Pfizer

Psychological symptom reports

Male, 60 - 75 years

Age Reported Symptoms Notes
60 2021-01-06 feeling abnormal, altered state of consciousness Low grade fever, malaise, headache, mild body aches, sort of out of it at times. Stated feeling bad... Read more
Low grade fever, malaise, headache, mild body aches, sort of out of it at times. Stated feeling bad within 2hrs of shot. Tx-rest, lots of sleep, Tamiflu. Felt bad for 2days.
60 2021-01-07 disturbance in attention, memory impairment, feeling abnormal Approximately 2 hours after receiving the vaccine I felt a heat flash, people setting in the area as... Read more
Approximately 2 hours after receiving the vaccine I felt a heat flash, people setting in the area asked if I was OK as my face was red. It cleared in approximately a minute. The 2nd heat flash came on about 5 to 10 minutes later and cleared about a minute later. The 3rd heat flash came on about another 5 to 10 minutes, again clearing at about 1 minute. Next I felt like my head was in a fog, found it very hard to focus, and was forgetting what I was doing. I walked over to the office, my supervisor asked if I was ok as she said it looked like my eyes were glazed over, my head was still in a fog. This cleared by 2:30 p.m.
60 2021-01-07 feeling abnormal Approximately 11:00 am I got crazy chills, put on my coat, and turned a heat lamp on, this lasted ab... Read more
Approximately 11:00 am I got crazy chills, put on my coat, and turned a heat lamp on, this lasted about 30 minutes. After the chills my mind went in to a fog, found it very hard to concentrate, and felt like I was moving in slow motion. Also had some GI upset, but discharge. The fog lasted until 4:00 pm.
60 2021-01-07 excessive sleepiness Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous... Read more
Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Batch number: 20201221E; Expiration date was not reported) on 21Dec2020 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included previously having COVID-19 from Oct2020 to an unspecified date; abnormal cholesterol; and abnormal blood pressure. Concomitant medications included acyclovir [aciclovir] (ACYCLOVIR); atorvastatin for abnormal cholesterol; hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS) for abnormal blood pressure; and vitamin D NOS. On 22Dec2020, the patient had fever. In Dec2020, the patient had sweated the whole night; and had slept for 24 hours and that was abnormal. The patient had body temperature values of 101.4 to 101.6 degrees Fahrenheit on 22Dec2020; and 98.8 to 99.9 degrees Fahrenheit on 23Dec2020. The patient had received ibuprofen (MOTRIN) and paracetamol (TYLENOL) as treatment for the fever. The patient considered his adverse reaction "mildish". The outcome of the events was recovered on 22Dec2020 (21:00) for 'fever'; and was recovered in Dec2020 for 'sweated the whole night' and 'slept for 24 hours and that was abnormal'. The reporter's assessment on the causal relationship between the vaccine and the event was related.
60 2021-01-07 mental impairment, feeling abnormal Approximately 2 hours post vaccination a heat flash came over my body, co-workers setting around me ... Read more
Approximately 2 hours post vaccination a heat flash came over my body, co-workers setting around me asked if I was ok as my face was red, cleared about 1 minute later. About 15 minutes later a 2nd heat flash came over my body and cleared about 1 minute later. About 15 minutes later the 3rd heat flash came across my body and cleared about 1 minute later. Approximately 30 minutes later my head was in a fog, I could not focus, thoughts left my mind. When returning to my office my manager asked if I was ok and said my eyes were glossed over and my face was red. All this cleared around 2:30 pm.
60 2021-01-14 feeling abnormal One week of the vaccine, while having some coffee and cookies. About tens of consuming them, I felt ... Read more
One week of the vaccine, while having some coffee and cookies. About tens of consuming them, I felt like I was getting a cold and had to keep clearing my throat. I told my wife I feel wired and she mentioned my right eye looked different. In about two more minutes my right was swollen closed and speaking became difficult due to the swelling. My wife drove me to Hospital and I received Epinephrine and Benadryl and fluids.
60 2021-01-18 memory impairment Slight dizziness, forgetfulness, increased sinus discharge, headache, memory lapse
60 2021-01-20 excessive sleepiness, sleep disorder BODY ACHES, RESTLESS SLEEP AND PAIN DAY OF INJECTION. SLEPT ALL DAY AFTER WORK, BUT FELT BETTER NEXT... Read more
BODY ACHES, RESTLESS SLEEP AND PAIN DAY OF INJECTION. SLEPT ALL DAY AFTER WORK, BUT FELT BETTER NEXT DAY
60 2021-01-25 anxiety Received vaccine at 10:44am. My arm was a little sore almost immediately. Approximately 12:30-1:00pm... Read more
Received vaccine at 10:44am. My arm was a little sore almost immediately. Approximately 12:30-1:00pm, I started getting a bit nauseated, pit in my stomach . Lasted until went to bed around 9:00pm. In morning felt fine except my arm felt much more sore at the shot point for about 2-3 hours after I woke up. 10:00am everything is normal.
60 2021-01-28 feeling abnormal This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration on 12Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes, stent, and cholesterol. Concomitant medication included metformin for diabetes, atorvastatin from 2009 (also reported as Jan2020) for cholesterol, ticagrelor (BRILINTA, NDC: 01860776-60, LOT: MM0189, EXP: Apr2023), saxagliptin hydrochloride (ONGLYZA, NDC: 0310-6105-90, LOT: MJ0731, EXP: Feb2023) for diabetes, and terbinafine. The patient experienced felt bad the first day, chills, wooziness/ woozy, felt wobbly all on 12Jan2021. Then experienced feeling like has a big weight on him, blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96/ checked his blood sugar again later and it was 153, which is not through the roof on 14Jan2021, and he is real tired on Jan2021. Patient says he got the Pfizer vaccine, clarified to Pfizer BioNTech COVID-19 vaccine, a couple days ago and the first day he felt bad and had chills and felt wobbly and woozy. He says yesterday (13Jan2021) he felt pretty good, and even worked out. He says he also worked out today, but he has had chills and feels like he has a big weight walking on him, he doesn't know the right word. He says he is also a diabetic, and he noticed today that his blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96. He says he is careful with his diet and eats the same thing. He says he hasn't taken his meds today, and he checked his blood sugar again later and it was 153, which is not through the roof, even without his medication so he would like to know does the vaccine affect your blood sugar? He says he got his first dose of the vaccination on Tuesday at 08:00AM, in his left arm. He clarifies that he has had chills today and then feels like there is a big heavy weight on him, he is real tired and his sugar is low, that was odd. The outcome of the events was unknown.
60 2021-02-01 memory impairment Forgetfulness/Lapses in memory; This is a spontaneous report from a contactable other healthcare pro... Read more
Forgetfulness/Lapses in memory; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-years-old male patient received the first dose of bnt162b2 (BNT162B2), lot number EK417, via an unspecified route of administration on 15Jan2021 at 14:00 (at the age of 60-years-old) at SINGLE DOSE in the left arm for COVID-19 immunization. Medical history was none. The patient did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other vaccines were in four weeks. The facility where the most recent COVID-19 vaccine was administered was at a nursing home/senior living facility. On 18Jan2021 at 19:00, the patient experienced forgetfulness/lapses in memory. The patient did not receive any treatment for the event. The clinical outcome of the forgetfulness/lapses in memory was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
60 2021-02-09 impaired work ability 2nd dose EL8982. About 6 hours after 1st vaccine had visual disturbances in left eye, got a little... Read more
2nd dose EL8982. About 6 hours after 1st vaccine had visual disturbances in left eye, got a little better after a week or so, but still has a floater in left eye, had 2nd dose and after 72 hours had to leave work (never left work before) to get emergency eye exam - thought I was going blind - diagnosed with "Posterior Vitreous Detachment". Now I still have a BIG thing in field of vision making it hard to see and "thousands" of tiny black floaters. Hard to see out of right eye.
60 2021-02-17 abnormal dreams I had a really severe left shoulder ache. I couldn't lay on that side, and I had general body aches ... Read more
I had a really severe left shoulder ache. I couldn't lay on that side, and I had general body aches and a low grade fever. Some nauseous. Really vivid dreams.
60 2021-02-25 memory impairment Pt received vaccine at 11:20. At 1132 staff member asked RN to assess pt as he began slurring his wo... Read more
Pt received vaccine at 11:20. At 1132 staff member asked RN to assess pt as he began slurring his words and mumbling. VS 97% RA, HR 92, temp 99.8, BP 168/92. Pt is conscious but unable to tell me his name or location. Skin is clammy, patient?s hands are shaky. Wife was notified that we are calling an ambulance for further assessment. Ambulance arrived at 11:48 and pt was taken out shortly before noon.
60 2021-03-02 anxiety Dizziness, anxiety, nausea. BP 111/74 (pulse 73), 93% O2 sat. Stable.
60 2021-03-02 feeling abnormal Patient was monitored for 30 minutes after first dose of Pfizer vaccine as he reported rash after ta... Read more
Patient was monitored for 30 minutes after first dose of Pfizer vaccine as he reported rash after taking PO Sulfa medication. Per pt he has had no reaction to flu vaccines in the past. Patient left clinic at 0932 but later returned at 0940 c/o feeling loopy. BP at 0940 180/97 HR 63, Radial Pulse 60, Oxygen saturation 100% RA. BP at 0945 172/96 HR 60 left arm. BP at 0958 left arm 167/82 HR 57. Patient monitored by NP and was advised to follow up with his primary care doctor. Pt reports he had derma filers a few weeks ago. Patient c/o feeling redness and numbing in his cheek bones and feeling loopy. Per pt denied history of hypertension only had 2 cups of coffee this morning. Patient?s husband will pick up patient and take him to Hospital as he was advised to do by his primary care doctor who he spoke with while in clinic. Temperature 97.5 F on forehead. Pt declined feeling any itching. Patient was picked up by husband and he will drive patient to Hospital. BP at 1043 184/94 HR 64 Apical Oxygen saturation 97% RA. Patient denied any itching, stated swelling in cheeks and tingling has improved. NP walked patient out of clinic.
60 2021-03-11 anxiety After first dose of vaccine, developed 5/10 persistent chest pain accompanied by diaphoresis. Known ... Read more
After first dose of vaccine, developed 5/10 persistent chest pain accompanied by diaphoresis. Known history of CAD. EMS was called for transport to hospital for urgent medical evaluation. Per family, the patient was taken to local ED on 2/27/21. Had EKG, blood enzymes x 2 and "everything checked out" and he was discharged home. Family notes that PCP follow up arranged and patient reported anxiety.
60 2021-03-15 insomnia Dizziness on Day 1 Ongoing insomnia x 4 days
60 2021-03-21 anxiety AT 1052, patient waited 27 minutes due to elevated heart rate and anxiety. Afterwards, patient state... Read more
AT 1052, patient waited 27 minutes due to elevated heart rate and anxiety. Afterwards, patient stated he felt ok and heart rate was 70. Instructed to go to the emergency room if symptoms resume and persisted greater than 30-60 minutes.
60 2021-03-21 insomnia STARTING THE NIGHT AFTER VACCINE, WAS UNABLE TO SLEEP FROM SUNDAY 3/14/2021 UNTIL WEDNESDAY 3/17/202... Read more
STARTING THE NIGHT AFTER VACCINE, WAS UNABLE TO SLEEP FROM SUNDAY 3/14/2021 UNTIL WEDNESDAY 3/17/2021. BEGAN GETTING A FEW HOURS A NIGHT STARTING WEDNESDAY NIGHT 3/17 - SATURDAY NIGHT 3/20. BEGAN NORMAL AVERAGE NIGHTLY SLEEP SCHEDULE OF 6.5 HOURS STARTING SUNDAY 3/21. DURING THE WHOLE PERIOD OF TIME DID NOT FEEL TIRED OR HAVE MANY SIGNS OF EXHAUSTION. ACTUALLY FELT A FEELING OF REJUVENATION DURING PERIOD. CURRENTLY FEELING AS DID BEFORE DATE OF FIRST VACCINATION.
60 2021-03-21 sleep disorder, disturbance in attention I have had minor tinnitus for years. It was noticeable when I was going to sleep, but had never bot... Read more
I have had minor tinnitus for years. It was noticeable when I was going to sleep, but had never bothered me during the day. After getting my first vaccination it has gotten much worse. It makes it hard to get to sleep and hard to concentrate on work during the day.
60 2021-03-24 amnesia Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and... Read more
Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and chills Related difficulty urinating and frequent urination due to prostate inflammation Loss of memory (Brain Fog?) in which I had no memory of events occurring from 3/7-3/9 and little memory on 3/10. Memory was close to normal on 3/12. Two Covid tests with negative results (taken on 3/8 and 3/11) Some lung congestion which could be due to bloody sinus mucus and post nasal drip I did retain my sense of smell and taste but had no appetite and did not eat or ate very minimally from 3/7pm until 3/11pm Very fatigued and weak with knee, hip and general joint pain. Increasing levels of fatigue started on 3/2 with little energy from 3/7-3/11. Fatigue is mostly gone as of 3/23.
60 2021-03-24 feeling abnormal ER Doctor said I have Bell's Palsy. Left side facial paralysis.; I started feeling funny; I started ... Read more
ER Doctor said I have Bell's Palsy. Left side facial paralysis.; I started feeling funny; I started feeling funny and weak; Eye is watering, feels like there is grit in there; Eye is watering, feels like there is grit; Uncomfortable.; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 12:15 (at the age of 60 years old) as SINGLE DOSE for covid-19 immunisation. Historical Vaccine includes BNT162b2 Dose 1, 10Feb2021 at 14:00 , Lot number=EL9263 in Left arm Medical history included diabetes mellitus. There were no concomitant medications. The patient has no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19 Facility where the most recent COVID-19 vaccine was administered was a Hospital. On 04Mar2021 at 13:15, The patient experienced Bell's palsy. left side facial paralysis (medically significant), started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable. The adverse events resulted in an Emergency Room Visit. Treatment was given for the events. The clinical course is as follows the day after I went to the (Withheld). Patient started feeling funny and weak. Since he was close to a local Hospital Emergency room. ER Doctor said 'I have Bell's Palsy. Left side facial paralysis'. He prescribed prednisone. Have to wear eye patch on left eye. Eye wont close. Can't eat or drink on left side. I was told by my primary care doctor that this could last up to 6 months. And that 85 percent of cases clear up. Eye is watering, feels like there is grit in there. Uncomfortable. Treatment (Prednisone therapy) was given for the events. The clinical outcome of the events Bell's palsy. left side facial paralysis, started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable was not recovered.
60 2021-03-29 excessive sleepiness About 45 minutes after first Pfizer shot I experienced a feeling like a warm starburst in the center... Read more
About 45 minutes after first Pfizer shot I experienced a feeling like a warm starburst in the center of my head... and got very dizzy. It started in the center of my head and spread in all directions to fill my head. I was driving and had to pull over. It passed after about five minutes. After that I felt a bit weak and slept that afternoon and most of next day.
60 2021-03-30 disturbance in attention, hallucination, feeling abnormal I don't know if I hallucinated that or not; I feel like I am on drugs like I on 'some acid'; my visi... Read more
I don't know if I hallucinated that or not; I feel like I am on drugs like I on 'some acid'; my vision is blurry and it's kind of hard to concentrate on television; hard to concentrate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported)\ via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included mental issues since 1988. The patient stated "I am calling about an adverse reaction to the second Pfizer shot. If you guys have anybody called in and find out if anybody is having the same. After the second shot, about a day after the shot, it was terrible. I got the shot last Tuesday and I feel like I am on drugs like I on 'some acid' (not clarified). But I am not hallucinating, I am not seeing things, I am not hearing things, I just physically feel that way. Everything is kind of blurry, my vision is blurry and it's kind of hard to concentrate on television and stuff like that. It seems like some people are playing mind games with it but I don't think they have (further clarification unknown, hence not captured as event). I don't know if I hallucinated that or not (consumer was not sure). That's pretty much here I feel like I am on drugs constantly and it is just kind of scary. I have mental issues since 1988, I take psych meds but it seems whenever I take my psych meds (unspecified medications) I feel worst for couple of hours." Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-03-30 feeling abnormal Woke up feeling foggy, achey, low grade fever (98.8 F). Just moved slow for most of the day, really ... Read more
Woke up feeling foggy, achey, low grade fever (98.8 F). Just moved slow for most of the day, really had to concentrate as I went through my work day. Not as sharp or quick with mental processing and decisioning making. Work from home, so it's really obvious when I am off my game. Drank 6 x water at 12 oz per. Took two ExStrength Tylenol about 130, no fever, knocked down achey joints, head began to clear, but still not sharp. Not sharp mentally continued into morning of 31 March.
60 2021-03-31 abnormal dreams Strange vivid dreams. Four nights in a row now after the shot. Hopefully they will stop soon.
60 2021-03-31 feeling abnormal He got his vaccine, and on Saturday 3/27/21 started having a slight fever, head cold/foggy head, sli... Read more
He got his vaccine, and on Saturday 3/27/21 started having a slight fever, head cold/foggy head, slightly runny nose, loss of appetite. Had a COVID test yesterday which was negative, but he still continues to run low grade fevers which was 100. He has taken Ibuprofen for the symptoms. His temperature today 4/1/21 at 8:58 AM is 99.5, his blood oxygen has been between 95-97%, his pulse and BP have been a little high as well, and his pulse is 90, his BP was 141/99 yesterday at the store BP machine. He has not called his doctor to report his reactions.
60 2021-03-31 nightmare, sleep disorder Initially headache, and sore arm at injection site. Only sore on contact and not too bad. Fatigue an... Read more
Initially headache, and sore arm at injection site. Only sore on contact and not too bad. Fatigue and loss of muscle strength (I am a hard core cyclist), not detectable during normal activities. A week later it persists. On the fourth evening, I could not stay asleep. As soon as I would drop off I would dream. It would be a violent encounter. I would physically strike out and I would wake up.
60 2021-04-02 feeling abnormal Feels like flu, exhaustion, lousy feeling, headache
60 2021-04-06 feeling abnormal stroke; feel "foggy"; This is a spontaneous report received from a contactable consumer (Patient). A... Read more
stroke; feel "foggy"; This is a spontaneous report received from a contactable consumer (Patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration in left arm on an unspecified date in Mar2021 at 11:00 AM as single dose for COVID-19 immunization. Medical history included none. Allergies to medications, food, or other products: No. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Other. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced feel "foggy" on Mar2021 with outcome of recovering, stroke on 14Mar2021 20:30 with outcome of recovering. Clinical course: About an hour after receiving the shot the patient began to feel "foggy", the feeling continued over to the next day. The patient didn't remember how long after that it continued. The patient then had a stroke 5 days after receiving the vaccine. The patient had no health risks prior to the vaccine and the hospital was unable to find a cause or leading indicator of what could have triggered the stroke, leaving the vaccine as the elephant in the room. Treatment received for the adverse events: Everything. The evens resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for feel "foggy" and stroke for 2 days. Seriousness criteria-Results in death/Disabling/Incapacitating/Congenital anomaly/birth defect: No.
60 2021-04-07 anxiety Pt anxious and states lightheaded and numbness in mouth area. Pt was in ADA drive thru observation;... Read more
Pt anxious and states lightheaded and numbness in mouth area. Pt was in ADA drive thru observation; laid seat chair back, removed mask and encouraged sips of water. Noticed pt had portable oxygen in passenger seat, states he was COVID positive in Jan and was discharged with the O2 to be used prn. Medics evaluated pt; VSS, O2 sats 98%. Pt left but was not in distress.
60 2021-04-11 confusional state, amnesia Constant tiredness for over a week. Lost consciousness in a parking lot and hit head. Bleeding aroun... Read more
Constant tiredness for over a week. Lost consciousness in a parking lot and hit head. Bleeding around the brain causing confusion and loss of memory
60 2021-04-13 sleep disorder Developed Pulsatile Tinnitus in right ear which lasted for 3 weeks, causing difficulty sleeping. Aft... Read more
Developed Pulsatile Tinnitus in right ear which lasted for 3 weeks, causing difficulty sleeping. After 3 weeks, symptoms became intermittent and then stopped after 4 weeks.
60 2021-04-15 feeling abnormal AFTER THE VACCINE HE WAS COMPLAINING ABOUT BEING UNCOMFORTABLE. ON SITE EMS RESPONDED, VITALS LISTED... Read more
AFTER THE VACCINE HE WAS COMPLAINING ABOUT BEING UNCOMFORTABLE. ON SITE EMS RESPONDED, VITALS LISTED BELOW. EMS HAS IT LISTED AS A POSSIBLE ALLERGIC REACTION. HE RECOVERED AND LEFT TO HOME.
60 2021-04-20 sleep disorder My tinnitus symptoms have been raging since I have received my second dose of phizer covid-19 vacina... Read more
My tinnitus symptoms have been raging since I have received my second dose of phizer covid-19 vacination. I can not say 100% that the vacine is the the sole reason for the extreme symptoms but can tie nothing else to the change. The ringing, screeching and high pitch sounds are louder than I have ever e,peri encased in my 15 years with tinnitus. I TS constant, unnerving, stressful, and never ending. Difficult to impossible to sleep and if I do happen to fall asleep the symptoms wake me up within an hour. Kinda at my wits end at this piint.
60 2021-04-22 loss of personal independence in daily activities Vertigo/dizziness. Lost control and fell to the bed on the first symptom morning. Vertigo lasted for... Read more
Vertigo/dizziness. Lost control and fell to the bed on the first symptom morning. Vertigo lasted for 10 days with varying, unpredictable intensity. Then, it was downgraded to occasional dizziness until now, Day 14. The vertigo restricted my movement and driving out of precaution. After reading similar experiences at website and others, started taking Ibuprofen and diphenhydramine, which helped a bit. Currently waiting for my second shot in 5 days warily.
60 2021-04-25 anxiety post vaccination pt. reports " sharp pain to right side of chest " on a scale of1-10 discomfort wa... Read more
post vaccination pt. reports " sharp pain to right side of chest " on a scale of1-10 discomfort was a "6" initially but is now a "4" continues to originate from mid sternum radiating to right side pt. denies any nausea or shortness of breath Pt. does admit having "anxiety " at times and has had this "pain before" his primary care physician has cleared him for cardiac event in the past After a 15 minute observation period pt. reported chest discomfort was first a "1" then soon after a "0" Pt. was released and continues to have 0 pain upon ambulating
60 2021-04-25 feeling abnormal 48 hours before my Covid vac, I received my first dose of a Singles vac on March 19, 2021. I rec... Read more
48 hours before my Covid vac, I received my first dose of a Singles vac on March 19, 2021. I received my first Covid vac on March 21, 2021 and within a couple of days i began to develop a fairly serious BRAIN FOG. It was difficult to concentrate and make decisions. This lasted for about 2-3 weeks.
60 2021-04-25 feeling abnormal Caller reports ER visit day after getting vaccine for chest tightness and ?extreme sedation?. Calle... Read more
Caller reports ER visit day after getting vaccine for chest tightness and ?extreme sedation?. Caller was discharged and has had some chills since then. Also reports fogginess and tension headaches. States he was in the ER last night and was treated and released.
60 2021-04-26 sleep disorder I've had a mild tinnitus for about 5-6 years. 6-7 days after my first Pfizer shot, my tinnitus has ... Read more
I've had a mild tinnitus for about 5-6 years. 6-7 days after my first Pfizer shot, my tinnitus has become very bad. In the last week, twice I was awakened by it in the middle of the night and was not able to fall back to sleep because it is so loud. In the past, I never heard it during the day, but now it is very loud even in the daytime. This is very serious. Not being able to sleep and rest at night is very hard to cope during the day. I'm not sure what to do as there is no cure for this tinnitus.
60 2021-04-27 insomnia Noticed a increase in tinitus. Making it difficult to sleep no hearing loss.
60 2021-04-27 sleep disorder I experienced a very sudden and intense Gout flare up that caused and is still causing an unbearable... Read more
I experienced a very sudden and intense Gout flare up that caused and is still causing an unbearable swelling in my right foot and ankle. I have not had a flare up of this intensity and severity for over 12 years. My Gout has been successfully managed by Allopurinal for over 12 years and I have not experienced any significant events during this time. This time includes over 20,000 miles on my road bicycle and dozens of days over 100 miles. Never have I had a problem. Last Tuesday, I received the second dose of the Pfizer vaccine and I have yet to be able to walk or sleep through the night for six days and counting. This adverse effect should be followed and researched. I also will be requesting reimbursement for out of pocket expenses due to this event.
60 2021-04-29 nervousness On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home... Read more
On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home and I was finished with work at 7pm. My legs felt like led weights and my right hand had lots of joint pain. I ate supper at 7pm. It was getting towards 8pm and was starting to have signs that Unintentional tremors. shaking in my legs, hands and head. I laid in bed and it was far worse, this was a seizure. was having hard time speaking or breathing at times. I managed to take a clonazepan and with in a hour it starting to calm down.
60 2021-05-01 abnormal dreams, sleep disorder -12 hours after 2nd Pfizer vaccine, woke up repeatedly throughout the night with bizarre, vivid drea... Read more
-12 hours after 2nd Pfizer vaccine, woke up repeatedly throughout the night with bizarre, vivid dreams; also awoke 3 times with eyes open and distinctly heard my cat purring on the bed, even though she passed away two years ago. These symptoms ended after the first night post-vaccine. -18 hours after 2nd Pfizer vaccine, in the morning noticed distinct neck puffiness and swelling, especially just under the jaw line. After 1 week the puffiness persists, but is slightly less. -48 hours after the 2nd Pfizer vaccine, noticed high-pitched buzz (tinnitus) in both ears. In a completely quiet room, I continue to hear it throughout the day and night after one week.
60 2021-05-02 delirium Patient first presented with extreme nausea, vomiting and dizziness about 30 minutes after his secon... Read more
Patient first presented with extreme nausea, vomiting and dizziness about 30 minutes after his second dose. Another 15 minutes later as he has a seizure and then was still very delirious. Ambulance was called but patient refused to go to the hospital.
60 2021-05-02 memory impairment, confusional state 4 days after 1st shot my husband became ,confused,garbled ,speech,,did not know who the president wa... Read more
4 days after 1st shot my husband became ,confused,garbled ,speech,,did not know who the president was or what year it was.admitted to Hospital .Released with a diagnosis of TIA.Went back to work .Sent home due to garbled speech and confusion .Second shot given.Sick for 10 days .Fever 101,diarrhea ,slurred speech ,confusion .awaiting to get second MRI.
60 2021-05-04 feeling abnormal flu-like symptoms; Headache; fever / low grade fever after second dose; felt bad all over; face was ... Read more
flu-like symptoms; Headache; fever / low grade fever after second dose; felt bad all over; face was red; This is a spontaneous report from a contactable consumer. A 60-years-old male consumer (patient) reported for himself that he received second dose of second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW6170) via an unspecified route of administration in right arm on 19Apr2021 at 13:00 at single dose for COVID-19 immunization. The patient had Covid before Christmas. he was active and gets around. He had friends who had Covid (2020) and he had a bad run with it. The patient's concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in right arm on 29Mar2021 at 09:30 COVID-19 immunization and felt bad. The patient took second dose of Pfizer covid vaccine yesterday i.e. on 19Apr2021 at 13:00. He felt bad after the first. He felt great yesterday until he started feeling bad in the evening. He went to work today, he was feeling better, but now he was experiencing a low grade fever. Caller was asking if he was a slight risk to his coworkers or if he is a potential carrier of the COVID19 virus. He knows there was no live virus in the vaccine. He was just looking for clarification. He felt like he had the flu, felt like crap. He felt bad all over. Last night his wife told him his face was red. He had an infrared thermometer at his desk, he thinks his temperature is 99.5 to 100 tops. He did not take his temperature last night but thinks the fever started last night. He started feeling flu-like at 10:30 today. He was going home after he gets off the phone. Clarified his temperature was 98.8 degrees, but he felt hotter than it reads. His face was 101.8 degrees on his cheek and 100.4 or 101.2 degrees when checking on another area. He took 3 Excedrin this morning for a headache. The outcome of events was unknown. No follow-up attempts are possible; No further information expected.
60 2021-05-04 sleep disorder Red marks and severe itching mostly on the palms of my hands. Fades at times. Wakes me up in the mid... Read more
Red marks and severe itching mostly on the palms of my hands. Fades at times. Wakes me up in the middle of night and Im scratching
60 2021-05-06 anxiety Patient states that he feels anxious .He was observed for 30 minutes before leaving the vaccination ... Read more
Patient states that he feels anxious .He was observed for 30 minutes before leaving the vaccination site.
60 2021-05-06 feeling abnormal Feeling terrible all over; aching all over; his urine started smelling bad; Hepatitis C; His chest w... Read more
Feeling terrible all over; aching all over; his urine started smelling bad; Hepatitis C; His chest was also hurting; Dizzy; his arm hurt just from the shot.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient (weight: 83.91 kg, height: 178 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734, Expiration date: 31Jul2021) at single dose, in the right upper arm, on 10Apr2021 at 14:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included arachnoiditis adhesive chronic from an unspecified date, in 1999 and ongoing, ulcerative colitis from an unspecified date, in 1996 and ongoing, chronic sinusitis from an unspecified date, venous reflux disease from an unspecified date and ongoing and polyps from an unspecified date (7 surgeries performed from polyps. Last surgery was Mar2016). The patient preciously, on 20Mar2021, at 14:00, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EP7534, Expiration date: 31Jul2021) in the right deltoid, at single dose, on for COVID-19 immunisation. He was good after the first shot, he had no problems. Concomitant medications were unknown. On 10Apr2021, the patient experienced dizzy ("after the second dose they got home and that evening while getting up off the couch, he got really dizzy") and his arm hurt just from the shot. On 13Apr2021, he developed chest pain (his chest was also hurting) and had hepatitis C ("he got blood work done and just got it back and was told he has hepatitis C"). On 20Apr2021, his urine started smelling bad. On an unspecified date, the patient also experienced generalised aching ("aching all over") and was feeling terrible all over. Relevant laboratory test, performed on an unspecified date, showed the following value: alkaline phosphate high, blood cholesterol high, eosinophil count 5.4 %, hepatitis C positive, low density lipoprotein (LDL) high and infectious mononucleosis (Mono) 13.5. The patient recovered from vaccination site pain on 10Apr2021, recovered from dizzy on 14Apr2021 and recovered from chest pain on 20Apr2021. The patient did not recover from hepatitis C and urine abnormal. Clinical outcome of feeling bad and generalised aching was unknown at time of this report.
60 2021-05-06 insomnia, feeling abnormal Chills body swats extreme aches and fatgue loss of appetite brain fog. Sleeplessness Started 05/02 a... Read more
Chills body swats extreme aches and fatgue loss of appetite brain fog. Sleeplessness Started 05/02 and continues today. It hasnt gotten better
60 2021-05-09 confusional state Admitted 04/30/2021 for increasing slurred speech and confusion; previously admitted to outside faci... Read more
Admitted 04/30/2021 for increasing slurred speech and confusion; previously admitted to outside facility 04/15/2021 through 04/19/2021 for similar symptoms
60 2021-05-11 insomnia 2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense o... Read more
2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense of taste
60 2021-05-13 sleep disorder About 1 week following first Pfizer vaccination, I began having achiness in left leg and thought thi... Read more
About 1 week following first Pfizer vaccination, I began having achiness in left leg and thought this was possibly from sitting in a chair without enough cushion. I simply could not get leg comfortable. Over a couple days duration the leg continued to be achy and slightly swollen. On December 23rd at night I awoke due to such discomfort in leg and could not get comfortable enough to go to sleep. I went to ED where I was examined and found to be mildly short of breath and in pain. Ultrasound of leg showed large upper leg DVT. CT of chest showed submassive Pulmonary Horseshoe Embolus. I was placed on Heparin and anticoagulated. Hospitalized for several days while anticoagulated and observed for any clot progression or respiratory distress and discharged home on Xarelto for anticoagulation and follow up with PCP, Hematology, Pulmonary medicine.
60 2021-05-16 sleep disorder Immediately after the injection I felt a warm sensation flowing through my body and my head felt war... Read more
Immediately after the injection I felt a warm sensation flowing through my body and my head felt warm but I did not have a temperature. This subsided within 20 minutes. Prior to the vaccination I had slight Tinnitus on a scale of 1-10 I would say it was a 2. I had no trouble sleeping at night and did not use any sound machines to mask the tinnitus. I would characterize myself as a great sleeper. About 48 hours after the vaccination in my left ear my Tinnitus went from a 2 to a 5. Now to sleep I must run a fan or noise machine to mask the tinnitus and sometimes have to take benadryl or Tylenol PM to sleep.
60 2021-05-30 insomnia On Friday, 5/28/2021 I had my second Covid vaccine. My first vaccine in my left arm on 4/30/2021 was... Read more
On Friday, 5/28/2021 I had my second Covid vaccine. My first vaccine in my left arm on 4/30/2021 was accompanied by a sharp soreness under my left arm and 12 hours of iritis in my right eye. Both symptoms were mild. For my second Coivd vaccine in my right arm on Friday, 5/28/2021, my symptoms included a headache and fatigue which lasted for Friday and Saturday. I also had a bad night on Saturday. I had trouble sleeping, was achy and may have been running a slight fever. I have been slightly more sweaty than normal. Today, 5/31/2021, I had some blood in my urine.
60 2021-06-02 altered state of consciousness Patient here for 2nd dose of Pfizer Covid-19 vaccine. No h/o allergies or significant medical histor... Read more
Patient here for 2nd dose of Pfizer Covid-19 vaccine. No h/o allergies or significant medical history. LPN arrived on scene after vaccinator was yelling for help. Patient was "in and out of consciousness", awake and alert and then would have LOC for a few seconds and then become awake and alert again. This happened about 4 times with LOC with also some "convulsing like movements in the arms". Emergency responders and clinical lead, RN called. Patient laid back in seat as far as the seat would go, face pale and lips white. Pulse-ox put on and BP taken, 36 bpm (according to pulse-ox) and oxygen level 89%, BP 100/54. LPN gave epinephrine injection at this point at 1151, 0.3mg IM in right thigh. HCP arrived on site, patients VS after epi: pulse 76, 100/76, O2 sats 94% at 1155. Patient awake and alert, oriented to person, place and time. Lips and face pink. Care turned over to Paramedics who arrived on site at 1200.
60 2021-06-03 euphoric mood Flu-ish; nauseous; feeling quite wonderful; This is a spontaneous report received from a contactable... Read more
Flu-ish; nauseous; feeling quite wonderful; This is a spontaneous report received from a contactable consumer, the patient . A 60-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 05Mar2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and he was A-1 healthy specimen. Concomitant medications were not reported. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that he was not advised not to drink alcohol, and as this shot happened to be administered on a friday late afternoon, he went home and about an hour later had a glass of Scotch. About an hour after that, he apparently was feeling quite wonderful (loopy)(05Mar2021 at 18:15) but do not remember saying or doing things much at all. The next day the felt nauseous and flu-ish all day long. The patient did not receive any treatment for the event. The clinical outcome of events nauseous ,flu like symptoms and Euphoric mood was recovered with sequelae at the time of the report.. No follow-up attempts are needed. No further information is expected.
60 2021-06-06 feeling abnormal, confusional state Normal reactions sore arm -fatigue lasted 3 days 3 weeks later he was getting some brain fog ... Read more
Normal reactions sore arm -fatigue lasted 3 days 3 weeks later he was getting some brain fog and little confusion 2nd shot fatigue- sore arm which lasted a week more brain fog more confusion couldn't get his words out. could not work his phone or computer Went to doctorMay 24th
60 2021-06-06 feeling abnormal Got 2nd Pfizer vaccine on Tuesday 3/30. Felt bad afterwards. Went to another city next day Wednesday... Read more
Got 2nd Pfizer vaccine on Tuesday 3/30. Felt bad afterwards. Went to another city next day Wednesday-Thursday-Friday for work. By Monday 6/7 I was very sick with bronchitis. It got very bad, went to ER. Went ER a second time and they did a CT Scan. Found fluid buildup on heart- Pericarditis. Hospitalized, sent to ICU. Two days in a row BP 85/35 HR47. Finally a Thoracic Surgeon agreed to take me to surgery following morning. Drained 300ml fluid off heart. Heart arrhythmia went into afib. Chemically converted- released on 6/22/2021. Chronic cough has lingered for 10 weeks.
60 2021-06-07 sleep disorder urticaria (hives) or drug eruption; urticaria (hives) or drug eruption; disrupting sleep; allergic r... Read more
urticaria (hives) or drug eruption; urticaria (hives) or drug eruption; disrupting sleep; allergic reaction to COVID vaccine; Severely swollen left hand; rash bounced between hands and feet/ Rash kept moving randomly around all over body; Itchy rash inner left arm/ itchy rashes on left palm; Lump on left arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of BNT162B2 (Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 13Apr2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 19Mar2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 15Apr2021 (Day 2), patient had lump on left arm at injection site. On 16Apr2021 (Day 3), itchy rash inner left arm. On 17Apr2021 (Day 4), itchy rashes on left palm. Over next few days rash bounced between hands and feet. On 21Apr2021 (Day 8), patient went to clinic for severely swollen left hand. They almost cut off wedding ring. Tested for Limes Disease. Next major swelling and rash traded between Rt hand, Left foot, Rt foot. At one point left fingertips felt burnt. On 29Apr2021 (Day 16), family doctor told the patient Lyme disease test was negative. Doctor suggested he was having allergic reaction to COVID vaccine. Rash kept moving randomly around all over body, disrupting sleep. Took antihistamines Benadryl, Loratadine and used steroid cream. On 04May2021 (Day 21), dermatologist took skin sample from rash to test. Rash continued. On 19May2021 (Day 36), dermatologist said test suggests urticaria (hives) or drug eruption. Told me to take 4 Loratadine, 2 Benadryl, 1 Pepcid. Rash almost totally disappeared (4 days ago). Supposed to continue regimen for two months. The adverse event resulted in Doctor or other healthcare professional office/ clinic visit, emergency room/ department or urgent care. The outcome of events was recovering. Follow up needed, further information has been requested.
60 2021-06-08 excessive sleepiness, confusional state 20 hours after shot i became very dizzy and confused i made it to my bed were i slept interrupted wi... Read more
20 hours after shot i became very dizzy and confused i made it to my bed were i slept interrupted with night terrors' upset stomach and shaky legs this continued for two days 5 days later i became strong enough to continue with daily activities
60 2021-07-10 mental status changes Patient was a previously healthy 60 year old male who developed an acute change in mental status on ... Read more
Patient was a previously healthy 60 year old male who developed an acute change in mental status on 4/9/21 after first receiving the Pfizer COVID-19 vaccine; he was ultimately diagnosed to have hemophagocytic lymphohistiocytosis, and other underlying etiologies were ruled out (malignancy, infection, autoimmune disorders) and improved only after initiation of HLH-directed treatment with etoposide and dexamethasone. He is currently in remission. Patient was initially admitted in 4/2021 for fevers, night sweats, weight loss, and worsening altered mental status. Patient symptoms reportedly started in ~ 4/2021. Per patient's wife, there is a temporal correlation between the patient receiving the COVID-19 vaccine and his symptoms worsening. He was admitted in 4/2021 for stroke-like symptoms after his 1st dose and was diagnosed with a TIA. He was cleared to receive the 2nd dose of the COVID-19 vaccine (received on 4/25/21), and he reportedly became worse after this dose as well. He underwent an extensive workup over the last 2 months to further evaluate his symptoms. He was found to have mediastinal lymphadenopathy on imaging. He had an excisional biopsy of these LNs which were ultimately reactive in nature (negative for lymphoma). There was no evidence of a lymphoma or a lymphoproliferative disorder. Patient was ultimately readmitted to hospital on 5/17/21 due to worsening symptoms. His labs were notable for anemia/thrombocytopenia. A bone marrow biopsy and aspirate to rule out suspected lymphoma was performed and his labs/bone marrow were consistent with a diagnosis of HLH. He was found to meet 6/8 criteria (splenomegaly, peripheral blood cytopenias, elevated ferritin, hemophagocytosis noted on bone marrow, fevers, and elevated Soluble IL-2). The hope was to do a PET/CT and LP before starting therapy to rule out secondary causes of HLH. However, his clinical status continued to deteriorate before these tests could be performed and so he was ultimately started on Dexamethasone and Etoposide as per HLH protocol. These therapies were started on June 3rd. His mental status significantly improved once the medications were started. A PET/CT and LP on 6/7/21 were finally obtained ; however, both did not show overt evidence of an underlying trigger for HLH. "Prominent mediastinal, hilar, and RP LNs seen on previous imaging were not FDG-avid." It did show a few small, mildly FDG-avid patchy B/L pulmonary opacities which were likely infectious or inflammatory for which a follow-up CT Chest was recommended. The flow from the CSF was grossly unremarkable. CSF PCR and other viral studies were negative. Of note, it is uncertain at this juncture if these tests are negative because they are truly negative, or if they are possibly falsely negative since patient was started on treatment before they were obtained. Currently, patient's mental status has significantly improved with Dexamethasone and Etoposide. Per the HLH protocol (which is a scheduled over 8 weeks), patient was started on Dexamethasone 10mg/m2 (equates to 20mg daily) and Etoposide 150mg/m2 biweekly for the 1st 2 weeks. Pt received his 2 weeks of biweekly Etoposide while inpatient (6/3, 6/9, 6/11, and 6/15). The remaining Etoposide doses are to be given weekly and his next dose would be ideally due on 6/22/21 (today). He also completed his 14-day course of Dexamethasone 10mg/m2 on day of discharge (6/16/21). Pt was advised to reduce his Dexamethasone to 5mg/m2 (or 10mg daily) on 6/17. Of note, ID was contacted on day of discharge who recommends that patient be placed on PCP PPx while on HLH therapy. He was recommended to start Mepron on 6/17/21.
60 2021-07-14 impaired work ability Extreme onset of arthritis in both hands, numb fingers in both hands with pins/needles with high deg... Read more
Extreme onset of arthritis in both hands, numb fingers in both hands with pins/needles with high degree of pain occurring one week after 2nd injection.
60 2021-07-17 insomnia Extreme joint pain lasting; Chest painful with every breath; Could not sleep even; This is a spontan... Read more
Extreme joint pain lasting; Chest painful with every breath; Could not sleep even; This is a spontaneous report from a non-contactable consumer, the patient. A 60-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 right arm on 11Mar2021 at 13:30 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included lung cancer and diabetes. The patient did not have allergies to medications, food, or other products. Concomitant medications included chemoradiation, metformin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 15:00, the patient experienced extreme joint pain which lasted for 15 hours. The patient also experienced chest pain with every breath and was not able to sleep with Tylenol PM, had to sit up in the chair for five hours, could not stand pain lying down and hence took 3 more Tylenol regular strength 4 hours after first dose. The chest pain then moved to neck area lasted rest of the day with Tylenol helped. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of joint pain, chest pain, sleep difficult and included treatment with TYLENOL. The clinical outcomes of the events joint pain, sleep difficult and chest pain was resolved in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-07-21 impaired work ability After vaccine, could not sleep for 2 nights, less than an hour a night, normally take 1 melatonin a ... Read more
After vaccine, could not sleep for 2 nights, less than an hour a night, normally take 1 melatonin a night, but took 2 and it did not. Told to take Benadryl by cardiologist, which helped sleep. Extreme stomach cramps, nausea, joint pain, sprained ankle flared up again, fatigue. Went to work, but had to leave early because of symptoms.
60 2021-07-23 delirium Severe thrombocytopenia; bone marrow showed hemophagocytosis/Met criteria for hemophagocytic lymphoh... Read more
Severe thrombocytopenia; bone marrow showed hemophagocytosis/Met criteria for hemophagocytic lymphohystiocytosis (HLH); other causes triggers of HLH (infection, cancer, autoimmune disorder ruled out); Delirium; Worse after 2nd COVID-19 vaccine; fevers; Lymphadenopathy; Transaminitis; Splenomegaly; Anemia; This is a spontaneous report from a contactable physician. A 60-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8735, expiration date unspecified), via intramuscular route on 25Apr2021 (at the age of 60-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient reported she was healthy before vaccination. Medical history included depression and gastroesophageal reflux disease from an unknown date. Concomitant medications (received within 2 weeks of vaccination) included sertraline, lansoprazole (PREVACID), both concomitant medications taken for an unspecified indication, from an unknown start date. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EP7533, expiration date unspecified), intramuscularly on 03Apr2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 60-year-old) and experienced altered mental status. 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 the vaccination. Since the vaccination, the patient had been tested for COVID-19 (on 17May2021, Test: COVID-19 PCR, Nasal swab) which was negative. Clinical course of the events was reported as: Previously healthy 60-year-old male, presented to hospital with altered mental status 6 days after the first COVID-19 vaccine, on 09Apr2021. Had a negative neurological work up but continued to decline, worse after 2nd COVID-19 vaccine (fevers, lymphadenopathy, transaminitis, splenomegaly, anemia, severe thrombocytopenia, delirium). Suspected to have lymphoma ruled out but ruled out; bone marrow showed hemophagocytosis, and labs showed high soluble IL-2 receptor (33,903). Met criteria for hemophagocytic lymphohystiocytosis (HLH); other causes triggers of HLH (infection, cancer, autoimmune disorder ruled out). Positron emission tomogram (PET) scan negative for malignancy. Patient improved only after starting Etoposide and dexamethasone, now (as reported) in remission. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 68 days for the events. The events assessed as serious (life threatening and caused/prolonged hospitalization). Outcome of the events at the time of report was resolving.; Sender's Comments: Limited information precludes a comprehensive causality assessment ,however causal of BNT162B2 vaccine cannot be excluded for the reported 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
60 2021-07-25 motion sickness Constant headache since the nite after the vaccine. Some headaches are really bad, almost migrane ... Read more
Constant headache since the nite after the vaccine. Some headaches are really bad, almost migrane level occurring on right side of temple. After a month, headaches are not as bad, still persistent. Dizziness to the point that i have gotten nausea 5 out of 5 times being a passenger in a car, 2 of those times vomiting. Driving a car is fine with no dizziness or car sickness. 2 intense bouts of vertigo, starting 1 week after the vaccine Could hardly walk, bumping into things, like i got off a spinning carnival ride drunk. I took zanax and went to bed, and woke up fine. Overheating, hot flashes, and fatigue also come and go.
60 2021-07-27 impaired work ability Left wrist began to hurt and swell around mid April 2021. I went to Medical Office Building where it... Read more
Left wrist began to hurt and swell around mid April 2021. I went to Medical Office Building where it was discovered through ultra sound I had blood clots in my left wrist. I was immediately sent to the Advanced Care where I was told that I would not be able to go home and to call a family member because I had to remain for treatment which was an intravenous treatment then had to start immediate injections and medication. My wrist is in constant pain and I am unable to work due to the adverse reaction to the COVID 19 vaccine. Follow up appointment with Oncology 5/19/21, Follow up appointment with Primary Care Physician 6/17/21, US DVT Bilateral with Ultrasound-7/19/21
60 2021-07-28 feeling abnormal initial reactions for 5 days: sore arm, tiredness, fuzzy brain, fever, gastric distress. All of th... Read more
initial reactions for 5 days: sore arm, tiredness, fuzzy brain, fever, gastric distress. All of these would fluctuate in intensity and sometimes weren't noticeable at all, except the sore arm which started strong and gradually lessened and disappeared after 3 days. The real adverse reaction I've experienced and has actually been getting worse is a racing heart. It may have actually started in May but I simply thought I had gotten out shape. I really noticed it going uphill. But starting in July, especially the last two weeks, the racing from just a brisk walk on flat land. I have to stop and rest when I haven't really exerted myself. There's no rational explanation where this has suddenly come from, until I just googled and found that it's been a reaction for some to the vaccine.
