episode followed with convulsions. Stabilized patient. Vitals monitored, assessed by MD and released with referral to PCP.
29 2021-04-16 flushing Flushing/sweating, dizziness BP 113/72, HR 70, RR 14 -- > 109/63, HR 63, RR 16. Water was given, th... Read more
Flushing/sweating, dizziness BP 113/72, HR 70, RR 14 -- > 109/63, HR 63, RR 16. Water was given, therapeutic talk, patient layed down until he felt better. Patient stable and released from vaccination site
29 2021-04-16 muscle spasms Fever, nausea, cramping, body aches, head/chest congestion.
29 2021-04-16 pain in extremity Arm sore/pain, tiredness, tight throat, Poor appetite, slightly chilling but no fever
29 2021-04-17 migraine, tension headache Severe vice like headache morning after vaccine - headache persists despite OTC meds - Wednesday cam... Read more
Severe vice like headache morning after vaccine - headache persists despite OTC meds - Wednesday came home from work at 10 AM nausea - went to ER Friday treated for migraine - given IV fluids and migraine cocktail (Toradol, Benadryl and Zofran) headache returned 2 hours after meds given - headache persists so had Covid test done Sunday afternoon and will make appointment with PCP on 4/19
29 2021-04-17 night sweats Nausea beginning about 6 days after vaccine; repeated vomiting and, for 10 hours, inability to retai... Read more
Nausea beginning about 6 days after vaccine; repeated vomiting and, for 10 hours, inability to retain even small amount of any fluid without vomiting; vomiting occurred one more time 30 hours after onset after eating small amount of chicken soup; night sweats, chills, and joint pain accompanied vomiting; night sweats and joint pain remain to date, approximately 4 days after onset of symptoms; no diarrhea. Vomiting was far worse than ever experienced in memory, except possibly when having a stomach bug as a child.
29 2021-04-17 pain in extremity 4/9/21- pain in left arm 4/10/21 to 4/13/21 - body aches and sore 4/13/21 to 4/15/21 - body aches w... Read more
4/9/21- pain in left arm 4/10/21 to 4/13/21 - body aches and sore 4/13/21 to 4/15/21 - body aches went away, started diarrhea. Eating was normal around 4/13/21 and then ate less because of the diarrhea and stomach aches/cramp increasing 4/15/21 (evening) - ate a bit of sushi, instant diarrhea and vomitting. Vomitted 4 times and 12 times of diarrhea from 18:00 to the next morning. 4/16/21 - vomitting stopped and not really nauseous but still diarrhea. Ate a half banana at night and drank water 4/17/21 - ate half a banana in the morning made me super nauseous but didn?t vomit. Ate a lipton soup for diner, drank water and apple just during the day. Night: slept good from 22:30 to 2:30 and then diarrhea every hour.
29 2021-04-17 seizure Patient received shot and told us about 2 minutes later that he did not feel good. His eyes rolled b... Read more
Patient received shot and told us about 2 minutes later that he did not feel good. His eyes rolled back into his head and he lost consciousness. He started convulsing and seizing for about 20 seconds.
29 2021-04-18 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: a... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: after receiving 2nd shot, patient feels dizziness and swating, feels like passing out. but he was alert. asked about diabetes issue and he denied. offered gatoraid and he said he would like to drink that and provided one bottle with store manager's authorization and after 20 minuts he was feeling better.
29 2021-04-19 feeling cold Very anxious prior to injection, became lightheaded directly after injection. Then became nauseated... Read more
Very anxious prior to injection, became lightheaded directly after injection. Then became nauseated and began vomiting. Diaphoretic and pale in color, assisted to monitoring room with cot for client to lay down. Became chilled ,warm blankets placed on client and continued to monitor. PSO2 99 % b/p120/78 pulse 80 Client improved ready to be released. Informed to see medical attention for any further problems.
29 2021-04-21 weakness Heart rate increase, body weak, shortness of breathe, stomach pain, rib cage hurts, heart hurts
29 2021-04-22 involuntary muscle movements Four hours after receiving my 2nd vaccine, I fainted while standing in my kitchen. Bystanders said I... Read more
Four hours after receiving my 2nd vaccine, I fainted while standing in my kitchen. Bystanders said I was out cold for about 1 minute, and was flailing my arms and legs, but did not appear to be a full on seizure.