61 2021-01-03 feeling abnormal, impaired work ability I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next ... Read more
I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next morning I felt fine but had swelling to the face more swelling to the left side then the right with a heavy feeling to my left side of my face along with pain to the eye. I feel very lethargic and very tired I could not go to work. I feel to bad to work.
61 2021-01-11 feeling abnormal Awakened 0300 the next day, Saturday the 9th with chills, fever 2 degrees above normal, headache an... Read more
Awakened 0300 the next day, Saturday the 9th with chills, fever 2 degrees above normal, headache and left arm pain from deltoid to elbow. Went to work in ICU at 0638, feeling like i had been ran over by a truck. Fatigue and general malaise throughout day. Sunday, i had no problems. Monday morning awakened with diarrhea, I never have diarrhea! I felt bad most of Monday. Tuesday today, i feel fine!
61 2021-01-12 impaired work ability, feeling abnormal left side will blur; Left side of face was sagging/ water leaking out of mouth/Progressive weakness ... Read more
left side will blur; Left side of face was sagging/ water leaking out of mouth/Progressive weakness on left side of face/ Swelling on lower left mandible/ diagnosed with Bell's Palsy.; Eye tearing; This is a spontaneous report from a contactable nurse who reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK5780) in left arm on 26Dec2020 at 08:30 at single dose for covid-19 immunisation (worked in surgical ICU and was over 61 years old). Medical history included Pre-diabetic. Family history included: mother died; mother's side had colon cancer and grandparents and uncles had cardiovascular diseases.Concomitant medication included exenatide (BYDUREON), amlodipine besilate (NORVASC), omeprazole (PROTONIX), hydrochlorothiazide, lisinopril and pneumococcal vaccine on 08Dec2020 and tetanus vaccine on 08Dec2020. It was reported that on 31Dec2020 at 07:30, the patient had eye tearing and water leaking out of mouth, left side of face was sagging, swelling on lower left mandible (eye tearing was first, as reported); on 31Dec2020 he also experienced progressive weakness on left side of face; on 02Jan2021 the patient was diagnosed with Bell's Palsy. Then on an unknown date, left side will blur occurred. All events required emergency room visit and physician office visit. Diagnosis of Bell's Palsy and event eye tearing were serious per disability; left side will blur was non serious. Patient described the events as follows: on 31Dec2020 he was brushing teeth and noticed the water was going everywhere. Left side of face was sagging, noticed some swelling and thought it was from a bug bite. He wasn't sure if it was a stroke or not. In the morning of 01Jan2021 noticed it was progressively causing a problem. Days before noticed tearing of left eye (as reported). On 31Dec2020 before midnight, something felt wrong. He saw four cases on clinical trial with similar side effects (he clarified he had no patient information for the four patients mentioned with similar side effects from Pfizer Clinical trial. He saw this information from a article; stated four from Pfizer and Moderna). In the morning of 02Jan202, he went to Emergency Room (ER) and was diagnosed with Bells Palsy. He was given prednisone 20mg to take 3 times by mouth every day for 5 days, tetracycline 100mg, at 1 capsule by mouth twice a day for 10 days and methylprednisolone (SOLU MEDROL; Lot: 9945776;Exp: Nov2021) 4mg dose pack, started with 6 tablets first day. It was told by doctor it might cause tick problems. He was waiting for results. On 04Jan2021 went to family doctor and more blood work was taken. Because he was taking prednisone, noticed his sugar was up a little bit (date unspecified). It was prescribed Glitizide extended release, 2.5mg one tablet twice a day with breakfast. Patient was checking sugar every 6 hours. It was also prescribed Acyclovir 400mg one tablet orally five times per day for 10 days. 08Jan2021 is last day of prednisone 5 day dose and will follow up with methylprednisolone tablets. Patient had an appointment with a neurologist on 13Jan2021. Patient was still having symptoms. It was really hard for him. Not hard to swallow. Face was still drooping. Eyes were still tearing. Could not work with eyes tearing all of the time. Needed to be alert. When driving, had to focus on the right side because his left side will blur. He had to chew only on the right side because food will be left behind in between his cheeks and gums. If he drank through a straw, he had to cover the left side of his lips so he was able to suck out fluids. He thought symptoms were progressively getting worse, he didn't see much improvement. He clarified swelling was on lower part of mandible on left side. It was slightly bigger than right. When looking at face, the lines on his forehead on the left side were down. If he smiled he cannot raise his left eye brow, when before the COVID-19 vaccine he could. Noticed left side of nose was lower than the right. Cannot raise left side of lips. Outcome of the event Eyes tearing and Bell's Palsy was not recovered; outcome of the other event was unknown. Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Bell's palsy, Lacrimation increased and vision blurred due to temporal relationship. However, the Bell's palsy may likely possibly represent concurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-01-13 motion sickness I'm feeling like I have motion sickness.; This is a spontaneous report from a contactable other heal... Read more
I'm feeling like I have motion sickness.; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received bnt162b2, lot El0143, via an unspecified route of administration in the right arm on 06Jan2021 14:00 at single dose for covid-19 immunisation. The patient's medical has no relevant medical history. Patient has allergies to medications, food, or other products. The patient's concomitant medications were not reported. On an 07Jan2021 05:00, the patient felt like he has a motion sickness. The outcome of the event was recovering. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.
61 2021-01-26 anxiety Systemic: Rash (other than injection site)-Medium, Systemic: Other- Anxiety-Medium
61 2021-01-27 feeling abnormal Patient experienced vomiting, no fever, generally feels "awful"
61 2021-01-27 mental status changes All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced ... Read more
All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting. Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair. Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583. Resident deceased upon re-check after calling PCP to report status change.
61 2021-01-28 poor quality sleep Got the injection around 8:15 AM, by around 2:00 PM started to feel mildly achy and tired. Around 6:... Read more
Got the injection around 8:15 AM, by around 2:00 PM started to feel mildly achy and tired. Around 6:00 PM arm was sore, I was tired, not feeling well. Went to bed, started to get chills, nausea, and vomited around 9:30 PM. Did not sleep well. The next day I had a headache, felt tired and wiped out. Started to feel better around 2:00 PM . Lost day of work was able to return to work on 1/21/2021. My arm still ached for several days. It felt like someone had hit me in the shoulder with their fist
61 2021-02-03 impaired work ability Employee described malaise and body aches the day after receipt of the vaccination (1/13/21). The s... Read more
Employee described malaise and body aches the day after receipt of the vaccination (1/13/21). The symptoms were bothersome enough to keep the the employee out of work for one day.
61 2021-02-04 anxiety, sleep disorder I have been have contact with my primary care doctor because of the reaction with the first dose. He... Read more
I have been have contact with my primary care doctor because of the reaction with the first dose. He advised me to take Benadryl 15 minutes before receiving the injection. I stayed at the vaccination site for an hour instead of 15 minutes. I left the vaccination site and went home and went to sleep, I worked over night. I did not sleep well that day. I got up around 6pm and I went to work at 10pm and I was extremely anxious and tired all night. I was a little confused while at work. I got off work and went to my chiropractor who noticed and my wife also noticed that I was extremely pale, after the appointment I went home and went back to bed. When I woke up I was still exhausted that I ended up calling out out of work that night. I went back to bed and slept all night till 9am this morning. The next morning my color was back and I was looking better. My energy level is slowing improving but still feel tired even when I got a good nights of sleep. I don't know if it related, but I went and brought some new shoes and then my hip started hurting. It is to the point where I set up a doctor's appointment on Monday to have my hip looked at. See VAERS report 906796 for first dose reaction.
61 2021-02-06 anxiety, restlessness anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost ... Read more
anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, "shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease." No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got "that shot" he hasn't felt well. When asked what shot pt replied "COVID shot." Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped.
61 2021-02-07 confusional state 1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non res... Read more
1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non responsive twitching. Sent to Hospital with EMS to rule out stroke. Admitted 1/31/21.
61 2021-02-08 anxiety hives; anxious; This is a spontaneous report from a contactable other healthcare professional. A 61-... Read more
hives; anxious; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right leg on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home/senior living facility. Medical history included COVID prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced hives and was anxious, the patient was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events hives and anxious was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the urticaria and anxiety. 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.
61 2021-02-08 impaired work ability 31 Jan 2021-Sunday-Very weak, diarrhea, migraines,-no diagnosis-pt states nights sweats 1Feb 2021-Mo... Read more
31 Jan 2021-Sunday-Very weak, diarrhea, migraines,-no diagnosis-pt states nights sweats 1Feb 2021-Monday-Same as above 2 Feb-Tuesday-feeling a little better 3 Feb-WED-more fatigued 4th Feb-TH-home from work-later that day 5th Feb-Fri-no work-at home 6th FEB-Sat-feeling up & up-has a migraine-takes aleve 7th Feb-Sun-still diarrhea-stayed in bed 8th Feb-Monday-**diarrhea-taking Immodium AD
61 2021-02-15 memory impairment Pt reports he started shaking all over on 2/6/21 and it gradually improved over the next week. He c... Read more
Pt reports he started shaking all over on 2/6/21 and it gradually improved over the next week. He continues to experience problems with short term memory and recall. Headaches, myalgias/arthralgias. Positive for mild nausea, constipation. Dizziness with turning his head started on 2/6/21 but has now resolved.
61 2021-02-23 mental status changes 1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER ... Read more
1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER and was diagnosed with kidney failure & hyperkalemia, also positive for covid. Hospitalized till 1/13, underwent dialysis. Received 2nd vaccination 1/25, once again "passed out" in breakroom while at work. Pt was awoken after approx 1 hour, unable to move arm at that time, went home and did not seek medical care at that time. Pt was re-hospitalized on 2/2/2021 due to difficulty breathing & AMS. Dx with pneumonia & hyperkalemia at that time, discharged home 2/11/2021. Continues on hemodialysis 3x/week.
61 2021-02-28 feeling abnormal he was not comfortable; allergic reaction; dizziness; feeling a lot of pressure in his head like his... Read more
he was not comfortable; allergic reaction; dizziness; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime; almost passed out; This is a spontaneous report from a contactable consumer reporting for himself. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9621), intramuscular on the left arm on 22Jan2021 (reported as 07:45 to 08:00) at a SINGLE DOSE for prevent COVID, at 61 years old. Medical history included triple bypass surgery from an unknown date. There were no concomitant medications. The patient previously took morphine and experienced the same thing with his brain, almost identical to what he was experiencing after the COVID vaccine. He reported that the first time he received morphine it was fine and then he got a shot of morphine and he experienced the pressure on his brain after receiving morphine, about 5 or 6 years before reporting time. He stated it was almost the same reaction. He was given a shot of Demerol (he was not sure if it was Demerol) to counteract it. History of all previous immunization reported as none. No additional vaccines administered on the same date. No prior vaccinations within 4 weeks. The patient reported he experienced an "allergic reaction"/ bad reaction to his first dose of BNT162B2 on 22Jan2021. His symptoms included dizziness as soon as he got the vaccine, got dizzy right off the bat, still dizzy, very little; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime. Symptoms (unspecified which) reported as recurring and are notably worse at bedtime. Patient is hesitant to receive the second dose. The patient stated he just went to sleep and prayed and then when he woke the next day, at night it did it again. At night it comes and goes, and he still has it happen but not like the first time. He tried to describe that he was washing his hands and he almost passed out like on an unspecified date in Jan2021, he was going to lose his mind. Last night he went to bed no problem, he felt a little pressure on his brain, stated it is hard to describe, it was not a good feeling. He was running a fever. Last night he had a slight fever, like it was going away. He was not able to drive when this was happening and today was the first day he could drive and he was not comfortable (27Jan2021). The patient declined any treatment. He already talked to his doctor and was told to call Pfizer. He asked if he was to get the second shot, is there something he could to take to make that feeling go away or counteract it. No relevant tests were reported. Events did not require a visit to the emergency room nor physician office. The outcome of the events, allergic reaction, headache is recurring- worse at bedtime, almost passed out and he was not comfortable was unknown. Outcome of the events dizziness, "feeling a lot of pressure in his head like his brain wanted to pop out of his head/ his brain wanted to swell up", felt like he was going to lose his mind / go crazy, and fever was reported as recovering.
61 2021-03-06 nervousness THE SAME DAY OF MY SECOND VACCINE AND ONE DAY LATER I EXPERIENCED A KIND OF JUMPS ON MY LEFT CHEK, M... Read more
THE SAME DAY OF MY SECOND VACCINE AND ONE DAY LATER I EXPERIENCED A KIND OF JUMPS ON MY LEFT CHEK, MY NOSE FLOW MORE THAN NORMAL AND A LITTLE BLOOD CAME OUT OF MY NOSE
61 2021-03-11 anxiety, sleep disorder Warm red skin of face arms hands feet. Swelling in feet and hands. Trouble sleeping, anxiety, shaky.... Read more
Warm red skin of face arms hands feet. Swelling in feet and hands. Trouble sleeping, anxiety, shaky. Prickly feeling throughout body.
61 2021-03-11 sleep disorder, feeling abnormal Headache, sore arm at injection, leg cramps - evening of injection >>> Blood pressure spike to 150/... Read more
Headache, sore arm at injection, leg cramps - evening of injection >>> Blood pressure spike to 150/100 on second evening after injection, felt funny, bad sleep <<<
61 2021-03-12 feeling abnormal patient was given 1st injection and about 5 minutes afterward @ 1205 he started to fell like a warm... Read more
patient was given 1st injection and about 5 minutes afterward @ 1205 he started to fell like a warm flushing feeling, and feeling a little fuzzy in the head, heart rate 64bpm, patient blood pressure on the monitor did not appear to be accurate indicating 180/118 and this was also tried on the right wrist. Patient did not have any complaints with the elevated with this blood pressure, patient was conversing and without headache, patient denied any itching or signs of anaphylaxis. patient was monitored for a total of 55 minutes before being released. Patient was instructed to call 911 with signs of anaphylactic reaction and to call his provider with any other symtpoms that he was concerned with.
61 2021-03-15 feeling abnormal Had chills, head ache, body aches threw up for three(3) days could not keep anything down took prom... Read more
Had chills, head ache, body aches threw up for three(3) days could not keep anything down took promethazine did not help. Still felt bad a few days after vomiting stopped.
61 2021-03-17 disorientation, anxiety Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, dis... Read more
Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, disorientation, dehydration and consequently extreme anxiety from the incident. I was taken to an examination room at the vaccination clinic by their nurse director. Blood pressure was high and there was a question if I was having a stroke or heart incident. the director sent me by ambulance to Hospital as they didn't know if I was having an anaphylactic shock or cardiac incident. All this occurred within an hour if the first symptoms.
61 2021-03-20 sleep disorder Fever (up to 101.6), body aches, nausea and headache peaking between 12-18 hours after dose, mostly ... Read more
Fever (up to 101.6), body aches, nausea and headache peaking between 12-18 hours after dose, mostly resolved by 30 hours. Nausea, and headache persisted until about 30 hours (took Tylenol Extra Strength at 24 hours). Pain at injection site, could not sleep on that side. Gradually developed and peaked 12-18 hours after dosing. Still slightly sore at 30 hours.
61 2021-03-21 feeling abnormal migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november,... Read more
migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november, felt about the same, was very sick for 5 days, felling much better 8 days after the vaccine, very afraid to get the second dose, if reaction is more severe as reported in the second dose, i'm afraid i won't servive
61 2021-03-25 feeling abnormal Body aches Flulike symptoms without fever Brain fog Lethargy
61 2021-03-28 confusional state, mental status changes UNKNOWN VACCINATION LOCATION. ADMITTED TO CENTER THE DAY AFTER HIS 2ND SHOT FOR CONFUSION, MENTAL ST... Read more
UNKNOWN VACCINATION LOCATION. ADMITTED TO CENTER THE DAY AFTER HIS 2ND SHOT FOR CONFUSION, MENTAL STATUS CHANGES, SYNCOPE VS SEIZURE ACTIVITY, LOSS OF CONSCIOUSNESS. NEURO CONSULTED AND THOUGHT POSSIBLE ADVERSE REACTION TO COVID VACCINE #2 AS NO OTHER REASON HAS BEEN FOUND WITH LABS, IMAGING, ETC. NEURO CALLING IT A 2 HOUR FUGUE EVENT.
61 2021-03-28 loss of personal independence in daily activities On going flu symptoms since the 2nd vaccination. It is going on 8 days and I still have flu symptoms... Read more
On going flu symptoms since the 2nd vaccination. It is going on 8 days and I still have flu symptoms. I feel weak, sometimes low level headache, mostly feel weak and tired. Don't feel like I have a temp. On scale of 1-10, I would say it's around 2-3. It does affect my work ability. Not overly hungry(which can be good).
61 2021-03-31 insomnia he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and h... Read more
he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and hives all over his body; sore arm; This is a spontaneous report from a contactable consumer reported for self. This 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 in the morning on Arm right at single dose (Lot # EN6205) for COVID Prevention. Medical history included ongoing leukemia CML from 2013, ongoing chronic lymphocytic leukemia from 2013, prostate cancer, white blood cell count runs high anyway, PSA (prostate specific antigen) last time he had blood work done, was 5.1. Concomitant therapy was none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 26Feb2021 in the morning, in the evening (26Feb2021), he had a rash and hives all over his body, he also experienced sore arm. He states that he had itching sooner. He also has leukemia CML, his oncologist told him to receive the vaccine. He would like to know if he should receive the second dose of the vaccine, and get ready for rashes. He broke out in hives and it was really uncomfortable, and he was not getting any sleep. He states that the hives got so bad, it looks like he has alligator skin. He states that he took Benadryl (UPC: 81131 07825, Lot number: P113775, Expiry: Oct2020, he has been using the product since the expiry date) and used Cortisone, and it helped but did not work 100%, but it helped enough he got some sleep. He stated that he felt like it is getting better, but he was taking Benadryl, and when the Benadryl wears off, it starts doing it again, but it was bad at first, like alligator skin, so he does feel like it is improving some. Outcome of the event hives was recovering. Outcome of other events was unknown.
61 2021-04-01 anxiety Tachyacarida/anxiety Pulse Ox: 95 @ 4:23pm Pulse/Heart Rate: 95 @ 4:23, 73 @ 4:26pm Transfered to... Read more
Tachyacarida/anxiety Pulse Ox: 95 @ 4:23pm Pulse/Heart Rate: 95 @ 4:23, 73 @ 4:26pm Transfered to EMS @ 4:29pm for evaluation, evaluated in back of ambulance, left in personal vehicle
61 2021-04-01 confusional state Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: pt passed out for 10 seconds, blood pressure low, when he regained consciouness he vomited.Recovered in about a half hour.
61 2021-04-01 insomnia Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lin... Read more
Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lingering through the next day.
61 2021-04-03 feeling abnormal Note: I AM reporting this because I strongly believe that patient's death was caused by his second C... Read more
Note: I AM reporting this because I strongly believe that patient's death was caused by his second COvid-19 vaccine. The exact date of the vaccine is unknown. His girlfriend told me he got his second Vaccine at the end of February. I also don't know what vaccine (Moderna or Pfizer) he got, so the Pfizer is just a guess. Patient started feeling bad and looking bad after his second vaccine. He complained that he wasn't feeling well and missed appointments saying he wasn't feeling well during the two weeks or so between the time of his second vaccine and his death.
61 2021-04-04 amnesia Experienced temporary short term memory loss after both the first and second doses of the Pfizer COV... Read more
Experienced temporary short term memory loss after both the first and second doses of the Pfizer COVID-19 vaccine. Symptoms are worse in the days following the vaccine.
61 2021-04-04 insomnia Severe chills (unable to hold a glass of liquid). Fever of 101.5. Inability to sleep until 5 am. Tir... Read more
Severe chills (unable to hold a glass of liquid). Fever of 101.5. Inability to sleep until 5 am. Tiredness all day the second day.
61 2021-04-05 feeling abnormal Pt given Pfizer vaccine at 0810. Shortly after, pt c/o "vaccine pumping through my chest and indige... Read more
Pt given Pfizer vaccine at 0810. Shortly after, pt c/o "vaccine pumping through my chest and indigestion." ; No c/o SOB, chest pain, or dizziness.Vitals: 830 89/60 100% O2 HR 81832 97/66 830 89/60 100% O2 HR 81832 97/66; 850 100/68 (manual) HR 81 O2 100%Dr called to bedside for assessment; 900 112/78 100% O2 HR 77910 110/78 100% O2 HR 76; BP stabilized, no c/o SOB, dizziness, chest pain.Dr. updated on patient status and cleared
61 2021-04-07 feeling abnormal, insomnia Approximately 12 hours after the injection I started to get chills headache dizziness and was not ab... Read more
Approximately 12 hours after the injection I started to get chills headache dizziness and was not able to sleep, it is the next day now and I?m still feeling pretty bad and body aches all over
61 2021-04-07 mental impairment tinnitus - started at 2nd shot and is still continuing. It is significant enough to get medical trea... Read more
tinnitus - started at 2nd shot and is still continuing. It is significant enough to get medical treatment and is very annoying. Over Easter I was with family, the TV was on and people were talking. I had significant trouble understanding people talking to me. I had significant joint pain of the left hand, knee's, and ankles which has decreased. I had headaches which have decreased but still continue
61 2021-04-08 insomnia Started with a severe runny nose. Runny nose and sneezing lasted approx 48hrs. When nose stopped run... Read more
Started with a severe runny nose. Runny nose and sneezing lasted approx 48hrs. When nose stopped running breathing got more laborious and a cough persisted. Slight fever and muscle aches for two more days. Trouble sleeping and cough started to produce mucus. It has been over 1 week since symptoms started and I am still experiencing coughing and mucus, as well as a loss of appetite. This was what I have experienced before when I have had a severe cold.
61 2021-04-08 insomnia A few weeks after my first shot I've developed ringing in my ears. it gets worse at night trying to ... Read more
A few weeks after my first shot I've developed ringing in my ears. it gets worse at night trying to sleep.
61 2021-04-10 confusional state, disturbance in attention, impaired work ability Immediately have ringing in ears. Bouts of confusion if too many people are talking in a room voice... Read more
Immediately have ringing in ears. Bouts of confusion if too many people are talking in a room voices become muffled. I have lost my concentration. I'm a programmer I'm praying I get it back or I will loose my job... Also erratic mood swings. I received the second shot 4/9/2021 and still have these simptoms.
61 2021-04-10 sleep disorder 4/7/2021 @ noontime: Began to have cold shakes. Approximately 15 minutes later, began to experience ... Read more
4/7/2021 @ noontime: Began to have cold shakes. Approximately 15 minutes later, began to experience slight headache and some fatigue. Within an hour, extreme shaking, fatigue and worse headache ever experienced in my life. Went to bed, covered up and tried to rest, but headache was too severe. About 6:00pm, took ibuprofen and headache began to subside, but too weak to walk without holding onto support items. Nausea left me unable to eat and drinking water was unpleasant. Fell asleep about 10pm and woke at midnight with cold shakes and did not get back to sleep. Went to work next morning and just felt somewhat fatigue and had no appetite.
61 2021-04-10 sleep disorder About two weeks after the 1st shot I noticed my facial skin was very itchy. This was a constant thi... Read more
About two weeks after the 1st shot I noticed my facial skin was very itchy. This was a constant thing. Two days after I had the shot shot my face swoll up and was very itchy. I was waking up in the middle of the night several times a night because of the itches and I was going my best no to scratch. i rubbed moisturizer in to my face and later started using some over the counter itching creams that would work for a few hours. I began to realize the itching was worse in places where I had five years ago had Bellafill infected into acne scars and deep wrinkles by a licensed cosmetic surgeon. I like the results and have no issue with the doctor or filler, but this stuff itched terribly. I see on the internet some complaints from others, but I wanted to report that I too have this. As of today, weeks later, it is not as bad, but as I write this I want to itch a place above my right cheek bone that was injected with Bellafill. I thought it was a problem with the Bellafill, I am convinced now it is a side effect of the vaccine. Guess this means it is working to adopt to odd things in my body.
61 2021-04-11 excessive sleepiness Fever and tiredness Can take ibuprofen/motrin/tylenol for fever, use cool compress/wet rag on forehe... Read more
Fever and tiredness Can take ibuprofen/motrin/tylenol for fever, use cool compress/wet rag on forehead to help 4/9-Spoke with wife. Patient slept all day yesterday and then woke up this morning feeling fine and went to work. Did not really take anything other than 1 expired ibuprofen.
61 2021-04-13 feeling abnormal He received his vaccine, he did have a sore arm but nothing else. When he woke up today at 4/14/21 ... Read more
He received his vaccine, he did have a sore arm but nothing else. When he woke up today at 4/14/21 with an upset stomach, has been nauseated, feeling run down. He has thrown up 3 times. His bones are aching and light headed. He has not taken anything for the reaction, just trying to stay hydrated, very little appetite. Does have an appointment to see his doctor today at 4:20 PM.
61 2021-04-13 feeling abnormal Lightheadedness, felt like he was going to black out, he did not faint. He was evaluated by a MD and... Read more
Lightheadedness, felt like he was going to black out, he did not faint. He was evaluated by a MD and due to the distance of his drive home was advised to go to ER via ambulance. Seen in ER- no chest pain, nausea, or vomiting. He did have some diaphoresis. Has a history of vasovagal syncope associated with needles. Seen and released without further interventions.
61 2021-04-14 restlessness, sleep disorder After receiving my shot around 4:00 pm on April 13, 2021, I was restless and did not sleep well that... Read more
After receiving my shot around 4:00 pm on April 13, 2021, I was restless and did not sleep well that night. When I woke up on April 14, I was tired but otherwise felt fine except my arm was a bit sore. However, after working at home for a couple of hours, shortly before 10:00 am I began to feel nauseous. I rushed to the bathroom thinking I was going to throw up, and almost immediately fainted. My wife and sons found me on the floor and woke me up. I threw up shortly after and felt pretty lousy the rest of the day with low grade fever, chills, body aches, fatigue, and a headache. I began to feel better at night and had a good night of sleep. Today (April 15), I feel fine except I'm a little tired.
61 2021-04-15 anxiety APPREHENSION AND CHOLING SENSATION PATIENT HAD NOT HAD ANYTHING TO EAT SINCE 6:30AM
61 2021-04-20 feeling abnormal Fatigue for approx 36 hours Cognitive impairment ?brain fog? lasted about 5 days
61 2021-04-22 loss of personal independence in daily activities I had no ill reaction-no swelling, no redness, no fever, no trouble breathing at all. By next mornin... Read more
I had no ill reaction-no swelling, no redness, no fever, no trouble breathing at all. By next morning, my Parkinson's symptoms, overall weakness, "frozen foot" and (left) foot-turned-in-bent-at-ankle, resulting in my needing assistance to walk, get up out of chairs, use the bathroom, worse than I had experienced prior. Normally I have much relief with Rytary, Carbidopa-Levodopa, and deep brain stimulator, but nothing helped. I'm now at 65-70% of where I had been. While I can't say with certainty that my medication failure resulted from the vaccine, I have no other explanation. I would rather risk whatever one vaccine has done for me against COVID, than go through this again, or worse!
61 2021-04-24 feeling abnormal muscle cramp; tightness in chest; shoulders cold sweat with no fever; body weakness; 7days brain fog... Read more
muscle cramp; tightness in chest; shoulders cold sweat with no fever; body weakness; 7days brain fog; This is a spontaneous report from a contactable consumer reported for himself that a 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733, expiry date: Jul2021) at the age of 61-years, via an unspecified route of administration in right arm on 29Mar2021 11:30 at single dose for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient experienced 7days brain fog, muscle cramp, tightness in chest, shoulders cold sweat with no fever and body weakness. These events started since unknown date (reported as 28Mar2021, pending clarification). No treatment received for the adverse events. Outcome of the events was recovered/resolved. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
61 2021-04-24 mental impairment Blistering, wet rashes on legs; Rash and blisters affecting feet; muscle pain has been going on for ... Read more
Blistering, wet rashes on legs; Rash and blisters affecting feet; muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine; Fever; Feeling unwell/Wasn't feeling good; Lost a lot of weight; Had to overuse inhaler; joint problems; Couldn't think; Affecting mental health; Blistering, wet rashes on legs; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 09Mar2021 (received at 61-year-old) as single dose for COVID-19 immunization. Medical history included arthritis, overactive immune system, unspecified mental health issues, and ongoing muscle pain. Concomitant medications were unspecified; the patient stated that he is on 4 vials of different medicine, or maybe 5. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), on an unspecified date for COVID-19 immunization. The patient reported that he had the Covid-19 vaccine. He reported that he was given a handout sheet that he read after he had the second dose of the Covid-19 vaccine. It was highlighted in yellow that he shouldn't have taken the Covid-19 vaccine with an overactive immune system. He further reported that the second dose of the Covid-19 vaccine is affecting his mental health. His mental health started being affected about 7-8 days after receiving the second dose of the Covid-19 vaccine. He stated that he is getting blistering, wet rashes on his legs again. He would like to see what he can do about this, but he will have to do it by mail. He reported that he has to get pictures taken of himself. He has an appointment tomorrow where he got the Covid-19 vaccine. He stated that he also has to go back to the dermatologist that is taking care of his immune system. He reported that he has lost a lot of weight. He reported that his weight is 147 pounds or maybe 141 pounds. He has lost a lot of weight since receiving the Covid-19 vaccine. He was given an emergency authorization release after he got the second dose of the Covid-19 vaccine. He noticed that he wasn't feeling good right away after getting the Covid-19 vaccine. When his legs started getting a rash and then blisters, his medical provider took pictures. The rash and blisters are affecting his feet too. The rash on his legs appears about 7-8 days after the second dose of the Covid-19 vaccine on 09Mar2021. He reported that what is on his legs started as rash and then turned into blisters. The blisters popped and it's like poison comes out. The fluid from the blisters smells, and that the fluid is ruining his clothes and is going to ruin shoes. The rash got worse the other day, with blisters forming. The blisters have now popped and there's going to be scars. The patient reported that he now has open wounds on his legs that bleed from the popped blisters. He also reported that it felt like all of his arthritis and muscles were affected. He took something for muscle spasms and arthritis, a muscle relaxant, for his back. Everything hit about the same time, 7-8 days after receiving the Covid-19 vaccine on 09Mar2021. The muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine. The patient also experienced joint problems, fever, feeling unwell on an unspecified date, had to overuse inhaler, couldn't think on an unspecified date. Outcome of affecting his mental health was recovering. Outcome of blistering, wet rashes on legs, muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine was not recovered. Outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2021-04-25 anxiety Flushing, minor breathing issue, anxiousness occurring about 8 minutes after getting the vacciine. ... Read more
Flushing, minor breathing issue, anxiousness occurring about 8 minutes after getting the vacciine. Patient admitted to anxiety discorder. Nurse and EMT assessed patient and obtained vitals. Patient got out and walked and stated that he felt better.
61 2021-04-25 anxiety Ringing, buzzing, chirping , humming in both ears general practitioner prescribed allergy medicine,... Read more
Ringing, buzzing, chirping , humming in both ears general practitioner prescribed allergy medicine, still have this side effect Dizziness - no treatment Ear ache , ears burning - no treatment Flushed feeling in head - no treatment Anxiety and stress - went to ER with chest pains, found nothing wrong with heart
61 2021-04-26 anxiety, insomnia Diarrhea, chills, tiredness, fatigue, anxiety, insomnia, aching joints, aching muscles, headache, di... Read more
Diarrhea, chills, tiredness, fatigue, anxiety, insomnia, aching joints, aching muscles, headache, dizziness.
61 2021-04-27 insomnia sweating; felt cold/intense cold even in his bones; He was told by the professional health care that... Read more
sweating; felt cold/intense cold even in his bones; He was told by the professional health care that he had small clots in his blood; death cause: Medication; arm started to sore; Doctor identified he had DVT; her husband during that night was not able to sleep; He started having fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 61-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Mar2021 09:00 (Batch/Lot number was not reported) as single dose f(at the age of 61-year-old) or COVID-19 immunisation. Medical history included dialysis, diabetes mellitus, known allergies: A7, Penicillin, Aspirin, Iodine, Povidone, Pepcid, dyes, iodine allergy. The patient's concomitant medications were not reported. The patient previously took Aspirin, povidone and pepcid ac and experienced drug hypersensitivity with all. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced death cause: medication on 18Apr2021, he was told by the professional health care that he had small clots in his blood in Mar2021, felt cold/intense cold even in his bones on 21Mar2021, sweating on 26Mar2021, her husband during that night was not able to sleep on 21Mar2021, he started having fever on 21Mar2021, arm started to sore and DVT on 29Mar2021. The patient was hospitalized for he had small clots in his blood, felt cold/intense cold even in his bones, sweating for 27 days. The event DVT was medically significant. The course of events was as follows: After getting the vaccine in 21Mar2021 her husband during that night was not able to sleep. He started having fever and felt cold. Days later he continued with the symptoms. On 26Mar2021 after vaccination he had dialysis same day in the afternoon. When arriving home the person notifies symptoms of intense cold even in his bones and then he started to sweat excessively on 26Mar2021 (Friday). The reporter decided to take her husband to the emergency room on 28Mar2021 (Sunday) where he had a general checkup. He was told by the professional health care that he had small clots in his blood. After some time he had health complications where they had suggested to amputate some of the limbs because of this, the reporter alleges those complications were due to the vaccine. On Monday 29Mar2021 same symptoms reappeared and he was admitted to Hospital. Had a blood test and notified to health professional that blood presents small clots. His arm started to sore severely after the sample. Doctor identified he had DVT. Doctor decided to proceed with various medications. Patient received treatment and he was injected: Percose, Morphine, Benadryl, Triphetarin for blood clot reduction. The patient underwent lab tests and procedures which included blood test: blood clot in Mar2021, Sars-cov-2 Nasal swab test: negative in Mar2021 post vaccination. The patient died on 18Apr2021. It was not reported if an autopsy was performed. The outcome of death cause: medication was fatal, of the other events was unknown. Information about the lot/batch number has been requested.; Reported Cause(s) of Death: death cause: Medication
61 2021-04-30 feeling abnormal Brain fog; Cognitive issues; Fevers; Stated that he had a positive test to Covid; This is a spontane... Read more
Brain fog; Cognitive issues; Fevers; Stated that he had a positive test to Covid; This is a spontaneous report from contactable consumer. A 61-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated that her husband's friend received his first dose of the Pfizer Covid19 vaccine on 25Mar2021 and was exposed to Covid-19 prior to getting the vaccine. Stated that he had a positive test to Covid on 02Apr2021 and he has been having significant Covid related brain fog, like cognitive issues and fevers. He rescheduled his second dose due to the infection and wanted to know if he should wait to take the second dose until he has no symptoms of the disease. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
61 2021-05-02 sleep disorder Five days after vaccination, started experience bloating with pain related to pressure. Bloating is ... Read more
Five days after vaccination, started experience bloating with pain related to pressure. Bloating is very uncommon for me. While there has been somewhat of a decrease in symptoms, I have now been experiencing symptoms for 12 days at a level sufficient to interfere with sleep patterns.
61 2021-05-04 impaired work ability 4/21: BPPV & treatment: onset of dizziness symptoms 6 PM 4/19/21, followed by extreme dizziness th... Read more
4/21: BPPV & treatment: onset of dizziness symptoms 6 PM 4/19/21, followed by extreme dizziness the next morning 4/20 & and visit to Genesis ready med to check out the dizziness, then doctors office. Meclazine by doctor Diagnosis: for vestibular BPPV. PT issued by doctor. 4/22: PT treatments began but, unable to return to work on Thursday excessive symptoms, doctor provided orders to be off work till Monday the 26th. 4/29: discharge from PT. 53/21: symptoms returned to level of 4 to 7 will contact doctor Monday. Continued Epley maneuver and barbecue roll maneuver with some benefit. 5/4/21: orders for MRI Of the head and follow up visit with doctor two days later to review and determine if more PT is warranted. More; continue epley and bbq roll at home, post PT exercises, continue meclizine. Return to work orders with climbing restrictions
61 2021-05-07 nervousness, anxiety, insomnia sinus infection; couldn't breathe; extreme high anxiety; couldn't sleep; lack of appetite; nervous a... Read more
sinus infection; couldn't breathe; extreme high anxiety; couldn't sleep; lack of appetite; nervous about everything; dehydrated; kidney levels numbers raised; headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 2 via an unspecified route of administration, administered in the right arm on 12Apr2021 at 11:15 (at the age of 61 years-old) for COVID-19 immunization. Medical history included blood glucose abnormal from an unknown date and unknown if ongoing other medical history: sugar, kidney problems, coronary artery disease (CAD), high blood pressure and renal disorder from an unknown date and unknown if ongoing. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 in the right arm on 22Mar2021 at 11:15 AM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medication for high blood pressure and "sugar medicine." The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 14Apr2021 at 06:00 AM, the patient experienced sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache. The patient was hospitalized for sinus infection for 1 days. The patient was hospitalized for couldn't breathe for 1 day. The patient was hospitalized for extreme high anxiety, couldn't sleep and lack of appetite for 1 day. The events sinus infection, couldn't breathe which led to extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache required an emergency room and physician's office visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021. Therapeutic measures were taken as a result of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache and included antibiotics and medicine to help sleep. The clinical outcome of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache were recovering. It was also reported that since the vaccination, the patient was tested for COVID-19. Information on the lot/batch number has been requested.
61 2021-05-11 anxiety Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection... Read more
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Additional Details: patient's husband says pt was admitted to hospital with burning in chest, heart, throat swelling, anxiety and trouble breathing.
61 2021-05-11 feeling abnormal having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; naus... Read more
having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
61 2021-05-17 anxiety, sleep disorder On April 27 felt tingle / pulse shoot down left arm, on April 28 felt tingle / pulse shoot down rig... Read more
On April 27 felt tingle / pulse shoot down left arm, on April 28 felt tingle / pulse shoot down right arm, on May 1 fely tingle in legs knee down to toes and also arms , from that point I have have pins and needles, burn, tingle numb pulsing off and on in arms to fingers, knees to toes and also in face numbness , have seen muscles soften and skin sag and lost autonomic nerve sensation in privates area and have not had bowel movements for over a week and a half other than wit hlaxative until last 3 days have had very small bowel movements , also eyes had been for years but vision has gotten worse , additionally anxiety i high and not sleeping well as worry and concern increases .
61 2021-05-18 anxiety Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). RN noticed Client t... Read more
Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). RN noticed Client turn red and become flushed to the skin. RN provided supplemental nutrition and fluids. Client accepted. At 1740 RN and PHN responded to this event. At 1741, vital signs are blood pressure 150/90, heart rate 100, oxygen saturation 96%. Client reports anxiety, no dizziness, no headache, no blurred vision, no chest pain. Client reports history of hypertension, takes blood pressure medication every morning (today's morning dose was administered via self at home), takes over the counter aspirin as needed, and no known allergies. At 1745, vital signs are blood pressure 144/88, heart rate 101, oxygen saturation 95%. Client reports no complaints with the 1st dose. Per Client had a very stressful day. The flush reaction of the face happened within 2 minutes of administration. RN educated Client in regards to ED precautions and common adverse effects of COVID vaccine. At 1750, vital signs are blood pressure 140/88, heart rate 90, oxygen saturation 98. Client reports symptoms have resolved and skin tone returned to appropriate coloration to ethnicity. At 1800, vita signs are blood pressure 130/88, heart rate 92, oxygen saturation 97%. At 1801, Client stood up with no complaints. At 1802, Client walked out of facility with a steady gait.
61 2021-05-18 mental status changes ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatme... Read more
ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatment team Severe sepsis with acute organ dysfunction Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/10/2021 Admission Date: 4/3/2021 Length of stay: 6 Days PCP: MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Severe sepsis with acute organ dysfunction Yes Left hip pain Yes Primary osteoarthritis of left hip Yes Intractable vomiting with nausea Yes Acute metabolic encephalopathy Yes COVID-19 virus infection Yes Gastrointestinal hemorrhage with hematemesis No Urinary tract infection associated with indwelling urethral catheter Yes HPI: Admitted with severe left hip pain and altered mental status. patient with history of stroke Was also found to have Covid positive at the time of admission Hospital Course: Following issues were addressed during this hospitalization Acute encephalopathy: At the time of admission Most likely secondary to gabapentin Held medication during this hospitalization and also stopped at the time of the discharge. Patient was started on this medication recently due to his left hip pain. COVID-19 infection D-dimer was elevated at the time of presentation. CT chest ruled out pulmonary embolism. Ultrasound did not reveal any DVT. Patient did not qualify for any convalescent plasma remdesivir during this hospitalization as he is saturating well on room air. Possible catheter associated urinary tract infection Patient with chronic indwelling Foley catheter. Urine culture grew Staphylococcus hemolyticus and Enterococcus faecalis faecalis. Patient was started on ampicillin during this hospitalization he completed the 5-day course. Sepsis ruled out at the time of admission Acute kidney injury present at the time of admission Suspect underlying chronic kidney disease Patient needs to follow-up with the PCP for the follow-up on the creatinine in 1 week. Left hip pain Patient underwent extensive work-up during this hospitalization. MRI of the left hip showed high-grade tear of the iliopsoas tendon. Patient was seen by orthopedics recommending continued therapy and pain management. Acute GI bleed, presented as coffee-ground emesis Acute on chronic anemia Iron deficiency anemia Underwent extensive work-up during this hospitalization. CT angiogram of abdomen pelvis revealed suspected bleeding in the stomach. Patient underwent EGD which showed severe esophagitis most likely cause of the bleed. Gastroenterology recommending continuing pantoprazole twice daily. Patient hemoglobin remained stable during this hospitalization. Biopsy did not reveal any H. pylori infection. Patient was seen by PT OT during this hospitalization who recommended acute inpatient rehab. But patient and family decided to take the patient home patient was discharged home in stable condition with home health.
61 2021-05-25 thinking abnormal Bad cold; Coughing, from a dry cough at first to a very wet cough; Coughing, from a dry cough at fir... Read more
Bad cold; Coughing, from a dry cough at first to a very wet cough; Coughing, from a dry cough at first to a very wet cough; Very large thick solid segments of gelled mucous coming out of my sinuses; could not think as tightly as usual on 19Apr2021; Sinuses became burning; Bad headaches; Unusally tired; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 17:00 (Lot Number: Lot EW0151) as 2nd dose, single for covid-19 immunisation. Medical history included Mild seizure disorder and Hay fever. No known allergies. Concomitant medications received within 2 weeks of vaccination included carbamazepine; oxcarbazepine; diphenhydramine hydrochloride (BENADRYL). The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 in arm left on 20Mar2021 05:00 PM (Lot number: ER8727). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The patient felt fine following the 2nd shot, for 48 hours on 18Apr2021, but unusually tired so he knew it must had been the shot. The next day on 19Apr2021 his sinuses became burning and he assumed it was hay fever because he had experienced some symptoms of that for the previous two weeks. But the next day on 20Apr2021, Tuesday, it was worst, like a bad cold (which all of this "reaction" may had been), but then the next 3 days he could barely get out of bed and that's unusual because he run every day and nothing stops him, including a cold. he had bad headaches on 19Apr2021 for 5 days or so and symptoms included coughing, from a dry cough at first that Wednesday to a very wet cough and very large thick solid segments of gelled mucous coming out of his sinuses, something he had never seen before. After almost two weeks he felt better but was still coughing, and now three weeks later he was still really tired, could not think as tightly as usual on 19Apr2021. His doctor's office told him not to come in, just to take pain reliever and cough syrup, which he was doing anyway. Test was neg. The adverse event result in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient underwent lab tests included covid test (Nasal Swab): negative on 24Apr2021. The outcome of events could not think as tightly as usual on 19Apr2021, sinuses became burning, bad cold, bad headaches and very large thick solid segments of gelled mucous coming out of my sinuses was recovered and other events was not recovered. No follow-up attempts are needed. No further information is expected.
61 2021-05-26 feeling abnormal blood pressure had dropped a lot/blood pressure dropped a good deal; his heart rate was 30 beats per... Read more
blood pressure had dropped a lot/blood pressure dropped a good deal; his heart rate was 30 beats per minute; Not feeling well; Sore arm; felt strange; his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 09Apr2021 (lot number: EW0158), as 1st dose, single, for COVID-19 immunization, at a clinic. Medical history included high cholesterol (controlled with diet); bone spur in left heel (bone spur in his left heel began coming on gradually, probably for 10 or 12 years) which has gotten little worse and made it hard for him to walk in the evening, in long distances, it was like a knife in his heel and he would get that real soreness and pulling after a walk; and allergy to sulfa drugs, more specifically sulfa antibiotics (he was given them 25 years ago and had a reaction). The patient has not had any vaccines or shots for years. He reported that he is very healthy and has not had the flu or anything in 25 years. The patient does not smoke and is careful with what he eats. There were no concomitant medications. On 09Apr2021, within minutes of receiving the first dose of the COVID-19 vaccine, the patient was not feeling well, he felt strange. He wondered if it was his imagination or if something was going on. Then it got worse and worse within 12-15 minutes after the COVID-19 vaccine. The staff member sent paramedics over to him. The paramedics set him up with a blood pressure cuff and heart monitor. Apparently, his blood pressure dropped a lot/dropped a good deal and his heart rate went to 30 beats per minute. His heart rate is normally around 65 beats per minute. The paramedics informed him that if his blood pressure and heart rate didn't come up, he was going to have to go to the hospital. The paramedics instructed him to stand up and it seemed to bring his blood pressure and heart rate back up to normal. The patient reported that everything returned to normal within a 15-20-minute time frame. He was then able to leave the vaccination facility. His health care provider advised him not to take the second dose of the COVID-19 vaccine. His physician informed him that he could possibly go into cardiac arrest. The patient did not have any problems after that other than a sore arm later in the day on 09Apr2021. His arm was sore for a day or two. The patient stated that this was the only effect after the incident in the vaccination facility. The patient also reported that on the weekend after receiving the COVID-19 vaccine, in Apr2021, he can walk long distance and his bone spur in his heel quit bothering him immediately. He reported that if he walks a mile and back, it quit the hurt. He reported that he would get that real soreness or pulling after a walk and that kind of stopped. The patient thought this was really strange. The patient reported that he cancelled the appointment for the second dose and did not get it. He was a little apprehensive about the second dose of as he didn't know if his reaction would be worse. The patient asked if the vaccine is 80% effective after one dose, if Pfizer has heard of that type of reaction from others, if his reaction was rare, and if he should get the second dose of the COVID-19 vaccine. He mentioned that he would like to have a second dose of the Covid-19 vaccine, but he is afraid to get it because he doesn't want to go into cardiac arrest. The patient recovered from "blood pressure had dropped a lot/blood pressure dropped a good deal", "his heart rate was 30 beats per minute", not feeling well and felt strange on 09Apr2021, and from sore arm in Apr2021. The outcome of "his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped" was not recovered. No follow-up attempts are needed. No further information is expected.