29 2021-04-23 feeling cold Body aches, chills, sweating, possible fever
29 2021-04-23 unresponsive to stimuli, tremor, flushing Systemic: Chills-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Seve... Read more
Systemic: Chills-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Additional Details: none
29 2021-04-23 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient complained of feeling light he... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient complained of feeling light headed and then passed out. He was laid on the floor until he regained consciousness. We called EMS and kept an eye on the patient. EMS arrived and checked him out and he was responsive and was sent home.
29 2021-04-24 tremor Dehydration (Severe); Trembling / Shaky Feeling (Occasional - Moderate); Lethargy (Moderate); Body A... Read more
Dehydration (Severe); Trembling / Shaky Feeling (Occasional - Moderate); Lethargy (Moderate); Body Ache (Moderate); Trembling / Shaky Feeling (Occasional - Moderate); Light Fever; Nausea (Severe); severe headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 08Apr2021 at 12:00 PM (at the age of 29-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 17Mar2021 at 1:00 PM as single dose for COVID-19 immunization. There was no list of any other medications the patient received within 2 weeks of vaccination.The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.There were no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 10:00 AM, the patient experienced moderate lethargy, moderate body ache, severe nausea, severe dehydration, occasional - moderate trembling / shaky feeling, light fever and severe headache. The events were considered serious due to medically significant. The patient was admitted to emergency room and Intravenous treatment was administered for the events. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
29 2021-04-25 flushing pt received covid shot. waited around the 15 minutes after and girlfriend reported that he fainted ... Read more
pt received covid shot. waited around the 15 minutes after and girlfriend reported that he fainted in the aisle. He had a gash on his scalp and said he fainted. We put in in a chair with legs raised. took bp and hr. all were normal. pt reported he was still feeling faint and flushed so we called the emt. amubulance and fire truck came. pt reported feeling better and refused medical care.
29 2021-04-26 involuntary muscle movements 1455 1ST DOSE PFIZER VACCINE ADMINISTERED 1457 PT WITH LOSS OF CONSCIOUSNESS, WITH ARMS AND LEGS JER... Read more
1455 1ST DOSE PFIZER VACCINE ADMINISTERED 1457 PT WITH LOSS OF CONSCIOUSNESS, WITH ARMS AND LEGS JERKING MOVEMENTS. AMMONIA INHALANT USED, PT AROUSED AFTER STERNAL RUB AND INHALANT. ORIENTED TO SITUATION PROVIDED. PT STATES "I'M SO EMBARRASSED, I FELT THAT COMING ON" 911 CONTACTED AND PT ASSISTED TO STRETCHER. 1458 BP 137/81 HR 72. PT DENIES ANY OTHER COMPLAINTS. DOES CONFIRM HE WAS ANXIOUS ABOUT INJECTION AND WAS SCARED HE WOULD FAINT. 1500 EMS HERE, BP128/80 HR 92. PT REFUSED TRANSPORT WITH EMS AFTER DISCUSSION WITH EMTS. 1530 PT STATES FEEL OK TO LEAVE WITH GIRLFRIEND DRIVING. BP 165/64 HR 65. DENIES ANY COMPLAINTS. INSTRUCTED TO CALL 911 OR SEEK MEDICAL ATTENTION IF NEEDED. VOICED UNDERSTANDING.
29 2021-04-27 feeling cold Cold chills, fever, headache, body ache, fatigue, nausea. This effect happened on both shots to the ... Read more
Cold chills, fever, headache, body ache, fatigue, nausea. This effect happened on both shots to the same intensity.
29 2021-04-27 night sweats Got shivers and a fever 102F. The fever was broke by 2 Acetaminophen. 100F Fever lasted for a day an... Read more
Got shivers and a fever 102F. The fever was broke by 2 Acetaminophen. 100F Fever lasted for a day and a half. I had night sweats from the first night on Wednesday which gradually receded ending on Saturday night.