61 2021-05-26 sleep disorder After receiving the second shot on April 17, 2021 over a month later he still can not lift his arm u... Read more
After receiving the second shot on April 17, 2021 over a month later he still can not lift his arm up all the way, he has been to our primary Dr, twice complaining about pain two weeks after shot. PCP stated could take a month. It has now been over a month went to PCP again 05/24/2021 and gave him a script of pain. Why is he still having this issues over a month later. Please please explain why he can not sleep at night cause when he moves his arm in his sleep i takes him up all night long. There must be a reason for this to still be causing him this much pain.
61 2021-05-28 depression Severe joint pain, fever, sweating, shortness of breath, chills, weight loss, depression
61 2021-06-05 disorientation, feeling abnormal I had a stroke on April 30, 2021, 10 days after the second dose of Pfizer on April 20, 2021. The st... Read more
I had a stroke on April 30, 2021, 10 days after the second dose of Pfizer on April 20, 2021. The stroke was the result of a blood clot. I've never had blood clots until I subjected my perfectly healthy body to the Covid vaccination. On the morning of April 30, 2021, I was suddenly overcome with a sense of disorientation and dizziness. Spouse drove me to the ER. They discovered I had experienced a stroke. Let me be absolutely clear. The Pfizer vaccine is the sole reason I developed blood clots and had a stroke. I was perfectly healthy until I got vaccinated. I now have brain fog, dizziness, and every day is a challenge. I feel so dumb for falling for the get vaccinated garbage.
61 2021-06-08 feeling abnormal I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneo... Read more
I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneous report from a contactable consumer(patient). A 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581) via an unspecified route of administration, administered in right arm on 18Feb2021 12:00 as single dose for COVID-19 immunization. Patient medical history included Early Onset Alzheimers, high blood pressure, acid reflux, diverticulitis, and allergies to pollen and ragweed. Past drug event included Lipitor orifarm, amlodipine for allergies (Hypersensitivity). The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via intramuscular, administered in arm Left on 28Jan2021 12:00 as single dose for COVID-19 immunization. Patient stated that on 19Feb2021 01:00 when she was in store, she had terrible feeling came over her. She lost all her energy, she got a sinus headache, she was cold, her body ached all over. She had to leave the store. Barely had enough energy to walk from the car into her house. The patient did not receive any other vaccines prior to the COVID vaccine in four weeks. Patient received other medications in two weeks after vaccination. Patient did not receive any treatment for AE. Patient was not tested covid prior vaccination or post vaccination. The clinical outcome of events was not recovered.
61 2021-06-10 loss of personal independence in daily activities First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and eve... Read more
First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and every joint in my body hurts to the point I have experiences a severe reduction in quality of life. So, extreme fatigue and pain. I just can't seem to catch up on sleep and have to think twice about the next move due to the pain it will cause.
61 2021-06-24 insomnia (Tinnitus) terrible Ear ringing in both ears; Cannot sleep.; This is a spontaneous report received f... Read more
(Tinnitus) terrible Ear ringing in both ears; Cannot sleep.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration on the left arm on 10Mar2021 at 13:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for 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. It was unknown whether the patient was tested for COVID-19, since having the vaccine. On 10Mar2021 at 20:00, the patient had experienced terrible ear ringing in both ears(tinnitus) and was not able to sleep. The patient did not receive treatment for the reported events. The clinical outcome of events tinnitus and sleeplessness were not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
61 2021-06-25 memory impairment, mental status changes, confusional state Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy... Read more
Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy. He became weaker, more tired and sleep afterwards, He developed decreased oral intake. He was unable to recall his name, so family brought him to the ER. In the ER he was noted with significant anemia Hgb 6.5 and thrombocytopenia with platelet of 6. There is question of hemolysis with reticulocyte 8, LDH 1757, total bill 3.8. There is elevated D-dimer and renal function. Hematology consultation was placed for possible TTP versus COVID vaccine induced thrombocytopenia. PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times on 4, 5, 6, 8, 9, 10, 11, 12, 13, 17, 19 May 2021. Received Rituximab 375 mg/m2 = 731 mg IV weekly X 4 on 5, 13, 19, 26 May 2021. Completed high dose steroids 1000 mg x 3 days AMS and seizures 2/2 TTP related metabolic encephalopathy(i mproved), Small R parietal subdural hematoma­ likely related to TTP. No focal deficits. Treated for TTP with plasmaphoresis.initially alert but not oriented. Had an episode of seizure, intubated for airway protection Patient was hospitalized for 15 days 4-19 May 2021. He was in ICU for 1 week and 8 days in general ward. He was unconscious for the first week experienced 2 episodes of seizure. He has been comatos since he developed the first episode of seizure on 5/5/21. He developed another episode of seizure after the brain MRI on 5/5/21. PT discharged on 19/5/21 and continued blood works and Ritoximab therapy as out patient. Assessment: TTP, based on his clinical features including altered mental status, fe1er, hemolytic anemia and thrombocytopenia, renal insufficiency, and peripheral smear with 7-8 schistocytes per HPF (5/4/2021). Adam Ts 13 activity <3 Hemolytic anemia, severe thrombocytopenia 212 TTP with AdamTs13 deficiency In setting of hemolytic anemia, thrombocytopenia, AKI and AMS Hgb 6.5, Bili 3.8, LOH 1757, ARC 3.6 significant for hemolytic anemia on adm Peripheral smear showed anisocytosis, microspherocytosis and possible 1 schistocytes Platelet 6, multiple petechiae, no active bleeding, guaiac negative. Received 1U PRBC. Direct Coombs test -ve , Tbili elevated Plasmic score 6 Acute kidney injury 212 TTP vis Prerenal (Resolved) , Hyponatremia (resolved) FENA 0.5 Hematology followup: TTP (THROMBOTIC THROMBOCYTOPENIC PUPURA) 5/14/21 He developed a new ulcer in the mid of tongue. He coughs and sputum is clear. He feels better. Sip plasmapheresis and rituximab infusion yesterday. 5/13/21 He continues improling. Good appetite. He still coughs with blood streak, slightly pinkish sputum. 5/12121 His mental status is back to baseline. He is able to eat regular food and walk inside his room. Clo cough with blood streak, slightly pinkish sputum. 5/10/21 Fully alert and awake, but reported confusion and forgetful episodes. Eating better. Clo tightness in arms 5/9/21 More alert and awake. Started eating. Feeling tired. Clo mild pain at shoulders. Sip 1 unit PRBCs 5/8/2021 Mild improvement. Wife is at bedside. No acute overnight events. Still has intermittent confusion. Surgery re-placed left IJ Shiley for PEX 5/7/2021 He has intermittent confusion and irritation, mixed with short-term of AAO x 3. He pulled out his PEX line and has urinary incontinence. He is NPO and remains sleeping most of time. 5/6/2021 Sip extubated. He appears tired, but arousable, follows commands and carries normal communication with b/I symmetric strength with no motor deficits. Afebrile since last night. 5/5/2021 He developed 1 episode of seizure. Sip Ativan and 1 dose of propofol for intubation. He has been in comatose since then. Brain MRI was performed this afternoon. He developed another episode of seizure after the brain MRI. Sip 1 unit packed RBC 5/4/2021 and 1 unit packed RBC 5/5/2021. He de1.eloped mild bleeding from the bronchial suction and Foley catheter. He de1.eloped fe1.er temperature 101 during the first plasmapheresis. Temperature was 104 about 2 hours after the first plasmapheresis. He has had persistent high fe1.er since then. 5/4/2021 Lab showed WBC 7.1, Hb 6.5, pit 6, MCB 92.1, neut 68%, re!8%, PT 14, PTT 30. 5, D-dimer 2.19, fibrinogen 490, CMP normal except Ca 8.1, Glu 189, BUN 47, Cr 1.57, T bili 3.9, direc!0.9, and AST 56. LOH 1757, TSH 4.828, serum HIV and hepatitis panel negati1.e, COVID-19 Ag, SARS-CoV2 Rapid and Flu Ag negati1.e. 5/5/2021 WBC 21,500, hemoglobin 6.2, platelets 17,000, neutrophils 69%, PT 14.9, PTT 28.3, D-dimer 5.5, glucose of 296, BUN 63, creatinine 2.18, total bilirubin 2.5, albumin 3.6, LOH 891, AST 57, ALT 32, alkaline phosphatase 51. Laboratory results: WBC H 13.2 (MAY 14) H 11.6 (MAY 13) H 13.4 (MAY 12) H 16.8 (MAY 11) ? Hgb L 9.9 (MAY 14) L 11.3 (MAY 13) L 10.8 (MAY 12) L 10.4 (MAY 11) Hct L 30.2 (MAY 14) L 33.3 (MAY 13) L 31.5 (MAY 12) L 31.2 (MAY 11) Pit L 92 (MAY 14) L 58 (MAY 13) L 63 (MAY 12) L 74 (MAY 11) Risk Assessment: Denies Alcohol Use Substance Abuse Risk As sessment: Denies Substance Abuse Tobacco Risk Assessment: Denies Tobacco Use
61 2021-06-27 impaired work ability shoulder muscle pain that has not resolved I did two weeks of tylenol as prescribed by my doctor to ... Read more
shoulder muscle pain that has not resolved I did two weeks of tylenol as prescribed by my doctor to no avail It is difficult to lift my arm out from my side which is paunful and makes it difficult to lift items at my work (farming) there is a knot in the shoulder muscle(s) first dose March 10, 2021 second dose April 8, 2021
61 2021-06-29 nervousness Headache; Internal shaking when lie down.; This is a spontaneous report received from a contactable ... Read more
Headache; Internal shaking when lie down.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ENG206) in the right arm via an unspecified route on 06Mar2021 at 14:45 as a single dose (at the age of 61-year-old) for COVID-19 immunisation. The patients past drug history included allergy to sulfur. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included multi vitamins (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), crestor (MANUFACTURER UNKNOWN), RAPFLO all for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Mar2021, the patient had SARS CoV-2 test via rapid nasal swab and resulted negative. On 11Mar2021 at 07:00 am (5 days after vaccination), the patient had headache started with internal shaking when patient lied down. Therapeutic measures were taken as resulted events and included treatment with muscle relaxer. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events headache and internal shaking was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
61 2021-07-07 delirium Fever, delirium, stomach pain. Thrombocytopenia, Encephalitis, viral and bacterial meningitis, Rhabd... Read more
Fever, delirium, stomach pain. Thrombocytopenia, Encephalitis, viral and bacterial meningitis, Rhabdomyolyses, episode of torsades de pointe, pulmonary pneumonia, pneumonitis. Eventual double lung transplant.
61 2021-07-07 feeling abnormal, disturbance in attention, insomnia, anxiety Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty c... Read more
Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty concentrating; Extreme sensitivity to sound; Vertigo; Dizziness; Earache; Anxiety; Chest pains; Chest stress; Spasms in chest and back; Began to get blur in right eye; Bowel movements changed; Numbness on face: lips, checks, forehead; Muscles have shrunk throughout body; Joints popping; Neck ache; Throat tight; Face and smile have changed; Hair is thinner; Hair gotten gotten more grey since these issues; Feet burning; numbness and tingling sensation in both legs to feet and both arms to hands and extremities; Back aching; muscle weakness; Brain fog; Fatigue - constantly feel like laying down; Difficulty Sleeping through night/Unable to nap throughout day; feet aching in joints; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0150) via an unspecified route of administration, administered in left arm on 30Mar2021 at 14:45 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included finasteride, ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride. The patient previously took augmentin s. On 03Apr2021 at 18:00, the patient experienced tinnitus/ringing/buzzing/chirping/humming in both ears, difficulty concentrating, extreme sensitivity to sound, vertigo, dizziness, earache, anxiety, chest pains, chest stress, spasms in chest and back, began to get blur in right eye, bowel movements changed, numbness on face: lips, checks, forehead, muscles have shrunk throughout body, joints popping, neck ache, fatigue - constantly feel like laying down, throat tight, face and smile have changed and hair is thinner. The outcome of the events was not resolved.
61 2021-07-17 feeling abnormal Severe brain fog and ringing ears 3 full months after my 2nd shot. The symptoms started within hour... Read more
Severe brain fog and ringing ears 3 full months after my 2nd shot. The symptoms started within hours of getting the 2nd shot and have yet to subside. I've been to my doctor twice, have had blood work and most recently a brain scan. Still awaiting the results of the MRI brain scan. I was prescribed Prednisone for a few weeks and I felt instantly great, which tells my doctor I have some swelling in my brain.
61 2021-07-19 insomnia Dehydration; Symptoms of the flu; Soreness; Unable to sleep; Aches in joints; Nausea; Fever; Tiredne... Read more
Dehydration; Symptoms of the flu; Soreness; Unable to sleep; Aches in joints; Nausea; Fever; Tiredness; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. 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 medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on an unspecified date in Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
61 2021-07-20 sleep disorder shortness of breath chest pain both would come and go i waited about 3 months before i went to hosp... Read more
shortness of breath chest pain both would come and go i waited about 3 months before i went to hospital i would wake up in middle of the night hyperventilating got to the point i could not walk up a small hill with out going completely out of breath and forced to stop and try to breath
61 2021-07-21 agitation Short of breath 7/19, called EMS and arrived in ED morning of 7/20. While in ED became agitated hy... Read more
Short of breath 7/19, called EMS and arrived in ED morning of 7/20. While in ED became agitated hypoxic and apneic. Intubated. Diagnosed with PE and admitted.
61 2021-07-26 amnesia, feeling abnormal, confusional state, memory impairment I was immediately confused about where I was at, when leaving the vaccination site. I immediately f... Read more
I was immediately confused about where I was at, when leaving the vaccination site. I immediately felt flush with red splotches on my face. I came home and took a nap just to sleep it off. I woke up with severe tinnitus, a headache, and brain fog. Both the tinnitus and headaches have only gotten worse. The flush feeling, (suspecting higher blood pressure than usual), comes and goes with more frequency as time goes by. The ?brain fog? has been more like brain damage. At first, I just couldn?t think. My ability to think has slowly improved, but it is no where near the same as my abilities prior to the vaccine. My memory has been impaired, both long term and short term. My hand/eye coordination has been impaired. Prior to the vaccine, I didn?t feel my age. After the vaccine I felt like I aged 25 years in a week. I need to figure out what is going on inside my head, and what can be done about it. The degeneration is a serious concern. Both in the severity of the adverse reactions, and in the permanence of the damage. This will be devastating if I?m entering early stages of dementia, decades before the course of natural causes of aging.
61 2021-07-28 insomnia Developed tinnitus in both ears.; Had trouble sleeping the past few weeks but am sleeping better; Th... Read more
Developed tinnitus in both ears.; Had trouble sleeping the past few weeks but am sleeping better; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm right on 12Mar2021 at 20:00 (at the age of 61-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm right on 02Apr2021 at 17:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol and blood pressure high. Concomitant medications included atorvastatin calcium (LIPITOR) 40mg and amlodipine (MANUFACTURER UNKNOWN) 5mg from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. After receiving the first dose on 12March2021, the patient developed tinnitus in both ears late Sunday on 21March2021 into early Monday 22March2021. The patient started to take some over the counter supplements to help. The patient's right ear was normal as of 06April2021 but had slight tinnitus in the left ear. The right tinnitus had resolved several days ago. The patient felt that the left ear was bit better as ringing can dissipate during different times of the day. The patient had trouble sleeping for the past few weeks but was able to sleep better at the time of reporting. The patient was still trying to get the left ear line the right. The patient would clean the ears daily with Q-tips (outer areas) and would always see wax and the weirdest thing was that there was no ear wax. The patient got nothing and no wax at all even if the ears were not cleaned for days which was very, very strange. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of tinnitus, trouble sleeping and included treatment with over-the-counter herbs with ginkgo biloba (MANUFACTURER UNKNOWN) and SYNAPSE XT from 22Mar2021 to unknown date. The clinical outcome of the events tinnitus in ears and difficulty sleeping were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
62 2021-01-07 anxiety Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness ... Read more
Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine; Postnasal drip in throat; Feeling warm then really hot; Feeling weak; Clammy; sweaty; As if he was going to pass out; almost like a vagal reaction if you got a needle or were scared; vagal reaction but delayed; Heart might have been beating fast; Experience is like the dizziness related in the signs of a severe allergic reaction; Experience is like the dizziness related in the signs of a severe allergic reaction; Anxiety; anxious; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left deltoid, on 30Dec2020 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing mild intraocular pressure. The patient's concomitant medication included unspecified eye drops for a mild intraocular pressure. The patient previously took tetanus vaccine and experienced vagal reaction and passed out (in his childhood). The patient's past COVID tests were always negative. On 30Dec2020, the patient received it at a facility where he is a physician on staff, and they started giving it that day. It was administered by a pharmacist who was very clean and professional, and everything was fine. The patient received the COVID-19 vaccine in the left deltoid and felt pinched when the vaccine was administered, and he felt fine. He did not have any immediate reaction. He sat down, then got up and was standing talking to some colleagues, and about 10 to 15 minutes later, they were talking and felt a little postnasal drip in throat. His colleagues said that is what they felt as well. About 10 minutes later, the patient was feeling warm then really hot to the point where he felt the need for cool air. He added feeling weak and clammy as if he was going to pass out. He started to feel weak and warm and almost like a vagal reaction if you got a needle or were scared. It was almost like he felt hot, sweaty, and weak and feeling like he needed to get to a cool place and sit down. The patient's heart might have been beating fast, but he did not check his pulse. The patient went outside where the temperature was in the thirties and cold. The patient broke out in sweat and felt weak. The patient sat down, and it was cold outside, and he felt better. It passed and he felt fine after that. The symptoms lasted 10-15 minutes top, and it was resolved after the peak. The patient had soreness at the muscle site which got better overnight; little muscle soreness from the vaccine. The patient then got better and felt no other symptoms. He looked up the side effects and talked to the pharmacist. He spoke with a pharmacist, who provided the information on the reported adverse reaction of the COVID-19 vaccines and the signs of a severe allergic reaction included in the PI. He is not an allergic type person. He is familiar with those reactions and never had any trouble. He wasn't quite sure if it was related but then said it is probably somewhat related. The patient explained that he doesn't have any of the reported adverse reactions in the PI; but his experience is like the dizziness related in the signs of a severe allergic reaction in the PI, and he did feel that his heartbeat was fast. He is fine now though. The patient asked if his event is related to the vaccine and what is the impact on getting the second dose when reacting to the first. The patient was thinking that this event is a vagal reaction but delayed. He also explained that he was speaking with his colleagues, right after receiving the COVID-19 vaccine, regarding postnasal drip reaction. The patient also wondered if anxiety related to this discussion could have triggered his symptoms. Originally, he thought it was just him. But after talking to colleagues, maybe he was just a little anxious. He did not feel anxious going in. He did not need any intervention. He did not take any diphenhydramine hydrochloride (BENADRYL) or anything. He sat and rested, and it passed. He has been fine since. He needs a second dose in 3 weeks. There is not a lot of information about the side effects. It was not like he got a rash. He did not have any swelling of the tongue or throat. He just wanted to find out about if he should get the second dose. He really wanted to get the second dose. He just wanted to know if this was common or a concern and should he take the second dose. There were a lot of people getting the vaccine and this was not anything that stopped anyone from getting it. He is just trying to make sure and see how likely it was that it was related to the vaccine and how does it affect him getting the second dose. The patient was recovering from "Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine". The outcome of "Postnasal drip in throat" and "Anxiety; anxious" was unknown. The patient recovered from the other events on 30Dec2020. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
62 2021-01-11 anxiety Severe neck and throat pain, throat hurt when breathing. No chest pain, no shortness of breath. La... Read more
Severe neck and throat pain, throat hurt when breathing. No chest pain, no shortness of breath. Lasted until about 2am. Anxious because concern about being cardiac. Next day very tired and headache.
62 2021-01-13 insomnia Abdominal pain, Abdominal distention, severe acid reflux, awake until 4 am with severe abdominal pai... Read more
Abdominal pain, Abdominal distention, severe acid reflux, awake until 4 am with severe abdominal pain,
62 2021-01-20 feeling abnormal Patient received her second COVID-19 vaccine. Rapid response called when patient returned to vaccine... Read more
Patient received her second COVID-19 vaccine. Rapid response called when patient returned to vaccine clinic and reported feeling "funny," itchy, and with a blotchy red rash around her neck. Heart rate noted to be 220/109, SpO2 100% on room air. Heart rate of 85. Emergency department PA notes questionable allergic reaction to the vaccine. Very mild erythema at the base of her beck. Given Benadryl, Solu-Medrrol and Pepcid. Heart rate of 183/95 trended down to 157/90 by the time of discharge.
62 2021-01-20 loss of personal independence in daily activities Shaking chills onset 12 hours after the vaccine, followed by fever to 101.6, sore throat, dry cough,... Read more
Shaking chills onset 12 hours after the vaccine, followed by fever to 101.6, sore throat, dry cough, headache, nasal congestion, muscle aches, and fatigue at 24 hours post-injection. The fever and other symptoms subsided within 48-72 hours, however, I was unable to return to work for 4 days and continue to experience a mild headache.
62 2021-01-21 feeling abnormal 20-25 min post vaccine pt complains of dizziness, sweating. Patient laid down for approx 10 - 15 min... Read more
20-25 min post vaccine pt complains of dizziness, sweating. Patient laid down for approx 10 - 15 min and drank cola. BP taken was 160/120, which elevated but not abnormal. Pulse Rate - 67. After 10-15 min of sitting and cola dizziness improved as well as sweating. Pt. f/u @ 2pm. Feels "off". Not dizzy, but feels ok to work and drive.
62 2021-01-24 insomnia Got COVID shot about 10am Friday and started to feel sick about 6pm. Tiredness, headache, muscle pai... Read more
Got COVID shot about 10am Friday and started to feel sick about 6pm. Tiredness, headache, muscle pain, fever, nausea. Rough night and still had symptoms all day Sat 1/23/21. By Sunday morning only headache remained, mild compared to day before. Now Monday, and still have light headache and tired.
62 2021-01-25 disorientation fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive... Read more
fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive to touch
62 2021-01-26 impaired work ability 19th vaccinated; my wife was exposed to COVID on 26th and she developed symptoms on 29th; I develope... Read more
19th vaccinated; my wife was exposed to COVID on 26th and she developed symptoms on 29th; I developed on 31st and tested Positive on January 2 for COVID; January3, I was admitted to ER for shortness of breath, my oxygen saturation - between 88 and 94; I was in the hospital and discharged on January 8. Remdesivir and Decadron treated with and also Eliquis. I was on oxygen until Wednesday (three days) and then I went home on 8th and continued on Prednisone for last week (Friday). Haven't gone back to work - shortness of breath, fatigue and headaches continue.
62 2021-02-01 hallucination Pt had some amazing hallucinations and was actively communicating while I believe he was asleep. He... Read more
Pt had some amazing hallucinations and was actively communicating while I believe he was asleep. He called me on the phone and his voice was slurred and he thought he was being held down by some things that were flying around. I was able to direct him to sit up after ensuring him that he wasn't being held down and eventually get him to walk to the bathroom, turn on the light and look in the mirror and describe to me what he saw (he lives at a different address than I do). By this time, he had "woken" up and his voice was no longer slurred and he was "making sense". My concern was that he had had a stroke or Bell's palsy or something. He was fine and slept well the rest of the night. I will bring him to my home after his second shot just in case this happens again. He hallucinated after his anti-anxiety medications for the first couple of weeks and to a more minor amount with his other medications, again for the first couple of weeks. I am assuming that his brain reacted to the vaccine with hallucinations but I don't know. This may be nothing or it may be something that other patients are experiencing, who the heck knows.
62 2021-02-04 impaired work ability Muscle cramps in lower back area. Feels like Kidney area Cramps started on 1/31/2021. I called out o... Read more
Muscle cramps in lower back area. Feels like Kidney area Cramps started on 1/31/2021. I called out of work on 2/1/2021 Went to urgent care on 2/5/2021. I had blood work done
62 2021-02-04 panic attack Blood pressure was high; tired from the night before; Itchy; slight headache; little lightheaded; He... Read more
Blood pressure was high; tired from the night before; Itchy; slight headache; little lightheaded; Heart racing; panic attack; Hot flashes; Sweating; Chills; achy/body aches; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for himself, a 62-year-old male patient who received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration (reported as by injection) to left arm on 14Jan2021 at 3pm at single dose to prevent COVID/COVID-19 immunization. Medical history included anxiety. Concomitant medications included antidepressants. The patient received his first dose of Pfizer COVID vaccine last 14Jan2021 at 3pm, and everything went well. When he left the place, he had a slight headache. He had to stay there for 15-20 minutes to make sure he had no reaction. He just got a little lightheaded, he didn't think much, and it didn't get worse. The patient took 2 paracetamol (TYLENOL) and forgot about it. It went away for a while. He took the shot at 3 pm and he took paracetamol at 4 pm. Later that night, about 10 pm, everything kicked in. He was sick again at 10:30 pm, or so, the headache was gone for several hours. He was ok between 4 pm and 10 pm. Then about 10 to 10:30 pm, when he went to go to sleep, his heart started racing, like he was having a panic attack, then he started getting hot flashes, sweating, chills, and aching, and this went all night from like 10 pm to 11 to the next morning. He had a doctor's appointment to get his knee examined for an upcoming knee surgery. The patient clarified that he didn't go to the doctor because of the symptoms, he went for his knee. He asked the doctor, before getting examined, and the doctor said he got off easy, as the doctor himself was sick for 3 days. The patient asked the doctor if he could take something to calm down, as his blood pressure was high on 15Jan2021 at 8 am. They had taken his blood pressure to examine his knee, and the doctor said it was alright. He was prescribed with alprazolam (XANAX), and the doctor said it would be fine. The next day, he was tired from the night before. He had no symptoms the next day. After he took alprazolam, he slept fine, he felt better. The hot flashes, heart racing, body aches, and chills were gone, and he read everything as far as symptoms. The heart racing went away about 11 the next morning because he took alprazolam. The patient stated that he forgot to add one more, he had all the symptoms described as side effects, but he also had itching. He had very mild itching and was given cetirizine hydrochloride (ZYRTEC, lot number: OHE2723, expiry date: Feb2022, UPC: 4122053077), it was like 80% gone. Every now and again he has a little itch, but it was bothering him all night that first night. Currently, the patient felt pretty good. He has no symptoms other than the slight itch. He further stated that his second dose is on 04Feb2021. Out of all symptoms, the thing that freaked him out the most was the heart racing, he asked if he could take diphenhydramine hydrochloride (BENADRYL) before the shot. He has been on antidepressants for a while, he has a lot of anxiety, but the day he went in, he felt good, and didn't take alprazolam. He also asked if this have triggered all that heart racing stuff. He was seeking for information if there was anything to do to prepare him better, he knew you have to sit there for 15-20 minutes to see if there was a reaction. The outcome of the event headache and lightheadedness was recovered on 14Jan2021, unknown for blood pressure high and tiredness, recovering for itchy, and recovered on 15Jan2021 at 11 am for all other events.
62 2021-02-16 sleep disorder Right chest, right shoulder, right shoulder blade pain, extreme to the point where i wasn't able sle... Read more
Right chest, right shoulder, right shoulder blade pain, extreme to the point where i wasn't able sleep and a burning sensation in those areas as well
62 2021-03-03 insomnia, feeling abnormal diarrhea; whole body aches; He can't sleep; feels like crap; This is a spontaneous report from a con... Read more
diarrhea; whole body aches; He can't sleep; feels like crap; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EL9264 expiry date not reported) via an unspecified route of administration from 31Jan2021 at single dose for covid-19 immunization. The patient's medical history includes ongoing nausea and Not able to eat/ he can't drink or eat. Just thinking about eating makes him nauseated and threw up. Concomitant medications were not reported. The patient experienced whole body aches, he can't sleep and feels like crap on 31Jan2021. The patient also experienced diarrhea on 02Feb2021. The patient mentioned that on the morning of the vaccine, Sunday, he woke up, and tried to drink coffee and threw up. The Sunday morning he was nauseous before the shot. When he drank his coffee that morning. In the mornings, he can't drink or eat. Just thinking about eating makes him nauseated. His body aches started a little while after the shot. It was still Sunday when they started though. He can't sleep the body aches are so bad. Sunday evening is when he started to feel like crap. He has also had diarrhea. The outcome of the events whole body aches, feels like crap and diarrhea was not recovered. Outcome of the event He can't sleep was unknown.
62 2021-03-06 feeling abnormal acute fatigue for 4 days & arthralgia. acute Clouding of consciousness for 15+ days
62 2021-03-10 sensation of foreign body Slight lump in throat, of the kind experienced with previous anaphylaxis episodes, that developed a ... Read more
Slight lump in throat, of the kind experienced with previous anaphylaxis episodes, that developed a couple of hours after vaccination, and is continuing.
62 2021-03-11 feeling abnormal Brain fog, fatigue
62 2021-03-11 memory impairment, confusional state Patient was seen at Facility 10 minutes after his Pfizer immunization. He had wooziness, and hyper... Read more
Patient was seen at Facility 10 minutes after his Pfizer immunization. He had wooziness, and hyperventilation with a breathing rate of 40. He was transferred by wheelchair to a stretcher. Initial Vitals: BP 128/68, O2 sat 96% on 2 liters O2, pulse 68; veteran was diaphoretic, with clear lungs. He did not recall he had an immunization, and was uncertain of his own age. He did report he was on metformin for DMII. 911 was called. He was transported to Hospital ER by EMTs.
62 2021-03-13 anxiety he was excited and/or anxious about getting vax after having Covid in November. vax dose approx 305 ... Read more
he was excited and/or anxious about getting vax after having Covid in November. vax dose approx 305 pm, by 310 he reported feeling weak with rapid pulse and heart fluttering. Gave water to drink, he declined food. 315 he felt hot sweaty and took off his overcoat. 325 said he felt better after drinking the water and declined to have his bp or pulse checked. Follow up phone call 3/14 to check on condition, said he felt ok after leaving pharmacy and has no allergies, no current illnesses and no vaccines within past month.
62 2021-03-13 sleep disorder Extremely dizzy when got up during night (2 am). Fell twice. Extremely dizzy when got up during nigh... Read more
Extremely dizzy when got up during night (2 am). Fell twice. Extremely dizzy when got up during night 2nd time (5 am). Fell once. In the morning (about 7:30) I noticed a rash all over his trunk (small pink spots) As the result of the falls, he hit chin and cut it. Hit left temple and bruised it. Back is very sore and painful. May have cracked rib(s). Currently 2:20 pm on March 14. He is no longer experiencing the dizziness. The rash seems to be clearing up (brownish spots instead of pink spots on trunk). He's resting.
62 2021-03-14 insomnia Chills, blood clot R DVT, Dizzy, balance difficulty, itchy upper torso, sleeplessness
62 2021-03-17 thinking abnormal Had body aches, cold chills, thought processing was slow and some what scattered, eyes were dilated ... Read more
Had body aches, cold chills, thought processing was slow and some what scattered, eyes were dilated slightly, loud noises were painful
62 2021-03-21 disorientation Chest pain (middle of chest); wheezing; back pain; disorientation; light headed
62 2021-03-21 mental impairment Exacerbation of Parkinson?s symptoms, trouble walking, speaking, mental slowness, worsening balance
62 2021-03-25 insomnia Fever to 102. Chills. Full body aches, headache. Unable to sleep. Resting heart rate was about 20... Read more
Fever to 102. Chills. Full body aches, headache. Unable to sleep. Resting heart rate was about 20 beats higher than normal. Mild tinnitus got louder. At 24 hours from shot fever has reduced to 100.
62 2021-03-25 restlessness Severe headache, fatigue, very sleepy about two hours after injection. Woke about 1:00 a.m. with se... Read more
Severe headache, fatigue, very sleepy about two hours after injection. Woke about 1:00 a.m. with severe headache. Gave two Tylenol and cold wash cloth for forehead. Started tossing and turning about five minutes later. Sat up in bed, fell over and struck bedside table. EMT said he suffered stroke around 1:30 am. He passed away on the 5th.
62 2021-04-01 anxiety PT (DOB 12/14/1958) received the COVID vaccine (Pfizer dose 1, Lot# EW0150, exp 7/31/2021) at 1525.... Read more
PT (DOB 12/14/1958) received the COVID vaccine (Pfizer dose 1, Lot# EW0150, exp 7/31/2021) at 1525. The client reported feeling dizzy and lightheaded, and his caregiver reported that he was "red and sweaty". EMT alerted the RNs and responded to the client. Upon observation, the EMT observed that the client appeared flushed and diaphoretic. The client was accompanied by his caregiver who reported that the client has a medical history of hypertension, orthostatic hypotension, intellectual disability, schizophrenia, diabetes mellitus 2, and bell's palsy. The client has no allergies and takes the following medications: metformin, lipitor. clozapam, metoprolol, cogentin, iron, prostigmine, and farxiga. At 1530, the EMT obtained a blood pressure of 180/118, with a heart rate of 116, respiratory rate of 22, temperature of 99.1 F and pulse oximeter reading of 94%. At 1536, the client's blood pressure was 172/118, with a heart rate of 116, respiratory rate of 20, and pulse oximeter reading of 95%. At this time, the client stated that he was dizzy and feeling anxious. The client reported that he was feeling dizzy before he was vaccinated but that he "forgot" to tell his caregiver. His caregiver reported that the client had not yet eaten or had anything to drink that day. The client was offered and accepted water. The client and his caregiver deferred Benadryl. Repeat vital signs were obtained at 1542: blood pressure of 166/112, heart rate of 116, respiratory rate of 24, temperature of 99.1 F, and a pulse oximeter reading of 95%. The client practiced deep breathing, denied any difficulty breathing, itching or swelling. At 1550, the client reported no longer feeling anxious or dizzy. At this time, the client's color was improved, he no longer was diaphoretic, and he stated "I'm pretty hungry now." Repeat vital signs were as follows: 156/115, heart rate 108, respiratory rate 20, and pulse oximeter reading of 95%. Client left the facility at 1600 after waiting the recommended 30 minutes from initial symptoms, with symptoms resolved at that time. The client ambulated to his car with a steady gait, escorted by the EMT and his caregiver, and his caregiver drove him home.
62 2021-04-01 hallucination I began shaking violently and severe cold chills. I began hallucinating and felt like I was turning ... Read more
I began shaking violently and severe cold chills. I began hallucinating and felt like I was turning inside out. I blacked out and woke 2 hours later with severe flu like pain in my entire body and a severe headache. I do not do drugs and I had no alcohol in the 3 days before I wa vaccinated. It is now 47 hours after the vaccination and I have moderate flu like symptoms.
62 2021-04-03 disturbance in attention severe headache, muscle aches, fatigue, sore arm, lack of appetite, weight loss, trouble focusing
62 2021-04-06 excessive sleepiness, feeling abnormal, thinking abnormal 'blood pressure had been up to 180/increase in blood pressure'; he was freezing; he was cold; ''he i... Read more
'blood pressure had been up to 180/increase in blood pressure'; he was freezing; he was cold; ''he is usually up at work every day and he hasn't been able to work the last few days''; feels like he can't think'', ''tired; ''he may be getting in for breathing treatments today''; so sick; feels like he can't think'', ''tired; Feeling lousy; Lethargic; Running temperature; Chills; Hives; Anaphylaxis; fell asleep for 16 hours. Caller reported that he doesn't normally sleep for 16 hours; Throat scratching; Eye itching; Bags under eyes; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: EN6207), via unspecified route of administration on right arm on 19Mar2021 13:09 as a single dose, for COVID-19 immunization. The patient medical history included Ongoing COPD (about 5 years ago), high blood pressure (about 10 years ago and still ongoing) extensive allergies to food and insect bites. The patient was diagnosed with the allergies when he was a little kid, allergic to penicillin ongoing. Concomitant medications included lisinopril at 20 mg once daily in the morning for high blood pressure and albuterol at 2 pumps in AM and 2 in PM before going to bed for COPD (Chronic obstructive pulmonary disease). The patient previously took historical vaccine ampicillin for infection. On 19Mar2021, the patient experienced, ended up feeling really sick right after the shot. He has a lot of allergies and he was advised to take his Epi-Pen kit and stay an additional 30 minutes past the recommended waiting time after receiving his vaccine. His throat began scratching after getting the shot and lasted for about 3 to 4 hours for which the patient received Benadryl and resolved completely. His eyes were itching and lasted for 24 hours, and bags started to form under his eyes like anaphylactic shock. It was reported that the bags under his eyes would normally stay after anaphylaxis for a day or two. His eyes were still a little puffy at the bottom. He did not saw a rash but started to get hives, the paramedics were called and monitored him for another 30 minutes. The paramedics administered a shot of Benadryl. After the Benadryl was administered, his body and blood pressure started to come down. The paramedics reported that his blood pressure had been up to 180. It was reported that on 19Mar2021, afternoon, when the patient got home, he was sick, laid down and fell asleep for 16 hours. He does not normally sleep for 16 hours. He was unsure if his eyes were itchy in his sleep. Later in the call it was clarified that this might have only lasted 3-4 hours, he was so tired he just went to sleep. It was reported that he was not a sleeper, that he was usually up at work every day and he had not been able to work the last few days. It was reported that he started feeling the side effects of the Covid-19 vaccine at 13:20 on 19Mar2021. On 20Mar2021, he felt lousy ever since he received the COVID-19 vaccine. On the same day, his wife took his temperature, and his temperature was hovering around 100-100.9. He felt lethargic, running a temperature between 100.5 and 100.9 pretty consistent every day. On an unspecified date, his wife took his temperature, and it was 99.9. He felt like his mind was in a fog, intoxicated and he had not felt good since receiving the first dose of the Covid-19 vaccine. It was reported that the mental fog made him felt like he cannot think. The paramedics gave him a test and asked him to add 5+7. The patient answered 14, even though he knew that the answer is 12because he could not think, and he felt punch drunk. He reported that he can concentrate a little more, but he still felt drunk, this was hanging around the same now. It was reported that the paramedics were asking him questions and gave him things to do, addition and subtraction formulas, to keep his mind. He could not finish those formulas and that he told the paramedics that he felt foggy or punch drunk. He spoke with his health care provider at the VA and the provider advised him not to get the second dose of the Covid-19 vaccine. It was reported that the patient was inquired if he had any immunity to Covid-19 without taking the second shot and if he was protected with just the one dose of the Covid-19 vaccine. It was also reported that, the reporter also looked through the list of side effects for Covid-19 vaccine and it was like patient had all of them. The patient experienced chills, he was freezing, and he was cold. The patient had the whole list of them. It reported that he had doctor appointment on Monday, 29Mar2021, and that he may be getting in for breathing treatments today. He was waiting for his insurance to finalize the approval for the breathing treatments in the evening. The outcome of the events throat scratching and eye itching was recovered on 19Mar2021, Outcome of the events bags under eyes and blood pressure had been up to 180/increase in blood pressure were recovering. The outcome of the events feeling lousy, lethargic, running temperature and chills were not recovered. Outcome of the other events was unknown. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.
62 2021-04-08 confusional state mental fog for all the following day; Chills; first dose on 16Feb2021/second dose on 21Feb2021; firs... Read more
mental fog for all the following day; Chills; first dose on 16Feb2021/second dose on 21Feb2021; first dose on 16Feb2021/second dose on 21Feb2021; This is a spontaneous report from a contactable Other HCP reported for self. A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose in Left arm on 21Feb2021 12:30 PM (lot number: EN6198) for COVID-19 immunisation. There was no other vaccine in four weeks, no other medications in two weeks. The patient's medical history included known allergies: penicillium and sulfa. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number: En5318) in Left arm on 16Feb2021 10:00 AM for COVID-19 immunisation. The patient experienced chills and mental fog on 22Feb2021 and for all the following day, no treatment received for the events. No COVID tested post vaccination. Outcome of the events chills and mental fog was not recovered.
62 2021-04-11 feeling abnormal Continued soreness in injection arm every day since first injection. Near-continuous cognitive befu... Read more
Continued soreness in injection arm every day since first injection. Near-continuous cognitive befuddlement / inability to think clearly - only have had this before with severe sinus infection / head cold (I'm a practicing degree'ed engineer - very scary to me). Had a bout of "double vision" for approximately a minute - never had this before - another very scary thing. Two days ago experienced "highway hypnosis" - zoned out while driving for 10 minutes - lost time event / can't remember driving the route I did - never had this before - another very scary thing.
62 2021-04-12 insomnia Tough to sleep; Ringing in ears; This is a spontaneous report from a non-contactable consumer. A 62-... Read more
Tough to sleep; Ringing in ears; This is a spontaneous report from a non-contactable consumer. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: En6201) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) and losartan, both for unspecified indication. On 16Mar2021 at 16:00, the patient experienced ringing in ears and tough to sleep for a couple days. The patient did not received treatment for the events. The events resulted in disability or permanent damage. The outcome of the event was not recovered. The patient did not had COVID prior to vaccination and was not tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
62 2021-04-15 impaired work ability Woke up next morning, 04/09, after receiving 2nd dose of Pfizer vaccine. Started as feeling like a h... Read more
Woke up next morning, 04/09, after receiving 2nd dose of Pfizer vaccine. Started as feeling like a head cold. Some chills etc. by the time I went to work right side hearing was severely affected with what sounded like phase shifter in my head. No relief through weekend, too dangerous to work due to my job in a busy kitchen. Saw my Dr. on Tuesday 04/13. Treated as an ear infection. 3 day steroid with nasal spray. No relief. By now the ringing, whooshing, roaring and chirping in my right side are extremely disorienting! Started antibiotics on 04/15 with wait and see effectiveness. Today is 04/16 at 10:15am. To date no relief of symptoms.
62 2021-04-22 excessive sleepiness Initially, the first day as with the first dose, my left arm ached but this time it lingered for abo... Read more
Initially, the first day as with the first dose, my left arm ached but this time it lingered for about 4 days. I was working a job that requires heavy lifting and at first thought it was the work, but after not working at all for about 3 days, my body would start aching all over. This is approximately 10 days after my second dose of Phizer. My bones ached, sort of like getting the flu. Late in the afternoons is when this pain would begin and by 7-8 at night, all I wanted to do was sleep. Each day, when waking most all the aching would be gone only to start up again about the same time in the afternoon/early evening. Last night, I went to bed about 7 pm and slept up until 6 am. As I am writing this, the aching is beginning in my arms again and I have tons of tiredness. It is 4:25 pm. and day 12 after the 2nd dose of Phizer.
62 2021-04-22 sleep disorder Intense muscle twitching in my lower extremities, especially in the feet and calf muscles of both le... Read more
Intense muscle twitching in my lower extremities, especially in the feet and calf muscles of both legs. Abodominal muscle spasms were present but not as prevalent or obnoxious as my legs. Also twitching in my right deltoids, triceps and thumb muscle. Could not sleep for two days . I began to get a headache due to no sleep so I took two 200 mg Advil tablets. I was able to sleep that night because the twitches had greatly subsided. I still have frequent but light twitches .
62 2021-04-24 feeling abnormal anemia; elevated liver enzymes; low protien; Elevated Blood Sugars; Fatigue; Headache; Chills; Fever... Read more
anemia; elevated liver enzymes; low protien; Elevated Blood Sugars; Fatigue; Headache; Chills; Fever; Feels awful/ I feel really bad; Feel terrible; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not reported) via an unspecified route of administration, administered in right arm on 08Mar2021 05:00 as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin; tamsulosin and insulin aspart (NOVOLOG). The patient reported that he regulates his blood sugar by insulin pump giving him insulin when he needed it. The patient stated that he felt awful. He felt terrible. He could not function. Without drugs, he feels really bad. He got the vaccine on 08Mar2021 and for a couple of days, he felt okay but after that, he just feels really terrible. He does not know what to do. He stated that the events probably started on 10Mar2021. He does not remember but it has been a couple of days since he got the vaccine, quite "hard feeling for him". He stated that he drove up to the stadium in his car, answered a bunch of questions, sat down at his reservation number, got his shot on his arm and drove away. As treatment for these events, he stated, Tylenol, he had taken about 1000 units at least once a day or sometimes twice a day but it varies. If he does not take it, he feels really bad. He does not like to take drugs so, he was trying not to take it. He asked what he was supposed to do. It was also reported that on 11Mar2021 16:00, the patient experienced Fatigue, Headache, Chills, Fever. He had elevated blood sugars on 19Mar2021. On an unspecified date, he had a CBC done which showed anemia, elevated liver enzymes and low protein. He had not been able to function at a normal level. No treatment was given in response to these events. The outcome of the events was not recovered. The patient underwent COVID test post vaccination via nasal swab (PCR) on 02Mar2021 and was negative and on 19Mar2021 and was negative. The reporter assessed the events Feels awful and Feel terrible was related.
62 2021-04-30 feeling abnormal Something kicked in like drinking espresso; Everything, all senses seemed like they were amplified/B... Read more
Something kicked in like drinking espresso; Everything, all senses seemed like they were amplified/Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced.; Seemed like had more energy; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 62-year-old-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731) administered in left arm on 13Apr2021 09:15 at age of 62-year-old at single dose for COVID-19 immunization. Medical history was not reported. Prior vaccinations: the only one caller can really think of is when caller was 8 or 9 years old, received the DPT vaccine and had rash and fever of 102. Caller cannot provide NDC/lot/expiration. Caller states he has a Vaccination card for all the vaccines received in the last 15-20 years. The last vaccine caller received was the second dose for shingles in Jul2020. There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medications were not reported. Caller is a consumer reporting he received the first dose of the Pfizer Covid 19 Vaccine took first dose vaccine yesterday, 13Apr2021 at 0915. Reports this is crazy, he hears a lot of people talking about negative effects, caller had the weirdest side effects that are still going on. Caller states all the symptoms began about two hours after receiving the first dose Pfizer Covid 19 Vaccine. Caller received the first dose Pfizer Covid 19 Vaccine at 0915 and on 13Apr2021 at 1115 something kicked in, like drinking espresso. On 13Apr2021, everything, all senses seemed like they were amplified. Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced. Everything amplified, everything kicked into overdrive. It was like caller did not have to drink coffee today. Reports it was a good feeling, it was an awakening. It was just like the whole body seems like its amplified. On 13Apr2021, seemed like had more energy, everything, almost like drinking two doses of espresso coffee, enhanced all senses and everything. Caller states it was like the wildest thing ever experienced with a vaccine. Everybody else is talking about negative side effects and mine is like drinking high potency coffee, energy level spiked up. Caller did not know if the Pfizer Covid 19 Vaccine amped up his immune system or whatever. States he has never had any real problems before. The adverse events did not require a visit to Emergency room or Physician office. Non-serious. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
62 2021-04-30 sleep disorder a couple days later started getting a rash pretty much/ have rash pretty much all over my whole body... Read more
a couple days later started getting a rash pretty much/ have rash pretty much all over my whole body; hives; he was up until 1:30am for 3 hours on hold last night and didn't get through and fell asleep; The is a spontaneous report received from contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0150, NDC number: Unknown, UPC number: Unknown, Expiry Date: Unknown), via an unspecified route of administration at left arm on 31Mar2021 as a single dose for COVID-19 immunisation (everyone is saying he should take it). There was no patient history. There were no AE prior vaccinations. There were no prior vaccinations within 4 weeks. Concomitant medications included allopurinol, atorvastatin, gemfibrozil (patient states he takes these). The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Patient stated took the Pfizer-COVID-19 Vaccine on 31Mar2021, last Wednesday around noon, a couple days later Saturday morning he was breaking out with hives and rash. Started getting a rash pretty much all over his whole body. As of today, he has a rash, second dose is scheduled for 20Apr2021, Patient asked have other people reported the rash and gotten second dose. Patient states the rash is over his whole body now and he doesn't know if it is clearing up. States he is taking Benadryl, that he called his doctor and was told to take Benadryl and see what happens. Patient states he has some questions, he is wondering if he should take something else and he is scheduled for his 2nd shot and he needs help with what to do. Patient relays that it seems the rash may be drying up a little and is wondering is he should still get the 2nd shot. Patient relays that the rash started about 48 hours later on 02Apr2021 in the evening, Saturday, Sunday and a little worse yesterday and today he doesn't know if it is drying up but he still has it all over his body. States the card says 0.3mg and believes that is the dose. Patient asking if his healthcare provider is going to know any information as it's a brand-new drug, states he has 3 friends that are doctors and they have all said to call Pfizer. Patient was asking if other people have reported this. Patient states he was up until 1:30 am for 3 hours on hold last night and didn't get through and fell asleep. Report was not related to a study or programme. There was no investigation assessment. The outcome of event was unknown. No Follow-up attempts are needed. No further information is expected.
62 2021-05-04 sleep disorder, loss of personal independence in daily activities About 1 week after the 1st dose, beginning on 4/20/21, I started experiencing a significant increase... Read more
About 1 week after the 1st dose, beginning on 4/20/21, I started experiencing a significant increase in my tinnitus condition in my right ear. 2 wks later, it also started in my left ear. The ringing, buzzing and whistling sounds have become louder and very difficult to tolerate affecting my sleep and some other daily resting activities. I informed my doctor and was advise to do Audiology test and discuss with ENT specialist.
62 2021-05-07 insomnia, restlessness, abnormal dreams Hives left hand, left cheek bone and then profound fatigue, bad insomnia and restlessness, severe bo... Read more
Hives left hand, left cheek bone and then profound fatigue, bad insomnia and restlessness, severe bone pain in right foot and right arm; heart palpitations and fast heart rate with dizziness and nausea; headache; Day 8 started having muscle twitches and cranial/ear buzzing; Day 8 experienced severe malaise and nausea and lightheadness; Day 18 difficulty walking in straight line; muscle twitches with heart palpitations very bad in evening; localized headache at left temple area, stiff neck and shoulders; eye vision blurry with heavy floaters and eye socket pain; extremely vivid dreams
62 2021-05-10 feeling abnormal Body aches, brain fog, inflammation ..lasted for 22 days.
62 2021-05-13 insomnia, impaired work ability 7:45am April 13th, 2021 at hospital I was very excited to finally get the vaccine ...I was given th... Read more
7:45am April 13th, 2021 at hospital I was very excited to finally get the vaccine ...I was given the Pfizer shot in my upper left arm and felt small pain a the site of injection ...In 5 minutes I felt nauseated, very dizzy and weak to the point of falling off the chair ...they gave me two cups of orange juice and a few fig bars in the hopes that I was just having low blood sugar ...I was offered a hospital bed to lay down ...I experienced numbness in my left arm and in both hands ...also across the lower part of my face ...I was at the hospital for over an hour an was unable to return to work ... A few days later I began experiencing high pitch ringing in both ears that has gotten worse to the point of being so loud I can't hear a person talking to me on the phone ...noises around me are extremely painful to my inner ear ...this high pitch sound wont go away and keeps me up all night ...I have been to the hospital several times to see ENT doctors and I have tried many medications to help me sleep with this 24/7 tortuous ringing sound ...I can keep myself busy all day trying to ignore it yet at night it haunts me like a demon ...please contact me with any help you know of to reduce this sound in my ears ...I am extremely desperate for sleep ...
62 2021-05-13 insomnia Soreness on the around the shot site; Severe arm pain up where the rotator cuff is; Severe arm pain ... Read more
Soreness on the around the shot site; Severe arm pain up where the rotator cuff is; Severe arm pain up where the rotator cuff is; Has not slept due to pain; cannot sleep, the pain wakes him up; Could not use his arm; 50% deficit with the use of his left arm; After the vaccine, he could not lift his arm above his mid face level; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Nauseous; This is a spontaneous report from a contactable consumer (patient who is a retired paramedic). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration in left arm, on 30Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included bipolar depression from probably 10 years ago (2011) and ongoing, torn rotator cuff (15 to 20 years ago), and food poisoning in mid-Aug2020 (maybe it was more than that; may get tested to see if he ever had COVID-19). The patient's concomitant medication included vilazodone hydrochloride (VIIBRYD) from 2017 and ongoing (for at least four years) for bipolar depression. The patient has no known allergies. The patient was one of those people who doesn't get sick and he doesn't normally get the flu shot and everyone told him to get this Pfizer vaccine. The patient was not panicking but got the first dose of the Pfizer Vaccine on Tuesday (30Mar2021) around 01:00 PM and saw some things about having soreness on the around the shot site and all of that from that night (30Mar2021). This is going on for three days (from 30Mar2021) with severe arm pain up where the rotator cuff is; if you ever have pulled a rotator cuff it feels like that and he has not slept in almost 3 days due to pain from 30Mar2021. The pain is severe at times that it makes him nauseous (Mar2021). He figured the soreness was normal and later in the evening on 30Mar2021, the pain became an issue when he tried to go to bed that evening. Since the first two nights compared to last night, the soreness is actually improved; every time he tries to sleep with pain as a factor it is not easy. The patient can feel throbbing with his heartbeat and with the circulation there is throbbing pain. The pain was terrible and was throbbing like his heartbeat and similar to like a shoulder rotator cuff injury. For the first two days, on Tuesday (30Mar2021) and Wednesday (31Mar2021) after the vaccine, he could not use his arm or lift his arm above his mid face level. According to the patient, it was like a rotator cuff and he had a torn rotator cuff 15 to 20 years ago and this is the same arm that his torn rotator cuff occurred in; this is very painful and he is comparing it to the torn rotator cuff. In Mar2021, the patient had burning and tingling down the left arm and 3 days no sleep because the pain is worse at night. During the last week (Mar2021), his left leg down to his foot is also tingling and burning. The patient's primary care physician just retired, and he is in the process of finding a new one. The patient had no treatment or physician or emergency room (ER) visit for the reported events because being in the ER field, he can tell right now that it would be a waste of time of the effort to go into the ER as they would do nothing but tell him to take paracetamol (TYLENOL) and that is it. The patient did not like to take paracetamol and hates taking paracetamol. The patient clarified it is generic acetaminophen extra strength (Strength: 500 mg; Lot Number: P119682, Expiration Date: Mar2022, UPC Number: 5084417594) that he has taken (maybe every 6 hours oral) and it does relieve the pain so that is only so good. He does not know if in motion of the course of the day, something happened because at night laying still in bed is when he has pain. The patient did a lot of research before he made this call and the severity of the pain is enough to actually keep him awake for three days. He thought it was severe pain; maybe he should have told them to administer the vaccine in his right arm, but it was administered into his left arm. The only reason he made this call was because he wanted someone to know what he was having which could be just completely normal and he is sure every reaction is different and he expected the soreness because he remembers as a kid having shots. Also, this level of pain he is experiencing is what he wanted to report; imagine having himself going three days without a full night of sleep and he wanted to report this to make sure Pfizer knew this if they were keeping track of numbers of how many people have a similar pain level. The patient also asked if there were other people who called and reported these symptoms and if there is any information or treatment recommendations. As of 08Apr2021, even up to five days after getting the shot, now going on seven days that he has had some pretty severe reactions. The patient called in after 3 nights of getting no sleep. The patient was calling today to see if someone was ever going to call him back and asking will there be a follow up call from someone to see if he's still alive. The patient had some pretty severe reactions and they have actually gotten worse. There also have been new developments. The patient had pain in his arm that pulses along with his heart rate. It is so bad that it kept him up for 3 nights and still wakes him up at night. The pulsing pain in his arm started on the first night and has gradually gotten worse. The pain in the arm that is enough that it keeps him awake at night only starts getting severe when he goes to bed. He has tried sleeping in an upright position and he has tried everything, and nothing seems to alleviate it. The patient took generic acetaminophen which did not work during his last phone call. The patient also tried naproxen sodium (ALEVE) and that doesn't work wither. It was absolutely debilitating at times to where he has a 50% deficit with the use of his left arm (Mar2021). The patient initially reported burning and tingling sensation that was on his left arm and went to his hand and fingertips but now it has progressed to the whole left side of his body including his rib line, hip, leg, and foot. He is a retired paramedic and is pretty sure he is not having a long stroke. The patient feels it is too long to have symptoms from a shot he got. The patient has a lot of friends in the medical field and he's been told even going to a primary care physician, it is kind of gray area when it comes to dealing with COVID-19 vaccines. The patient was having second thoughts about getting the second shot. He had been told he can take NSAIDS over the counter for pain which has not helped him; there is no protocol for diagnosing or treating anything that happens from the shot. People in the medical field have told him there is thin line now to treat side effects because of liability; some doctors won't even get into it, just refer to Pfizer because medical insurance will not cover any services related to COVID-19 vaccine reactions. The patient continues to explain that is why the federal government is the only one that owns the shot due to liability. The patient's main concern is calling and reporting and maybe getting some help in deciding whether or not to get the second dose of the Pfizer COVID-19 vaccine. In his opinion, that is too long to have pain that he cannot sleep, the pain wakes him up. This all happened along with the shot, the same night and there are times where he can't work due to it. The patient asks if anyone is concerned with it and will someone feel bad because he doesn't get the second shot. His main concern is that people are underscoring or even lying about side effects, stating he can't believe he is an isolated case. The patient continued to ask if this is something he's stuck with, or if it is something he would have to deal with from now on from getting this shot. The patient regrets getting the first shot and stated that if he knew then what he would be going through now, he wouldn't have got it. The patient has no sort of history of being a hypochondriac and the feelings he is going through right now are sensations that he has never felt in his life. The patient continues to explain he doesn't even know how to categorize it other than mentally relating it to the shot since it all occurred in line with Mar2021 getting the shot. The patient further commented that if he ran a call with an ambulance right now with a patient telling him what i he was telling the company, he wouldn't even know what to do with them other than getting them comfortable and to a hospital. The patient had not recovered from "Soreness on the around the shot site", "Severe arm pain up where the rotator cuff is", and " Has not slept due to pain; cannot sleep, the pain wakes him up". The outcome of the other events was unknown.
62 2021-05-14 thinking abnormal, disturbance in attention it could potentially be his Parkinsons; he started to shake and now is still shaking; he can't conce... Read more
it could potentially be his Parkinsons; he started to shake and now is still shaking; he can't concentrate; he doesn't think right; cannot talk right; he has a hard time moving, he moves so slowly; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old (age at time of vaccination) male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on 14Apr2021, as a single dose for COVID-19 immunization at clinic. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history included ongoing Parkinson's from 2010. He did not know about family history of having Parkinson's. Concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient reported that after two vaccines on an unknown date in Apr2021, he started to shake and now was still shaking. He was wondering why he was shaking so hard. He said it could potentially be his Parkinson's and asked what he should do. Mailing and email address declined. Primary care doctor's address, telephone number, and email address declined. The patient stated the doctor was not in. Shaking was noticed after the second dose. It was improved, but he didn't like it. He could not concentrate, he didn't think right, and could not talk right. When asked to provide information from vaccine card, the patient stated he had a hard time moving, he moved so slowly and had card but could not find it. He also could not recall date of first vaccine, but both doses were given to right arm. Time the vaccination was given: 10:14:2020, was the time that second dose was received. Time was documented as provided, and confirmed, by caller. He had first one and was given another 3 weeks to come back. He was waiting for his doctor and stated he had Parkinson's, diagnosed in 2010. There was no product complaint to report. Outcome of the event he started to shake and now is still shaking was recovering and for all other events, it was unknown. Communication: Caller had a thick accent- details were as provided by caller with clarifying attempts. Information about lot/batch number has been requested.
62 2021-05-19 anxiety Patient states he felt some diffuse palpitation did not feel right and wanted to get himself checked... Read more
Patient states he felt some diffuse palpitation did not feel right and wanted to get himself checked. On arrival patient is somewhat anxious has some diffuse skin erythema over the chest wife is not sure if that is at baseline or if its new. Patient denies any shortness of breath states his chest felt funny earlier but has no symptoms at this time. Reported SOB earlier. Patient is having hiccups. Patient has no emesis has no respiratory difficulty denies shortness of breath saturations are 98% on room air with respiratory rate of 20. Patient has no abdominal pain no other rash to the abdomen torso extremities etc. Patient had first vaccination with no allergic reaction. Patient denies any history of allergies to medication. Patient is symptom free and is able to give good history no change in voice no neurological symptoms. Patient treated with diphenhydramine 25mg IV x1, Famotidine 20mg IV x1, Lorazepam 0.5mg IV x1, Methylprednisolone 125mg IV x1; Discharged to home with prescriptions/ OTC for Epinephrine 0.3mg/0.3ml IM, Famotidine 20mg po , Benadryl 25mg po
62 2021-05-24 feeling abnormal pervious visit had a "funny feeling" in his face and throat, currently has same "funny feeling" in t... Read more
pervious visit had a "funny feeling" in his face and throat, currently has same "funny feeling" in throat only
62 2021-06-02 loss of personal independence in daily activities, amnesia within 6 days my brother was sick, everyone said it's the side effects from the Covid vaccine becaus... Read more
within 6 days my brother was sick, everyone said it's the side effects from the Covid vaccine because it was the exact same side effects, chills-headaches, lethargic, just wanted to sleep he said that's all he needed. However that wasn't the case here 4 days later he has brain damage from Encephalitis and meningitis which is so Rare to have together, This all happen to his having the second shot, He was a very health person, body builder/MMA etc now he lays in bed or wonders the room not knowing whats going on this is just Wrong .We're told with his brain damage he won't heal from it. No Short Term Memory.
62 2021-06-03 crying, hallucination pt says the next day after taking the vax his arm was a little sore but when he stood up he had a ha... Read more
pt says the next day after taking the vax his arm was a little sore but when he stood up he had a hard time moving around, he was hyperventilating and he felt very exhausted. He got a severe pain in his left hip. He said the pain was so intense he could barely move so he took a low dose pain killer. He was in so much pain he curled up in a fetal position and rock back and forth. He says he was crying and in a hallucination state for about an hour. After that the he said the symptoms seemed to be getting better but was completely exhausted. His eyes were red and had trouble with his vision. On 6/4/2021 he still has some pain and has an ache inside the bone, gets winded w/ moving around but says his symptoms seemed to be improving.
62 2021-06-07 abnormal dreams Chills; tired; a dream of going over a glacier trying to slide over the other side; This is a sponta... Read more
Chills; tired; a dream of going over a glacier trying to slide over the other side; This is a spontaneous report from a contactable consumer(patient). A 62-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, in Arm Left on 06Mar2021 08:30 as 1 DOSE, SINGLE DOSE for covid-19 immunization. The medical history was reported as none. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 16:00 the patient experienced chills, tired (fatigue), a dream of going over a glacier trying to slide over the other side (abnormal dreams). The patient did not receive any treatment. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
62 2021-06-08 loss of personal independence in daily activities having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain an... Read more
having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; The pain is increasing it is really getting worse; I cannot eat from my hand at the back, I cannot lift anything; having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729 and Expiration Date: 31Jul2021) via intramuscular route in the arm left on 10Apr2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included diabetes and Blood pressure high. The concomitant medications included metformin hydrochloride 1000mg, sitagliptin phosphate monohydrate 50mg (Janumet XR) and Glimepiride 1mg tablet (taking half because diabetes was not that high) taken for diabetes mellitus the morning and in evening and taking for 7 years, lisinopril taken for High blood pressure taking for 3 years, tadalafil; the patient went in surgery in 2020 (start feeling the excursion) So that time the patient was taking medication so would say 3 months and having appointment to continue or discontinue. After that the only thing the patient was taking tadalafil. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: N6207 and Expiration Date: 31Jul2021) via an unspecified route of administration on 20Mar2021 for COVID-19 immunization and experienced no adverse event and in 2008, flu shot (lot number and expiration date was unknown) for immunization and experienced was sick, got sick and flu or fever or headache (After that did not take the shot again). On 10Apr2021 after the 3 weeks of first dose the patient received second dose of vaccine and waited for like 20 minutes before leaving the facility, the hospital, and like on third day (may be on 13Apr2021) the patient experienced having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain. The patient reported that, the pain was not that severe and did not have fever, headache and any other side effect at all. It was just the pain 3 days after, and then it did continue to increase and maybe like one week of joint pain because of that injection and it continue. The patient was feeling pain and then by May2021, the pain was like most and stated that I cannot eat from my hand at the back, I cannot lift anything, so that was new problem, the patient cannot lift anything and cannot turn hand at the back. The patient reported, it was not that very severe that I cannot eat and not that harsh, it was just in the joint and in the muscle. The patient reported, the first day and second day was not that much, the third day was when he started really experiencing and one week after he really feel it. The patient reported that, the pain was increasing. The patient was trying to see maybe within 1 week, within 2 week and within one month but now on 02Jun2021, it was really getting worse, and this was his experience. The patient started really feeling it and thought maybe after 2 weeks it will be going to be over, but it continued, so when it continued, he decided to go to the hospital and so they told me that. The patient took Tylenol and then kept taking Tylenol until for one month after it was lie if he was taking Tylenol it not really hurt maybe it was coming back, he cannot lift of his hand at back and cannot lift anything, the pain was not that kind of pain that it why I was taking. The patient reported that, the pain was continued. On 23Feb2021, the patient underwent laboratory tests, it was a general check-up for Diabetes to check it once and see the kidney, the blood pressure, everything the doctor was checking and then the physician said that that they wanted to check his system the blood work, they did find out that he had COVID 19 symptom on it. Physician told it was not positive. The physician told that, the patient has a strong immune system and if he tested positive, he would not feel anything, and physician told everything was excellent. The patient reported that, he took Tylenol 500mg, and that medication he always takes if he has too much pain. The patient reported that, he takes 2 tablets twice a day and sometimes 3 times in a day, sometimes 2 times in a day. The outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
62 2021-06-10 insomnia Severe vomiting during overnight period into next day (approximately 12 episodes in 12 hours), sever... Read more
Severe vomiting during overnight period into next day (approximately 12 episodes in 12 hours), severe cranial pain/headache, open sore in esophagus/lower throat that prevented eating solid foods for 10 days and liquids for at least the first week, even water. Painful area surrounding sternum (uncertain if it was from the vomiting action or possibly heart damage), which also prevented food or liquid to pass down the throat due to spasms, localized pain and possibility of inducing vomit reflex. High blood glucose (ketoacidosis). General overall weakness/lack of energy. Loss of mucous in nose, throat and stomach. Loss of saliva in mouth for first week. Insomnia. High blood pressure.
62 2021-06-10 mental impairment I have a high platelet level and inflammation from the vaccine caused blood flow problems resulting ... Read more
I have a high platelet level and inflammation from the vaccine caused blood flow problems resulting in trouble thinking clearly as well as walking.
62 2021-06-20 loss of personal independence in daily activities The AFIB occurred around May 5th and it was continuous almost the whole month of May. Shortness of b... Read more
The AFIB occurred around May 5th and it was continuous almost the whole month of May. Shortness of breath, tiredness and interference with my daily interactions. I would get tired about 30 minutes of anything. Whatever the medical term is for when you get tired easily, shortness of breath etc. Just basic AFIB symptoms. The Dr gave me Solital 2x per day and as soon as he did that, within two days the AFIB went away. He took away my blood pressure medication and gave me the Solital. But I still get tired easier than I did before.
62 2021-06-22 feeling abnormal Diabetes; His neck, his back on the left side, and his lung has been hurting; His neck, his back on ... Read more
Diabetes; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; He said it feels like a bug is eating inside or by his head; This is a spontaneous report from a contactable consumer (Patient's daughter). A 62-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732; Expiration Date: 30Jul2021), via an unspecified route of administration on 29Mar2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient previously took first dose bnt162b2 (BNT162B2, solution for injection, lot # EN6199 expiration date: 30Jun2021), via an unspecified route of administration single for covid-19 immunisation. It was reported that, the caller is the caregiver of the patient, her father. The caller was called to report an adverse event from the Covid-19 Vaccine. The patient received his second dose of the Pfizer covid-19 vaccine at the end of March. The patient's neck has been hurting, his back has been hurting on the left side and his lung has been hurting. It felt like a bug is eating inside or by the patient's head. The patient was diagnosed with diabetes a couple of weeks ago. The caller clarified and confirms that the patient was diagnosed with diabetes 1-2 weeks ago. The patient has had the pains for a while now, he got the second dose around 29Mar2021. The patient's neck that has been hurting is the same but getting worse. The patient's lung pain comes from time to time. The caller later clarifies and confirms that the patient is 62 years old, not 61 years old as previously reported. The outcome of the events was Not recovered. Follow-up attempts completed. No further information expected.
62 2021-07-01 insomnia Fatigue and swelling with joint inflammation in left extremities. Follow-up for polyarthralgia Bri... Read more
Fatigue and swelling with joint inflammation in left extremities. Follow-up for polyarthralgia Brief history: Probable reactive arthritis: One week after getting second COVID vaccine (Pfizer, 5/3/2021) he developed chills, sweats, SOB, cough and red/watery eyes. Initially given topical antibiotics for eyes in walk in clinic. Went back and on 5/17/2021 given Medrol dose pack which cleared up symptoms. From 5/10/2021 onward he developed left shoulder soreness and limited ROM. He has had persistent polyarthralgia with morning stiffness. Seen initially in June 2021 with noted joint effusions in left elbow and left knee. Evaluation around that time significant for positive ANA (1:160, speckled), RF (22, normal < 14), SSB, Scl-70 (weakly positive). Other ENA panel and CCP negative. X-ray of left shoulder (6/3/2021) showed only mild degenerative changes suggestive that the limited ROM in shoulder is related to frozen shoulder. Rheum Medications: Celebrex 200mg daily Doxycycline 100mg daily (started about 2 weeks) Interval history: Patient was last seen 6/3/2021. He reports that the swelling in the left calf has decreased. The left knee has been bothering him. The mornings are the worse time of day. He continues to have swelling in the left knee. He has been doing ROM exercises with the left shoulder. At night he is not sleeping because of pain. He has morning stiffness which lasts from 20-30 minutes. He has noticed some pain in the left thumb. No eye pain/redness. No rashes. As in HPI, otherwise 12 point ROS was reviewed and negative
62 2021-07-14 confusional state Occipital Stroke, with vertigo, vision disturbance and confusion
62 2021-07-25 insomnia Chronic severe Tinnitus. Non-stop ringing in the ears. Driving me crazy, Causing insomnia. This ri... Read more
Chronic severe Tinnitus. Non-stop ringing in the ears. Driving me crazy, Causing insomnia. This ringing in my ears is 24/7. Seems to be getting worse.
62 2021-07-27 depression, feeling abnormal, anxiety Since the vaccine: nerve issues including tingling and pain, heart palpitation/racing heart beat, bu... Read more
Since the vaccine: nerve issues including tingling and pain, heart palpitation/racing heart beat, burning in arms and shoulders, anxiety, depression, weakness, dizziness, itchy skin, sun sensitivity, heat sensitivity, brain fog, exhaustion/fatigue, tremors, tight chest
62 2021-07-27 insomnia Approximately 5 hours after the first jab I became very weak and exhausted. I laid down and got chil... Read more
Approximately 5 hours after the first jab I became very weak and exhausted. I laid down and got chills to the point I covered up with multiple blankets and started to tremble. Next at the time (unknown afterwards), I experienced the sensation like I was burning up and I began to sweat profusely. I literally felt like I was burning up. I suffer from osteoarthritis and the following day I experienced excruciating pain down my legs and in both hands. While this was occurring my hands became inflamed and I couldn't make a fist. The chills and pain continued over the next four days with the addition of a dull yet present headache in the centre of the forehead. Approximately two days later I experienced the continued swelling in both hands but now the pain lessened and was replaced with needles and pins type tingling in both hands and feet. this lasted about 4 more days. What remained permanent is a trigger finger in the left index finger that is very painful especially in the morning. Also I am have difficulty sleeping
62 2021-07-27 sensation of foreign body 62 year old male presented for 1st dose COVID vaccine with pfizer. 15-minutes post-vaccination the p... Read more
62 year old male presented for 1st dose COVID vaccine with pfizer. 15-minutes post-vaccination the patient complained of having a minor headache. At this time he expressed no other concerns or symptoms. The patient was moved to a shaded area and provided water. Upon further questioning in Spanish the patient reported that his HA was progressively worsening since onset and he had an associated "tightness" and sensation of a growing lump in his throat. Patient denied SOB, chest tightness, difficulty breathing, itching, hives, lightheadedness, N/V. At this time the decision was made to contact EMS. EMS arrived at 1804 and evaluated the patient. During evaluation the patient reported improvement of his HA and throat discomfort. EMS instructed patient to be evaluated at the local ER. However, the patient refused and signed to leave AMA. Patient left the site at 1825 and stated he would take the bus home. Education was provided and patient instructed to follow-up in ER if symptoms re-emerge.
63 2021-01-06 anxiety Dizziness cough (allergies, per Pt.) noted; appeared anxious Narrative: c/o dizziness. given juice.... Read more
Dizziness cough (allergies, per Pt.) noted; appeared anxious Narrative: c/o dizziness. given juice. HX. HTN. @0945 BP 170/81, P. 93, R 18, O2 96%; @ 0955 BP 143/76, P. 89, R 18, O2 97%; @ 1005, BP 175/82, P. 87, R. 18, O2sat 97%. Sent to ED for further evaluation. Given IV fluids for dehydration. resolved.
63 2021-01-14 feeling abnormal About seven hours after I received the second vaccine I had migraine headache foggy feeling in my he... Read more
About seven hours after I received the second vaccine I had migraine headache foggy feeling in my head a little bit of achiness, same thing the following day not as bad. Two days after the shot I am feeling fine
63 2021-01-19 sleep disorder, feeling drunk, feeling abnormal Pt awoke multiple times in the early morning sleeping period profusely sweating and needing to chan... Read more
Pt awoke multiple times in the early morning sleeping period profusely sweating and needing to change of clothes, sheets/blankets and undergarments at times 1:00AM, 3:00AM, 5:00AM, fever, headache. Symptoms have improved with Panadol medicine dose. Pt states since 1st dose feeling of drunkenness' and imbalanced has persisted.
63 2021-01-23 feeling abnormal Change in taste (not loss of) in food, coffee, and alcohol. Foggy sensation in head. Increase in m... Read more
Change in taste (not loss of) in food, coffee, and alcohol. Foggy sensation in head. Increase in metabolism leading to being warm all the time ( no sweating). Two weeks after second vaccine and while experiencing the above symptoms, I had sudden palpitations with a rapid ventricular response ( 186 beats per minute), severe light headedness, ambulance transport to hospital leading to admission for two days. This has never happened to me or any family members before. Discharged from hospital after 2 days in normal rhythm. Also at this time, taste has returned to normal and foggy feeling has improved.
63 2021-01-26 feeling abnormal The second dose of Covid Vaccine knocked me out completely : headache, fever ,chills and pain at th... Read more
The second dose of Covid Vaccine knocked me out completely : headache, fever ,chills and pain at the injection site . Duration of effects: 48 hours
63 2021-01-26 feeling abnormal Following morning patient was "Foggy" in the brain and unable to string words together in a sentence... Read more
Following morning patient was "Foggy" in the brain and unable to string words together in a sentence very well. He let me know he could not focus enough to read and retain anything. He wanted to talk but couldn't find the words. He remained very quiet but had no other symptoms of fever, pain, or anything else. 10 days post vaccine and he is doing better but still not feeling normal and not talking and holding conversations as usual. He is able to answer appropriately . The last two days he said all food is tasting bland without a lot of flavor. He has taken a couple Tylenol the last two days and drank Echinacea tea to try and make an improvement. Is there data or information to give us any idea how long this could last?
63 2021-02-09 impaired work ability This was my first COVID-19 vaccine. Second is scheduled for 2 March. Soreness developed at point o... Read more
This was my first COVID-19 vaccine. Second is scheduled for 2 March. Soreness developed at point of injection that evening, but not unusual. I felt pressure in head/neck area and had dry cough that evening. Took Advil PM before going to bed. About 2am that night I started having severe chills. I took temp at 5am and it was 101.7. Took Tylenol and temp went to 99.8 by 7 am. Temp went back up to 101.5 by noon. Had called my workplace medical and they want me to stay out for 3 days due to the reaction.
63 2021-02-09 impaired work ability Fever 101 F; rigors; chills; malaise; nausea; anorexia; arthralgias; myalgia; 36 hours duration Ibu... Read more
Fever 101 F; rigors; chills; malaise; nausea; anorexia; arthralgias; myalgia; 36 hours duration Ibuprofen; hydration; bed rest; Work absenteeism x 3 days
63 2021-02-11 impaired work ability Pain to injection arm, had to leave work
63 2021-02-14 impaired work ability Morning after Could not go to work And I have worked 30 years without one sick day. Low grade feve... Read more
Morning after Could not go to work And I have worked 30 years without one sick day. Low grade fever in am with shaking but not cold. Started around 6 AM by 9 AM couldn't stand very weak slightly lightheaded Threw up till almost choking. At noon my temp hit 103.7 Took tylenol all AM and wasn't lowering temp. That was the highest temp Then gradually began to come down At 5:00 PM temp at 100 and able to put soup down. Woke up 4 AM next day in total sweat that had to move to other side of bed Soaked but felt OK On 23rd Got headache above right eye to side of frontal lobe, Not any strong headache at all Dull Like a 2 out of 10. My concern is I still have the exact same headache as I did three weeks ago Not a smidgen lower at all SAME. And I booked second vaccine for Sat 2/27th I am concerned as I have heard second can be worse. I have never had the flu and this was my first ever vaccine of any kind Please advise
63 2021-02-14 insomnia Body aches, chills, muscle soreness, fatigue, GI upset for 48hours, no measurable fever but feeling... Read more
Body aches, chills, muscle soreness, fatigue, GI upset for 48hours, no measurable fever but feeling feverish, lack of appetite, severe back soreness which has escalated in the last 5 days to severe back pain, severe insomnia, fatigue is severe.
63 2021-02-23 insomnia Pain in left arm/ runs/ cotton mouth/ Very poor ability to sleep for everyday after/some light heade... Read more
Pain in left arm/ runs/ cotton mouth/ Very poor ability to sleep for everyday after/some light headed/ cough / chills/ shakes/ extremely warm/poor appetite
63 2021-02-25 confusional state Acute confusion, then combative. Acute Psychosis. treated with precedx. reaohulot 24hrs.
63 2021-03-14 feeling abnormal body ache; feeling worse; when I went to bed, got chills and shivers real bad; headache; Mild fever;... Read more
body ache; feeling worse; when I went to bed, got chills and shivers real bad; headache; Mild fever; mildly sore arm; Bad prostate and bladder infection; Bad prostate and bladder infection; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team and Pfizer-sponsored program COVAX US Support. A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/ lot number: EL9269, Expiration date: Unknown, NDC number: Unknown), via an unspecified route of administration in left shoulder area on 08Feb2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included ongoing asthma for about 60 years, ongoing high blood pressure for about 3 years and was on blood pressure medication, issues with thyroid for about 3 years and was on thyroid medication (ongoing). Concomitant medication included ongoing thyroid medication. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse events was none. Prior vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. The patient experienced bad prostate, bladder infection, sore arm on an unspecified date in Feb2021. On 11Feb2021, the patient experienced body aches, feeling worse, shivers, headache, mild fever. It was reported that, caller received his first dose of bnt162b2 on Monday 08Feb2021. He's reporting adverse events and would like to know: If he takes Tylenol to treat his symptoms, would it decrease the effectiveness of the vaccine or not. Also, if he were to go for a COVID-19 viral test, would the fact that he was received the vaccine interact with the test and cause a false positive result or not. Patient was reporting that yesterday, day 4, he started with body aches, headache, and "when he got in bed, he had chills and shivers real bad, little chilly" so possibly a mild fever. Enquired could these all be side effects of the vaccine or not. If he go for the COVID test - would it be positive or not. He also states he has a history of asthma and has been hypervigilant about avoiding COVID infections. Caller, reporting on the COVID vaccine and who explains that he got the first shot on Monday and he had a mildly sore arm- this lasted 2-3 days, no big deal. Then 5 days later he had really bad body aches and a headache. He went to bed cause he was feeling worse but before going to bed he noticed he had shivers really bad, uncontrollably almost which lasted over an hour. He presume they are fairly normal side effects but wants to confirm this could happen after five days. Also, he was told not to take Aspirin or Tylenol before getting the vaccine because it could affect the efficacy, but he wants to know could he take a Tylenol now 5 days later for the headache and body aches. He was better now than he was doing. Caller clarified the event was 4 days after the shot, the shot was Monday and events started Thursday. On Thursday evening, 11Feb2021, was when he had the bad body aches, headache, and shivers. At this point he still has the headache and body ache. He felt like, last night, he had a fever, but he didn't check it. At the same time, he had the chill and the shivers. Those feelings were resolved by this morning. Caller received COVID vaccine on 08Feb2021-Internal Infection-Bad prostate and bladder infection. Adverse events did not require visit to emergency room and physician office. No relevant tests. No investigation assessment. The events were considered as non-serious by the consumer. The outcome of the events mild fever, feeling worse, bad prostate, bladder infection was unknown, recovering for body aches, headache, recovered on 12Feb2021 for shivers, recovered on an unspecified date in Feb2021 for sore arm.
63 2021-03-18 loss of personal independence in daily activities difficulty speaking... hesitancy. Fuzzy thinking. Dizzy. Achy. Laying down and watching TV was about... Read more
difficulty speaking... hesitancy. Fuzzy thinking. Dizzy. Achy. Laying down and watching TV was about all I could do. constipated Started when I awoke and was mostly done by 5 PM The next day I spent quite a bit of time on toilet.
63 2021-03-23 impaired work ability Twenty-Four Hours after the vaccine I experienced severe headaches, muscle aches, and fatigue includ... Read more
Twenty-Four Hours after the vaccine I experienced severe headaches, muscle aches, and fatigue including fever 101-102, reducing to moderate levels after 6 hours but persisting for 7 days. Symptoms varied in severity over days but significantly impacted ability to work.
63 2021-03-23 insomnia could not sleep that evening, ran a temperature of 102 for most of the next day, chills, ongoing hea... Read more
could not sleep that evening, ran a temperature of 102 for most of the next day, chills, ongoing headache; fever broke about 8 p.m. next day
63 2021-03-27 anxiety About 10 minutes after receiving vaccine the patient developed tightness in his throat,anxiety,redne... Read more
About 10 minutes after receiving vaccine the patient developed tightness in his throat,anxiety,redness in face and hands and shortness of breath.The patient was given epinephrine 0.3 mg intramuscularly in his left lateral thigh at 11:10 am.The patient responded nicely to the epinephrine and vs at 11:20 were bp 138/68,pulse 102,pulse oximeter 95%.His treatment occurred at the vaccination site. He then was transferred to our local emergency room and was observed for 2 hours.His symptoms abated and he was discharged. He informed us that he had received a moderna vaccine on 01/28/2021 without complications.We learned this after his vaccination.
63 2021-03-29 feeling abnormal Extreme bout of peripheral neuropathy that lasted 4 days - still occurring Brain fog that lasted 3 ... Read more
Extreme bout of peripheral neuropathy that lasted 4 days - still occurring Brain fog that lasted 3 days
63 2021-03-30 sleep disorder Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient came t... Read more
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient came to our pharmacy to pick up prescriptions for Diclofenac 50 mg and Norco 5/325, and informed me that ever since he received his Covid vaccine, his right shoulder has been in pain to the point that he could no longer sleep at night. I have called Store 4742 and informed the pharmacist on duty about this report from the patient the same afternoon.
63 2021-03-31 feeling abnormal At 1023 patient was into post vaccine approximately 10 minutes when complaining of feeling light hea... Read more
At 1023 patient was into post vaccine approximately 10 minutes when complaining of feeling light headed. He did not eat prior to vaccine. Pt vital 136/118 Pulse 62, Pulse Ox 98%. Patient given juice and crackers. After 4 more minutes, patient stated he feels if he stood up, he would pass out. Emergency Response called for further eval. Patient refused further eval via ER. Left facility at 1036, still feeling "something wasn't right".
63 2021-04-01 feeling abnormal he just feels bad; white blood cell count is high; both him and his wife have body aches; flare up o... Read more
he just feels bad; white blood cell count is high; both him and his wife have body aches; flare up of an infection in his scrotum; I am crippled and I had not it before; I am sick; he has a rash on his scrotum; I am crippled and I had not it before; I am sick; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Not Reported), via an unspecified route of administration on Arm Right on 18Mar2021 at single dose for COVID-19 immunisation. Medical history included spinal injury, an infection in his scrotum, some neurogenic things, white blood cells (his white blood cells and scrotum started prior to him getting the vaccine). There were no concomitant medications. It was reported that, the consumer stated, "my wife and me went to hospital and we got a COVID vaccine first one, we had some, my wife had terrible side effects, I am crippled, and I had not it before in Mar2021, she is ok, but she is just sick, I am sick, but she is very sick and she got bad stuffs (rash)." Caller states that both him and his wife were having some side effects, although his wife was having the worse trouble. Caller states that last night, him and his wife were up all night. Caller was up because his wife was up so sick. Caller states that both him and his wife are sick and disabled, that is why they got the shot. Caller reports that he is retired and disabled because he got hurt at work. Caller states that what he is experiencing, is he just feels bad on 18Mar2021. Caller states that he did previously go to a doctor to do a blood study, the doctor is looking for blood diseases or cancer in the caller, and caller thinks that taking the COVID shot just exposed his weak spots. Caller reports that both him and his wife have body aches. Caller was wondering if there was anything, he can go get over the counter at the pharmacy to help. Caller reports that he cannot call his doctor, because they are all out on Fridays. Caller states that him and his wife are not planning to take the second dose of the product. Caller states that they have a lot of hurricanes where they live. Their house got tore up in one, and they sold it to one of their sons, and the caller and his wife moved out to their beach house for a while. He had an infection in his scrotum, something stung him, and that is what the doctors are looking for in him now, because his white blood cell count is high, and he has a rash on his scrotum in Mar2021. It was infected. Caller states that this infection in his scrotum has flared back up since getting the COVID vaccine yesterday, so caller had thought it went away but he guesses it never went away. Caller confirms that the issues with his white blood cells and scrotum started prior to him getting the vaccine, but the caller thinks that the vaccine was exposing the caller's weak spots, and maybe that is a god send because it is all flared up now, and the caller will be able to tell his doctor that. Caller states that he has been getting high white blood cell count readings since the stuff with his scrotum first started, and that is why his doctor sent him to an Oncologist for all this blood testing, so maybe this will be a b lessing in disguise for the caller, in finding out what is wrong with him. The outcome of the events was reported as unknown. Information about lot/batch number has been requested.
63 2021-04-02 feeling abnormal I just feel it is like had a weigh on my entire body/ I am feeling like I got run over; Chills; Feve... Read more
I just feel it is like had a weigh on my entire body/ I am feeling like I got run over; Chills; Fever; This is a spontaneous report from a contactable nurse (patient). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 29Jan2021 16:00 at single dose for COVID-19 immunisation. The patient had no medical history and no concomitant medications. On 30Jan2021, when he woke up in the morning, he felt like had a weigh on his entire body and got up and he just instantly started having chills, and fever usual (statement incomplete). He looked at all the symptoms of getting the vaccine and he had like 98 percent of them that was just normal, just like a flu. But he was travelling tomorrow morning at 5am and he don't want to travel right now. He still have a fever on and off. He doesn't know if it was safe enough to go on a plane after getting my first dose and how long the symptoms will last. The patient felt like he got run over. His wife got her second dose a couple of days ago and had really bad reactions like flu and could not move all day and that was a Moderna one. Patient stated that he was 6 ft; however, not appropriately paraphrased and clarified. The patient received unspecified treatment for the events. The patient considered a causality between the event because of the vaccine. Outcome of event fever was not recovered; outcome of the rest of events was unknown. Information about Lot/Batch number is requested.
63 2021-04-04 confusional state Headache, Chills, Aches, Confusion for about 24 hours
63 2021-04-04 feeling abnormal Rash covering the majority of my face when I woke up the next day. No hives and did not itch. Red pa... Read more
Rash covering the majority of my face when I woke up the next day. No hives and did not itch. Red patches and blotches. Not really bothersome. Got a little better every day until it was hard to see any a week later. Momentary dizziness, also the next day, like a three second flash, when rising from laying flat, laying flat from standing or sitting, or rolling over while laying down. Passes and I can sleep and not notice it unless I am awake enough, and cognizant enough, to notice it when I roll over. Once standing and moving about there is no problem except a feeling, I have seen described as brain fog, of being a little off mentally. Not sharp, but no dizziness. Can maintain normal activity that includes bending over, kneeling down, driving and riding in a car without any dizziness. Have tried eply maneuver, something I can do, but have not had any improvement. Brain fog seems to improve with normal daily movement and I have been trying to avoid my normal caffeine intake.
63 2021-04-06 confusional state Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which ha... Read more
Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which had gotten worse over the day 4/3/21. He had a rash all over his body.. After the respiratory treatments failed, pt was intubated and transferred to a higher level of care and expired on 4/4/21
63 2021-04-09 anxiety Irregular heartbeat, anxious, lasted 4 hours
63 2021-04-11 feeling abnormal Around 330 on 4/6, I started feeling bad and arrived home around 530pm and had a slight Temperature... Read more
Around 330 on 4/6, I started feeling bad and arrived home around 530pm and had a slight Temperature (99) with hearing loss in both ears. But the right one had complete hearing loss. Thinking it would be a short term side effect, but realizing on Thursday am with was not, I called my physician office on Thursday and they called back on Thursday for a Friday 9am appt with the PA. She said it was sinus related , fluid in the ears was pushing the ear drum back and gave me a prescription for Fluticasone and to take my Zyretx and Sudafed. Call her in a week if symptoms did not away. On 4/12/21, I still have massive hearing loss and pain, so called a ENT for an appt and received a 1:15pm on the same day. This was the first day I had balance issues.
63 2021-04-12 feeling abnormal Patient experienced feelings of being out of it.
63 2021-04-12 feeling abnormal Within about 12 hours after taking the vaccine a capillary in the white part of my eye bust and the ... Read more
Within about 12 hours after taking the vaccine a capillary in the white part of my eye bust and the left side of my left eye was/is bloody; It's been about 2 days and for the first day and a half I experienced the normal flu like symptoms.; dazed; when I leaned back to put eye drops in eye I lost my balance a little which does not normally happen; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534), via an unspecified route of administration, administered in left arm on 27Mar2021 14:30 at single dose for COVID-19 immunisation. The patient's medical history included asthma, prediabetic, low thyroid, overweight but not obese, and capillary in the white part of his eye bust (right eye) about 4 months ago. The patient's concomitant medications included alprazolam (XANAX), colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and levothyroxine sodium (SYNTHROID). The patient previously took cryproheptadine hydrochloride (CYPRO) and had known allergies. The patient also previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient had no COVID prior to vaccination and has not been tested for COVID post-vaccination. The vaccine facility type was Public Health Department. The patient has no other vaccine in four weeks. On 29Mar2021 at 14:00, it's been about 2 days and for the first day and a half, the patient experienced the normal flu like symptoms. Now after about two days (29Mar2021 at 14:00), he feel just a little out of it, dazed. Also when he leaned back to put eye drops in his eye, he lost his balance a little which does not normally happen. Also within about 12 hours after taking the vaccine, a capillary in the white part of his eye bust and the left side of his left eye was bloody. No treatment was received for the events. The outcome of the events were not recovered.
63 2021-04-12 incoherent When Patient presented for his 2nd dose of vaccine he stated about 2 hours after receiving the 1st i... Read more
When Patient presented for his 2nd dose of vaccine he stated about 2 hours after receiving the 1st injection he noted he had slurred speech, was incoherent and was not able to move. Symptoms lasted about 24 hr. and resolved completely in 24-48 hr. Patient denied any history of hypertension or heart disease. He did not report this to his PCP. 4/13/2021--2nd dose of Covid vaccine NOT given per recommendation of Chief Medical Officer--Patient and spouse instructed to contact PCP for additional evaluation and to reschedule appointment for 2nd dose.
63 2021-04-13 confusional state Constant Headache All over body aches Confusion Lethargic
63 2021-04-14 mental status changes R41.82 - Altered mental status I63.9 - CVA (cerebral vascular accident) (CMS/HCC) D70.9 - Neutropeni... Read more
R41.82 - Altered mental status I63.9 - CVA (cerebral vascular accident) (CMS/HCC) D70.9 - Neutropenia (CMS/HCC)
63 2021-04-15 disorientation Chills, headache, body ache, fever, coughing, disorientation, loss of appetite, dizziness, extreme f... Read more
Chills, headache, body ache, fever, coughing, disorientation, loss of appetite, dizziness, extreme fatigue
63 2021-04-16 impaired work ability tingling and jolting pain down left leg starting in lower back, pain level 10 out of 10, unable to w... Read more
tingling and jolting pain down left leg starting in lower back, pain level 10 out of 10, unable to work remainder of day and the following day, pain resolved later Tuesday, back to work Wednesday
63 2021-04-16 loss of personal independence in daily activities, insomnia Severe diarrhea, extreme abdominal gas and bloating, this caused a pause in radiation treatments, na... Read more
Severe diarrhea, extreme abdominal gas and bloating, this caused a pause in radiation treatments, nausea, chills, insomnia, cognitive impairment
63 2021-04-17 sleep disorder Mild soreness in art for about 1 day after first dose About 12 hrs. after receiving 2nd. dose, fatig... Read more
Mild soreness in art for about 1 day after first dose About 12 hrs. after receiving 2nd. dose, fatigue, exhaustion, but could not sleep. I felt cold and had chills with movement (but not severe chills). Adverse effects subsided after about 12 hours and another 24 hrs. required for complete recovery (36 hrs. all together).