29 2021-04-27 tremor, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Additio... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Additional Details: PATIENT RECIEVED VACCINE AND WAS WAITING IN DESIGNATED AREA AND TRIED TO MOVE AND FAINTED - RPH WAS NOTIFIED AND PT BP WAS CHECKED WNL AND PT WAS GIVEN WATER AND SPOKEN TOO AND STARTED TO FEEL BETTER AFTER 5 MINS
29 2021-04-28 weakness Dizzy, faint, blurred vision, headache started 5 minutes after shot. I was wheelchaired to fresh air... Read more
Dizzy, faint, blurred vision, headache started 5 minutes after shot. I was wheelchaired to fresh air and moved to a cot for 30 minutes of monitoring. I slowly recovered over the 30 minutes. The following day I had a 99.6 fever, headache, chills and weakness. The vaccination site is sore.
29 2021-04-28 cold sweat Pain at injection site, headache, fever, nasal/sinus congestion and cold sweats.
29 2021-04-28 pain in extremity unprovoked right leg DVT; bilateral PEs; Factor V Leiden positive (hetereozygous); right leg swellin... Read more
unprovoked right leg DVT; bilateral PEs; Factor V Leiden positive (hetereozygous); right leg swelling and pain progressively worsening; right leg swelling; This is a spontaneous report from a contactable consumer (patient). A 29 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:00 (Lot Number: EL1283) as SINGLE DOSE for COVID-19 immunisation. The patient previously had first dose of BNT162B2 on 29Dec2020 at the age of 29 years old for COVID-19 immunisation. Medical history included pleural effusion w/ thoracentesis x2 (5 years ago), known allergies: penicillin and sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included armodafinil taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the workplace. 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 been tested for COVID-19 (nasal swab): negative on 28Jan2021. On 28Jan2021, the patient presented to the ED with right leg swelling and pain progressively worsening over the past week. Subsequently diagnosed with unprovoked right leg DVT and bilateral PEs, admitted overnight and given anticoagulation therapy. Labs ordered and reviewed with hematology consult 1 week later and found to be Factor V Leiden positive (hetereozygous). Treatment plan therapeutic dose of Eliquis twice a day for 1 year, prophylactic dose indefinitely after that. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events were reported as life threatening illness as patient was in immediate risk of death from the events. The patient was hospitalized for 1 day. The events was recovering. The events was treated with anticoagulation therapy, pain medicine and stockings.
29 2021-04-28 seizure, weakness, flushing, unresponsive to stimuli, tremor Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: conv... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: convulsion-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: patient recieved first dose, went to go sit in observation area, few minutes later fell forward off his chair and starting having a seizure. called 911. patient was able to get up and sit in chair with feet elevated. paramedics came, patient refused hospital visit. Patient was oriented and went home after the paramedics.
29 2021-04-28 seizure Pt reported having one seizure the evening of his vaccination and two seizures back to back the morn... Read more
Pt reported having one seizure the evening of his vaccination and two seizures back to back the morning after his vaccination. Per neurology, pt will be admitted to an epilepsy monitoring unit to better characterize the seizures.
29 2021-04-29 cold sweat, unresponsive to stimuli Syncope Vital Signs: BP 110/80 HR 82 O2Sat 95% Skin Signs: Clammy, diaphoretic, Other - Pale Circ... Read more
Syncope Vital Signs: BP 110/80 HR 82 O2Sat 95% Skin Signs: Clammy, diaphoretic, Other - Pale Circulation: Cap refill <2sec Initial Treatment: Raised legs, patient had moved from original position 911 called - denied 7:25 PM: Vital Signs: BP 110/77 HR 76 Resp 16 O2Sat 97% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Laying down on cot, Juice box 7:41 PM BP 110/75 Notes: Provider called to patient side due to patient becoming unresponsive in chair. Patient assisted to floor and noted to be unresponsive. Pale, diaphoretic, and pupils dilated. Patient did not initially have a palpable pulse, however, initiate CPR patient became responsive. AOx3. EMS arrived and evaluated. Home with wife.
29 2021-04-29 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
29 2021-04-29 seizure Suffered a seizure in the minutes after injection. Urinated on self.
29 2021-04-30 weakness, feeling of body temperature change Started out feeling out of energy about 12 hours after the 2nd dose along with having aching arms an... Read more
Started out feeling out of energy about 12 hours after the 2nd dose along with having aching arms and legs. Around 14 hours after the dose I got a fever, chills, hot flashes. Took Tylenol and went to bed Went to bed and kept waking up feeling hot or cold. Woke up in the middle of the night and experienced a vivid hallucination. This morning as I write this I still have a small fever and headache, running nose. My arm became really sore at the site of injection.
29 2021-04-30 weakness Approximately 5 minutes after vaccine administration, pt. C/O tiredness, weakness/fatigued, slow l... Read more
Approximately 5 minutes after vaccine administration, pt. C/O tiredness, weakness/fatigued, slow loss of vision. He was guided to a flat surface in a supine position with legs elevated , Slow deep breaths were encounter, ice pack applied at the back of his neck. Vitals included 90/60, 68, @18, 98% RA. Pt. Was alert and oriented x4. At 11:44 am, second vitals were, 110/70, 57, 26, t=98.2, @ 98%RA. Vision was restored back tk normal with minimal dizziness. At 11:44, all symptoms had subsided as per pt. report. Pt. did mmot experience any falls or trauma while at the clinic. At
29 2021-04-30 burning sensation Widespread hives/rash in middle stomach and lower back, with accompanying burning sensation on conta... Read more
Widespread hives/rash in middle stomach and lower back, with accompanying burning sensation on contact. First noticed late Thursday but spread rapidly overnight, prompting doctor visit. Doctor prescribed Xyzal, famitodine and a topical cream. Hives have not responded to treatment and have continued spreading to neck.
29 2021-04-30 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild
29 2021-05-01 tremor At 1100, patient reported feeling shaky, dizzy, and faint to EMT. Patient had unlabored respirations... Read more
At 1100, patient reported feeling shaky, dizzy, and faint to EMT. Patient had unlabored respirations, alert and oriented x4, and able to follow commands. Patient assisted to anti-gravity chair. EMT assessed patient vitals: blood pressure 98/58 mmHg, heart rate 42 beats/minute, and SpO2 96%. Patient reported not eating breakfast. Patient given water and crackers. Patient advised to wait for further observation. Patient reassessed at 1130. Patient vitals were blood pressure 122/72 mmHg, heart rate 70 beats/minute, and SpO2 97%. Patient stated he felt good and reported no earlier symptoms. Patient educated patient on eating before his second dose appointment. At 1134, patient left facility to self with unlabored respirations and steady gait.
29 2021-05-03 numbness Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient felt numbne... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient felt numbness on right forearm several minutes after the vaccination. It was very mild and came and went for several days. I'm confused because patient stated first shot was in right arm but our records show he received on the left arm. Didn't report any symptoms. He did nothing for the numbess. He said it was barely noticeable. After a couple days, it went away completely.
29 2021-05-04 hot flush, seizure After my 2nd vaccine shot I kept getting heat flashes, headaches, felt dazed throughout the time I g... Read more
After my 2nd vaccine shot I kept getting heat flashes, headaches, felt dazed throughout the time I got the shot at noon till I have a seizure a few hours later at work. It took about 4 hours till I got a seizure in reaction to the 2nd covid shot.
29 2021-05-04 numbness Severe pox like rash all over body, swelling in extremities, pain in joints, numbness in fingers
29 2021-05-05 feeling hot, seizure Patient got the 1st dose of Pfizer vaccine at 1:58 pm on 5/6/21. Patient felt slightly dizzy about 3... Read more
Patient got the 1st dose of Pfizer vaccine at 1:58 pm on 5/6/21. Patient felt slightly dizzy about 3 minutes after getting the vaccine. Then he passed out and fell on the floor with seizure for about 5 seconds. He regain conscious and said he didn't remember anything. He also said his stomach felt upset. Later he felt chest tightness and blurry vision. We called 911 at 2:02 pm. They came in at 2:07 pm. They checked the patient's blood pressure. Patient had low blood pressure. He was sweating and felt hot. He didn't eat or drink anything before getting the vaccine. They transferred him to the emergency room for further check-up.
29 2021-05-05 tremor Within two or three minutes minutes of receiving the injection, patient experienced lightheadedness ... Read more
Within two or three minutes minutes of receiving the injection, patient experienced lightheadedness and felt like fainting. Shaking or pulsating sensation felt in the arms and hands, along with sweating and elevated heart rate, lasting for about 10 minutes. Lightheadedness went away after about 30 minutes.