63 2021-04-18 feeling abnormal full blown Respiratory infection; sore throat; feel poorly; This is a spontaneous report from a cont... Read more
full blown Respiratory infection; sore throat; feel poorly; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7934), via an unspecified route of administration, administered in Arm Right on 28Mar2021 10:15 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced full blown respiratory infection, sore throat and feel poorly on 31Mar2021 17:00. The patient did not received any treatment for the events.The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. Outcome of the events was not recovered.
63 2021-04-19 sleep disorder, disturbance in attention I've had mild tinnitus for several years. Shortly after getting the first Pfizer shot, the tinnitus ... Read more
I've had mild tinnitus for several years. Shortly after getting the first Pfizer shot, the tinnitus got much worse. The buzzing is much louder than ever before. It's now a constant buzz that impacts my sleep, concentration and just trying to relax.
63 2021-04-20 feeling abnormal high fever (over 102, 103.7, 102.7, 99 or 100); Blurred vision; shaking like crazy; has no energy; i... Read more
high fever (over 102, 103.7, 102.7, 99 or 100); Blurred vision; shaking like crazy; has no energy; it was double vision, like looking in a fun house mirror; he is still freezing; does not feel like himself; Had been feeling tired and rundown; Headache; horrible chills; night sweats; This is a spontaneous report from a contactable consumer (sister). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient medical history: no. Family medical history: no. The patient's concomitant medications were not reported. Vaccination facility type: hospital. Vaccine administered at military facility: no. The patient experienced high fever (over 102, 103.7, 102.7, 99 or 100) on 04Apr2021, blurred vision on 04Apr2021, headache on 2021, horrible chills on 2021, night sweats on 2021, shaking like crazy on Apr2021, has no energy on Apr2021, had been feeling tired and rundown on 2021, it was double vision, like looking in a fun house mirror on Apr2021, he was still freezing on Apr2021, did not feel like himself on Apr2021. On Saturday, her brother was out shopping with her and stated that he felt very tired and run down and had a headache. He started running a high fever but stuck it out at home. On 04Apr2021, he was taken to the emergency room and admitted to the hospital. They had been running test after test and can't seem to find anything wrong. The doctor thought that it was some kind of reaction to the vaccine. The patient was still running a high fever over 102 and was still experiencing fatigue and headaches on and off, and horrible chills and night sweats. The patient wanted to wait until the day after Easter to go to the hospital but started experiencing new symptoms. He was starting to experience blurred vision. Was then taken to the emergency room. The fever went down with Tylenol but continued to go up again when Tylenol wears off. Temperature was 103.7 at one point and has mostly been over 102, stating that this morning was 102.7. It had been one week that he was still having these symptoms. It was strange because the patient was feeling all right for the first 2 weeks. At the hospital, they kept giving him Tylenol to bring the fever down. He had been shaking like crazy. Had horrible chills and night sweats. He had no energy. He had not had the second dose. They cannot find anything else wrong. He was a health nut and run five miles a day. Took good care of himself. He seemed ok the first 2 weeks. Had been a week that he still can't break the fever. When looked up the symptoms, he had everything except for nausea. He also had blurred vision. They did a spinal tap, echocardiogram, EKG and blood work. He had seen 5 different doctors. The fever was highest at 103.7 and has consistently been over 102. With Tylenol, it had gone down to 99 or 100 but always shoots back up. 2 weeks after the shot, he took his temperature and wasn't feeling good all day. He stayed home from Wednesday until Sunday when he started experiencing new crazy vision symptoms. Stated that started Saturday. He was taken to the hospital on Easter and was admitted to the hospital, and was still there. The vision problem was new and it started to develop Saturday night. It was double vision, like looking in a fun house mirror. He still experienced the double and blurry vision now but only occasionally, when he tried to get up. It was on and off when he had to get up to go to the bathroom. He was still freezing and had shake and chills. He got night sweats and fever, chills, and did not feel like himself. The reporter didn't think he had high cholesterol or high blood pressure, diabetes, or anything like that. Tests: They did bloodwork, CT scans, MRI of the brain, echocardiogram, EKG, spinal tap. There were no white blood cells found in the spinal tap and that the echocardiogram was good. Everything came back normal. He had seen cardiologists, neurologists, gastroenterologists, primary care doctors, and no one can find anything. They did another kind of test regarding his vision. Her brother was depressed and wanted his energy back. It had been a whole week. The outcome of the events high fever (over 102, 103.7, 102.7, 99 or 100) and blurred vision was not recovered, outcome of the remaining events was unknown. The patient was hospitalized for high fever (over 102, 103.7, 102.7, 99 or 100) and blurred vision from 04Apr2021 to an unknown date. The reporter was not sure if this was happening because of the vaccine. Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
63 2021-04-20 loss of personal independence in daily activities severe chest pain and left shoulder down to hand and neck; severe chest pain and left shoulder down ... Read more
severe chest pain and left shoulder down to hand and neck; severe chest pain and left shoulder down to hand and neck; internal swelling; Feeling discomfort; unable to perform daily activities; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration, administered in arm right on 30Mar2021 13:00 (at the age of 63-years-old) as a single dose for covid-19 immunization. The vaccine was administered. The patient medical history included diabetic and blood pressure. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), administered in arm left on 09Mar2021 11:30 PM (at the age of 63-years-old) for covid-19 immunization and had left shoulder joint pain for about 10 days. 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. The patient's concomitant medications were not reported. It was reported that after the second dose, on the second day (reported on 02Apr2021 at 06:00 AM) had to go to emergency hospital due to severe chest pain and left shoulder down to hand and neck. Developed internal swelling 10 times more than normal. Feeling discomfort and unable to perform daily activities. The events resulted in Emergency room/department or urgent care, Hospitalization for 1 day. No treatment was received for the events. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
63 2021-04-24 delirium unconscious at times; perspiring profusely; bad cough; coughing until he throws up; He was very ill;... Read more
unconscious at times; perspiring profusely; bad cough; coughing until he throws up; He was very ill; high fever" of 104; really bad pain in his arm; delirious and out of it; This is a spontaneous report from a contactable nurse (patient's wife). A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included sick from Dec2019, down to the eye, diarrhea and fever. There were no concomitant medications. The patient experienced high fever" of 104, had really bad pain in his arm, was delirious and out of it and he was very ill on 08Apr2021. The reporter also stated that the patient also was unconscious at times, perspiring profusely, had bad cough, was coughing until he throws up on an unspecified date. The event pyrexia was assessed as life-threatening and pain in arm was assessed as disability by the reporter. The patient underwent lab tests and procedures which included fever: 104 on 08Apr2021. Therapeutic measures were taken as a result of pyrexia included Tylenol. Outcome of the events was unknown. Information on about lot/batch number has been requested.; Sender's Comments: The information currently provided is very limited, hence the reported events are conservatively assessed as related to the administration of the vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
63 2021-04-25 sleep disorder Chills, Fever, Chest Pains, Lungs Hurt to Breathe, Extreme Weakness, Joint Pains and Burning, Heart ... Read more
Chills, Fever, Chest Pains, Lungs Hurt to Breathe, Extreme Weakness, Joint Pains and Burning, Heart Racing, Headache, Neck Pain, Diarrhea, Slight Swollen Thyroid. Arm Soreness With my first shot, all I had was a sore arm for 4+ days. The second shot I has diarrhea the day before going to be only to wake up in the middle of the night with all of the above symptoms at 4:00 AM, By Noon that day, I was fatigued but able to go to work. A week later, I had chills again and lost my taste and smell which I had a majority back from having COVID-19 3 months earlier.
63 2021-04-29 feeling abnormal Started with moderate arm pain about 11 hours after injection. Progressed to fatigue, moderate musc... Read more
Started with moderate arm pain about 11 hours after injection. Progressed to fatigue, moderate muscle and joint pain and slight fever over the next 12 hours. Felt terrible for about 24 hours and slowly began to feel better within 48 hours.
63 2021-04-29 feeling abnormal Slurred speech, drooping left upper lip, feeling funny. One episode at @ 9:00 am, second episode @ 3... Read more
Slurred speech, drooping left upper lip, feeling funny. One episode at @ 9:00 am, second episode @ 3:00 pm on the same day. Treatments at ER: Plavix, IV fluids
63 2021-04-30 feeling abnormal got shot around 10 am . At 7pm i was in bed and had a peak temperature of 104.6 . Next day i had fev... Read more
got shot around 10 am . At 7pm i was in bed and had a peak temperature of 104.6 . Next day i had fever of 102+ even after 2000mg of Tylenol . Temperature still 101+ that evening . Next day still felt bad and had temperature over 100 . have normal temperatures today
63 2021-05-01 feeling abnormal Weakness in arm and popping in muscle.
63 2021-05-05 impaired work ability, feeling abnormal Less than 24 hours later experienced severe dizziness, almost passed out. took me 20 minutes to regr... Read more
Less than 24 hours later experienced severe dizziness, almost passed out. took me 20 minutes to regroup to be able to drive back to jobsite. The next day ,I was shakey ,but I got threw half of the day. On friday ,I drove from Cape Cod to Maine. I was doing fine ,but I had another spell
63 2021-05-08 loss of personal independence in daily activities, mental impairment First: April 25~27: Sore Arm, similar to a bruised muscle. Second: April 27 my right forehead just b... Read more
First: April 25~27: Sore Arm, similar to a bruised muscle. Second: April 27 my right forehead just below the hairline and in the right ear area where the top of the ear meets the head, had minor itching and were turning red. On April 28. Hives began on my left arm's lower wrist and in the general area of my right leg's knee. The hives became more numerous in these areas until a general red rash condition was appearing between them as well. By Saturday Morning May 1 the knee and wrist areas were noticeably red like a rash and hives were also appearing with itching below the right knee on the upper half of my shin, above this knee, on my right lower wrist and on my left lower fore arm. My right ear was starting to swell at just the top. I tried putting Gold Bond Medicated Powder on these areas, but it didn't reduce the itching much. Sunday May 2, I called my mom who is a Registered Nurse about this. She advised going to my health care provider to substantiate these symptoms. Monday May 3 I visited my health care provider's office after work and got an appointment for Tuesday at 10:15 from a cancellation. One of their RN's looked at my hives and rashes. New hives had now also formed on my left leg just below the knee on the back side. It was a red string of itching a couple inches long. I called my boss Tuesday so I could take the day off for the appointment and he agreed that I should do this. At the doctor's office, PA-C after extensive questioning and examination said he thought this was an allergic reaction possibly related to the polyethylene content of the vaccination. He further advised that I not get the second shot until I was checked by an allergist. He put in a referral for this. I think I picked up cold-like symptoms (sore throat and cough) from the doctor's office that were minor. Wednesday morning I had much worse symptoms. I was weak, groggy, couldn't think without great effort, was more itchy, and my right knee was starting to ooze. I called my boss at work to take the day off since I was quite sure driving would be risky, and that I would have to leave work early for lack of energy. My right front thigh had a new area of hives along with my right and left fore arms. I started treating all my affected areas with Caladryl topical Analgesic and taking generic Benedryl. I had breakfast and then slept until 2:30 PM, had lunch and slept until evening. By then my forehead and right ear areas had reduced in severity. I had lost (2) days of work. The rest of the week, all my symptoms diminished. As of this writing Sunday May 9, my knee is still tender, sore, and red, and left wrist hives are still pronounced.
63 2021-05-10 insomnia patient stated that he took the vaccine on 3/24/21 and a few days later is when he started to experi... Read more
patient stated that he took the vaccine on 3/24/21 and a few days later is when he started to experience ringing in the ears. He stated he thought he slept wrong on his neck and maybe the ringing was due to that. He doesn't c/o any other symptoms besides trouble sleeping and hearing (a high pitched sound). Patient stated he's tried tylenol and ibuprofen and its not helping.
63 2021-05-10 loss of personal independence in daily activities Received first vaccine on 3/17/2021 - had mild shoulder pain. Received 2nd dose on 4/6/2021. After s... Read more
Received first vaccine on 3/17/2021 - had mild shoulder pain. Received 2nd dose on 4/6/2021. After second dose I have had severe shoulder pain - both shoulder and mild hip pain on both sides. The shoulder pain is severe enough that I can't put on my own shirt, coat and trouble with putting on socks due to shoulders leaning forward. Shoulder pain is in the area where shoulder and upper arm connect. I saw a internal medicine physician on 5/7 and he is sending me to sports medicine physicians 5/14 - my pain is not due to an injury, it was mild after first vaccine but has been severe after 2nd vaccine. I am taking no medication besides Aleve before bed but in pain while sleeping and when I get up. Pain is constant when moving shoulder or hips. If I drive for more then 1 hour, my hips are in pain and I need to get out of car and walk around.
63 2021-05-11 insomnia You gave me shingles thanks alot for the warning. Severe muscle pain entire upper body. Rash from ou... Read more
You gave me shingles thanks alot for the warning. Severe muscle pain entire upper body. Rash from outbreak. Inability to sleep due to not being able to rest for 5 days. Hard to breathe. Worst 5 days ever for a totally healthy person.
63 2021-05-13 sleep disorder A blast of pain in the right side of my head woke me up out of a sound sleep, i think i heard a slig... Read more
A blast of pain in the right side of my head woke me up out of a sound sleep, i think i heard a slight pop right before and as soon as the intense pain came, it radiated outward and away from between my temple and right ear upward and was gone in a matter of 2 to 3 seconds. I have never felt anything like this, or scare me as much to make me think it might be life threatening as this. I couldnt sleep right after for 1.5 hours and I emailed my primary doctor immediately. In the morning, I spoke on the phone to 2 Nurses at my docs office before bs. hours who advised me to go to the emergency. rm for a CTA and did. I've never really had headaches that have amounted to much.
63 2021-05-14 insomnia Diagnosed with a blood clot; Diagnosed with stroke; not feeling well; wakes up at night; Numbness of... Read more
Diagnosed with a blood clot; Diagnosed with stroke; not feeling well; wakes up at night; Numbness of left hand and mouth; Numbness of left hand and mouth; Constipation; severe headache, described as he felt his eyes were exploding out of his head.; Temperature of 100.2; Could not sleep; This is a spontaneous report from a contactable consumer (spouse reporting on behalf of husband). A 63-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 09:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing rheumatoid arthritis started few years ago, ongoing back pain (for many years), ongoing pain (for many years) (patient is a farmer 'seeing another doctor' for back pain/pain, testis cancer from 1986 and ongoing. Concomitant medication(s) included adalimumab (HUMIRA) taken for rheumatoid arthritis from an unspecified start date ' a few years ago.' and ongoing; tramadol (TRAMADOL) taken for back pain from an unspecified start date ' for years' and ongoing. Vaccine was not Administered at Military Facility. No other vaccines were given within 4 weeks. No additional vaccines were administered on the same date of the Pfizer suspect product. The patient experienced diagnosed with a blood clot, diagnosed with stroke, numbness of left hand and mouth on 12Apr2021, severe headache, described as he felt his eyes were exploding out of his head, temperature of 100.2 (in the evening.) , could not sleep on 03Apr2021, constipation on 05Apr2021, not feeling well and wakes up at night on an unspecified date. The patient was hospitalized for stroke and blood clot from 12Apr2021 to 14Apr2021. The patient underwent lab tests and procedures which included body temperature increased: 100.2 on 03Apr2021; computerized tomogram: first cat scan, a blood clot was diagnosed on unspecified date., computerised tomogram head: unknown result on an unspecified date, electrocardiogram: unknown results (husband was not having a heart attack) on 12Apr2021 , laboratory test: unknown results an unknown date , sars-cov-2 test: negative on 12Apr2021, computerised tomogram: negative on an unspecified date. Treatment was given thrombosis, Stroke, Headache, Insomnia. On an unspecified date patient contacted his primary care doctor and was told to take some extra Motrin, twice a day but Motrin was not effective for his headache. The patient was not feeling well he went to his primary care doctor. Caller states her husband was at his doctor on 07Apr2021, and he went to radiology for a Cat Scan on an unspecified date and the results was negative. He had lab work drawn and a CT of the head. Her husband was given a medication to help him sleep, medication not specified. Caller mentioned she rescheduled her husband's second vaccine. On 12Apr2021, in the evening when he was getting out of the shower, he developed numbness in his left hand, and added later in the report, numbness of his mouth. Patient went to the emergency room, where they performed several tests, Multiple Cat Scans. Results of the first Cat Scan, a blood clot was diagnosed, and an EKG because they thought he may be having a heart attack but it was confirmed he was not having a heart attack.. When her husband was in the emergency room, they did a Covid test and it was negative. The patient was diagnosed with a blood clot and got Tissue plasminogen activator. At 7:33 pm, when he was given tissue plasminogen activator. After the treatment, the headache went away, but she is not sure if he has lasting effects. He was admitted to the Intensive Care Unit and was in the hospital for two days and diagnosed with a stroke, but he was able to walk out of the hospital. The patient still gets an ache in his head, and it comes and goes. Caller states it seems that these events were not coincidental, as they all happened after he got the vaccine. Since her husband has been home from the hospital, he is sleeping better but normally does not get a full night of sleep, and he usually wakes up at night and husband gets constipated when he takes Motrin. Caller mentioned that her husband is not fully constipated anymore, but he feels that his system is not back to normal. Caller assumed the stroke has cleared up, but is not sure. Caller rescheduled her husband's second vaccine, and she is not sure her husband should get the second vaccine. Caller states if these events were caused from the Covid vaccine, what will happen in the future? The clinical outcome of the events Clot blood, Stroke, malaise and wakes up at night was unknown; Numbness of left hand and mouth was recovered on 12Apr2021, Fever was recovered on 04Apr2021, while headache and Constipation was recovering. Follow up attempts are needed. Further information has been requested.
63 2021-05-20 confusional state He got his vaccine, immediately had dizziness. Within 30 minutes could not move real good due to th... Read more
He got his vaccine, immediately had dizziness. Within 30 minutes could not move real good due to the Parkinson's. He got more confused, more dizzy, and worsening of his Parkinson's. He was very thirsty and drank a lot of water (4 liters of bottled water). He was then urinating and sweating a lot as a way of his body trying to get rid of something in his body. He was urinating more than he normally does. He started getting harder for him to breath. He noticed he had a bad taste in his mouth similar to when he had the COVID virus. He got a horrible splitting headache/migraine type that kept coming and going. He still has the taste in his mouth, and it affected the taste of food. These were all symptoms similar to when he had COVID. The headache was worse than when he had the virus. No appetite still, but still continuing to drink the water and not urinating like you did the first day and a half. He is not having to drink as much as he did before and not feeling like he was dehydrating. Does have the soreness from the vaccine or any rashes. He did have chills and low grade fever of about 100-101, which have resolved. He also had a sore throat which he still has. He had a very bad case of the COVID virus 3/1/21, which lasted for a week or two. He still has some residual symptoms from the virus with balancing/dizziness or worsening of his Parkinson's disease. His neurologist told him that he would recover from the cognitive effects from the COVID with his Parkinson's, but his motor skills may not return.
63 2021-05-23 sleep disorder Soreness and pain, sometimes very sharp, in upper arm in area of injection since receiving first dos... Read more
Soreness and pain, sometimes very sharp, in upper arm in area of injection since receiving first dose. Arm was still sore when second injection was received on 5/5/2021. Upper arm area around injection area is still very sore. Sharp pains are a constant. Pain makes a sound sleep almost impossible at night. Pain disrupts sleep and must put my arm above my head to help lesson the pain. I will be making an appointment to my primary health care provider in near future.
63 2021-06-01 sleep disorder, disturbance in attention Continued soreness and sharp pain in upper left arm since first dose; Disrupts sleep and concentrati... Read more
Continued soreness and sharp pain in upper left arm since first dose; Disrupts sleep and concentration; Disrupts sleep and concentration; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in left arm on Apr2021 10:00 am as 1st dose, single dose for COVID-19 immunization. The patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration in left arm on May2021 09:00 am as 2nd dose, single dose for COVID-19 immunization.Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Penicillin. The patient's concomitant medications were not reported.Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not 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 did not receive any other medications within 2 weeks of vaccination. On Apr2021, the patient experienced continued soreness and sharp pain in upper left arm since first dose. Disrupts sleep and concentration. The events were assessed as non-serious. The treatment was not received for the events. The outcome of the events was reported as not recovered.
63 2021-06-03 feeling abnormal uncomfortable; my upper Right lip began to swell, slowly; This is a spontaneous report from a contac... Read more
uncomfortable; my upper Right lip began to swell, slowly; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received second dose BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6203), via an unspecified route of administration, administered in Left arm on 04Mar2021 16:45 as 2nd dose, single dose; and previously took 1st dose of BNT162B2 for COVID-19 immunization. No covid prior vaccination and no known allergies. The patient medical history and concomitant medications were not reported. No vaccines within 4weeks. On 04Mar2021 17:00, 18 minutes after vaccination, patient upper Right lip began to swell, slowly. 30 minutes later when home it was very noticeable and uncomfortable. patient reported it was only point of concern. 6 hours later after 2 Tylenols, the swelling has decreased, Somewhat. No covid tested post vaccination. Patient reported no treatment was received. Patient was not recovered from events. No follow-up attempts are possible. No further information is expected.
63 2021-06-09 feeling abnormal Within 2 hours of 1st Pfizer COVID injection pt had sudden onset left-sided paralysis with facial dr... Read more
Within 2 hours of 1st Pfizer COVID injection pt had sudden onset left-sided paralysis with facial droop and slurred speech and then brief loss of consciousness with loss of bowel and bladder function. This happened on 5/21/2021. His wife is here giving the history. Him and his wife have the first Covid injection by Pfizer on 5/21/2021 at 3:30 PM at pharmacy. Within 2 hours they were back home sitting on the porch relaxing and he had the sudden onset of stroke like symptoms as noted above. EMS was called. Apparently by the time EMS arrived he had recovered to baseline and they advised him he did not have to go to the hospital for evaluation if he did not want to apparently. Since that time he has had no further stroke like symptoms but has continued to feel a bit foggy in the head with a slight dizziness.
63 2021-06-09 sleep disorder Joint pain, unable to raise arm over head, then some improvement, now seeming worse- pain sleeping ... Read more
Joint pain, unable to raise arm over head, then some improvement, now seeming worse- pain sleeping on shoulder, pain using shoulder, limited range
63 2021-06-13 sleep disorder Intermittent chest pains starting 3 days after second injection lasting about 7 days. Pain was suf... Read more
Intermittent chest pains starting 3 days after second injection lasting about 7 days. Pain was sufficient to disrupt sleep and was more noticeable during period of rest / low heartrate. Also had intermittent severe fatigue over same 7 day period.
63 2021-06-15 sleep disorder, feeling abnormal Inflammation around sinus area, ears, eyes, and lower back of head. Dizziness and balance problems. ... Read more
Inflammation around sinus area, ears, eyes, and lower back of head. Dizziness and balance problems. Brain fog (impaired thinking). All symptoms continued to get worse for 2 weeks after initial dose. Took 1600 mg of ibuprofen daily to reduce symptoms with limited success. Stopped ibuprofen after 1 week due to upset stomach. Used natural anti-inflammatories (alpha lipoic acid 600 mg).Dizziness and balance problems improved and were mostly resolved by the end of week 4. Brain fog slowly improved and mostly resolved by the end of week 5. Inflammation in head still present around right ear even after week 7. Inflammation is the worst sleeping flat on back. Must sleep in reclined position.
63 2021-06-16 insomnia feels that his "heart rate is higher than normal; the minor symptoms a person gets with the flu; pai... Read more
feels that his "heart rate is higher than normal; the minor symptoms a person gets with the flu; pain in the arm; Typical Tiredness; nausea; difficulty sleeping and getting rested, he feels like he is trying to sleep; This is a spontaneous report from a contactable consumer. This 63-year-old male patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0180) via an unspecified route of administration on 01Jun2021 at 18:00 hours (at 63-years-old) on left arm as 2nd dose, single dose for COVID-19 immunization. Medical history of the patient included ongoing high blood pressure for over 20 years. The concomitant medications of the patient included losartan at a dose of 100 mg, 1x/day, amlodipine at a dose of 5 mg, 1x/day and hydrochlorothiazide at a dose of 12.5 mg, 1x/day, the patient had been taking these for at least 20 years for high blood pressure. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182) via an unspecified route of administration on 11May2021 (at 63-years-old) on left arm as 1st dose, single dose for COVID-19 immunization. The caller mentioned that he does not recall getting any vaccines as an adult, but his parents had him vaccinated as a child. It was mentioned that the patient did not require visit to emergency room and physician office and prior vaccinations within 4 weeks were reported as none. On 01-Jun-2021, the same day the patient experienced typical side effects of pain in the arm, tiredness, nausea. The patient also has difficulty sleeping as well as feels that his heart rate was higher than normal. Caller was asking if similar side effects have been reported. The patient states he is calling about his Second Shot of the Pfizer BioNTech Covid Vaccine. He had it a week ago and he is still having a side effect from it, it was on Tuesday a week ago from today. Caller states the main side effects are he feels like he has a rapid heart beat and he has difficulty sleeping and getting rested, he feels like he is trying to sleep at grand central station, his body won't rest. Caller asking if anyone else has reported symptoms similar to this. The treatment received was reported as none, the patient wanted to wait and see if they would go away. On 02Jun2021 the event of typical tiredness, nausea and the minor symptoms a person gets with the flu recovered. On 03Jun2021 the event of pain in the arm recovered. The event of difficulty sleeping and getting rested, he feels like he is trying to sleep and feels that his heart rate is higher than normal had not recovered.
63 2021-06-19 loss of personal independence in daily activities COMPLETE PAIN IN LEFT ARM AND NUMBESS TOTAL DISCOMFORT. CANT SLEEP AT NIGHT AFFECTING MY JOB . MIS... Read more
COMPLETE PAIN IN LEFT ARM AND NUMBESS TOTAL DISCOMFORT. CANT SLEEP AT NIGHT AFFECTING MY JOB . MISSING TIME FROM WORK. NECK PAIN LEFT SIDE. PAIN IN MY CHEST LEFT SIDE. PAIN IN LEFT SIDE ARMPIT.
63 2021-06-19 sleep disorder At 8PM the day after the shot I felt chills as if I had a fever. I went to bed and woke up at 2AM. T... Read more
At 8PM the day after the shot I felt chills as if I had a fever. I went to bed and woke up at 2AM. The fever was gone but I felt a swelling in my left armpit (the arm in which I had the shot). For several days I could not raise my left arm more than half-way. On the 5th day after the shot I could raise my arm straight overhead, but it was difficult and painful. By the 8th day the arm and armpit were back to normal.
63 2021-06-20 sleep disorder On the week of March 14, symptoms started mild and by the following week they were unbearable. On b... Read more
On the week of March 14, symptoms started mild and by the following week they were unbearable. On both legs, my muscles from my hips to my ankles became fatigued and got burning sensation when I was just standing up or sitting down. The pain was mostly relieved when laying down. I did not sleep well. Also, I got fevers only at night when asleep. Measured about 101 degrees temperature. Got up with tee shirt wet with sweat. On March 22, I went to my doctor and did some blood work and was told I had a lot of inflamation. Started on Prednisone. Went to RA doctor at Rheumatology on March 30, and went to an infectious disease doctor. I was told that I had an auto-immune response. I was on Prednisone from March 25 to May 16.
63 2021-06-23 loss of personal independence in daily activities Loud ringing in left ear feel left side of neck. Treatment: Nothing Cannot do daily function.
63 2021-06-24 feeling abnormal This is a spontaneous report from a contactable consumer or other non HCP (patient himself). A 63-ye... Read more
This is a spontaneous report from a contactable consumer or other non HCP (patient himself). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (at the age of 63-years-old) as 2nd dose, single for COVID-19 immunization. The patient's medical history included ongoing diabetes mellitus diagnosed decades ago and wasn't feeling good from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 10:00 AM as 1st dose, single for COVID-19 immunization and no reaction on exposure to vaccine. The patient had no history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated he went to the hospital because he wasn't feeling good in Dec2020 of last year and all the test results were fine, so he got his first vaccine, believes it was, 05Apr2021 for the first dose and 27Apr2021 for the second one. After that, the patient had extreme itching in his body and his liver enzymes are off and he just wanted to report what was going. The itching began after the first shot in Apr2021. He had to go to the hospital one time, and he had to go to the doctor 3 times, they say liver enzymes are off. He has a copy of the test. The patient stated prior to that, they were way higher when he went to the doctor. The patient's blood urea nitrogen (BUN) was 25 high, Aspartate aminotransferase (AST) was 100 high, Alanine aminotransferase (ALT) 176 high, alkaline phosphatase was 318 high, albumin was 3.2 low. He was also lost like 30 pounds. He has been experiencing extremely dizzy. Sometimes he stands up and he feels very dizzy and sometimes he feels strange, he has no other way to explain. He doesn't feel himself. He stated 8 days after the shot, he started feeling bad. It all started all together. The patient stated Pfizer can get that information from the doctor, he doesn't feel so good to keep up with that. The patient stated the extreme itching and extremely dizzy was worsened, that's why he had to go to the emergency room on 11Jun2021. Regarding the liver enzymes were off the patient stated, Pfizer can speak to the doctor. His doctor knows who he was and will give specifics. According to his doctor, the doctor was going to report it wherever it has to be reported to. He doesn't feel good, he was itching, and he doesn't know what to do about it. The event extreme itching and extremely dizzy required emergency room and physician office visit. The outcome of the events extreme itching and extremely dizzy was not recovered. The outcome of the events liver enzymes are off, lost like 30 pounds and he feels strange was unknown.
63 2021-06-29 amnesia, loss of personal independence in daily activities, disorientation Extreme Fatigue Disoriented Imbalanced Memory Loss Inability to perform daily tasks
63 2021-06-30 anxiety, suicidal thoughts the patient experienced left knee joint pain and creeking; I wanted to die rather than endure the pa... Read more
the patient experienced left knee joint pain and creeking; I wanted to die rather than endure the pain any longer; 6 hours of all joints pain and body aches; Worried I won't be able o walk or use my hands again; 6 hours of all joints pain and body aches/Left knee joint pain and creeking/Now right knee and all joints hurting all the time.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: En 6198 en 6207) via an unspecified route of administration, in left arm on 18Mar2021 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. On 27Mar2021 at 03:00, the patient experienced left knee joint pain and creeking. 6 hours of all joints pain and felt like he wanted to die rather than endure the pain any longer. He said that right knee and all joints was hurting all the time. Worried he won't be able to walk or use his hands again. Have read online of others the same. On 12May2021, the patient underwent lab tests and procedures which included negative sars-cov-2 test (nasal swab). The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Patient received steroids as treatment for the reported events. Outcome of all events was not recovered. Information on the lot/batch was available, Additional information has been requested.
63 2021-07-05 feeling abnormal Day after 2nd shot I had most all my covid symptoms (heavy fatigue, brain fog, bad constipation, sto... Read more
Day after 2nd shot I had most all my covid symptoms (heavy fatigue, brain fog, bad constipation, stomach pain. severe joint pain that moves all over my body. 5 plus nights get chills and bad head fever. My breathing progressed worse as time went on and was hospitalized 7/1/21 with covid pneumonia, they worked hard and got it controlled fast and was released late 7/2/21. Now I am working from home on oxygen and quarantined.
63 2021-07-07 anxiety Started with chills/fever spike, loss of touch/feeling in extremities (fingers, toes). These started... Read more
Started with chills/fever spike, loss of touch/feeling in extremities (fingers, toes). These started approx 12 hours after injection. Has now been 2 and a half months. Have issues with anxiety, muscle aches, weakness in legs. Experienced pulled tendon in left arm accompanied by extreme bruising down arm. Developed cancerous lesion on lower lip (squamous cell carcinoma).
63 2021-07-17 anxiety Prednisone taking and received vaccine; should not been vaccinated; vaccine completely ineffective a... Read more
Prednisone taking and received vaccine; should not been vaccinated; vaccine completely ineffective and Antibody Blood test came negative; Prednisone taking and received vaccine; should not been vaccinated; vaccine completely ineffective and Antibody Blood test came negative; Shocked and disturbed that vaccine will not work; incredibly dangerous circumstance; Vaccine no longer viable; This is a spontaneous report from a contactable other hcp. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 15Apr2021 as dose 2, single, dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included Diabetes type 2, obesity. Concomitant medication(s) included prednisone (PREDNISONE) taken for skin disorder, start and stop date were not reported. On an unspecified date the patient experienced prednisone taking and received vaccine; should not been vaccinated; vaccine completely ineffective and antibody blood test came negative, shocked and disturbed that vaccine will not work; incredibly dangerous circumstance; vaccine no longer viable. He was prescribed by a Dermatologist with # Steroid Prednisone and he is been taking it since March till present but in Apr2021 he receives his first dose of Pfizer Covid-19 vaccine and as directed later he received his second dose, but he became fully vaccinated against Covid-19 virus in the Month May2021. was taking prednisone each time when he received Pfizer Covid-19 vaccine shot which was administer to him at that point of time. There was absolutely never any warning that he should not been vaccinated while taking # prednisone. And mentioned that he heard a tragic story of a women who took immunosuppressant drug and who was also vaccinated for Covid-19 vaccine at that time when she was taking immunosuppressant drug. She subsequently learned that Covid-19 vaccine was completely ineffective because she was taking immunosuppressant drug at that time she was vaccinated where the story was in the news title about 3 weeks ago after that story the consumer learned prednisone just not steroid but also classified as a immunosuppressant drug. he had a discussion with two Medical Doctors in last couple of weeks the results of Covid-19 antibody test that he had yesterday showed that prednisone he had been taking rendered his Pfizer Covid-19 vaccine ineffective. He was on Prednisone 10 mg tablet white in colour bearing the twice a day and every other day that was prednisone dosage and He has been taking steroid that is the prednisone over a year at various dosage to manage Dermatological disorder as it is a result of ingredient in a Blood Pressure medication, and he had his second Pfizer Covid-19 Vaccine shot on 15Apr2021. The patient underwent lab tests and procedures which included antibody test was negative. The outcome of events was unknown. Description of Product Complaint: Reporter stated, "He was saying that it is not effective because of vaccine drug interaction the antibody test negative. There is also nothing else. Consumer stated that he had a discussion with two Medical Doctors in last couple of weeks the results of Covid-19 antibody test that he had yesterday showed that prednisone he had been taking rendered his Pfizer Covid-19 vaccine ineffective." Information about lot/batch number has been requested.
63 2021-07-17 confusional state it started to give me bad headache; Passed out; My head just Spun; I think I might have messed up my... Read more
it started to give me bad headache; Passed out; My head just Spun; I think I might have messed up my certain position of my neck and I had neck issues; It caused some massive confusion; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiry date not reported, age at the time of vaccination: 63-year-old), via an unspecified route of administration, in Arm Right (shoulder) on 06May2021 13:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number not reported), in Arm right (shoulder) on 15Apr2021(got about noon time, got it about may be earlier at about 10 am) for covid-19 immunization. The patient did have any vaccination since he was a child. On 06May2021, the patient had the shot in noon right above 1 pm and went home laid down and felt kind of like he did the first time only little better. Actually he felt pretty good and came and laid down for 24 hour period, and on 07May2021, he went to do some laundry at 3 pm, just one 'load of sheets' and then came home, and upon coming home in his apartment complex it's kind of, snakes as come in those left and right kind of and let permit from going fast, so, he come home and pulled in and when he pull in he got this nasty feeling like, but he was looking at the rare view and got 4 cars behind him, and they were really tight behind, but he can't move any faster and he was not going to speed up just because, and when he was looking at them, at the rare view and forward, and was doing those 3 things, he probably turned around to see and while doing his head just Spun and got the sick feeling and passed out and his head ended up in the passenger seat and bounced up and he think he might have messed up his certain position of neck and had neck issues, and blow the car and wreck his car and it's in shop right now. And also it caused some massive confusion and he wrecked his car and may have the surgery on neck again because of banging of neck on the seat, it was the bad accident but thank god he didn't hit anybody. That the only good thing about the whole thing, that nobody else got hurt but I got hurt. He also have to go to 2 emergency rooms. When patient was asked about the lot number and other questions, he asked to slow down as his head was hurting as he just can't keep up with the caller and it starting to bother him and started to give bad headache but because his brain was working over time. As a corrective therapy, the patient's doctor has not offered any kind of medication for that occurrence. The outcome of events was unknown. Information about lot/batch number is requested.
63 2021-07-18 loss of personal independence in daily activities Patient/patient's wife reported reaction as "inflammation" and lack of energy/stamina with things s... Read more
Patient/patient's wife reported reaction as "inflammation" and lack of energy/stamina with things such as climbing stairs, difficulty with normal activities that require exertion. Reports that normally he is active, fit and healthy, and that he has been having issues since the day after his second shot. Was treated by urgent care with prescriptions for azithromycin and prednisone filled 6/12/21, saying Dr. at urgent care was thinking possible pneumonia, but treatment did not help per Gregory's wife. This was reported to pharmacy today 7/19/21. Wife reports that he is still not improved.
63 2021-07-21 anxiety nausea, dizzy and anxious
63 2021-07-26 restlessness SECOND SHOT: He felt nauseated; His hiatal hernia had gotten worse since his car accident; Reported ... Read more
SECOND SHOT: He felt nauseated; His hiatal hernia had gotten worse since his car accident; Reported his neck was injured; my head just Spun; I get the sick feeling and passed out and my head ended up in the passenger seat and bounced up; might have messed up my certain position of my neck and I had neck issues; SECOND SHOT: he had gotten real dizzy; SECOND DOSE: He passed out behind the wheel of his 2015 Mitsbushi Eclipse the day after he had his second Pfizer COVID-19 Vaccine; SECOND SHOT: he felt antsy after he got the vaccine shot; FIRST DOSE: with his first Pfizer COVID-19 Vaccine shot, he was down for a week; FIRST SHOT: he felt antsy after he got the vaccine shot; SECOND SHOT: He felt really weak now; This is spontaneous report from a contactable consumer (patient). This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: EW0161 and expiry date 31Jul2021) via an unspecified route of administration on 15Ap2021 at 12:00 hours (at the age of 63-year-old) on right arm as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: EW0176 and expiry date 31Aug2021) via an unspecified route of administration on 06May2021 at 12:00 hours (at the age of 63-year-old) on right arm as dose 2, single for COVID-19 immunization. The patient's medical history included Stomach cancer, 14Feb2021 after being exposed to heavy metals. The patient's concomitant medications were not reported. Reported he had an adverse reaction to the Pfizer COVID-19 Vaccine. He said it had been one heck of a ride, and he felt like the Pfizer COVID-19 Vaccine almost killed him. He passed out behind the wheel (of his 2015 Mitsubishi Eclipse) the day after he had his second Pfizer COVID-19 Vaccine, and he knew it was the Pfizer COVID-19 Vaccine shot because he felt antsy after he got the vaccine shot. He said he felt antsy after his first Pfizer COVID-19 Vaccine shot, too and with his first Pfizer COVID-19 Vaccine shot, he was down for a week. Reported his doctor seemed to be the least concerned about him being knocked out. His doctor did not appear to be receptive to what his complaints were after he received his second Pfizer COVID-19 Vaccine shot. His insurance company was aware he was going to change doctors. The patient reported that he collapsed on 14Feb2021 after being exposed to heavy metals, and was hospitalized, stating his primary care doctor had not helped him at all. On an unknown day he felt nauseated. It was reported on 07May2021, the day after his 2nd Pfizer COVID-19 Vaccine injection, he felt antsy by the time he got home, threw his body in bed, and was down for a day. He felt nauseated, but (on 07May2021) did some sheets at the laundromat. While coming home he had gotten real dizzy, and passed out. He ended up flooring the gas pedal on his car, and bounding over the curb in his apartment complex's parking lot. He bounced his head on the front passenger side seat. He clarified he passed out over the center console of his car, and his rib cage went over the car's center console. His head bounced off of the passenger seat. He said his rib cage was pushed up inside him when it hit the car's center console, and had to do something to his insides. He said it was a one car accident, and his apartment manager may have the car accident on film. He was looking in three directions and my head just Spun, I get the sick feeling. Reported his car accident caused a tear in his hiatal hernia in his stomach and he needed surgery. Reported his neck was injured. He had follow ups with his doctor since then, and his neck had been getting worse. He felt like something foreign was stuck in his throat, so he went to the Emergency Room (on 22Jun2021). The patient needed to see an endoscopy doctor to be ruled out for stomach cancer. He was told by the Emergency Room doctor that he had a mass in his stomach, and his hiatal hernia needed repair. His hiatal hernia had gotten worse since his car accident. He stated that he went home and laid down after his car accident. He said he felt ok and had his own pain medication to take to help recover from the car accident. He clarified he took Hydromorphone that was prescribed by his pain doctor. He did not have the Hydromorphone , Lot, and Expiry Date. He had an appointment on 23Jul2021 to see doctor for a new Hydromorphone prescription. No further details provided. The patient reported he was concerned about the stomach thing. He recalled his stomach swelled up after his car accident. He tried to take oxygen through a CPAP machine after the car accident to help him feel better and using the CPAP machine was not normal. His CPAP machine worked perfectly before the accident, but now he had a problem, and could not take the CPAP machines pressurized breathing. He now fought to get a breath while the CPAP machine was pushing oxygen in because he was trying to push his breath out at the same time. He felt really weak now, and the CPAP had helped all along. I did passed out behind to wheel of my car and 'it doesn't stopped'(Further not clarified) and I didn't have any information to you because all the information I had is in back of my car. The first shot I was given 09Apr2021 no 15Apr2021 looks like, I think this was she said worked down 15Apr2021 (Further not clarified), second shot I received on May 6, but on 07May2021 at 5 pm I just passed out upon pulling into my Apartment complex and the snakes you known 'just slow you down'(Further not clarified) you know of course I didn't have any problems to slow down but there were 4 cars behind me, I am looking at the cars, I am looking at the rare view and I am looking ahead of me to make sure , you know I am following 'snake' and everything's being cool and I am been forced to go fast what I mean I was driving car but I was looking to those 3 different areas my head just Spun, I get the sick feeling and passed out and my head ended up in the passenger seat and bounced up and I think I might have messed up my certain position of my neck and I had neck issues, that happened on 07May2021, the day after the second Covid shot, I think if I had not gotten, if I stayed down may be the thing better but First time I got the first shot, it was 3 months the same thing I felt the same like I have to be really careful you know what I did, if I did it (Further not clarified, hence event not captured ). The second one I didn't feel that way. The patient required emergency room and physician office visit. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.
63 2021-07-27 memory impairment 11 days after 1st shot, I woke up not remembering anything or knowing were I was. An ambulance trans... Read more
11 days after 1st shot, I woke up not remembering anything or knowing were I was. An ambulance transported me to the hospital with stroke symptoms. At the hospital I was diagnosed with a mild stroke, TIA. My memory of the events never came back but my consciousness returned about 10-12 hours later. I was released from the hospital when stable to my Son's care, a medical doctor to watch me. I also had a fever for three days after the second shot which was 3 weeks after the first shot.
63 2021-07-27 sleep disorder After 2nd vax began having pains in upper arm, shoulder area. If pt sleeps on left side he has sever... Read more
After 2nd vax began having pains in upper arm, shoulder area. If pt sleeps on left side he has severe pain in area. This limits pt's mobility.
63 2021-07-28 feeling abnormal small stroke; TIA; blood clot; completely blind; went blind in his right eye; weakness in his left a... Read more
small stroke; TIA; blood clot; completely blind; went blind in his right eye; weakness in his left arm; headaches; Fatigue; was sleeping 12-14 hours; did not feel right/kept telling everyone how bad he felt; dragged left leg; not able to raise his legs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient (height:173 cm, weight: 74.84 kg) in perfect health received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8737) at 0.3 mL, single dose, in the left arm, on 07Apr2021, for COVID-19 immunisation. Relevant medical history included stent placement on an unspecified date (had just had stents put in before getting COVID-19 shots). The patient previously, on 16Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6268) at single dose, in the left arm, for COVID-19 immunisation. The patient did not experience any adverse reaction after the first dose. No problems with vaccines in the past. No further details provided. The patient received concomitant medications (unspecified). On an unspecified date, in 2021, the patient had small stroke/ transient ischaemic attack (TIA), blood clot, experienced blindness (he went blind in his right eye for about 30-40 minutes, completely blind), weakness in his left arm, headache, fatigue (became very fatigued), he was sleepy (was sleeping 12-14 hours), he was feeling bad (did not feel right/kept telling everyone how bad he felt), leg dragging (he dragged left leg) and he was not able to raise his legs. The patient went to emergency room and they said it was a small stroke or TIA. It was reported that it was a blood clot that went through his head and that was where the blindness came from. A lot of blood work were performed at the hospital (unspecified result). Clinical outcome of the adverse event blood clot was unknown, while clinical outcome of the other events was recovering at time of this report. Follow-up attempts are completed. No further information is expected.
64 2021-01-08 confusional state, disturbance in attention Confusion, numbness right cheek bone area, difficult to talk and concentrate for around 15-20 minute... Read more
Confusion, numbness right cheek bone area, difficult to talk and concentrate for around 15-20 minutes. Felt better and didn?t seek treatment till next day, never heard back from Dr.
64 2021-01-11 impaired work ability Headache, Myalgia, injection site pain Narrative: Side effects began the day after Injection: site ... Read more
Headache, Myalgia, injection site pain Narrative: Side effects began the day after Injection: site pain, significant myalgia and arthralgia, could not walk his dogs, rigors without fever, chills-has to take Acetaminophen every 6 hours, frontal headache. States fatigue is "disabling" Has had to take time off of work.