29 2021-05-06 feeling hot Patient finished 15 minutes of observation time and was in his car about to leave when patient becam... Read more
Patient finished 15 minutes of observation time and was in his car about to leave when patient became very warm and nauseous. Patient walked back into clinic and began to throw up and develop a headache. Patient sat down and blood pressure was taken which was noted to be slightly high (160/72). Patient initially did not want to go to the hospital. However, another 10 minutes went by and patient began to throw up again. Patient agreed to call an ambulance and be checked out by the hospital. 911 was called. Patient did not have a reaction to his first dose of Pfizer COVID vaccine.
29 2021-05-07 muscle spasms, weakness Around 4 AM I started to experience a fever of 101.2, full body weakness, trouble walking, muscle sp... Read more
Around 4 AM I started to experience a fever of 101.2, full body weakness, trouble walking, muscle spasms, irritability, and chills. It was a very strange experience. I took 3 Tylenol at about 7 AM and symptoms started to alleviate around 8:30 AM. The rest of the day I had random body aches, chills, and fatigue. I felt 100 percent by 10 PM on 5/7/2021
29 2021-05-09 hot flush, flushing Pt c/o flushing/sweating, dizziness, hot flashes. BP 96/51, HR 83, RR 16 -- > 116/80, 83. Patient ... Read more
Pt c/o flushing/sweating, dizziness, hot flashes. BP 96/51, HR 83, RR 16 -- > 116/80, 83. Patient stable and released from vaccination site.
29 2021-05-09 myelitis transverse Transverse myelitis
29 2021-05-09 restless legs syndrome, pain in extremity On 07May21 at 11:00PM, I experienced an immense pain on both of my arms that I've never experienced ... Read more
On 07May21 at 11:00PM, I experienced an immense pain on both of my arms that I've never experienced before in my life. Every time I move my arms, fingers, or apply any amount of pressure on any part of my arms, I will get a surge of pain raining down on my arms and only my arms from the shoulder down. At the same time, I also felt a surge of energy/adrenaline flowing throughout my legs, from the pelvis down, urging me to move around. I tried to force myself to sleep (without medication, just forcefully closing my eyes and trying to sleep) to no avail, so I got up and walked around my room and did some leg squats exercises without moving my arms too much from 11:10PM till 3:10AM, (I think getting my blood pumping throughout my body helped ease the pain a bit). The intensity of the pain on my arms decreased about half at around 3:10AM and I was finally able to fall asleep at around 3:30AM. I woke up once at around 7:45AM to go to the bathroom and drink some water. During this time, I think the intensity of the pain had dropped to 1/3 from when I first experienced this pain. I fell back asleep again and woke up at around 11:20AM. Most of the pain is gone by now, I only felt the lingering stings of the dreadful night from before. I continued to feel this phantom pain on both of my arms throughout the day and it wasn't until the day afterwards on the morning of 09May21 that relief was finally bestowed upon me.
29 2021-05-11 weakness, feeling cold 12 hours after vaccine began chills and aggressive shivering that lasted multiple hours. Lethargic, ... Read more
12 hours after vaccine began chills and aggressive shivering that lasted multiple hours. Lethargic, inability to sleep over an hour at a time. First Temperature check at roughly 13 hours from vaccine 102. 1000mg Tylenol taken. Temperature drops to 100 an hour or so later but jumps back to 102 a few hours later. 4 hours after first Tylenol dose took another 1000mg. Same outcome as before but Temperature spiked to 103.4 at about 26 hours post vaccine. Still very lethargic, no appetite since onset of symptoms. Headache, head feels weird when bending over. 36 hours post vaccine Temp raises to 103.8, another 1000mg Tylenol taken. Next five hours spent being cold yet sweating. 42 hours post vaccine Temp returns to normal. Rest of day feeling weak and head feeling odd when making quick movements.
29 2021-05-11 weakness, pain in extremity It started with arm pain at night. And then at 1am I woke up with chills. I fell asleep and woke up ... Read more
It started with arm pain at night. And then at 1am I woke up with chills. I fell asleep and woke up at 5am with severe fever. Fever was all day. I also felt weak, fatigued, dizzy, headache. Took Advil for most of the day. Took Tylenol at night. Took lots of fluids. Was in bed trying to sleep all day. Feeling good now the day after.
29 2021-05-13 tingling pt felt fine immediately after getting Pfizer Covid vaccine, but passed out in the aisle within 5 to... Read more
pt felt fine immediately after getting Pfizer Covid vaccine, bu