64 2021-01-15 motion sickness dizziness, motion sickness headache, lose of balance. sensitivity to dimly light places
64 2021-01-20 disorientation I felt slightly light headed; I felt a slight disorientation; a very heavy feeling in the center of ... Read more
I felt slightly light headed; I felt a slight disorientation; a very heavy feeling in the center of my chest; hip joint pain sever enough; This is a spontaneous report from a contactable consumer reported for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREH9899), via an unspecified route of administration at left arm on 29Dec2020 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included ongoing Chronic hip joint pain. Concomitant medication included celecoxib at 100mg once daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Dec2020 at 16:30, after patient left the observation tent, while walking to his car, He felt slightly lightheaded. Upon reaching his car he felt a slight disorientation and a very heavy feeling in the center of his chest. These symptoms lasted until he reached home which was about a 15 min drive. Once at home he experienced hip joint pain sever enough that he had to stop being mobile. All symptoms disappeared within 1-2 hours except for the heaviness in the center of his chest. This lasted for about another hour. After that no more issues. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
64 2021-01-20 insomnia Moderate left arm pain at injection site. Diffuse muscle and joint aches, migratory lasting 36 hours... Read more
Moderate left arm pain at injection site. Diffuse muscle and joint aches, migratory lasting 36 hours. Headaches,24 hours Increased nasal congestion 24 hours Moderate fatigue 36 hours Insomnia 2 nights Chills for 4 hours beginning 30 hours after injection Low grade fever beginning same time as chills and lasting for next 12 hours terminating with sweats
64 2021-01-25 insomnia tiredness; Chills; Fever; generalized aches; could hardly sleep through the night; This is a spontan... Read more
tiredness; Chills; Fever; generalized aches; could hardly sleep through the night; This is a spontaneous report from a contactable Physician (patient). A 64-year-old male patient reported received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176 and expiry date: Mar2021) via an unspecified route of administration on 10Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history bypass surgery (10.5 years ago, in June it will be 11 years ago) and hard of hearing. Patient said he used to be 5'7" but right now he is 5'6" or 5'5". He says that change in his height happened before he got the vaccine, that is effects of being short. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and simvastatin. It was reported that the patient had been healthy all his life, he doesn't have any medical conditions which could have contributed to side effects. He does not think they would have contributed but he takes Simvastatin and Baby Aspirin. The patient got the vaccination, the first one (BNT162B2 for COVID-19 immunization, on unspecified date) he did not have anything happen, no side effects or nothing. It was as if he didn't receive any vaccine. The second dose he received it at 8:45 AM on Sunday (10Jan2021) and Sunday night he began experiencing tiredness and then chills, fever, generalized aches and could hardly sleep through the night. It was reported as the worst night in his life and then, fortunately during the day on Monday, gradually, the intensity and severity of the symptoms began to subside but he was not able to do any of his normal functions. Then last night Monday night (11Jan2021) he slept well and today on Tuesday (12Jan2021) he was okay, this morning everything was fine. On Tuesday night he took Acetaminophen for pain, he clarified that was Sunday night after he had gotten the vaccine he took Acetaminophen and he still had the problems then Monday night he thought it would be the same so he put the medicine next to the bed on the night stand but he did not need to take it. He slept and woke up this morning and his back to work. Now it is like nothing has happened. He has recovered completely from all effects. The outcome of the event could hardly sleep through the night was recovered on 11Jan2021 and all the other events recovered on 12Jan2021.
64 2021-01-26 nervousness, anxiety feels tired; Exacerbation of anxiety; feels shaky; feels flushed; feels like his pressure his up; Ji... Read more
feels tired; Exacerbation of anxiety; feels shaky; feels flushed; feels like his pressure his up; Jitteriness; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 at single dose on Left arm for covid-19 immunisation. Medical history included ongoing anxiety (had for many years), Quadraple Bypass from 2008, TAVR valve replacement from 2020, Pegylation of lung from Mar2020. There were no concomitant medications. The consumer reported he took Covid 19-vaccine (Verbatim): for protection from Covid-19 because he has comorbidities, had a few ailments. The patient experienced feels shaky, feels flushed, feels like his pressure his up, jitteriness on 11Jan2021, feels tired and exacerbation of anxiety on 12Jan2021. The event outcome of feels tired was recovering, outcome of other events were not recovered. Information on the Lot/Batch number has been requested.
64 2021-02-03 feeling abnormal fever 101.3; bad headaches like migraines; back of neck was stiff and sore; back of neck was stiff a... Read more
fever 101.3; bad headaches like migraines; back of neck was stiff and sore; back of neck was stiff and sore; body ached and felt funny; body ached and felt funny; had no appetite and had to force himself to eat; felt woozy; watery mouth; his body was tingling; Chills; This is a spontaneous report from a contactable consumer (the patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1283), via an unspecified route of administration in the left arm on 15Jan2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included he had gotten sick way before talk of COVID. In late Dec and Jan he was sick and didn't feel better until Feb (unspecified dates prior to vaccination). He went to numerous doctors. He didn't have the flu. They weren't sure what he had. They gave him ibuprofen (MOTRIN) to take. He also had a really bad sinus infection. In Mar2020, he had really bad problems with his eye. His right eye could only move halfway towards his nose. It would not move to the right the all. Then his left eye was twisted. His mouth tasted sour. He does not taste food. This was all prior to receiving the vaccine. Concomitant medication included gabapentin from an unspecified date 6 years ago and ongoing for nerves. He also concomitantly took medication for blood pressure, diabetes, and cholesterol. He declined to provide details. The patient received the first dose of the vaccine on 15Jan2021 around 13:00. He had reactions to the vaccine. He felt the injection site that was given in his left arm. That evening, 15Jan2021, he felt woozy, his mouth was watery, his body was tingling, and he had chills. The next day was concerning. On Saturday, 16Jan2021, he had a fever of 101.3, bad headaches like migraines, watery mouth, the back of his neck was stiff and sore, and his body ached and felt funny. He had no appetite and had to force himself to eat as nothing tasted good (16Jan2021). He was scheduled to take the second dose. He was unsure if it was 21 or 22 days after the first one. He asked if he should get the second dose. The clinical outcome of felt woozy, chills, fever 101.3 was recovered on 17Jan2021. The clinical outcome of watery mouth was recovered with sequelae on 16Jan2021. The clinical outcome of his body was tingling was recovered on 16Jan2021. The clinical outcome of bad headaches like migraines, back of neck was stiff and sore, body ached and felt funny, had no appetite and had to force himself to eat was recovered on 18Jan2021.
64 2021-02-04 impaired work ability He states that he received the vaccine on 2/20 and three days later developed a red rash on his ches... Read more
He states that he received the vaccine on 2/20 and three days later developed a red rash on his chest and back that has not completely gone away. He states that on 1/25 he developed nausea and vomiting to the extent that he missed work both of those days - this has resolved.
64 2021-02-07 feeling abnormal 15 minutes after second dose of COVID 19 vaccine patient was brought to nurses due to lip swelling. ... Read more
15 minutes after second dose of COVID 19 vaccine patient was brought to nurses due to lip swelling. Patient took personal liquid benadryl prior to nurses. Unsure of dose patient states took "2 large swigs". VS taken. 911 called by patient refuses ambulance dispatch. Patient denies need to go to hospital states already took own benadryl and they will not do anything else. VS monitored q 5 minutes by nursing. House supervisor called and down to speak with patient. Patient denies difficulty breathing. Continues to deny need for ambulance to hospital for assessment. Patient alert and oriented and carrying on conversation without difficulty. No further increase in lower lip swelling noted by nursing. Nursing noted some flushing to face, patient states he does that from time to time but does not notice it but coworkers will tell him he has flushing. No increase in lip swelling but states now feels some nasal congestion. Patient continues to deny difficulty breathing. Patient does states still does not feel "quite right". Patient encouraged by multiple nurses to allow 911 transport. After 15 minutes of monitoring patient now agreeable to be assessed by ER and 911 called. Patient did notify spouse by phone that he was going to requested hospital- hospital Patient continued to be monitored by multiple nursing staff until ambulance arrival and transport to hospital.
64 2021-02-16 incoherent After vaccination, patient was okay until the 8 minute remaining mark. At this point patient became ... Read more
After vaccination, patient was okay until the 8 minute remaining mark. At this point patient became lethargic, clammy and passed out. Patient was revived with smelling salts, for a few seconds and the faded in and out of conciseness. Sternal rub was preformed in order to attempt to keep patient awake and present. Vital signs where taken, BP was elevated at 155/ 115. Patient was still not coherent at this point patient was team lifted to wheel chair and taken to the ER. Patient remains in the hospital at this time admitted for observation.
64 2021-02-28 confusional state Fever (to 103F), Encephalopathy (Confusion, somnolent) - improved with resolution of fever (with Tyl... Read more
Fever (to 103F), Encephalopathy (Confusion, somnolent) - improved with resolution of fever (with Tylenol)
64 2021-03-02 excessive sleepiness he has cold like symptoms; Stuffed up nose; doesn't feel really good; pain in the site area; slept a... Read more
he has cold like symptoms; Stuffed up nose; doesn't feel really good; pain in the site area; slept a lot and was tired; slept a lot and was tired; his stomach is nauseous and queasy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Jan2021 (also reported as "around 19Jan2021" or "19Jan2021 or 20Jan2021", pending clarification) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his first COVID dose around 19Jan2021 (also reported as "19Jan2021 or 20Jan2021") and now he has cold like symptoms. Stuffed up nose, doesn't feel really good and wanted to know if this part of the COVID vaccine. On the first day, he had pain in the site area, slept a lot and was tired. It has been 10 days since the shot and he had symptoms of a cold and his stomach was nauseous and queasy (also reported as squeezy). The reporter wanted to know if this was a part of the side effects or does she need to call his primary care. She was told about symptoms to watch for within the first seven days and this was well beyond the seven days. The outcome of the events was unknown. Information on the lot/batch number has been requested.
64 2021-03-02 excessive sleepiness The patient reports fatigue beginning the day of the vaccine, and persisting to the time of this rep... Read more
The patient reports fatigue beginning the day of the vaccine, and persisting to the time of this report. He had residual episodes of fatigue (1 per week) after his stroke 11/20, however after the vaccine he has been fatigued all day. His neurologist changed his Plavix to Brilinta on 2/11/2022 due to fatigue, without effect. During these episodes he sleeps excessively He does not report insomnia, dysarthria, focal weakness/numbness, dizziness or fainting, or new memory issues.
64 2021-03-11 anxiety I initially felt unease then I felt swelling in my throat with dry mouth and some difficulty swallow... Read more
I initially felt unease then I felt swelling in my throat with dry mouth and some difficulty swallowing
64 2021-03-14 feeling abnormal Pt reported "feeling funny" Pt was brought back to extended recovery room for closer monitoring. At ... Read more
Pt reported "feeling funny" Pt was brought back to extended recovery room for closer monitoring. At 9:15 vitals were; 134/70 HR87. Pt reported he did not eat breakfast and is "afraid of needles" at 0930 pt vitals were; 118*68 HR 80. Pt declined any further monitoring or treatment and was d/c at 0935 via ambulation accompanied.
64 2021-03-14 excessive sleepiness, feeling abnormal PATIENT FELT EXHAUSTED AND SLEPT FOR 2 DAYS. WAKING TO EAT AROUND 8:00 PM. FELT BAD IN HIS BODY, D... Read more
PATIENT FELT EXHAUSTED AND SLEPT FOR 2 DAYS. WAKING TO EAT AROUND 8:00 PM. FELT BAD IN HIS BODY, DESCRIBED AS LIKE A HANG OVER AFTER DRINKING. BUT HE DOES NOT DRINK. COULD NOT MOVE AROUND.
64 2021-03-14 irritability Patient was in recovery area per protocol. Patient developed light headedness, diaphoresis, irritabi... Read more
Patient was in recovery area per protocol. Patient developed light headedness, diaphoresis, irritability and then collapsed into chair and then floor (helped by nursing staff) patient appeared unconscious but was breathing, oxygen applied, emergency response initiated
64 2021-03-18 sleep disorder Extreme chills started at +/- 8:30 pm. Patient went to bed - fell asleep at about 8:45. Woke up pe... Read more
Extreme chills started at +/- 8:30 pm. Patient went to bed - fell asleep at about 8:45. Woke up periodically during the night drenched with sweat. Got up the following morning at about 8:00 am. Arm was sore but tolerable. Temperature was 98 F.
64 2021-03-22 anxiety Client verbalized feeling of anxiety after receiving the vaccine. Full assessment done by Paramedic... Read more
Client verbalized feeling of anxiety after receiving the vaccine. Full assessment done by Paramedics. Client was released for home at 4:33 pm. Per paramedics no further evaluation needed. Symptom resolved.
64 2021-03-22 loss of personal independence in daily activities Patient complains of dizziness and balance concerns. This lasted for at least 5 days following vacci... Read more
Patient complains of dizziness and balance concerns. This lasted for at least 5 days following vaccine administration. He has not been able to drive.
64 2021-03-24 depression, anxiety 63yoM with PMH Anxiety, Depression, GERD, Arthritis here for evaluation of rash x 2 days. Pruitic in... Read more
63yoM with PMH Anxiety, Depression, GERD, Arthritis here for evaluation of rash x 2 days. Pruitic in some spots. Started on L wrist yesterday. Awoke with red spots on face today. Got 2nd COVID19 vaccine (pfizer, with Norton) 48 hours ago. Called hotline and they advised coming for evaluation. Has applied no therapies. Took a single benadryl last night for pruritis. Denies chest pain, dyspnea, wheezing, dizziness. Did yard work 4 days ago and history of contact derm to plants, otherwise no prior history of rash like this.
64 2021-03-26 loss of personal independence in daily activities Next morning I had a static or whooshing noice in my left ear only. Sometimes it is worse than other... Read more
Next morning I had a static or whooshing noice in my left ear only. Sometimes it is worse than others.I thought it wasn?t cell phone problem and went to repair outlet. It wasn?t that . The sound / ringing in left ear is bad enough that I can?t have a conversation. My right ear is fine.
64 2021-03-31 anxiety Patient presented for Second dose vaccine and was vaccinated without incident. During 15 minute obs... Read more
Patient presented for Second dose vaccine and was vaccinated without incident. During 15 minute observation time patient complained of chills, body ache and stiff neck. BP at 12:45 was 180/100; HR 76. Patient states he is anxious, worries about side affects from vaccine. Denied SOB, no diaphoresis. Patient denied history of hypertension. BP at 12:50 200/100, HR 76, R 18; 12:55 pm BP 180/100 and EMS was called despite patient denying SOB or dizziness. 1:10 PM EMS arrived. BP 176/100, HR 80. Declined transport to hospital and left site at 1:15 ambulatory.
64 2021-03-31 feeling abnormal a few hours after getting vaccinated, I got a HUGE migraine headache, nausea and later a rash on my ... Read more
a few hours after getting vaccinated, I got a HUGE migraine headache, nausea and later a rash on my face. I couldn't lay down, had to keep my head elevated. It last almost two day. I felt brain fog for 4-5 days.
64 2021-04-01 insomnia Initial shot had no pain on day one. Sore Arm at injection site on day 2 & 3. Feeling chills (feel... Read more
Initial shot had no pain on day one. Sore Arm at injection site on day 2 & 3. Feeling chills (feeling cold) in 75 degree weather with blankets on. Night sweats and chills in bed. Insomnia has lasted 3 weeks (sleep about 4-4.5 hours and CANNOT go back to sleep). ZERO History of insomnia before vaccine.
64 2021-04-01 insomnia Kidney stone; Blood all over him; Falling down; Wobbliness; No energy; Could not sleep at all; Sweat... Read more
Kidney stone; Blood all over him; Falling down; Wobbliness; No energy; Could not sleep at all; Sweating like crazy; No appetite; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose (at the age of 64-years old) via an unspecified route of administration in the left arm (reported as injection in left shoulder) on 11Mar2021 at 13:00 (Batch/Lot number UNKNOWN) as a single dose for COVID-19 immunisation. Medical history included colitis ulcerative from 1982 and ongoing, ongoing seizure (he had seizures for about 6 years and they got worse, probably it has been 6 or 7 years he has had seizures), high blood pressure, heartburn and insomnia (comes and goes). Concomitant medication included atorvastatin (manufacturer unknown, Tablet) 40mg strength, oral administration, 20 mg daily (half a tablet at bedtime) taken for an unspecified indication from an unspecified start date and ongoing; cholecalciferol (manufacturer unknown, Tablets) oral administration, 2 tablets in morning taken for colitis ulcerative from an unspecified start date and ongoing; escitalopram (manufacturer unknown), oral administration, 20 mg once daily taken for seizure from an unspecified start date and ongoing; lacosamide (manufacturer unknown) oral administration, 200 mg twice daily taken for seizure from an unspecified start date (for approximately a couple of years) and ongoing; lisinopril (manufacturer unknown), oral administration, 20 mg daily taken for high blood pressure from an unspecified start date and ongoing; mesalazine (MESALAMINE, Tablet), oral administration, 4 tablets a day taken for colitis ulcerative from an unspecified start date and ongoing; omeprazole (manufacturer unknown) oral administration, 20 mg as needed (two or three pills daily as he feels like he needs) taken for heartburn and ulcerative colitis from 2001 (approximately 20 years ago) and ongoing and zonisamide (manufacturer unknown) oral administration, 100 mg twice a day taken for seizure from an unspecified start date (for a couple of years) and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received the vaccination on 11Mar2021. After he received his first dose of the vaccine he experienced a bunch of symptoms which he listed as sweating, he could not sleep at all the first night, he was falling down, he had no appetite, and had no energy that same day. This occurred after the 15 minute window of waiting after getting the vaccination. On 11Mar2021, after the vaccination, the patient went to the store to buy groceries and started sweating like crazy. He could hardly carry the groceries to the car. He also had wobbliness. On 11Mar2021, the patient fell down and passed out coming home that night and he had blood all over him. He later clarified that he did not pass out, he got into the house and fell down and somehow landed on the recliner. He was covered in blood and all kinds of stuff. On 11Mar2021, he could not sleep at all that first night and his prescription Melatonin (Manufacturer Rugby) 3mg did not help at all. The falling down occurred roughly that same night on 11Mar2021. The patient stated that they told him they thought he was having seizures again but he was not. He had imaging which showed no seizures and Xray of his brain with unknown results in Mar2021. He had to have another Xray to make sure he did not have bleeding on the brain. Xray of his stomach showed kidney stones on 12Mar2021. The patient was not admitted to the hospital. The patient was scheduled to return for the second dose 01Apr2021. The patient inquired if he should get the second dose of the vaccine. The outcome of events kidney stone, blood all over him, could not sleep at all and wobbliness was unknown. The outcome of events sweating and falling down was recovered on 11Mar2021 and no appetite was recovered in Mar2021. The outcome of no energy was recovering. The lot number for the vaccine was not provided and will be requested during follow up.
64 2021-04-02 feeling abnormal light headed, somewhat faint feeling. Continued intermittently for over 3 weeks. Intermittently get ... Read more
light headed, somewhat faint feeling. Continued intermittently for over 3 weeks. Intermittently get weird feeling/sensation, like a surge and get weak. Intermittent gurgling basically daily since vaccine. Feels sometimes like heart beats stronger or like maybe racing.
64 2021-04-06 impaired work ability unusual fatigue about 30 hours after shot. I stopped mowing and quit working for the day.
64 2021-04-06 insomnia SEVERE CHEST PAIN emanating from solar plexus area. Head/Neck/Body aches, chills/fever, nausea, loss... Read more
SEVERE CHEST PAIN emanating from solar plexus area. Head/Neck/Body aches, chills/fever, nausea, loss of appetite, difficult to breath, sleep and urinate. Dr. told me I have a virus (unknown). COVID-19 Rapid Test- None Detected. LAB RESULTS - 11 anomalies; P02 Venous-23 low, 02 Saturation-43% low, RBC-3.77 low, Hemoglobin-11.7 low, Hemocrit-39.5% low, MPV-7.3 low, Potassium-3.3 low, CK-293 high, Alkaline Phosphate-29 low, Amylase-108 high, Leukocyte Esterase- Trace. Script for 2 days med for nausea and released after 4hours. Symptoms lasted 8 days.
64 2021-04-06 sensation of foreign body Felt a ball to the throat. B/P 155/88, HR 87, O2Sat 98%, T 97. 12:42pm Patient left Park stating tha... Read more
Felt a ball to the throat. B/P 155/88, HR 87, O2Sat 98%, T 97. 12:42pm Patient left Park stating that he feels better.
64 2021-04-07 insomnia approximately 24 hours after the second vaccine, I noticed 3 swollen lymph nodes in left neck, same ... Read more
approximately 24 hours after the second vaccine, I noticed 3 swollen lymph nodes in left neck, same side as vaccine administered. at approximately 30 hours after the vaccine, pain became about a 4-5 on a scale of 10. not unbearable but too uncomfortable to sleep. by 4/4, approximately 6 days after the vaccine, one of the lymph nodes became large and very firm requiring a Dr. visit. My primary care physician immediately referred me who performed a needle biopsy on the reactive lymph node on 4/6. Test results show no cancer cells and determined it was most likely a benign reactive node. It is not known if this is a direct result of the vaccine.
64 2021-04-07 sleep disorder Lack of sleep, sweating while turning, headache in temple area
64 2021-04-08 amnesia, disorientation He started to be disoriented while I (daughter) was driving the car. He thought we were in Fort Laud... Read more
He started to be disoriented while I (daughter) was driving the car. He thought we were in Fort Lauderdale. When we got home he said he was disoriented and did not remember the month we were or the name of our dog. He was checking the phone saying he did never send the messages that were sent by him some minutes ago and did not remember the conversations he had in the morning. He never have had problems like this and we were very surprised. He rested a bit and the disorientation stop about an hour later. He is now feeling fine. My aunt, who is an MD said he should take a cardio aspirin and that's what he did. His blood pressure and temperature were always well. As a reference, he had COVID in March 2020 and was hospitalized due to it but recovered well. He then received the first covid dose in March 19, 2021 and had some fever, chills, and headache but was otherwise fine.
64 2021-04-09 anxiety feeling a little nauseous; bitter taste back of mouth; felt unwell; sore arm; racing heart; tachycar... Read more
feeling a little nauseous; bitter taste back of mouth; felt unwell; sore arm; racing heart; tachycardia; BP 220/110; anxious; a-FIB; crazy heart rate; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in the left arm on 05Mar2021 02:15 AM (lot number EN 6205 (also reported as or ENG205?) as a single dose for COVID-19 immunization. Medical history included high blood pressure 18 yrs, controlled and allergy to cats. Concomitant medication(s) included diltiazem; acetylsalicylic acid (ASPIRIN); magnesium; vitamin B complex (B COMPLEX); and ascorbic acid (C-VITAMIN) (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The shot went fine around 2:00 p.m. that afternoon. On 07Mar2021 12:15 PM, the patient experienced feeling a little nauseous, bitter taste back of mouth, felt unwell, sore arm, racing heart, tachycardia, BP 220/110, anxious, A-Fib, and crazy heart rate. The adverse events resulted in emergency room/department or urgent care (went to ER at 48 hrs after shot) and was hospitalized (admitted) for 2 more days from Mar2021 to Mar2021 (no. of days hospitalization was 2). About four or five hours later feeling a little nauseous, bitter taste back of mouth. Woke 12 hours later, very sore arm. Day 2 just felt unwell, Nausea, taste, day 3 still unwell, breathing, racing heart. BP 220/110, a-FIB, tachycardia, release day five. Day 7 felt normal. Day 9,10 crazy heart rate for a few hours. Day 18 2AM-6AM went into a-FIB. Very anxious now. Day 20 again wake up with Afib /Tachycardia for 2 hours. Scared to get the second shot. The patient heard that he could possibly get the Johnson & Johnson as his number 2. Treatment was received for the adverse events including unspecified medications and liquids. The outcome of the events was recovered with sequelae on Mar2021.
64 2021-04-11 insomnia Tinnitus with insomnia - flushed all ear wax, eliminated caffeine and alcohol consumption.
64 2021-04-12 fear There was a big amount of blood in the stool and the next day there was blood too; scared; This is a... Read more
There was a big amount of blood in the stool and the next day there was blood too; scared; This is a spontaneous report from a contactable consumer (patients son). A 64-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6266), via an unspecified route of administration in the left arm on 06Mar2021 at 08:30 as SINGLE DOSE for covid-19 immunisation. On 27Mar2021, at 08:30 the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration in the left arm as SINGLE DOSE for covid-19 immunisation. Medical history reported as None. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 09Mar2021, three days after getting the first shot of vaccine, there was a big amount of blood in the stool and the next day there was blood too, he was scared and never mentioned until 30Mar2021. The event resulted in a visit to Doctor or other healthcare professional office/clinic visit. The clinical outcome of events was unknown.
64 2021-04-13 anxiety Received first vaccine on 3/25/21 and had elevation in blood pressure, increased anxiety and had rep... Read more
Received first vaccine on 3/25/21 and had elevation in blood pressure, increased anxiety and had report made out. After 30 minutes, his blood pressure had decreased but stated that he gets almost like a panic attack. Shortly after receiving his 2nd Covid 19 shot, he started to feel very anxious but not at the same level as the first one. VSS at 1:32 pm 150/72 RA sitting; 97% pulse ox-90 HR. He stated that he was anxious just right after receiving the shot.
64 2021-04-22 loss of personal independence in daily activities Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Felt \"unwel... Read more
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Felt \"unwell\" for 4 days-Medium, Error: Incorrect Reconstitution, Additional Details: Patient states that his right arm feels weaker than normal and is impacting him at this job.
64 2021-04-23 sleep disorder Injection was given on top of shoulder instead of back of arm. Shoulder joint and arm started hur... Read more
Injection was given on top of shoulder instead of back of arm. Shoulder joint and arm started hurting 30 minutes after injection radiating down arm. Extreme exhaustion and sleepiness but unable to sleep due to pain. Nausea and stomach upset.
64 2021-04-24 feeling abnormal I have contracted COVID-19 3 weeks after getting 1st COVID Vacc; Covid-19 positive; mild allergy; lo... Read more
I have contracted COVID-19 3 weeks after getting 1st COVID Vacc; Covid-19 positive; mild allergy; lot of weird going on/ feeling odd; This is a spontaneous report from a contactable consumer (patient) via support team. Follow-up (08Apr2021) received from a contactable consumer was processed together with initial information. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 2 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient received 1 Pfizer dose on an unspecified date three weeks prior to second dose as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07Apr2021 after receiving second dose the patient contracted COVID-19. Further details are as follows: Patient was notified a few hours later that a niece he spent time with on 02Apr2021 just tested positive for COVID. Patient had been feeling odd and attributed it to allergies but after hearing news of his niece he scheduled a COVID test the next morning on 07Apr2021. He got the results that same night that he was also positive. On 06Apr2021, the patient has been feeling alright but have had feeling of allergies kind. The next day he was still feeling odd but not really, anything terrible just like mild allergy and lot of weird going on so he just assumes what it was. After testing positive the patient spoke to contact centre and he was informed that she had never heard of anybody doing that. Patient was having anecdotes individual here just one case, but it is kind of unusual. He doesn't mind testing for the variant he was having. Patient stated he is having symptoms to the onus. The symptoms of the onus he experienced, Monday 5Apr2021. Outcome of events was unknown. Information about lot/batch number has been requested.
64 2021-04-26 insomnia Strong chest pain that lasted several days. One day was so intense I had to sleep upright. I would... Read more
Strong chest pain that lasted several days. One day was so intense I had to sleep upright. I would get winded walking up a flight of stairs. Normally I run 3-4 miles for workouts. I had pericarditis in my 30s and it felt very similar.
64 2021-04-27 sleep disorder Woke from sleep 4/15/2021 with dizziness. 14 days later with no improvement. No worse, no better.
64 2021-04-29 feeling abnormal Started with a stiff neck turning to the right, then two days later woke up with a feeling of concus... Read more
Started with a stiff neck turning to the right, then two days later woke up with a feeling of concussion syndrome, vertigo, head nausea, brain fog and then buzzing in both ears, this has been on going since the first vaccine, it got worse after the second vaccine on February 21st . I have had a brain MRI, and Neck MRI both appear normal, I have been checked by ENT for ear issues none noted, being treated by neurologist now for all the head symptoms
64 2021-05-04 anxiety, insomnia Severe feminist in both ears 24/7 with dizziness. Dr. prescribed z pack and a week later thinking it... Read more
Severe feminist in both ears 24/7 with dizziness. Dr. prescribed z pack and a week later thinking it might be allergy related he gave me Flonase. I have had no relief and experience insomnia, anxiety, dizziness and tinnitus 24/7.
64 2021-05-04 confusional state, insomnia, disturbance in attention Racing thoughts, inability to concentrate, mood swings, confusion, severe insomnia, hyper activity, ... Read more
Racing thoughts, inability to concentrate, mood swings, confusion, severe insomnia, hyper activity, irritability, explosive anger, etc.
64 2021-05-07 feeling abnormal On 04/22/2021, a patient was determined to have pericarditis, possibly secondary to COVID-19 vaccina... Read more
On 04/22/2021, a patient was determined to have pericarditis, possibly secondary to COVID-19 vaccination. The patient received his first COVID-19 vaccination (Pfizer) on 2/27/2021. The patient reported feeling poorly and presented to ER on 03/02/2021 with chest pain and dyspnea. He states the chest pain he is experienced this week is similar to the 2 episodes of chest pain he had after each of the two-step Pfizer COVID vaccination that he received in February 02/27/2021 and March 03/15/2021. He underwent a stress test on 03/11/2021 which did not show any reversible perfusion defects. Of note, the patient had COVID-19 back in October 2020 which manifested with night sweats, malaise for a few days and then cleared completely without any "long hauler" symptoms. The patient was treated with ibuprofen and colchicine. I did not find any evidence suggesting a relationship between pericarditis and covid-19 vaccination. In clinical trials, pericarditis was not statistically significantly different between treatment arms. Other potential causes of pericarditis include atrial fibrillation.
64 2021-05-11 feeling abnormal SOB w/exertion, feels foggy in the head, nausea, bodyaches, joint pain, dry cough & severe intermitt... Read more
SOB w/exertion, feels foggy in the head, nausea, bodyaches, joint pain, dry cough & severe intermittent L side "ache" (feels like a pulled muscle) Pneumonia due to COVID-19 virus - carvediloL (COREG) 3.125 mg tablet; Take 1 tablet (3.125 mg total) by mouth 2 (two) times a day - HYDROcodone-acetaminophen (NORCO) 5-325 mg per tablet; Take 1 tablet by mouth 2 (two) times a day as needed for moderate pain or severe pain
64 2021-05-12 loss of personal independence in daily activities Severe pain to muscle and joint; Severe pain to muscle and joint; tingling from shoulder blade to wr... Read more
Severe pain to muscle and joint; Severe pain to muscle and joint; tingling from shoulder blade to wrist; unable to drive or work; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:00 at the age of 64 years old (Lot Number: Er8735) as 1st dose, single for covid-19 immunisation. Medical history was none. Known_allergies was no. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in the Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 00:15, the patient experienced Severe pain to muscle and joint, tingling from shoulder blade to wrist never went away x 4 weeks unable to extend arm unable to drive or work. The adverse events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received for the adverse events included Ongoing dr neurologist neurontin pain medicine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
64 2021-05-16 confusional state Severe confusion, dizziness, nausea, chronic diarrhea
64 2021-05-18 amnesia Shortly after taking the pfizer vaccine I suffered from blackout faint feelings off and on for more ... Read more
Shortly after taking the pfizer vaccine I suffered from blackout faint feelings off and on for more that 18 to 20 hours after taking this vaccine. server swelling of my entire body especially inside my head and heart pains. I also, suffered from episodes of memory loss even now. Problems with my balance when walking....never ever suffered from anything like this in my entire life. this vaccine is extremely dangerous and should not be given to everyone. nearly 19 hours later my face and feet numb.
64 2021-05-23 impaired work ability Severe debilitating headache, shaking chills, fever, aching joints, lethargy. Lost time from work.
64 2021-05-28 disturbance in attention having a heavy headache continuously...include when I sleep/continuous and severe headache; having p... Read more
having a heavy headache continuously...include when I sleep/continuous and severe headache; having problems concentrating on my job, read, work on the computer; Neck and back pain; Neck and back pain; Fever; This is a spontaneous report from a contactable other hcp (patient). A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW5318, Expiration date not reported), via an unspecified route of administration in arm left on 30Jan2021 18:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history allergies to medications, food and other products was reported as none. The patient had no known allergies. 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 medication(s) included fish oil (FISH OIL) and tocopherol (VITAMIN E [TOCOPHEROL]) both taken for an unspecified indication. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date not reported), via an unspecified route of administration in arm left on 09Jan2021 11:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Beginning (24/36hs), after the vaccination the patient experienced neck and back pain, neck and back pain and fever on 31Jan2021 22:30, (01Feb2021) Monday, Tuesday, Wednesday, Thursday I'm having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer on 01Feb2021. The patient received Tylenol for 24 hs as treatment for neck and back pain and fever and no treatment received for having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer. The seriousness of all the events was reported as non-serious. The outcome of all the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.
64 2021-06-01 feeling abnormal he was needing a little extra coffee because he was so tired during that 5 days; he was drinking lik... Read more
he was needing a little extra coffee because he was so tired during that 5 days; he was drinking like 3 cups of coffee daily; Suddenly he kind of went back to normal but felt very energetic; Felt tired for 5 days after the vaccine; Has had headaches; Stuffy nose; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in right arm on 20Jan2021 at 14:00(at the age of 64-year-old) as 1st dose, single dose for Covid-19 immunization. The patient's medical history included Prediabetes from unknown date and was ongoing. The patient had diabetes-went diet, lost 60lbs- pretty much reversed it. Now in Prediabetes. A1C was going down point every month from 11 something, to 6.7,6.3. Lost 15lbs by skipping breakfast, 5 weeks later down 35 lbs pretty much held off; gained 15lbs had rash put him on steroids, got very serious about fasting, not cheating down 65lbs at about 60lbs down now. Got a little stuffy sometimes with allergies from unknown date and ongoing, allergies in the air, pollens and stuff; he thinks there's some foods; He did not want to get all the needles for allergy tests to check again; he had one when he was young but does not remember the results, his mom does not remember results; allergic to all this regular stuff that was unknown. The patient's medical history does not include diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's family history was reported as none. Past medications included: Pneumococcal vaccine a few months back. Prior vaccination the patient was little leery of vaccines because he had gotten a little sick from flu vaccine in the past for a day or two. The patient's concomitant medications included tamsulosin (TAMSULOSIN) 0.4mg extended released capsule taken once daily for prostatectomy, finasteride (FINASTERIDE) 5mg tablet one by mouth daily taken for prostatectomy, cyclobenzaprine (CYCLOBENZAPRINE) 10mg-prescribed was for 1, twice daily as needed usually takes 1 night for leg cramps previously. Now taking 5mg sometimes 1-2 5mg, daily. The patient's doctor just upped to 10mg which was his previous dose. Vaccination facility type was reported as hospital clinic. No additional vaccines were administered along with Covid vaccine on the same day. The patient was neither visited emergency room/visited physician office nor hospitalized. On 21Jan2021 kind of early that daytime, he experienced onset of feeling tired which continued for about 5 days; On 27Jan2021, he then suddenly he kind of went back to normal but felt very energetic. He also had onset of headaches which are ongoing-not sure which date (in Jan2021) these started other than toward the end of the 5 days of feeling tired. He was not sure if the headaches are due to a stuffy nose, or because he was needing a little extra coffee because he was so tired during that 5 days; he was drinking like 3 cups of coffee daily. The reporter stated that, he was going to see his mom and dad who are 93 years old; he did not want to end up doing anything to them, so he got vaccination. The reporter wants to know the expected immunity level following the first dose. The reporter wanted to know if the side effects from the second dose are expected to be the same or worse as the first. The outcome of the event tired was recovered on 26Jan2021, the outcome of headaches, stuffy nose was not recovered and unknown for rest of the events. Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer (patient) via Pfizer Sponsored program. Added patient's demographics, medical history, concurrent conditions, concomitant medication details, suspect drug details, events details, and reporter comments. Follow-up (14May2021): Follow-up attempts completed. No further information expected.
64 2021-06-01 sleep disorder, loss of personal independence in daily activities He got his vaccine, he had the localized pain for a day or two. Then about the 3rd day he noticed t... Read more
He got his vaccine, he had the localized pain for a day or two. Then about the 3rd day he noticed the pain was still there and when he holds the phone for a long time talking he starts feeling the pain. Also when he's laying down on the left arm after a while it starts hurting and he has to turn over to get rid of the pain, and this happens all the time and when he's laying down every night he has the pain. He cannot hold his phone in his left hand for a long time due to the pain. The pain is localized around the injection site itself. He has a friend that is having the exact same symptoms as well. He has not taken anything for the pain/reaction or called his doctor. This has been going on for almost 2 months and wonders if he has a blockage in that arm. This pain wakes him up at night and he has to switch locations in order to get rid of the pain.
64 2021-06-05 confusional state, confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: No immediate reaction after vaccine administration. He was sweating profusely and momentarily lost consciousness/not responsive. He came around after a minute or two. He was shaking, so we got him down onto the floor & had him roll to his left side. We called the paramedics to check him out. He was responsive & was answering all questions. He said that he was tired. We questioned him about his medication schedule & he said he takes his blood pressure meds in the pm. He had not eaten.
64 2021-06-07 excessive sleepiness 01/27/2021 I woke up achy had a fever of 103.0, chills and I slept, this lasted 3 days, every time I... Read more
01/27/2021 I woke up achy had a fever of 103.0, chills and I slept, this lasted 3 days, every time I woke I still had a fever and chills, but it did subside.
64 2021-06-08 feeling abnormal, impaired work ability Had no decent sleep for the last few nights; His mouth wide open which then makes him dehydrated of ... Read more
Had no decent sleep for the last few nights; His mouth wide open which then makes him dehydrated of course; His mouth wide open which then makes him dehydrated of course; Moving so slow and had lower back and thigh tightness; shoulder aches like someone took a bat and hit it/ feels like he was 80 years old/ it looks like it is something with air in his bloodstream; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps/it hurts from his elbow down to his shoulder and it aches; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps/his shoulder area on the right side is a little bit in pain; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; he has some pain and there was pain in his triceps, he also has pain between those muscles, it hurts, and It was maybe where he had the COVID vaccine; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He rotates his head and looks around, neck pops frequently; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on 17May2021 (at the age of 64-year-old, Batch/Lot Number: EW0177) as a single dose for COVID-19 immunisation. Medical history included was walking pneumonia twice and other than that just a typical flu. The patient races dirt bikes so he was tough. Also, he had carpel tunnel from his job, and he had left over pain pills from that, and he had been taking them to help reduce the pain since he cannot really do anything about his side effects. Concomitant medication included pain pills, no other products reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: EW0162) as a single dose for COVID-19 immunisation and on an unspecified date in Apr2021, experienced muscle stiffness and soreness that was in left arm and around his buttocks and his thighs and reported felt soreness for a few days afterward. This report is not related to study or programme. It was reported that, honestly, he wishes he never got it because he cannot do anything. He was on the fence about getting it since we are at the end of the pandemic and the hospitals are not as overwhelmed anymore. Everyone thinks that he was still in his 50's, he was very healthy, and he has no medical or health issues and he works out all the time, which was why he was so concerned about why it was affecting him like this. He has had his second dose of the COVID vaccine, and he wanted to report what was going on with his body. It was reported that, then he got the 2nd dose and within a day or two he was sore, and he was at the 11th day of experiencing this. He was sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him. He had his 2nd dose not last Monday but the Monday before that. It did dissipate during the day. He jokingly said it was like the Pfizer vaccine retreats and hides during the day. Because of this he has had no decent sleep for the last few nights. His shoulder aches like someone took a bat and hit it. It feels like that on his left arm too but a little less pain. He was a side body sleeper, and he cannot sleep on his side because of this so then he ends up sleeping on his back with his mouth wide open which then makes him dehydrated of course. he has no energy, and the pain was like it was hitting a nerve where he barely can pick up 5 pounds. This was an extending issue and he just wanted to report and see if anyone else has had this before. The hospital said that they have not had anyone else report this before. It was slowly dissipating but he did not understand why it reinforces itself in the evening. Yesterday, he had to go service a customer and he was moving so slow and had lower back and thigh tightness. His upper body was sore and tight so when he got home, he was walking around trying to get his blood flowing and stretching some but then in the middle of the night those reserves came out and he gets attacked. The stiffness, soreness and pain were all concentrated mostly on his upper body. Also, his neck pops and he has never had that happen before. He looked it up and it looks like it was something with air in his bloodstream or something and when he rotates his head and looks around it makes a pop sound, and it has been doing it ever since his 2nd shot. He says this started probably on 18May2021 right after the vaccine. The patient clarified that for the side effects after his second dose that began soon after the COVID vaccine and he states that it was like all hell broke loose. This has gotten a little bit better but not a lot. Maybe 10% better or maybe 15% better. As he was sitting there his shoulder area on the right side was a little bit in pain. He feels like he was 80 years old, he was walking slow, and his body was stiff. No further details provided on the pain pills. He says he was flexing his bicep and he has some pain and there was pain in his triceps. He also has pain between those muscles, it hurts. It was maybe where he had the COVID vaccine. He also has this same pain on the left side except his bicep doesn't hurt but his tricep does and it hurts from his elbow down to his shoulder and it aches. On a scale of 1-10 his pain was at a 3-4 but at night it was worse. The patient and health care professional consent to be contacted was reported as yes. Investigation assessment was reported as no. The outcome of the events Sleep deficit, oral disorder, dehydration, hypokinesia, feeling abnormal was unknown and for all other events recovering. Information on Lot/Batch number was available. Additional information has been requested.
64 2021-06-16 insomnia, feeling abnormal Feeling sick; He felt pressure in his hands; He also reports that he gets nauseated after eating any... Read more
Feeling sick; He felt pressure in his hands; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; Lethargic; cant sleep night; sense of feeling of a warm oil running through his veins; He still feels terrible; This is a spontaneous report received from a contactable consumer (patient) (this is 1 of 3). A 64-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0177) intramuscularly in left deltoid on 14May2021 at 11:40 (at the of 64-years-old) as unknown, single dose for COVID-19 immunization. Medical history of the patient included COVID-19 in the first week of Sep2020. High blood pressure (after covid-19 it has been high as 200/130 and 180/120). Concomitant medication included Lisinopril (MANUFACTURER UNKNOWN), via an unspecified route of administration, from an unspecified date in Feb2021 and ongoing at unknown dose and frequency for blood pressure high. Patient had no prior Vaccinations (within 4 weeks) of COVID vaccine and had no AE(s) following prior vaccinations. On 14May2021, within an hour after vaccination, the events started, patient was not feeling well. He stayed at the pharmacy for a while to make sure there wasn't an immediate reaction. Once he got home, he wished he hadn't taken the shot. He felt pressure in his hands; he already felt comprised. Events were still ongoing but are at different times of the day, they were happening off and on throughout the day. Patient also gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time. After three weeks of vaccination patient was still feeling sick, lethargic, could not sleep at night, and has a sense of feeling of a warm oil running through his veins. Patient went to his medical doctor (physician office visit due to events) and he was basically sent on the way. Patient also went back to the Walmart where he got the shot and they told him there was nothing that could be done, it would just have to work through his body. Patient still feels terrible. Patient reported that it wouldn't be so bad or he wouldn't be so concerned if it wasn't already 3 weeks since having the shot. He was worried and so was his wife. The clinical outcome of the feeling sick, he felt pressure in his hands, he also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time, lethargic, cant sleep night, sense of feeling of a warm oil running through his veins, he still feels terrible were not recovered. Information on Lot/Batch number was available. Additional information has been requested.
64 2021-06-20 disorientation Immediately within two minutes, strange disoriented feeling, heavy sweating and weakness. Sitting d... Read more
Immediately within two minutes, strange disoriented feeling, heavy sweating and weakness. Sitting down I lost vision in my right eye (just dark grey with a tiny blurry spot of light in the center). Left eye could not focus. After about twenty minutes, both eyes became very sensitive to light (like a pupil dilation test in an eye exam). This lasted about additional 10 minutes. I remained pretty weak for the next hour but was then ok. The next day I felt 100%.
64 2021-06-21 sleep disorder I had painful breathing in the upper right quad of my abdomen. The deeper I took a breath, the more ... Read more
I had painful breathing in the upper right quad of my abdomen. The deeper I took a breath, the more it hurt. The onset was on that Thursday. I am a right side sleeper and I couldn't sleep on that right side. I went back to the surgeon who removed my gallbladder. No treatment was given because no cause of the pain could be found. I started feeling less pain while breathing while I was in the waiting room. Over the next 3 days, the pain got gradually less to a point where it was not hurting at all.
64 2021-06-25 suicidal thoughts getting suicidal thoughts; lymph nodes have large balls like an egg on his neck; really incapacitate... Read more
getting suicidal thoughts; lymph nodes have large balls like an egg on his neck; really incapacitated/ He can't move; joints are swollen; freezing and is hot and cold all night; voice didn't sound like normally./ sounds like he smokes four packs a day; This is a spontaneous report received from a contactable consumer. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in arm single dose for COVID-19 immunization on unknown date at 64-year-old. The patient medical history included paranoia. He was an easily over sensitive dude. The patient's concomitant medications were not reported. The patient was really incapacitated. His joints were swollen. He couldn't move. He was freezing and was hot and cold all night. Tuesday it was hot and he was outside on the deck in a hoodie and was freezing. His voice didn't sound like he normally did. It sounded like he smoked four packs a day. His lymph nodes had large balls like an egg on his neck. He won't go to the doctor or emergency room and he was scared. The patient wanted to commit suicide, just said that four days ago. It was not an emergency at this time. The patient was getting suicidal thoughts, but that was part of his paranoia anyway. He felt like he was being used as a test victim. His mind went nuts because he was paranoid, it was before he received the vaccine. Maybe the patient would take enough time to breathe and have logic to seep into his brain. All symptoms started immediately and were all ongoing. The reporter confirmed that by symptoms he was referring to 'his friend's joints being swollen', 'freezing, hot and cold all night', 'sounded like he smokes four packs a day', 'lymph nodes were large balls like an egg on his neck'. Outcome of the events getting suicidal thoughts and really incapacitated/ can't move was unknown, outcome of the other events was not resolved.
64 2021-06-27 feeling abnormal I started to feel like the in the morning that I felt weird and like my whole world was off. I took ... Read more
I started to feel like the in the morning that I felt weird and like my whole world was off. I took my blood pressure, and it was high. I talked to my doctor and they advised that I should go to the ER and I went to the ER and they diagnosed me with vertigo. My balance was completely off. He did give me medicine for the dizziness. He advised to have a follow-up.
64 2021-07-02 loss of personal independence in daily activities Two days after receiving the 2nd shot, began to experience inflammation and pain in joints from head... Read more
Two days after receiving the 2nd shot, began to experience inflammation and pain in joints from head to toe. These both have been debilitating, hard to move around, hard to get out of bed, hard climb stairs, hard to use hands due to swelling, hard turn head and cannot kneel down. Life has become very hard and painful. Gabapentin was prescribed and did nothing. My doctor prescribed celecoxib for the pain and inflammation. I've only been using it for 3 days and am having moderate relief, but too soon to tell.
64 2021-07-06 loss of personal independence in daily activities Feeling hot and cold; Cramping; He lost weight in the hospital; He wasn't feeling well; He just had ... Read more
Feeling hot and cold; Cramping; He lost weight in the hospital; He wasn't feeling well; He just had the feeling of being tired; blockage in the lower intestines.; Hard time going to the bathroom; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot number:ER8732) via an unspecified route of administration administered in left arm on 16-Apr-2021 at 10:30 (at age of 64-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient underwent lab test and procedures include cholesterol and result was unknown on unspecified and colonoscopy on 10May2021 result was unknown. It was reported that the patient received the first dose of the Pfizer covid vaccine and was in the hospital for blockage in the lower intestines on 17Apr2021. The patient wanted to know if that is associated with the Pfizer covid vaccine. He stated his nephew was a police dispatcher and got a call where someone else have reported similar issue what the patient has experienced. The patient did not know what vaccine that person had or age and gender of that person. The patient wanted to know about if Pfizer was going to get the FDA approval for the Covid vaccine. The patient reported that he had both doses and he was fine right now but when he had the first dose he was, he got it 16Apr2021 and he had some side effects the next day, on 17Apr2021 he was having cramping and he woke up and was feeling hot and cold and ended up in the hospital with a blockage in his intestine and he was wondering if that could have been anything that was related the vaccine. The patient has lost weight in the hospital, he thinks he was about 145 lbs now. It was reported that the patient was fine the whole day he got the vaccine, he ran errands and did things he needed to do, he went to bed and woke up and felt hot and cold and on 17Apr2021, he was having hard time going to the bathroom. He called his son and told him he wasn't feeling well on an unspecified date in Apr2021 and his son came over and called his other son who is a fireman and he told them to call the ambulance so they did and they took him to the hospital and they couldn't figure out, he was asking them and they had no answer, he just seen on the website and he has been wanting to call but he wasn't going to but he did so that they would have it documented. He confirms when the cramping and feeling of hot and cold and difficulty using the bathroom began it was after midnight and the date was 17Apr2021. When asked if the feeling of hot and cold is ongoing, he says he was in the hospital for 8 days. When asked if the feeling of hot and cold is ongoing or has it recovered, he says he just had the feeling of being tired on an unspecified date in Apr2021 and out of it even after the fact. He does not if it had to do with vaccine or if it was something, he had going on prior to that. The ER doctor told him it was possible that when he got the vaccine whatever could have been going on and put his system in overload. He confirms he was admitted to the hospital due to blockage in the intestine supposedly, the lower intestine. He says that is recovered, everything got taken care of, he had to schedule a colonoscopy after he got out of the hospital. He does not know why they couldn't have done it there while he was in the hospital. He was contemplating the second dose; it was scheduled on 07-May-2021 and he had his scheduled colonoscopy for 10-May-2021 and he didn't know what he should do. People were telling him do it or not to do it but his doctor told him to go ahead and get it so he followed what he said and he did get it. The hospitalization dates were from 17Apr2021 until 24Apr2021 was the day that he got out. He had blood work done for cholesterol in the hospital and he sees a cardiologist doctor for the cholesterol. They did blood work in the hospital every day, he has no idea what the results were. The events feeling hot and cold, cramping and hard time going to the bathroom after midnight and the middle of the night lead the patient to emergency room visit. He didn't know whether to call but it has been playing on his mind. He is sure they have given millions of doses and he did not know if it could be anything to do the vaccine. The outcome of events blockage in the lower intestines, feeling of hot and cold was recovered and outcome of other events was unknown. Follow-up attempts are needed: Further information has been requested.
64 2021-07-07 disturbance in attention I developed vision abberations such that when i focus or concentrate (e.g. reading a book or compute... Read more
I developed vision abberations such that when i focus or concentrate (e.g. reading a book or computer screen) my vision would 'jump' or 'blink' or flicker causing me to not follow words I had been reading. Very clearly concentration of attention driven. This condition came on slowly. It took weeks after injections for the symptoms to develop. They remain. And seem to be getting more severe. My opthamologist has refered me to a neuroopthamologist. I can not think of any other causative factor in the last years, month, and weeks that could account for what I am experiencing. I have had NO illnesses. I have not had Covid-19 to the best of my knowledge. (Note: date & time given for #5 above is approximate)
64 2021-07-08 feeling abnormal Flu-like symptoms; Stiffness; Mental fogginess; Fatigue; Headache; Body ache; This is a spontaneous ... Read more
Flu-like symptoms; Stiffness; Mental fogginess; Fatigue; Headache; Body ache; This is a spontaneous report from a contactable company representative, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via unspecified route of administration in the left arm on 17Mar2021 at 09:30 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had no allergies to medications, food, or other products. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); both were taken for unknown indications from unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 20:00, the patient experienced flu-like symptoms, fatigue, stiffness, body ache, headache and mental fogginess. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events flu-like symptoms, stiffness, mental fogginess, fatigue, body ache and headache were resolved on an unknown date of Mar2021. No follow-up attempts are needed. No further information is expected.
64 2021-07-11 sleep disorder Severe burning pain of left leg. Upper thigh above near hurts as a severe muscle pull. From knee ... Read more
Severe burning pain of left leg. Upper thigh above near hurts as a severe muscle pull. From knee cap down to ankle burning pain with occasional deeper burn pain up and down shin . Very uncomfortable. Hardly able to sleep
64 2021-07-14 feeling abnormal New Polymyalgia Rheumatica: Got Pfizer-BioNTech Covid vaccine #1 4/26/21. Then 5/9-5/15/21 both thig... Read more
New Polymyalgia Rheumatica: Got Pfizer-BioNTech Covid vaccine #1 4/26/21. Then 5/9-5/15/21 both thighs developed stiffness (R>L) in morning with AM stiffness for 1/2 day, and finally wore off day before second shot. Then, got 2nd shot 5/17/21, with fever first day, body aches starting the next day. After few days, felt better. However, Friday morning 5/21 woke up with pain in biceps, triceps, could not abduct arms above 7 o'clock position due to severe pain -- bedridden 4 days, felt like someone beat him up or got hit by a car, then improved sligthtly. 1 week later, developed stiffness in low back, hips, and thighs. Also with night sweats few nights.
64 2021-07-15 confusional state Fully vaccinated patient admitted through ED with COVID positive test upon admission. Admitted 06/2... Read more
Fully vaccinated patient admitted through ED with COVID positive test upon admission. Admitted 06/28/21 for weakness, confusion, difficulty urinating, and decreased oral intake. Found to have MSSA bacteremia. No s/s of COVID throughout stay.
64 2021-07-20 amnesia, feeling abnormal extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head,... Read more
extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; heart attack; Myocarditis; Heart racing; 20% loss of memory; light chest pain/pressure; foggy; severe headache; light chest pain/pressure; ill; horrible cough; Dizziness; High temperature; tiredness; This is a spontaneous report received from a contactable consumer (patient) reported for himself. This 64-year-old male patient received bnt162b2 (PFIZER BIONTIC COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right shoulder on 20Apr2021 at 12:25 (Batch/Lot Number: ER8735) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. There was no additional vaccines administered on same date of the Pfizer suspect. The patient received the first dose and after he had a horrible reaction and he had to go to the hospital. By 03May2021 he was in the ER and they were saying he had a heart attack; they were going to do emergency surgery to place a stent in his heart; but when they did the tests they found that a virus had caused the heart attack; he had myocarditis. Add then he had various medical care to keep him alive those two days. The doctor confirmed that he had myocarditis from a virus. He was still on mediation for his heart. The patient also mentioned his memory comes and goes now. Mentions the beta blocker his is prescribed is Metoprolol 25mg. Adds he was instructed to take one half of a 25mg tablet and then move up to 25mg, but he blacked out for a day when he took the 25mg, so he had to go back to one half of 25mg. Adds his heart races really fast and he has to have this medication to control it. He is also taking 81mg ASPIRIN. He was taking Atorvastatin 20mg once daily, but the other doctor told him to stop it because it is not doing him any good. The patient states he kept a journal of his symptoms after the vaccination on 20Apr2021. From 20Apr2021 to 22Apr2021, for two days he felt tired, slept all night on 21Apr2021, awake for two hours then back to sleep. From 22Apr2021 to 27Apr2021, he felt fine. On 28Apr2021 he was tired. On 29Apr2021, tired, dizzy, horrible cough, fever of 100 / high temperature. On 30Apr2021, the patient took off work, bad cough, resting, dizzy, ill. On 02May2021, ill, temperature. On 03May2021, ill, temperature 100, when he got out of bed at 05:00AM he had extreme pain in his head, back, shoulder, arms, and lungs feeling crushed so he went to the emergency room. The did two COVIDs tests that were negative. Blood tests that showed the heart attack need for a stent; but when they got in there with the camera it showed he had a viral attack on his heart that caused the blood flow to slow; EKG abnormal, mentions an MRI; and troponin level off the charts. The priest came in to talk to him and he had a horrible cough that has now gone away. He was in the hospital overnight and discharged 04May2021 at 15:00. After that he noticed he feels light chest pain/pressure all the time on 04May2021; the first week he was foggy on 04May2021 and had severe headache on 04May2021 and noticed about 20% loss of memory. The patient mentioned he made medical heart parts at work and he went back to work on 10May2021 but he just sat at his bench and examined the parts. He thought the vaccine activated his really good immune system and caused it to attack his heart. He had another EKG and the doctor said his right ventricle is damaged in his heart last week. Mentions he has had at least 30 different blood tests. Everyday for three weeks he thought he was going to die but his doctor did give him some hope. The event was hospitalized for myocarditis from a virus, heart attack and extreme pain in his head, back, shoulder, arms, and lungs feeling crushed from 03May2021 to 04May2021 at 15:00. Treatment received for myocarditis from a virus and heart attack. The outcome of tiredness, light chest pain/pressure was not recovered, of horrible cough was recovered. The outcome of other events was unknown. Heart racing results in Physician Office visit with follow up. Follow-up attempts are completed. No further information is expected.
64 2021-07-20 loss of personal independence in daily activities hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes... Read more
hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; not been able to use hands. They are numb, tingling, feel swollen, he can't bend them or hold things for maybe a couple of minutes. can't grip anything; not been able to use his hands; wrist to hurt; peripheral vision bad, his vision was bad; visual distortion; peripheral vision bad, his vision was bad; visual distortion; given a drug to take when they flared up (migraines); pains in upper thighs, felt like in muscles. Felt like little bubbles like they are going to pop; pains in upper thighs, felt like in muscles. Felt like little bubbles like they are going to pop; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything was worsened; hardly walk/ lower back got so painful; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINATION; lot number: ENG206), via an unspecified route of administration in right arm, on 17Mar2021 at 13:00 as dose 2, single for COVID-19 immunization. Medical history included heart attack from 1994, left side kidney removed in 2015 and single functional kidney on right side from 2015. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINATION; lot number: ENG202), via an unspecified route of administration in right arm, on 24Feb2021 at 13:00 as dose 1, single for COVID-19 immunization and experienced headache, stiff neck, peripheral vision was bad, migraine and swelling of hand and feet. The patient previously took (UBRELVY) for migraine and visual distortion. The patient had a headache and stiff neck really for no apparent reason and they continued. Then he noticed that his peripheral vision and vision was bad with visual distortion in Mar2021. He called his primary care provider and told him about this, and he was prescribed a steroid pack and for 2 months he was provided a muscle relaxer to help. They provided some relief but didn't get rid of it. Believes the steroid was a Zpack for inflammation and was unable to provide the name of the muscle relaxer or the NDC, Lot, or expiry for either Zpack or muscle relaxer given. Eventually, they continued and after he had the visual distortion, he went to an eye doctor to make sure nothing was wrong like a tumor that was causing the headaches or stiff neck. Eye doctor told him nothing wrong with his eyes and they were fine, not tumor, he just had migraines and he never had migraines before. He saw a neurologist and was diagnosed with migraines. On the first neurology appointment, they gave him an injection in the stomach, but he does not know the name of it. The second visit was given shots in the back of head and back of neck. On that next visit, he got a shot in the stomach and most of it was quiet down with the migraines and the visual distortion and he still had them. The patient was then given a drug to take to help when they flared up, for break through migraines in 2021. It was 100mg. He was given the free ones and he could only take up to 10 in a month. He was given 4 of them and only had to use 2 of them and the migraines and visual distortion has gone away. Provides NDC, lot number 1843724 and expiry of Jul2022. He started this in Apr2021 or in May2021 after his first visit with neurologist, (withheld). During the same time, he had the migraines and also started having pains in his upper thighs, felt like in his muscles. States imagine little bubbles like they are going to pop was how it felt in 2021. They went away and stopped. He then started to have back stuff, pains that started in Mar2021 or Apr2021. They stopped after 7-8 days later and then they were gone. He was then sent to a nerve specialist and they did a conduction nerve test to see if what happened affected his nerves and the test was fine. Then all of a sudden, after one thing happened and went away another one would start and then his lower back got so painful so that he could hardly walk and went to an orthopedist thinking it could be a pinched nerve in 2021. They did x-rays but could not see anything that caused this kind of pain. They didn't give him anything, but 7 days after that he was fine ever since, and it just went away. He also had pains in the upper arms that felt like someone was giving him shots at the same time in both arms and also a kind that hurts and stays hurting. Felt like they didn't pull out the needle, like someone was pressing the needle in the arm, directly in the area you are getting a shot, but this feeling lasted much longer. Had this very same feeling in the top of both shoulders and they were intermittent. One minute he would have them and the next they could last about 5 minutes, or it could be gone for 5 hours and show up again in 5 minutes. It was not consistent and happen every hour. This also resolved in May2021 along with the migraines. Patient had pains at top of shoulders fell in line with his neck, where the soft spot between the collar bone is which was like getting a shot in his arm. Again, he no longer has these symptoms and no problems with vaccines in the past. Provides he had second dose on 17Mar2021 in left arm and lot number of ENG206. No further details provided. Started in the beginning of Jun probably, it's been about two and half weeks. He had not been able to use his hands. They are numb, tingling, feel swollen, he can't bend them or hold things for maybe a couple of minutes. He can't grip anything in Jun2021 and also got worsened in 2021. Extending from the tip of his fingers all the way up to the shoulders, in his left arm especially causes the wrist to hurt in Jun2021. It hurts all up to the left shoulder. In the right arm it only goes up to the bicep and these have gotten worse and are continuing to get worse. The patient was given tramadol for that pain and unable to provide NDC, Lot, or expiry from orange pharmacy for tramadol bottle. He takes 50mg, 1-2 tablets by mouth four times daily. It was prescribed 16Jun2021 and expires 16Jun2022. These pain pills help some, it takes the pain away, but does not allow him to grip with his hands or anything else. Now it may sound crazy, but when he coughed it would make him feel like the inside of his biceps were going to explode. It went away and only lasted a week. After a week this went away, but to touch it hurts after he coughed. Still had tenderness in both sides in the muscles, but at that time it felt like they were exploding outwards. Again, mentions he no longer has this. His feet are swollen up and he has never had that before now. Went back to see his heart doctor. He had gone to have a Covid test and heart test in Jan2021. With the swelling in the feet, he felt it had something to do with the heart and he went to see the cardiologist where they asked about testing which was done by primary care provider and also had antinuclear antibody testing done with primary care and that test came back with no arthritis in the hands on an unknown date. The patient mentioned he had a heart attack at age 38 before he had COVID vaccine, since he is 64 now. He didn't have any chest pains and didn't fall under those heart symptom questions asked. None had anything to do with his heart and the provider felt symptoms probably due to with the vaccine, but there is not enough information out there on it yet. He saw about 6 specialist and they all say the same thing. The patient still had his feet and hands swelling. He had a heart attack in the past or how it will affect his muscles in his heart because he does not want to find out later that it had affected his heart, and nobody knew. The patient also had an magnetic resonance imaging (MRI) of the brain, blood vessels and nerves ordered by his Neurologist as well. The outcome of peripheral vision bad, his vision was bad; visual distortion was recovered in Mar2021; pains in upper thighs was recovered in May2021; lower back got so painful so that he could hardly walk was recovering; felt like bubbles in muscles like they pop was unknown while the other events was not recovered.
64 2021-07-22 feeling abnormal Headache; injection site pain; loss of balance; mental fog; congestion; breathing difficulty; lethar... Read more
Headache; injection site pain; loss of balance; mental fog; congestion; breathing difficulty; lethargy; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 02Apr2021 at 08:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD and COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR) and fluticasone propionate, salmeterol xinafoate (ADVAIR) both for an unknown indication and from an unknown date. The patient previously received levaquin for an unknown indication and experienced drug allergy. Prior to the vaccination, 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 02Apr2021 at 16:00, the patient experienced headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of events. The clinical outcomes of the events headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
64 2021-07-23 amnesia Loss of balance, loss of memory, blood clots, hospitalization, brain surgery, death
64 2021-07-27 feeling abnormal Fuzziness in head; This is a spontaneous report from a contactable consumer, the patient. A 64-year... Read more
Fuzziness in head; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 11:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included pacemaker for accelerated afib. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO), simvastatin (MANUFACTURER UNKNOWN) and hydrochlorothiazide (HCTZ), all for unknown indications from an unknown dates. 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 right arm on 26Mar2021 at 11:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient previously taken mustard (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 16:00, the patient experienced fuzziness in head, not dizzy or losing balance since the second dose but just not normal. The clinical outcome of the event of fuzziness was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
64 2021-07-27 feeling abnormal He just feels crappy today, and he feels bad; sore throat; runny nose; achiness; dizziness; soreness... Read more
He just feels crappy today, and he feels bad; sore throat; runny nose; achiness; dizziness; soreness; sweating; chills; headache; This is a spontaneous report from a contactable consumer. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EWO179, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 05:00 (age at vaccination 64 years) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included zolpidem tartrate (AMBIEN)taken for to go to sleep at night (has been on for 15 years); diphenhydramine hydrochloride (ANTIHISTAMINE ALLERGY RELIEF) taken for seasonal allergies. (Concomitant Products Brand Allergy Relief D 12 Hours: reporter states he takes Allegra and then states it is actually the Brand Allergy Relief D 12 Hours. He has been for many years, many many years). The patient took historical influenza vaccine (Flu shot) (He gets the flu shot every year and had the same effects as with those shots. He gets that every year at .) Persist Headache within minutes, he got a headache right away. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took flu vaccine vii for headache. On 18May2021 the patient experienced headache, on 19May2021 dizziness, soreness, sweating, chills, sore throat, runny nose, achiness, on an unspecified date he just feels crappy today, and he feels bad. Patient stated, soreness means his knees, and his ankle, and his elbows, everything, his neck, and everything. he talked to a few people, he is a mailman, and they have the same symptoms. He is going on a plane tomorrow, and he hopes he will be alright. He asks if he should see his doctor. Sore throat and runny nose he adds that this has also been the same and not gotten better or worse. he gets the flu shot every year and had the same effects as with those shots. Patient did not receive any treatment for occurred events. The outcome of event he just feels crappy today, and he feels bad was unknown, rest of all events outcome was not recovered. Additional Context: Caller is calling about the Pfizer Covid-19 Vaccine. He got the shot Tuesday, and he guesses he was reading the side effects. He just feels crappy today, and he feels bad. Caller adds he was going to call his doctor. Caller states by feeling crappy he means he got dizziness, achiness, sweating, and chills. Caller adds that is it, and should he call his doctor. Information on Lot/Batch number was available. Additional information has been requested.
65 2021-01-02 feeling abnormal Received vaccine on 12/28/2020 and c/o jitteriness on 12/29/2020 and dizziness with jitteriness on 1... Read more
Received vaccine on 12/28/2020 and c/o jitteriness on 12/29/2020 and dizziness with jitteriness on 12/30/2020. BP 152/83 HR 78. States he felt like he was floating when walking to his car this morning
65 2021-01-02 sleep disorder High fever continues into second day severe chills body aches constant headache and cannot sleep
65 2021-01-10 feeling abnormal Cheek swelling; Periorbital swelling/swelling around his eyes; feeling wiped out; Muscle pain; Joint... Read more
Cheek swelling; Periorbital swelling/swelling around his eyes; feeling wiped out; Muscle pain; Joint pain; Chills; Fever; General malaise; low grade headache; Sweating; injection site pain; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received bnt162b2 (BNT162B2) at single dose at left deltoid on 02Jan2021 17:00 for covid-19 immunisation, administered an injection team that is part of the local hospital system. Medical history included controlled hypertension and he has been taking the blood pressure medicine for a long time. The concomitant medications included unspecified medicines for controlled hypertension. History of all previous immunization with the Pfizer vaccine was none. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. No additional vaccines administered on same date of the BNT162B2 vaccine. On 02Jan2021 the patient experienced injection site pain. On 03Jan2021 the patient experienced cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, chills, fever, general malaise, low grade headache, sweating. No event did require a visit to Emergency Room or Physician Office. No relevant tests performed. Therapeutic measures were taken as a result of chills, fever, general malaise, low grade headache, sweating. Course of events: He said initially he had no adverse events after receiving the COVID-19 Vaccine, except injection site pain. He said he thought the injection site pain could be from the COVID-19 Vaccine being viscous, and didn't think anything else about the injection site pain. On 03Jan2021 he started to experience some. He stated he did not normally take vaccines, like the flu vaccine. He said he has been a podiatrist for 39 years, and realized the importance of getting the vaccine to protect his patients. He then developed chills, muscle pain, fever, and general malaise. He said he experienced every side effect listed on the received COVID-19 Vaccine paperwork, except he had no lymphadenopathy. He said all the side effects he experienced appeared 24 hours to the minute from when he received the COVID-19 Vaccine. On 03Jan2021, he had swelling in his cheeks and around his eyes. He did not get sick often. He said he had a rough night on 03Jan2021 and on 03Jan2021 he still felt wiped out. Treatment: he took 2 Tylenol 325mg at the start of the side effects, and then took another 2 Tylenol 325mg at 2:00AM. He said he woke up soaking wet with chills and sweats. He said his fever broke, but he did not know how high his fever was. He took from a fresh bottle of Tylenol 325mg. The outcome of injection site pain, cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, general malaise was recovering, of chills, fever, sweating was recovered in Jan2021, of low grade headache was not recovered. The reporter considered there was a reasonable possibility that all events were related to bnt162b2 vaccine. He was scheduled to receive another COVID-19 Vaccine injection in 3 weeks. Information about lot/batch number has been requested.
65 2021-01-25 sensation of foreign body He described having a lump in his throat as well as hives and itching 1 hr after his first vaccine. ... Read more
He described having a lump in his throat as well as hives and itching 1 hr after his first vaccine. Then, had taken Benadryl and sx were self limited. For the 2nd vaccine, he premedicated with Benadryl with a plan to observe 30 min. Approx 23 min after injection, developed L arm burning and redness. He developed a lump in his throat. BP 137/90, HR 71, SpO2 97%. He was directed to the ER where he received Benadryl, Solumedrol, Pepcid and was discharged home.
65 2021-01-26 depressed mood, feeling abnormal 1ST EPISODE, 01-15-21 10AM, it happened at the hospital where I work. I was walking flight of steps ... Read more
1ST EPISODE, 01-15-21 10AM, it happened at the hospital where I work. I was walking flight of steps when i felt i was not getting enough air, i went to sat down and was unable to recover and went to the therapy office to sit down, where a coworker said i didn't look good, my BP 148/92. I felt sleepy, global weakness throughout my body. they took me to the ER where i had an EKG, CBC, thyroid test, angiogap glucose test. The EKG was normal and I stayed about 6hrs in the ER but went home. As the day passed my BP was 122/88 when i got home. I wore a holter monitor for 5 days but don't have results yet. I felt fine for the next 6 days. SECOND EPISODE 01-21-21; i woke up at 5am feeling so sad with despair and feelings of loneliness. I went to work 11:45am, felt fine, sat down to do some work on my computer and I could feel it come up again, went to nurse station and checked my BP 144/90, i could feel my heart pounding and went to the ER again. I felt super foggy and unable to process things. They did a CTA of my neck and chest and a CT with perfusion which was normal. They did lab work and all was normal. THIRD EPISODE 01-25-2021, i was at home happened around 9am, felt fine all morning and then i felt another episode come again. Same symptoms just not as dense as before and texted my wife. I had body aches, felt like I had the flu. I saw my PCP 01-25-2021 (same day as my third episode)and set up an appointment with a neurologist.
65 2021-01-29 memory impairment On 1-23-21, less than 24 hours after the vaccine was administered, the person developed facial numbn... Read more
On 1-23-21, less than 24 hours after the vaccine was administered, the person developed facial numbness, slurred speech, memory difficulty. BP: 200/100. This occurred again on day 3. Hospitalized a total of 6 days. Discharged home on 1-29-21. Diagnosis: TIA, possible seizures. No history of either. Positive history for controlled hypertension.
65 2021-01-31 anxiety Sensation of tongue swelling after 10 minutes thinks it may have been anxiety about the vaccine 14:... Read more
Sensation of tongue swelling after 10 minutes thinks it may have been anxiety about the vaccine 14:34: BP 120/78 HR at 60 RR 16 Tongue midline, not enlarged no lymphadenopathy color normal - not pale sitting upright S1 S2 at apical
65 2021-02-06 sleep disorder Injection at approximately noon on 2/4/21. Began feeling poorly with flu like symptoms about 11 PM F... Read more
Injection at approximately noon on 2/4/21. Began feeling poorly with flu like symptoms about 11 PM Fitful Sleep.Extreme soreness at injection site. Awoke with fever (100.7), joint pain, nausea, lethargy. Took 400 mg of ibuprofen. Took "Nyquil" the next evening to help with symptoms. Fitful sleep and extreme sweating. Awoke Saturday feeling a bit better. Temperature (98.6) Rested all day. Better sleep Saturday night. Did not take any medication. Some sweating overnight. Awoke Sunday feeling better. Still not 100 percent Temperature 97.4.
65 2021-02-07 anxiety Patient received his first covid shot this past Saturday and about 20 minutes following he noticed a... Read more
Patient received his first covid shot this past Saturday and about 20 minutes following he noticed a right sided facial droop. Droop began to worsen, and he had difficulty moving his right eye lid, so he decided to go to Urgent Care and was diagnosed with Bells Palsy. He was started on Prednisone and Valtex which are reducing his symptoms. Symptoms are almost resolved. He does feel fatigued and slightly anxious.
65 2021-02-09 abnormal behaviour Patient is bedbound at home after multiple strokes. He also has dysarthria at baselin. Was in usual ... Read more
Patient is bedbound at home after multiple strokes. He also has dysarthria at baselin. Was in usual state of health. Received vaccine at medical facility on 1/29/21. Caregiver reported that he subsequently had behavioral change the following day and stopped oral nutrition intake. He was subsequently admitted to Hospital on 2/6/2021 with encephalopathy and severe dehydration.
65 2021-02-10 sleep disorder Stabbing pain over the right first metatarsophalangeal joint. Intermittent. No relation to activit... Read more
Stabbing pain over the right first metatarsophalangeal joint. Intermittent. No relation to activity. Progressed to nightly burning over the area, waking me up from sleep or preventing me from falling asleep.
65 2021-02-11 feeling abnormal Tremendous fatigue, slept for 12+ hours, followed by overall general achy back, joints, some light h... Read more
Tremendous fatigue, slept for 12+ hours, followed by overall general achy back, joints, some light headiness, unstable when standing at times.
65 2021-02-17 anxiety Dizziness, anxiety.
65 2021-02-17 anxiety pt anxious has flushed feeling; face red; has previous anxiety observed for 15 minutes; pt says he h... Read more
pt anxious has flushed feeling; face red; has previous anxiety observed for 15 minutes; pt says he has ipipen and will go to er if symptoms worsen or still present in24 hrs. insisted on leaving.
65 2021-02-21 impaired work ability started at 2 in the am I woke up with headache and nausea lasting all day, I tried alternating tylen... Read more
started at 2 in the am I woke up with headache and nausea lasting all day, I tried alternating tylenol and ibuprofen didn't help. EOD I was having severe body aches chills headache and nausea no fever, Saturday symptoms were worse, saturday night i added vomitting and temp spiked 101.3 or something like that. Continued low grade temp through wednesday running 99.3 99.8... and I didn't not work those days I stayed home, I was tested for covid and came out negative, I worked thursday and Friday and for the next week I continued with a low grade fever, I went to my primary after and he said it was most likely a reaction to the vaccine. 3 weeks total until I was back to normal.
65 2021-02-23 feeling abnormal Brain Fog; Abdominal pains; Shoulder Pains, Upper Respiratory discomfort
65 2021-02-23 sleep disorder, feeling abnormal Twenty minutes after injection mental fog, then onset of headache which became debilitating, requiri... Read more
Twenty minutes after injection mental fog, then onset of headache which became debilitating, requiring 5mg of Oxycodon every four hours for five days to be functional. Woke up every night after four hours, from pain, took meds, an hour later able to sleep again. Stabbing knifelike pain over right eye, Able to transition to naprosyn, Advil and Tylenol after five days, but still in constant pain eight days later, even with meds. No sensitivity to light, some mild nausea for first few days.
65 2021-02-24 memory impairment He received his first dose of Pfizer COVID vaccine today at 12:30 PM. Has h/o Ancef allergy with hi... Read more
He received his first dose of Pfizer COVID vaccine today at 12:30 PM. Has h/o Ancef allergy with hives. No h/o anaphylactic type allergies. Waiting in observation area for 15 min. After ~15 min, c/o feeling "shaky". Pt brought back to cot room. BP elevated. Denies unusal SOB, scratchy or swelling in throat. Denies tongue swelling, mouth numbness or tingling. No c/o rash or itching. No visible rash noted. Reports that he has chronic respiratory issues. Brief history reviewed with patient. He reports that he takes glipizide, but can't remember if he took it this AM or not. States he only had one cup of coffee all day. Symptoms progressed to feeling light-headed. Visible shaking of hands with lifting arms. Reports that symptoms were somewhat worsening. After ~15 min more of observation, First Responder was called. ED personnel arrived within minutes. Blood sugar per finger stick was 212. Patient able to ambulate to wheelchair. C/o tingling in scalp and feeling light-headed. Agreed to be transported to ED for further monitoring and possible treatment.
65 2021-02-26 disturbance in attention Rapid Heart Beat. Trouble breathing, Dizzy, Unable to focus Tiredness
65 2021-02-26 sleep disorder After not sleeping well Monday night I woke up on the 23rd of February not feeling 100%. So around 8... Read more
After not sleeping well Monday night I woke up on the 23rd of February not feeling 100%. So around 8:00 AM I took two Bayer Back & Body. Around 8:15 / 8:20am I began feeling very dizzy and unable to stand up on my own. I couldn't walk down the hallway without holding onto the wall. This went on all day, long after the effects of the Bayer Back & Body would have worn off . Even at dinner time I was uneasy / unstable walking around. The only time I felt well was when I was lying in bed. By the next morning, Wednesday the 24th, I wasn't 100% that morning either but I went to work and did the work. It was very difficult but by afternoon I was feeling much better. It wasn't until Thursday that I was feeling 100%. I had never felt this way in my life. No it was not Epilepsy related and I had been taking Bayer Back & Body FOR YEARS without problem except maybe taking two, occasionally would feel the caffeine.
65 2021-03-03 anxiety Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycard... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: Pt had anxiety about 30 minutes after dose. said \"he just needs some air\". EKG taken by EMT was normal. Did ortho stats and he was tilting and dehydrated. he takes HCTZ and does not like urinating often so does not drink much. HR was in 130s but after giving two glasses of water patient was fine and HR was down in 90s. He is diabetic and BS 236. Had just eaten.
65 2021-03-03 loss of personal independence in daily activities Sore arm at injection sight begging about 4 hours after injection continuing till day 3, Diarrhea be... Read more
Sore arm at injection sight begging about 4 hours after injection continuing till day 3, Diarrhea beginning day 3 about 4:30 Am continuing into the afternoon. Diarrhea not severe, but prevented me from leaving the house to perform scheduled activities.
65 2021-03-04 feeling abnormal Next day feeling brain fog and extreme tiredness
65 2021-03-07 feeling abnormal 6 days after the shot I thought I had a sinus infection. I received a steroid shot and z pak presc... Read more
6 days after the shot I thought I had a sinus infection. I received a steroid shot and z pak prescription on the morning of February 18. Was still feeling bad and checked myself into a local ER February 22 where I was diagnosed with congestive heart failure. Never had heart issues. I was in the hospital 6 days. I feel much better and now worried about getting second shot.
65 2021-03-07 motion sickness Side effects began almost 1 week after 1st dose. Patient had severe motion sickness and nausea resul... Read more
Side effects began almost 1 week after 1st dose. Patient had severe motion sickness and nausea resulting in vomiting, sporadic moments of fever chills and muscle aches. Symptoms persisted for 2 days, tapering off on the 3rd day. Side effects for 2nd dose appeared night of injection, include fever chills and muscle aches. Symptoms disappeared the next day.
65 2021-03-08 feeling abnormal Nausea, Body aches, joint aches, tiredness, chills, light headed. Feeling "off". No treatment
65 2021-03-09 feeling abnormal Pt describes feeling light headed and "floaty" approx 5 minutes post vax. Denies other SX. 1540 - BP... Read more
Pt describes feeling light headed and "floaty" approx 5 minutes post vax. Denies other SX. 1540 - BP - 128/90, P - 58, O2 sat 97% - provided water, rest 1555 - States sx resolved, BP - 130/84, P- 56, O2 sat 95% Pt leaves clinic.
65 2021-03-10 feeling abnormal Body aches, fatigue, stuffy head feeling but no congestion. I took Aleve and Advil for the aches.
65 2021-03-11 sleep disorder Patient woke up at 10:00PM, out of a sound sleep, having an acute asthma attack and generalized itch... Read more
Patient woke up at 10:00PM, out of a sound sleep, having an acute asthma attack and generalized itching. No rash. Used Albuterol inhaler twice, 5 minutes apart, and took Prednisone 20 mg orally. Within 60-90 minutes, symptoms completely resolved and did not reoccur. He did not seek medical attention at the time of this reaction, but called this office on 3/11/2021 so that the reaction could be documented. That prompted today's office visit and the completion of this VAERS form. Patient does have monthly allergy injections, but last injection was on 2/23/2021.
65 2021-03-12 confusional state Fatigue , confusion for 24-48hrs after, random shooting pains, numbness at corner of mouth
65 2021-03-17 feeling abnormal, poor quality sleep Initially some flu-like symptoms a few hours after getting the vaccination, but felt fine Friday mor... Read more
Initially some flu-like symptoms a few hours after getting the vaccination, but felt fine Friday morning. Late Sunday evening, developed a intense headache followed by chills overnight and restless sleep (1-hr periods thru the night). Continued Headache thru 3/18 with general body aches and weakness. No pain at injection site after first night. Lightheadedness when standing with loss of focus (brain fog). Occasional and temporary feeling of nausea.
65 2021-03-21 memory impairment, feeling abnormal, loss of personal independence in daily activities 101 fever for 5 days straight. Still get a fever every afternoon/evening but about 99. Extreme fatig... Read more
101 fever for 5 days straight. Still get a fever every afternoon/evening but about 99. Extreme fatigue for first 10 days. As soon as eat breakfast have to go back to bed for 1-3 hours. Same with lunch, eat, go back to bed about 3 hours and same with dinner. Then go to bed for evening. Extreme brain fog and forgetfulness. Can't think of words or make sentences. Can't remember anything. Feels like a very heavy feeling in head like head weighs a lot and very cloudy. Pain from shot in arm moved up to neck, ear and jaw the day after shot. Arm quit hurting but couldn't lift it. Pain stayed in neck, ear and jaw for a week and now is a stiff feeling. I think the lymph nodes are swollen. Effects eating, hard to keep food down. Nausea and stomach pain. I have appetite but have to eat while nauseous and pain. Still severely fatigued every day and have to sleep most of each day or at least sit and rest. So exhausted. Also night of shot started getting hot and cold chills. Still have them over 2 weeks after shot. Bad tinnitus started night of shot and still have it over 2 weeks after shot. Very loud and nothing makes it go away. Bad headache started morning after shot. I have had a headache pretty much everyday, all day since the shot over 2 weeks ago. I feel sick like I have flu.
65 2021-03-22 sleep disorder Initially a low-grade fever but after a few days, my arthritis in my hip became very painful radiati... Read more
Initially a low-grade fever but after a few days, my arthritis in my hip became very painful radiating to my knee and lower back to the point where I could not sleep or walk very well. I am still experiencing pain and difficulty walking or standing for more than a few minutes.
65 2021-03-23 feeling abnormal PT with history of previous syncopal events to both vaccinations and blood draw. 3 min after vaccine... Read more
PT with history of previous syncopal events to both vaccinations and blood draw. 3 min after vaccine PT became unresponsive, arrived immediately at carside, supported airway, patient quickly regained consciousness. Vitals stable, refused transport.
65 2021-03-25 insomnia, euphoric mood Got his vaccine, his arm hurt after the vaccine, but nothing severe. He tried to go to sleep but he... Read more
Got his vaccine, his arm hurt after the vaccine, but nothing severe. He tried to go to sleep but he cannot sleep at night, has insomnia. He threw up and ate something in his stomach, but has an aura of a high that he is having. Doesn't know if he can stay awake or go to sleep. He has soreness in his arm still.
65 2021-03-29 irritability, excessive sleepiness post nasal drip and irritation, kept falling asleep , slept all day on day 5
65 2021-03-30 panic attack 66 yp, states hes having shortness of breath. Pt is CAO x 3, airway is patent and self maintained. ... Read more
66 yp, states hes having shortness of breath. Pt is CAO x 3, airway is patent and self maintained. Pt was moved to exam area and vitals were stable. Patient has a history of anxiety, and denies any swelling rash or hives. Present crew determined patient had a panic attack. Crew was able to calm the patient, and care was transferred to ambulance unit.
65 2021-04-03 insomnia Chills, sweats, low fever, can?t sleep, head ache....arm is NOT sore.
65 2021-04-04 abnormal behaviour, mental status changes, confusional state The patient is a 65 yr/o male with a history of Afib on Xarelto and HTN presents via EMS for evaluat... Read more
The patient is a 65 yr/o male with a history of Afib on Xarelto and HTN presents via EMS for evaluation of AMS that was noted by wife this am. The wife states as soon as the pt woke up he was altered mainly acting confused and not speaking normally. She also states that his side of the bed was wet this am but is unsure if it was sweat or urine. LKW 2200 last night before the pt went to bed. Upon EMS arrival the pt was sitting on the floor, playing with a toilet brush, and speaking non-sense. While en route to the ED the pt reportedly had convulsive seizure like activity and was non-responsive 15-20min following the activity. He is now awake but not verbally responsive and still acting confused. No hx of seizures per wife. Hx otherwise limited as pt is non-verbal at this time
65 2021-04-07 feeling abnormal, mental impairment Felt kind of nauseated/ nausea; Could not think/his mind was blank/ couldn't think to do anything; f... Read more
Felt kind of nauseated/ nausea; Could not think/his mind was blank/ couldn't think to do anything; felt like he was in slow motion; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 22Mar2021 probably around noon (at age of 65 years old; lot number: ER8730) as single dose for COVID-19 immunization. Medical history included high blood pressure diagnosed about 10 years ago and diabetes type 2 diagnosed about 10 years ago (as of 24Mar2021). He caught COVID a few months ago (as of 24Mar2021) and was sick for 3 weeks and then came out of that and at that time got a rash and came out of that and wanted to get the vaccine because he was age 65 and did not want this thing to kill him. Concomitant medication(s) included gabapentin 300mg, 1 capsule three times per day by mouth, taken for neuropathy in his hands and his hands hurt from 22Mar2021 and ongoing. He was given the gabapentin to stop his hands from hurting. He also had medications he took every day and had diabetes type 2, and also had high blood pressure that he took medication for. No additional vaccines were administered on same date of the Pfizer suspect. There were no prior vaccinations within 4 weeks of the Pfizer vaccine. The patient reported he saw his healthcare professional (HCP) for the first time the same day he got the Pfizer Vaccine on 22Mar2021 and saw the HCP that morning. When he left he felt fine that day 22Mar2021 and felt fine that night. That night he tore up his bedroom and cleaned it and felt fine. Then the next morning (23Mar2021) he went to work and felt fine for a while and then got to building. He started working and then felt like he was in slow motion and couldn't think and it was crazy and his mind was blank and he could not think and felt like he was in slow motion; couldn't think to do anything. The feeling like he was in slow motion and not being able to think began yesterday morning on 23Mar2021 and stopped yesterday 23Mar2021 also. Yesterday he came home because he runs saws at work and stuff like that and he couldn't think and couldn't be around stuff like that because he was cutting things and could get hurt. He had not had this happen before and the feeling as if he couldn't think and felt in slow motion was not ongoing today, 24Mar2021. Today he now has nausea and the nausea was ongoing and about the same as when it began. Also stated as today (24Mar2021) he felt kind of nauseated and couldn't do anything again today and thought he would stay home because of these small side effects of the vaccine that he wanted to report. He had no treatment for the reported events but just went home and laid down. The events did not require an emergency room visit. Regarding whether the events required a visit to physician office the patient replied "Yes", he saw his HCP the morning of the day he got the vaccine on 22Mar2021. Patient was going to call the HCP to see if the medication she gave him would have these side effects and he had not taken the Gabapentin before; stated the HCP issued him Gabapentin that he began taking on 22Mar2021. He was calling the HCP to see if the reported events were related to the gabapentin as he had not taken that before. "Feeling like he was in slow motion and not being able to think" was recovered on 23Mar2021 and patient had not recovered from nauseated.
65 2021-04-07 insomnia Extreme fatigue, sleeplessness, body aches, sore arm where vaccination given. Lasted three days so f... Read more
Extreme fatigue, sleeplessness, body aches, sore arm where vaccination given. Lasted three days so far. Some relief with Tylenol
65 2021-04-08 disturbance in attention Dissiness, nausea, headache, preassure in head, extreme tenetus, feel as if I am spinning, unsteady ... Read more
Dissiness, nausea, headache, preassure in head, extreme tenetus, feel as if I am spinning, unsteady on my feet (could fall), tingling of all left side of my body, mostly in joints, sleuring speech, brain not connecting to mouth...slow.
65 2021-04-09 sleep disorder EXTREME muscle pain in legs starting 4 days after the injection - 4/3/21. The pain started the day a... Read more
EXTREME muscle pain in legs starting 4 days after the injection - 4/3/21. The pain started the day after a routine 5 mile run. By routine, I mean a run that I have done thousands of times without muscle soreness. At first, the pain was treatable with a 400mg dose of Ibuprofen but gradually worsened to the point where over the counter NSAIDS were no longer effective. Moving to 200mg Celecoxhib 2x day was only modestly effective. The pain was so intense that I am unable to get adequate sleep and has consolidated in the left leg.
65 2021-04-10 nervousness, sleep disorder, disturbance in attention Severe ringing of the ears. Can?t concentrate. No sleep Nervousness
65 2021-04-11 memory impairment, confusional state Confusion, forgetfulness, still going on now (4-12-2021)
65 2021-04-13 anxiety, feeling abnormal, panic attack Reported that 4-5 hours post vaccine he became very dizzy and unable to walk. HIs eyes at that time... Read more
Reported that 4-5 hours post vaccine he became very dizzy and unable to walk. HIs eyes at that time became sensitive to light; to this day he is still experiencing tenderness in his vision. His mind is foggy and feels anxious that he is not feeling better as of 04/14/2021. He went to his PCP on 04/13/2021 who referred him to a neurologist.
65 2021-04-13 mental impairment Patient stated that they will refuse the second dose of the Pfizer vaccine based on side effects exp... Read more
Patient stated that they will refuse the second dose of the Pfizer vaccine based on side effects experienced since. Complications include pain that felt like "lightning bolts", temporary loss of vision, and that their "mind went black" which has improved in the past few days. Pt. believes that his recent cognitive decline is directly attributed to receiving the vaccine and expresses concern with whoever else gets it.
65 2021-04-16 anxiety My thyroid went hyper 5 days after the first shot. I had high anxiety, and high blood pressure. The ... Read more
My thyroid went hyper 5 days after the first shot. I had high anxiety, and high blood pressure. The doctor said I had thyroiditis. Then 5 days after the second shot the same anxiety, and high blood pressure again. I am still being treated.
65 2021-04-17 depression, memory impairment mind and memory depression; mind and memory depression; tired; sleepy; back pain got worse; shoulder... Read more
mind and memory depression; mind and memory depression; tired; sleepy; back pain got worse; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, intramuscular in right arm on 26Feb2021 10:15, at 65 years of age, (Batch/Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included knee surgery on 23Jan2019, some tiredness, disability (reported 40% on back and 30% on mental) and mental depression since 1978 and ongoing. The patient had previously received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine on 05Feb2021 at 10:15 AM (Batch/Lot number: E23247), via intramuscular route in left arm and one dose of Flu vaccine on 14Jan2021 in left arm. Concomitant medications included acetaminophen 500 mg twice daily for back pain, lithium carbonate 1 tablet 300 mg for depression and lamotrigine 25 mg 1 tablet daily for depression, all taken since an unknown date and an unspecified medicine for Disability 40% since an unknown date. On 26Feb2021, 8 hours after the second vaccine dose, the patient experienced tired and sleepy "skeleton" and back pain got worse and shoulder pain and, on an unspecified date, he experienced mind and memory depression. No treatment was administered to the patient for the reported events. The events tired and sleepy resolved on 28Feb2021, the event shoulder pain was resolving, whereas the outcome of the events back pain got worse, mind and memory depression was unknown at the time of the report.
65 2021-04-17 insomnia urinating constantly; up all night, back and forth; This is a spontaneous report received from a con... Read more
urinating constantly; up all night, back and forth; This is a spontaneous report received from a contactable female consumer (Wife) reported for her husband (Patient). This consumer reported similar events for two patients. This is the second of 2 reports. A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose bnt162b2 on 05Mar21. On 28Mar2021 patient got his last shot with wife. The wife and patient have been urinating constantly, up all night, back and forth. The event outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374640 Same reporter/ product, similar event, different patient
65 2021-04-21 confusional state Extreme fatigue, loss of appetite, dizziness, some confusion of surroundings. Lasted about 24 hours... Read more
Extreme fatigue, loss of appetite, dizziness, some confusion of surroundings. Lasted about 24 hours.
65 2021-04-22 loss of personal independence in daily activities I was unable to perform any usual daily activities. I had a severe headache, joint aches, chills an... Read more
I was unable to perform any usual daily activities. I had a severe headache, joint aches, chills and extreme fatigue. I slept for 36 hours. I'm reporting this because I had the same reaction to my first dose. I had COVID in December but I'm otherwise very healthy. I would not be willing to receive another dose of this vaccine.
65 2021-04-25 feeling abnormal, memory impairment Pt reported to me on 4/23/2021: dry mouth, difficulty getting out of bed, h/a, fever and chills, fee... Read more
Pt reported to me on 4/23/2021: dry mouth, difficulty getting out of bed, h/a, fever and chills, feeling like was going to fall, some memory difficulties and ringing in ears. Reported that the sx gradually resolved and are completely resolved by date of reporting (4/23/2021)
65 2021-04-30 insomnia Salivary gland reactions; Was told by this doctor that he has seen 6 other patients with similar dry... Read more
Salivary gland reactions; Was told by this doctor that he has seen 6 other patients with similar dry mouth who have had the COVID-19 vaccination; Sleeplessness; I can barely breath; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on left arm on 04Feb2021 at single dose for covid-19 immunization. Patient also received zolpidem tartrate (AMBIEN) and mirtazapine (manufacturer unknown) for unknown indication. Medical history was not reported and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: it looks like ELR84), via an unspecified route of administration in the Left arm on 14Jan2021 at unknown time as a single dose for COVID-19 immunization. On 25Feb2021, almost exactly 3 weeks after receiving his second dose of the Pfizer BioNTech COVID-19 vaccine, the patient started experiencing horrible dry mouth conditions for 6-7 weeks. He stated that due to this persistent dry mouth, he had only been able to sleep on average 3 to 4 hours a night for the past 6 to 7 weeks. Patient reported that he hasn't come back from an ENT specialist regarding this and was told by this doctor that he had seen 6 other patients with similar dry mouth who have had the COVID-19 vaccination and/or COVID-19 itself. It was stated that his doctor also referenced an article in a journal that came out a few days ago that stated COVID-19 was shown to infect the salivary glands. He stated that his doctor was unable to give any further recommendations other than gave him things to keep him comfortable such as Salagen. He also mentioned that after receiving the vaccine, he was being awoken every 20 minutes all night long and many times had to urinate but reported that this side effects has subsided. He stated he read on the internet about a woman who also had COVID-19 who reported having bad dry mouth and was urinating more often than he had in her whole life. He called at the recommendation of her doctor nasal and throat surgeon who said he was going to speaking with his peers about this, but he suggested that he call him too. So, it would appear that he had and several of his patients had similar symptoms to him. He had been suffering from the extreme and when he said extreme, he said the most extreme case he had seen in his 45 years of medicine. Extreme case of might be dry mouth or sleeplessness to this point when he can barely breath. He had maybe 3-4 hours of sleep over the last 6 weeks. They kept thinking that she was allergic that the medication that she was on, but she did not off that medications for a week. They thought of food, he was ingesting they removed every food stuff he finally saw an ENT and he said well, he was the 5th patient he had seen like this, this month and she was telling them he cannot swear by it but it was COVID. He said the only thing that made any sense had seen medication before and they just don't know yet. This was not just enough information and he showed him an article for that he just found the other day that said this enough, COVID was infecting salivary glands or was believed to be so it would seem this might be something that was being recorded yet and might be somebody wanted to take a look at mine. He doesn't know but it was he can't find anything anywhere about this. He can't either except the story that he saw just a few days ago which was professional (Name) journal about COVID now infecting salivary glands that was exactly they know he was suffering it somewhat of freak salivary gland reactions that could be it or could had been COVID (Further not clarified hence PC filed conservatively). When probed for the Date of Vaccine administration for both COVID Vaccine shots, Patient stated that second dose was Feb 4th, and the second dose would be 4 weeks before that. When probed for the exact date of Vaccine administration for both COVID Vaccine shots, patient stated, if they hold on, she get her vaccination card. It would be there right. It was in January, he doesn't knew it looks like 14Jan2021. When probed whether the Vaccine was purchased or she got injected at the clinic, he stated that he got injected. The first on, it looked like ELR84 that was the first dose. When confirmed LOT# as ELR84: he stated, it looked like A but their writing was terrible. He though, it was A it said, or could be G. For second one, EN9581. (Hence second dose LOT captured in tab). Dose for both shots of vaccine: patient stated, that doesn't say. No one say about that. When probed for the site of administration for both shots of vaccine, she stated left arm. When confirmed the vaccine was administered on left arm both the times, stated, she did not remember. (Later confirmed as yes). When probed for Other medications, he stated that not now, no, he had been. (Further clarification unknown) Names of medications: he stated, that was taking Myrbetriq none of these were taken very long they expected these were causing the dry mouth. So, he stopped taking them. it was reported that It was Oxybutynin, let him get it. thought the dry mouth was being caused by the medications. So, they tried switching medications. He had several drugs in that stage for few weeks. So, Oxybutynin was the first one. He took Myrbetriq on February 25th 50 mg, Oxybutynin 50 mg tablet, 1 tablet her mouth daily and then they had Peficare that was for sulfonation and 5 mg,(Further clarification unknown) Tolterodine that was standard Detrol that was 4 mg, Darifenacin,(Was not clarified further hence not captured as concomitant medication) than there were sleep medications none of which worked, none of which solved dry mouth problem, they were Ambien that was Zolpidem 5 mg, Mirtazapine (hence captured as suspect) 50 mg and there was one more, looking that. On an unspecified date, the patient underwent laboratory tests, he was tested for Sjogren's Syndrome for the markers of Sjogren's Syndrome, and they were negative. It was approximately a 1 week ago, 7 days ago and here her result came like he cannot give them the exact date. The outcome was persisting. He was prescribed (further not clarified) Salagen (treatment) in order to generate more saliva. He stated that than there were sleep medication none of it worked, solved dry mouth problem, they were Ambien, Zolpidem 5 mg, Mirtazapine(treatment) 50 mg and there was one more, looking that. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
65 2021-05-02 anxiety anxiety attacks, hard to breathe, rapid heartbeat, throat swelling
65 2021-05-05 anxiety Patient was anxious and reported history of syncope 2 days prior. States he feels dizzy while sittin... Read more
Patient was anxious and reported history of syncope 2 days prior. States he feels dizzy while sitting. His blood pressure was elevated at 179/100 mmHg. Heart rate and oxygen saturation were within normal limits. Retook blood pressure a second time 165/91 mmHg. Third blood pressure 165/87 mmHg. Fourth blood pressure 164/84 mmHg.
65 2021-05-07 loss of personal independence in daily activities the neurologist agreed that the vaccine has attacked nervous system; developed signs of stroke, he c... Read more
the neurologist agreed that the vaccine has attacked nervous system; developed signs of stroke, he can't stand up and walk up straight; feeling unwell and was unable to work for a few days; he had tingling on the left side that moved to his right side; he has difficulty speaking/ word finding/Slurring his speech; tinnitus; nausea; pain in the rear of his neck, between the neck and skull; His symptoms continue to be severe and is unable to work; he cannot coordinate his thoughts and fantasies; dizziness, he felt his head was spinning; He had some kind of palsy where his face was not reacting bilaterally; pressure in his brain; Got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms; This is a spontaneous report from a contactable consumer (patients wife). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced the neurologist agreed that the vaccine has attacked nervous system (nervous system disorder) (hospitalization) on an unspecified date with outcome of unknown , developed signs of stroke, he can't stand up and walk up straight (cerebrovascular accident) (medically significant) on an unspecified date with outcome of unknown , feeling unwell and was unable to work for a few days (malaise) (medically significant) on an unspecified date with outcome of unknown , he had tingling on the left side that moved to his right side (paraesthesia) (medically significant) on an unspecified date with outcome of unknown , he has difficulty speaking/ word finding/slurring his speech (dysarthria) (medically significant) on an unspecified date with outcome of unknown , tinnitus (tinnitus) (non-serious) on an unspecified date with outcome of unknown , nausea (nausea) (non-serious) on an unspecified date with outcome of unknown , pain in the rear of his neck, between the neck and skull (neck pain) (non-serious) on an unspecified date with outcome of unknown , his symptoms continue to be severe and is unable to work (loss of personal independence in daily activities) (medically significant) on an unspecified date with outcome of unknown , he cannot coordinate his thoughts and fantasies (coordination abnormal) (medically significant) on an unspecified date with outcome of unknown , dizziness, he felt his head was spinning (dizziness) (medically significant) on an unspecified date with outcome of unknown , he had some kind of palsy where his face was not reacting bilaterally (paralysis) (medically significant) on an unspecified date with outcome of unknown , pressure in his brain (head discomfort) (non-serious) on an unspecified date with outcome of unknown , got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms (illness) (non-serious) on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.
65 2021-05-11 disturbance in attention Right after the injection, I felt flushed. For the following 2 days, I felt: chills, headache, a lig... Read more
Right after the injection, I felt flushed. For the following 2 days, I felt: chills, headache, a light/dry cough, light nausea, balance was off, concentration was off, fatigue, and joint pain (esp. in hands and fingers). Symptoms cleared by 2/15/2021 except for headache, which remained present every day and Intesified. i told my wife for the first time about it on 2/22/21, then told her that I worried it was a symptom of a stroke on 3/1/2021 and she told me to call my doctor. I met with PA on 3/3/2021 and had a CT scan on 3/9/21. I met again with PA on 3/9/21 and was told that my CT scan indictate normal brain abnormalities due age and an inflamation in the sinuses.
65 2021-05-14 loss of personal independence in daily activities massive itching; There is resolutions till date its painfull itching sleep interupted.; red rashes a... Read more
massive itching; There is resolutions till date its painfull itching sleep interupted.; red rashes all over body and face swollen/red rashes erruptions.; face swollen/worsen with swelling; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received he second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: ER8731), via an unspecified route of administration at the age of 65-year-old at arm Left on 14Apr2021 14:30 at single dose for COVID-19 immunization. Medical history was reported as no illness ever before, Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications were not reported. There were no other medications the patient received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EP7534) at the age of 65-year-old at left arm on 26Mar2021 01:15 PM for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in pharmacy or drug store. Since the vaccination, the patient hasn't been tested for COVID-19. In 8 hours of receiving vaccin second shot on Friday (as reported) red rashes all over body and face swollen on 14Apr2021. Went to Urgent care on Saturday (as reported) the hospital on Sunday (as reported) as situation worsen with swelling and massive itching and red rashes erruptions on 17Apr2021 12:00. There was resolutions till date its painfull itching sleep interrupted on 17Apr2021 12:00, over two weeks now. The patient was hospitalized for one day for events. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment (steroid intravenous then oral till date) for the adverse event. The outcome of events was not recovered.
65 2021-05-14 memory impairment Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Faintin... Read more
Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 12:45 PM at the age of 65-years-old (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Herniated discs L4,L5,S1,C4,C5C6C7, type 2 diabetes from an unknown date. Concomitant medications included apixaban (ELIQUIS); dipyridamole (METROPOLYN) and bupropion, all taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 01:15 PM, the patient experienced Fainting, pain, itching, fatigue, headache, nausea, Lost of smell, short term memory off and on. It was unknown if treatment received. The outcome of the events was resolving. Information on the lot/batch number has been requested.
65 2021-05-16 panic attack Patient received vaccine on tuesday 5/4. Patient developed a rash surrounding both ankles. Patient a... Read more
Patient received vaccine on tuesday 5/4. Patient developed a rash surrounding both ankles. Patient and wife dismissed this as possible side effect of vaccine. The patient had difficulty breathing and dismissed it as a panic attack on 5/10. Symptoms continued for several days, went to walk-in clinic on Wednesday 5/12 for tests and inconclusive. Thursday 5/13 the patient continued to experience these symptoms and elevated pain, tightness and cramping in legs and went to the ER where he was diagnosed with bilateral pulmonary emboli. Patient was admitted for 2 days and treated for clots. Upon discharge the patient was instructed to discontiue meloxicam, carbidopa/levodopa and started on eliquis for 6 months. After 6 months the patient will follow-up with a hemotologist.
65 2021-05-23 sleep disorder Extreme pain in shoulder, interrupted sleep, chest heavy, left side. pain spreading spreading left ... Read more
Extreme pain in shoulder, interrupted sleep, chest heavy, left side. pain spreading spreading left to right
65 2021-05-25 disturbance in attention feeling of light headedness for 3 straight days; felt fatigue; hard to focus; This is a spontaneous ... Read more
feeling of light headedness for 3 straight days; felt fatigue; hard to focus; This is a spontaneous report from a contactable consumer or other non hcp.A 65-years-old male patient received second dose of BNT162B2(BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 12Feb2021 10:30 as SINGLE DOSE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Historical vaccine includes patient received first dose of BNT162B2(BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 11:00 as SINGLE DOSE for covid-19 immunization. Patient did not get other vaccine in four weeks and no other medications in two weeks. Patient does not have covid prior vaccination and does not tested covid post vaccination. Patient does not have any other allergies. On 14Feb2021 12:00, after 2 days of the second vaccine patient felt fatigue and a feeling of light headedness for 3 straight days hard to focus. The outcome of the events was resolved. Information about lot/ batch number has been requested.
65 2021-05-31 confusional state Injection precipitated a Lyme's Disease episode: fatigue, confusion, dizziness, low grade fever, ri... Read more
Injection precipitated a Lyme's Disease episode: fatigue, confusion, dizziness, low grade fever, ringing in the ears. Treatment: Amoxicillin. 1000mg twice a day. Continued anti-biotics for 30 days. Symptoms receded after 30 day treatment ended
65 2021-06-03 depressed mood Urinating blood; very depressed; tired for one week; This is a spontaneous report from a contactable... Read more
Urinating blood; very depressed; tired for one week; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 27Feb2021 10:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were not reported. On 06Mar2021 06:00, the patient experienced urinating blood and very depressed and tired for one week. The treatment received for events was unknown. The outcome of the events recovered. No follow-up attempts are possible. No further information is expected.
65 2021-06-08 feeling abnormal lost a few pounds; Stomach pain; Vomited; Loss of appetite; Feels like he is in a fog; Twitching in ... Read more
lost a few pounds; Stomach pain; Vomited; Loss of appetite; Feels like he is in a fog; Twitching in left ankle; Injection site pain left arm; feeling very unwell; Headache; very tired; Feverish; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0177), via intramuscular route, in left arm on 27May2021 at 16:25 (at age of 65 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included cancer (family medical history), cholesterol, blood pressure and heart attack from an unknown date and his father had heart attack in his 50's but he chain smokes. AE(s) following prior vaccinations: When he was 16, he got the flu shot and got severely sick. The patient concomitant medications were not reported. Patient received the first shot on 27May2021. The next day on 28May2021, he had all the symptoms such as injection site pain, very tired, headache, chills, Feverish, feeling very unwell. The next day on 29May2021, it seemed like he was fine. Now, ever since then, all he wanted to do was lay down. He doesn't feel well. He had stomach pain. He was kind of in a fog. He just wanted to lay in bed. He did vomit one time. He had loss of appetite. He wanted to know if someone could provide advice, that he should get second dose or not. He lost a few pounds in the last week. He was still in a fog. Injection site pain went away the following day. Other than having stomach pain, he doesn't feel that bad. The headache lasted 3 days. Therapeutic measures were taken as a result of headache. He has been on Tylenol. Stomach pain was not as bad as it was for 4 days. He was feeling feverish though. Regarding loss of appetite, he did eat something for breakfast, but that was it. The foggy feeling lasted until 02 Jun 2021 (yesterday as reported) and improved on 03Jun2021 (today as reported). All of symptoms kicked in on 29 May 2021. He added that in his left ankle, he does not know how to describe it. It was not like an electric shock but a twitching. It only lasted one day and went away. The injection did not hurt and did not hit bone. He feels sure it was given in the muscle. He took blood pressure medication and never had any reaction. He did not think it was relevant. His cholesterol and blood pressure were good now. He had a test for his heart a couple of years ago. The doctor said one of his arteries for his age looks like it was pretty normal, but one had a build-up in it. The case was assessed as non-serious. Outcome of events Muscle twitching, Feeling abnormal, Decreased appetite, Vomiting, Pyrexia, Fatigue and Malaise was recovering while outcome of Abdominal pain upper was not recovered and unknown for weight decreased. Patient was recovered from Vaccination site pain and Headache on an unknown date and Chills on 29May2021.
65 2021-06-16 sleep disorder entire body muscle tightness, chills, headache, interrupted sleep through the night
65 2021-06-17 loss of personal independence in daily activities Symptoms: Numbness in fingers and hands; pain in arms, shoulders, lower back, hips, buttocks, and l... Read more
Symptoms: Numbness in fingers and hands; pain in arms, shoulders, lower back, hips, buttocks, and legs; sharp, jagged pain in hands and inability to form a fist in both hands; inability to walk, stand, sit for more than 15 minutes, dress self, inability to wash and groom self; total body weakness Treatment: Two one-week treatments of Medrol, pack of 21, Lioresal EQ 10 mg, Tramadol 50mg; one week treatment of Prednisone pack of 78, ortheses bilateral hands for carpal tunnel syndrome Outcomes: Some relief from hand and wrist pain
65 2021-06-22 mental status changes Cerebral venous thrombosis; bilateral intracerebral hemorrhage in the left, greater than the right; ... Read more
Cerebral venous thrombosis; bilateral intracerebral hemorrhage in the left, greater than the right; tonic-clonic seizure; brain swelling/cerebral edema; headaches; overall imbalance/having balance problems; he had a decline; kind of getting worse/ had the worst symptoms; His prostate is enlarged; patient's mental status is altered; This is a spontaneous report from a contactable physician. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: EN6203) as 0.3 ml single for COVID-19 immunisation. Patient age at vaccination was 65 years old. Medical history included hyperlipidemia and high cholesterol. Historical vaccine included 1st dose of BNT162B2 (LOT: EL3247) on 03Feb2021 for COVID-19 immunisation. Concomitant medication included pravastatin (strength: 10 mg) taken for an unspecified indication from an unspecified start date and ongoing. Reporter did not know all of the symptoms that the patient had and cannot get the history, because the patient's mental status was altered (from unknown date in 2021). It was reported that he was having symptoms for at least 2 weeks with some increasing over the last 2 weeks. Knew that he had an overall imbalance and was having headaches, both from unknown date in May2021. He had been having symptoms for weeks and went to his doctor as an outpatient. He had initial imaging that was concerning and he went to the hospital because he had a decline (from unknown date in 2021). He had declined and had a hemorrhagic hemorrhage with cerebral venous thrombosis, both from 04Jun2021. He was admitted to the hospital 04Jun2021, and 05Jun2021 he was transferred to the ICU. He had declined since his initial presentation and had been kind of getting worse over the last couple of weeks. Stated the patient was stoic and does not have a lot of medical problems, but everyone knew he was having symptoms over the last 2 weeks. 02Jun2021 he had the worst symptoms and was basically having balance problems. He was getting concerned and had called to get an appointment with his primary care physician. They had done an outpatient CT scan which found the cerebral venous thrombosis and he went to the hospital and was placed on Heparin. While in the hospital, he had a generalized tonic-clonic seizure and had further decline on 04Jun2021. Repeat imaging showed that he had bilateral intracerebral hemorrhaging, the left greater than the right, and they had expanded a bit. He was still on heparin and now (Jun2021) had some cerebral edema due to it but was not on a ventilator. He was still in the time period where he was continuing to have small declines. He was therapeutic on heparin. He had a central line and was getting hypertonic saline for the brain swelling and cerebral edema. Patient previous health condition was reported as he did not have a real significant past medical history. He maybe carried a diagnosis of hyperlipidemia and high cholesterol. He was pretty healthy; regularly went to the doctor and was otherwise pretty stable. Reporter did not even think his LDL was that high. He had never been on any blood thinners or anything like that. They did a full scan to look for cancer and had no history of blood clots. They did a scan that was negative for any types of masses or any concerns for cancer. His prostate was enlarged (from unknown date in 2021) and they had spoken to the family about it and they said he had been worked up with a biopsy which had been negative. Physician Office? Yes, He was directly admitted to the hospital from primary care. He presented to the clinic because he had these symptoms and headaches. The imaging was done and then he was admitted. He never went through the emergency room. Cerebral venous thrombosis, bilateral intracerebral hemorrhage, overall imbalance/having balance problems, he had a decline, headaches resulted in Physician Office Visit. Outcome of cerebral venous thrombosis, bilateral intracerebral hemorrhage was not resolved; outcome of tonic-clonic seizure, brain swelling/cerebral edema, headache, overall imbalance/having balance problems, he had a decline, kind of getting worse/ had the worst symptoms, enlarged prostate and mental status was altered was unknown. Causality: Cerebral venous thrombosis: Can't say for sure because reporter does not know the timeline but can't find any other reason, he would have cerebral venous thrombosis.; Sender's Comments: Based on the temporal relationship, the association between the events cerebral venous thrombosis, intracerebral hemorrhage, tonic-clonic seizure, and brain swelling with BNT162b2 can not be fully 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.
65 2021-06-22 motion sickness, memory impairment, feeling abnormal Symptoms (24x7, for last 15 weeks) o Feels like pressure inside my head. Occasionally headaches, bu... Read more
Symptoms (24x7, for last 15 weeks) o Feels like pressure inside my head. Occasionally headaches, but mostly pressure. o Best description is that I feel slightly "hung over" every day. Or like I have the flu or some other virus o Constant light headed, balance issues – Worse in morning , a little better later in the day o No dizziness, no vertigo o Memory and cognitive skills not at 100% (forgetful, using wrong words occasionally, foggy) o Ringing in ears; vision changes o Exhausted, weak o Get car sickness which has never been a problem before o Stiff, painful popping neck o Nagging cough for months o Possibly increased nasal congestion o Occasional palpitations – seem slightly more frequent than before but unsure o Occasional headaches behind my eyes
65 2021-06-24 feeling abnormal Out of sorts and dizzy; Out of sorts; Heaviness in his upper chest and shoulders; Heaviness in his u... Read more
Out of sorts and dizzy; Out of sorts; Heaviness in his upper chest and shoulders; Heaviness in his upper chest and shoulders; Felt wobbly; sneezed 4x in rapid succession then he felt like he couldn't breathe; Felt like his heart or left lung was going to burst; Aches and pains in his body like he had the flu; Sneezed 4x in rapid succession then he felt like he couldn't breathe; This is a spontaneous report from a Contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264) via unspecified route of administration, administered to right shoulder, on 04Feb2021 at 9 AM, as unknown dose, single for COVID-19 Immunisation. Medical history included bipolar disorder. The patient's concomitant medications included testosterone undecanoate (AVEED) taken for hypogonadism, start date was unknown and it was ongoing; Lithium Carbonate taken for Bipolar disorder, start date was unknown and it was ongoing; Valproate semisodium (DEPAKOTE) taken for Bipolar disorder, start date was unknown and it was ongoing; lurasidone hydrochloride (LATUDA) taken for Bipolar disorder, start date was unknown and it was ongoing; Levothyroxine sodium (SYNTHROID)taken for Hypothyroidism, start date was unknown and it was ongoing; Pantoprazole taken for Gastrooesophageal reflux disease (GERD), start date was unknown and it was ongoing; quinapril taken for blood pressure high, start date was unknown and it was ongoing; Metformin taken for diabetes, start date was unknown and it was ongoing; Mirabegron (MYRBETRIQ) taken for Urine abnormality, start date was unknown and it was ongoing. Caller stated that he had adverse effects immediately after getting the injection. On 04Feb2021 (also reported as: less than 30 seconds after the injection), the patient experienced like out of sorts and dizzy. He stood up and walked to the observation area and had a heaviness in his upper chest and shoulders and felt wobbly. After 15 minutes, he stood up and went to his car and felt almost normal. When he got home, about 2 hours later, he sneezed 4 times (4x) in rapid succession then he felt like he couldn't breathe. Stated that he had to try to stay calm and tried to relax, and almost immediately it felt like his heart or left lung was going to burst, but it went away after a second. Stated that about 2 hours later he had aches and pains in his body like he had the flu, and that lasted for about 30 minutes, then they went away. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 04Feb2021 at 2:30 PM, the outcome of the events were recovered. Follow-up attempts completed. No further information expected.
65 2021-06-24 impaired work ability I was working at a university and that is why I got the shot there. 30 minutes after my 2nd shot, I... Read more
I was working at a university and that is why I got the shot there. 30 minutes after my 2nd shot, I was driving home and my heart started beating rapidly and it felt like I was having a asthma attack. I drove the apartment and laid down. I had the rapid heart beat and tiredness for several days. I had days where I was so exhausted I called in sick or worked from home. I still get tired easily , have rapid heart beats for up to an hour at a time and some days just take it easy. I resigned from my job because I felt I could not function and I wanted to be closer to home where my doctors were located. I had only taken a day or two sick leave before my injection, but took many days after the shot. I feel much better other than what I described above. I am reporting this because all news is talking about younger individuals. But I had/have the same symptoms and over 65.
65 2021-06-24 sleep disorder can't really sleep; injection site pain to his right arm; pain at the top of his arm going down his ... Read more
can't really sleep; injection site pain to his right arm; pain at the top of his arm going down his arm/ the whole arm itself just hurts; pain at the top of his arm going down his arm/ arm hurts/when he turn had pain up his armpit; when he turns his neck to the right he has pain up his armpit; This is a spontaneous report from a two contactable consumer (patient and his wife). A 65-year-old male patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Batch/Lot Number: unspecified), via an unspecified route of administration on 30Jan2021 (age at the time of vaccine 65-year-old) as 1st dose, 0.3 mL, single dose on right arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were not specified but taking for blood pressure unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the pfizer suspect. On 01Feb2021, the patient experienced pain at the top of his arm going down his arm/ the whole arm itself just hurts/when he turns his neck to the right, he had pain up his armpit. On an unspecified date, the patient could not really sleep and had injection site pain on his right arm had kept him awake. The patient stated he was calling about the Pfizer BioNTech COVID19 vaccine and stated he had been having a reaction of side effects and asking how long the side effects could last. The patient stated that for the first couple of days after getting the vaccine he had nothing and then the pain started a little bit on Monday and then on Tuesday the pain got a little worse; stated that last night the pain was beginning to keep him up from sleep. The patient stated all the adverse events are ongoing. The patient's wife stated the indication for which the patient received the vaccine was they are trying to be safe, and the patient's HCP called him and asked the patient if he wanted to take the shot. The patient's wife stated they both received the vaccine. The patient stated he was given paperwork down at the site location where he got the shot but was given the paperwork after he was administered the shot and the paperwork was a list of side effects; stated if he had seen the list of side effects before, he was administered the shot, he probably would not have taken the shot. The patient's wife stated the patient received no testing or treatment for the reported events. The patient did not visit emergency room. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
65 2021-06-27 loss of personal independence in daily activities So, I started to have some epidermis outbreaks about a week after the second vaccine. Shortly, after... Read more
So, I started to have some epidermis outbreaks about a week after the second vaccine. Shortly, after that I had a poison ivy reaction, but this reaction was different in which it started to go, which is odd for poison ivy. I was having an overaction to certain irritants as well. I also would have an abnormal amount of warts that were showing up. I have a lot of epidermis outbreaks. I also have had terrible joint pains also which started a week after the second dose. I was not able to lift things or do normal activates. I am still having trouble with my joints.
65 2021-06-29 feeling abnormal Back pain; Leg pain; Right knee swelling; foot numbness in both left and right feet; Light headed; F... Read more
Back pain; Leg pain; Right knee swelling; foot numbness in both left and right feet; Light headed; Felt odd; Tired; Queasy; Sore Arm; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via unspecified route of administration in right arm on 12Mar2021 at 13:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The medical history included lower back disc surgery on 12Mar2014 was successful but had low level pain on right side and constant slight numbness in right foot 3 small toes and high blood pressure. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril (MANUFACTURER UNKNOWN) 20 mg daily for high blood pressure. The patient received no other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 12Mar2021 at 13:15, the patient felt light headed and felt odd initially after injection. At 1-3 days felt tired , queasy and experienced sore arm. On 15Mar2021, at 3-4 days the patient experienced back pain and leg pain, right knee swelling, foot numbness in both left and right feet which made the patient difficult to be active and experienced continued same symptoms as day 1-3. At 7-10 days, the patient was mostly back to normal. The patient did not receive any treatment for events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of light headed, feeling abnormal, tiredness, queasy, painful arm, back pain, leg pain, swelling of right knee, numbness in feet was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
65 2021-07-01 poor quality sleep Arthritis; pain down to the knee and lower back; pain down to the knee and lower back; hardly sleep.... Read more
Arthritis; pain down to the knee and lower back; pain down to the knee and lower back; hardly sleep.; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration on 04Mar2021 at 09:15 hours (at the age of 65-years-old) as a single dose, for COVID-19 immunisation. Medical history included hypertension (controlled), cholesterol (controlled) and allergies to intravenous pyelogram (IVP) contrast dye (iodine based). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included ezetimibe (ZETIA) 10mg once and omeprazole (MANUFACTURER UNKNOWN) 20 mg once a day; both from an unknown date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 08Mar2021 (after four days), the patient experienced a serious arthritis episode in the right hip with radiating pain down to the knee and lower back which as of this submission was still giving him problems. For a week, the patient could hardly sleep. The patient reported that even now (as of report), it hurts just lying on the bed. The patient had a doctor's appointment but cannot get in until 29 March (after the second shot). The patient did not receive any treatment for events. The clinical outcome of events arthritis, knee pain, lower back pain and sleep unwell were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
65 2021-07-17 excessive sleepiness His eyes felt hard and it was hard to focus and he had a little headache and little dizziness; wobbl... Read more
His eyes felt hard and it was hard to focus and he had a little headache and little dizziness; wobbling around; Headache; Dizzy; Sleeping a lot; Fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, Batch number: Unknown) via an unspecified route of administration, administered in the right arm on 28Jun2021 at 15:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history included ongoing blood pressure high (started 20 years ago). Concomitant medications were not provided. On 28Jun2021, the patient experienced fever, on 29Jun2021, he was dizzy and was sleeping a lot, and on 30Jun2021, he had headache. On an unspecified date, his eyes felt hard and it was hard to focus and he had a little headache and little dizziness and wobbling around. The clinical course of the events was reported as: he mentioned he had gotten the COVID-19 shot on Monday 28Jun2021 and had been dizzy for two days since he took it. He was also sleeping a lot. He got up and was dizzy and wobbling around. He wanted to know if this last a while. The events described as: dizzy: he clarified he first felt it when he got out of be yesterday, on Tuesday (as reported). His eyes felt hard and it was hard to focus and he had a little headache and little dizziness. Fever: He also had a fever, initially stated it was when he went to bed on that first night. He clarified while sleeping he woke up with a fever that first night. Headache: He believed he had headache because his eyes cold not focus and clarified he first felt it this morning and he was unable to provide an outcome, stating it just started this morning. Sleeping a lot: he first noticed this yesterday (as reported). He was sleeping all day yesterday and had been sleeping today. He drunk something, drank some tea, and ate, then went back to sleep. Now he had back up. He stated that he had already slept most of the day today, but he was up now. He further explained it seemed to be a little better now. Investigations: He confirmed he had not gone to the doctor's office, emergency room, or had any labs or testing due to events. He stated that was one of the reasons he was calling to determine if he should go. The outcome of the event dizzy was not recovered, sleeping a lot and fever were recovering, and the outcome of the other events was unknown.
65 2021-07-18 sleep disorder 65 y.o. African American male who suffered from COVID-19 PNA earlier this year, as well as MRSA endo... Read more
65 y.o. African American male who suffered from COVID-19 PNA earlier this year, as well as MRSA endocarditis with septic brain emboli and fungal empyema. He was in rehab and presented to SMC ER with persistent cough without fever x 1 week, and associated chest pain. He states he was unable to produce sputum for some time, but he has finally been able to expectorate clear/ yellow phlegm in the last day or so. The cough disrupts his sleep. He notes pulmonary wheezing.. He smokes 2-3 cigarettes per day at this time and does not use any inhalers. He also reports persistent diarrhea and new right foot swelling which started morning of admission. Patient reported being fully vaccinated for COVID19 and was found to be positive via PCR. His CXR showed CM, central vascular congestion, RT small effusion/atelectasis, but no infiltrates and no clear pneumonia. The patient was discharged to a SNF 7/2/21.
65 2021-07-20 abnormal dreams Dreams every time i fall asleep (Day or Night) Reoccurring mild headaches and light headedness which... Read more
Dreams every time i fall asleep (Day or Night) Reoccurring mild headaches and light headedness which last for a few seconds at a time
65 2021-07-26 insomnia After the second shot I started getting what feels like cramps in my thighs, buttocks, and calves al... Read more
After the second shot I started getting what feels like cramps in my thighs, buttocks, and calves along with pain in my lower back; at night it's hard to sleep with the pain and the leg stiffness that accompanies the pain. Getting up in the morning is agonizing as my legs are stiff and almost immovable. Symptoms usually appear late in the day, especially before bedtime! Pain is bad, and I've been going to my doctor but all he wants to do is give me painkillers that have bad side-effects, so I'm getting by with OTC pain relief products, both oral and topical.
66 2021-01-04 feeling abnormal he couldn't take a deep breathe; smothering feeling; felt an out of body; light headedness; This is ... Read more
he couldn't take a deep breathe; smothering feeling; felt an out of body; light headedness; This is a spontaneous report from two contactable physician received via Medical Information Team. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right shoulder on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that: "on 23Dec2020, a minute after vaccination he felt as if he couldn't take a deep breathe, it was like a smothering feeling, then he felt an out of body and light headedness, this only lasted for 3 minutes". The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test which resulted negative and SARS-CoV-2 test: no positive results for the COVID Test prior to the vaccine. The patient outcome of the events was recovered. Information on the lot/batch number has been requested.
66 2021-01-05 impaired work ability Absolutely no problems after the vaccination until about 24 hours later: Then sudden onset malaise, ... Read more
Absolutely no problems after the vaccination until about 24 hours later: Then sudden onset malaise, fever, myalgias (including injection site pain which was not previously present) arthralgias, headache, nausea, malaise to the point where I could not continue to work. I went home, took 600 mg ibuprofen, 25 mg of benadryl and slept for 4 hours. I felt better when I woke up and feel good today, as if nothing happened
66 2021-01-08 impaired work ability No immediate post vaccine symptoms other than slight clear rhinorrhea and mild sneezing for a few ho... Read more
No immediate post vaccine symptoms other than slight clear rhinorrhea and mild sneezing for a few hours. By evening about 12 hours post vaccine felt fatigue and some increase in mild baseline myalgias. During night sleep significantly disrupted by generalized myalgias, along with some strange transient paresthesia. Such that at about 4:30 AM I texted my 3 workplaces that I did not expect to go to work that day. Went back to bed, woke up around 9:30 AM 1/8/2021 and nearly all myalgias resolved, still fatigued but better. Paresthesia's were transient and resolved. Went to work after all. Today, Saturday 1/9/21 woke up and all symptoms resolved.
66 2021-01-14 impaired work ability Aches.pain, shakes, temp>100 and as high as 100.8. Cough. Tired.Missed work.
66 2021-01-21 insomnia Approximately 9 hours after injection, I was awakened with heart pounding in my chest and it felt fa... Read more
Approximately 9 hours after injection, I was awakened with heart pounding in my chest and it felt fast but I did not check it. Watch did not show higher than 84 through the night but I could not sleep much due to the heart pounding. Arose for work at 6:15 and felt tired but the palpitations did not bother while standing. Temperature 98.8. about 90 minutes later, while at work, HR was 130-148, I was breathing deeply, otherwise okay. Chills started about 17 hours post-injection and temperature rose as high as 102.4 in the next 3 hours. HR lowered to about 110 about 16 hours post injection and did not get below 100 for another 12 hours. some coughing throughout this time, not productive. Heavy night sweats around 34 hours post injection. I had mild chills about 48 hours post injection, and fine since then. The palpitations were very uncomfortable but stopped once the HR lowered to about 110
66 2021-01-28 insomnia Excessive thirst after both vaccines, just after second vaccine, face becoming bright red and blood ... Read more
Excessive thirst after both vaccines, just after second vaccine, face becoming bright red and blood pressure low, two days after second vaccine, unable to sleep, passed out when standing up X 1, nausea, fatigue
66 2021-01-31 feeling abnormal After the first dose I had no side effects but after the second dose I had various reactions: - abou... Read more
After the first dose I had no side effects but after the second dose I had various reactions: - about thirty minutes after the shot I developed a strange sensation on the left temporal area of my head extending to behind my eye. This went away after a few hours but when it started I thought of Bell's Palsy. - Later my arm got extremely sore at the site of the injection it still hurts and in a large area of the arm 5 days later - Painful area below the left armpit and in an area about 3 inches in diameter (area of the lymph node). Still have pain although less after 4 days.
66 2021-02-07 feeling abnormal The vaccine was given on 1/28/2021. The patient reported to the Medical Center ED on 2/7/2021 with ... Read more
The vaccine was given on 1/28/2021. The patient reported to the Medical Center ED on 2/7/2021 with complaints of worsening bilateral lower extremities pain, swelling, numbness L>R leg for about a week. He reports significant purple discoloration of his legs, "purple spots on lower legs", pain in bilateral legs worse with rest and standing still and associated DOE. Denied chest pain, abd pain, palpitations, fever, chills, NVDC, sick contacts, recent trauma/falls/injury. Denies regular use of NSAIDs, antiplatelet meds or chronic anticoagulation, clotting or bleeding disorders, history of DVT or PE. Patient was seen here by the ED staff on 2/3/2021 after a syncopal event at home where he described feeling light
66 2021-02-09 abnormal dreams Woke up at 2am with pain at the injection site, chills, and hallucinating dreams.
66 2021-02-16 feeling abnormal Thirty minutes after 1st vaccine administered mental foggiest and headache and acrid taste in mouth.... Read more
Thirty minutes after 1st vaccine administered mental foggiest and headache and acrid taste in mouth. Then three days post vaccine return of brain fog and headache. Gradually headaches subsided within ten days.
66 2021-02-16 sleep disorder 102F temperature, chills, headaches, tiredness, can't sleep at night. The headaches are weird in th... Read more
102F temperature, chills, headaches, tiredness, can't sleep at night. The headaches are weird in that I will get a sharp pain in my head that goes away in a second.
66 2021-02-18 anxiety, feeling abnormal Severe Sinus drainage starting 2 days prior to second dose. Constantly fatigued. Brain fog, or delay... Read more
Severe Sinus drainage starting 2 days prior to second dose. Constantly fatigued. Brain fog, or delay in being able to respond to questions. Trembling of hand and of body at times. Anxiety also at times.
66 2021-02-23 feeling abnormal Headache, Fuzzy Brain, Felt Cold, Lethargic and Tired
66 2021-02-24 mental status changes slipped in parking lot on cold day while transferring to car Narrative: pt, after this fall and ER... Read more
slipped in parking lot on cold day while transferring to car Narrative: pt, after this fall and ER trip that happened on the day of the vaccine, -pt had a history of metastatic lung cancer and was admitted to outside hospital with altered mental status and found to have brain mets, is now in hospice. Low likelihood that covid vaccine was responsible.
66 2021-02-26 nervousness, feeling abnormal According to staff....Recipient received the above vaccination and went to sit for 30 minutes. He h... Read more
According to staff....Recipient received the above vaccination and went to sit for 30 minutes. He had already explained to the staff that he had had previous reactions to bee stings that required epinephrine so the nurse practitioner had instructed him that he was to wait for 30 minutes vs the usual 15 minutes. It is unclear exactly how many minutes into the post-vaccination period passed before he began to report numbness around his lips. The nurse practitioner then indicated he began a "rash" on the back of his neck. The recipient reported that this was feeling very much like his previous allergic reactions. They took his BP and it was reported to be around 180/100 at that time. He did not report feeling SOB but reported his throat felt like it had in previous allergic reactions. Recipient remained alert and oriented the entire time. It was decided by the two nurse practitioners on site that he be given the epinephrine and Benadryl IM. His BP remained elevated and then, following the epinephrine, he became very shaky and a bit foggy. 911 was then notified for further assistance from the EMT's and possible evaluation at the local hospital which was about 5 minutes away. Paramedics evaluated the recipient and agreed that evaluation at the hospital would be warranted. He never lost consciousness or required oxygen or other assistance. He was able to place himself on the gurney and was speaking with his wife (that was present)as he was taken out the door. The transfer was done out of an abundance of caution. We do not know if the hospital kept him following the incident.
66 2021-03-01 insomnia, sleep disorder Sleep disturbances. Insomnia
66 2021-03-05 sleep disorder, hallucination, abnormal dreams Muscle soreness and joint pain with headache the following day for most of the day. Two days after t... Read more
Muscle soreness and joint pain with headache the following day for most of the day. Two days after the injection ,and for two days I experienced severe dizziness and abdominal pain producing yellow bile. I was unable to stand up for more than a couple of minutes for most of those two days. I was unable to eat and had only Pedialyte for most of those two days. I started to hallucinate mid day and had fever dreams that inhibited sleep. No treatment was given.
66 2021-03-06 feeling abnormal Mild dizziness, felt fuzzy. BP 156/90 (pulse 64), O2 sat 98%.
66 2021-03-13 impaired work ability Awoke March 8 with vertigo dizziness such that I could not walk without assistance or plus asthma sy... Read more
Awoke March 8 with vertigo dizziness such that I could not walk without assistance or plus asthma symptoms. Took meclizine and stayed in bed till March 10. Symptoms subsided on March 11 but continued absence from work & very limited activity until the 12th. Symptoms are better but still not completely recovered
66 2021-03-14 feeling abnormal He woke up this morning and felt awful; He is mainly fighting fatigue now and feeling rough; His sin... Read more
He woke up this morning and felt awful; He is mainly fighting fatigue now and feeling rough; His sinuses shut down yesterday; muscles hurt and legs hurt; muscles hurt and legs hurt; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; This is a spontaneous report from a contactable consumer reported for himself. A 66-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9269 via unspecified route of administration at the left shoulder on 08Feb2021 11:00 AM (at the age of 66-years-old) for COVID-19 immunization. The patient received the vaccine at hospital. Medical history included a bypass surgeries (18 stents), a chronic obstructive pulmonary disease and he donated a kidney in 1997 and immunosuppressed. The patient had COVID at the end of December.Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81 mg, 1x/day, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) 1x/day (200/25 one puff), sacubitril valsartan sodium hydrate (ENTRESTO) twice a day, fenofibrate 160 mg, 1x/day, isosorbide mononitrate (IMDUR) 120 mg, 2x/day, metolazone 5 mg, 1x/day, as needed, metoprolol 100 mg, 2x/day, famotidine (PEPCID) 40 mg, 2x/day, clopidogrel bisulfate (PLAVIX) 75 mg, 1x/day, potassium (POTASSIUM) as needed, 10mEq, evolocumab (REPATHA) 140 mg, biweekly, ranolazine (RANEXA) 1000 mg, 2x/day, montelukast sodium (SINGULAIR) 10 mg, 1x/day, torasemide as needed(40mg up to 160mg ), colecalciferol (VITAMIN D [COLECALCIFEROL]) 50,000 units once a week, nitroglycerin. On 08Feb2021 about midnight, he woke up and had shortness of breath and chest pain, he took 6mg Nitro and he took two at midnight; He took another one at 1:00AM and it had pretty much gone away. Around 2:30AM the chest pain hit again big time, he woke up on morning and felt awful. On 08Feb2021 his muscles hurt and legs hurt. He was mainly fighting fatigue now and feeling rough. His sinuses shut down on unknown date. The patient recovering from muscles hurt and legs hurt and recovered from chest pain. The outcome of the other adverse events was unknown.
66 2021-03-15 anxiety Anxiety. Severe concern about how I felt at the moment, lying in bed. Started at about 2:30 am. An e... Read more
Anxiety. Severe concern about how I felt at the moment, lying in bed. Started at about 2:30 am. An electric feeling. Hard to describe. I thought I might be having a heart attack. It happened several times, resolving to a normal state after 40 min or so, being ok for maybe 1/2 an hour then returning. After 3 or 4 worrisome crescendos, I decided to go to the Emergency Room at 4:30 am. Observed there, released with analysis being it was anxiety, not a heart problem.
66 2021-03-17 excessive sleepiness Swore arm at injection site and serious fatigue at ten pm after shot that continued through the fol... Read more
Swore arm at injection site and serious fatigue at ten pm after shot that continued through the following day and evening until feeling better on Wednesday morning after 12 hours of sleep! Also I noted that the 2nd covid-19 dose recorded on the15th of March is identical to the one I received on February 22, 2021, leading me to believe that the person who administrated the second shot simply copied the lot number information from the first shot that was recorded on card.
66 2021-03-18 confusional state, amnesia Pt presented after an episode of amnesia/ confusion at home with possible facial droop, & headache. ... Read more
Pt presented after an episode of amnesia/ confusion at home with possible facial droop, & headache. Found to have bite mark on tongue & cheek Evidence he fell onto face & broke glasses. Suspect 1st time Seizure with postictal confusion as MRI brain showed no stroke. Admit to hosp for further eval and treatment.
66 2021-03-18 sleep disorder 3-14-21 Knot in neck on left shoulder felt like golf ball, 3-14-21 pain was so bad could not go to s... Read more
3-14-21 Knot in neck on left shoulder felt like golf ball, 3-14-21 pain was so bad could not go to sleep I was up 28 straight hours before I slept, 3-15-21 After massage by girlfriend (has therapist license) moved to upper neck/spine area, pain was severe but felt like a large marble, 3-16-21 same pain 3-17-21 pain still there and make any head movement extremely difficult almost paralyzing, 3-18-21 pain subsided some, slight sweating periodically and experienced occassional chills. The neck issue is the worse problem I am having. Ending tis report at 9:50 PM on 3-18-21. I have been tested twice for covid 19 in 2020, both tests were negative.
66 2021-03-19 loss of personal independence in daily activities EXTREME tiredness, headache, body ache. Unable to work or carry out daily activities. Still having "... Read more
EXTREME tiredness, headache, body ache. Unable to work or carry out daily activities. Still having "symptoms" 14 days after vaccination.
66 2021-03-19 memory impairment, nervousness Trembling, loss of consciousness periodically, memory lapse, nervousness after 15 mins of the vaccin... Read more
Trembling, loss of consciousness periodically, memory lapse, nervousness after 15 mins of the vaccine administration
66 2021-03-21 feeling abnormal 2/27 Patient presented to a Clinic with ~4 days of nausea, chills, muscle aches and fatigue. He was ... Read more
2/27 Patient presented to a Clinic with ~4 days of nausea, chills, muscle aches and fatigue. He was diagnosed with COVID-19. He continued to feel poorly and 3/1 was started on doxycycline as an outpt. 3/3 was started as outpt on dexamethasone. 3/6 Presented to ED w/ worsening symptoms including SOB. RA pulse ox was 88%. He was admitted for COVID/COPD exacerbation and was changed to IV azithromycin/rocephin and dexamethasone. He was maintained on oxygen. He was unable to be weaned off oxygen and was discharged to home on 3/9 on oxygen.
66 2021-03-21 feeling abnormal After 3 hours of vaccine, extreme diarrhea lasting 1 evening. Normal stools the next day. Normal act... Read more
After 3 hours of vaccine, extreme diarrhea lasting 1 evening. Normal stools the next day. Normal activity until 03/20/2021. 03/20/201 had coffee at 6:30 am didn?t feel good. Didn?t take meds, had 2-3 hours nausea, had fluids, then vomited. No food for a day and a half. Had soup on the 21st and tuna and had more diarrhea that night and Monday morning. Other side effects include chills, brain fog, body aches in the back and legs, rash development on left knuckle, itchy head and body, slight headache. The red spot where the needle went into the left arm. Temperature 98.4. blood pressure 140/90 pulse rate 80.
66 2021-03-23 hallucination Hallucinations; severe abdominal pain; producing yellow bile; severe dizziness; fever; muscle sorene... Read more
Hallucinations; severe abdominal pain; producing yellow bile; severe dizziness; fever; muscle soreness; joint pain; headache; first dose 13Feb2021 - second dose 02Mar2021 which is 17 days; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 02Mar2021 02:15 PM (lot number: EN6202), at the age of 66-year-old, as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, no allergies to food or medicine, allergic to dogs, cats, tree pollen, grasses, dust mites, mold, horses. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, start and stop date were not reported; azelastine taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 on 13Feb2021 01:45 PM on Left arm (lot number: EL9267). The patient did not have COVID prior vaccination. On 03Mar2021 07:00 am, the patient experienced muscle soreness, joint pain and headache. On 04Mar2021, the experienced severe abdominal pain producing yellow bile, severe dizziness with hallucinations and fever. The patient was unable to stand for more than a few minutes for most of that 48 hours. The outcome of the events severe abdominal pain producing yellow bile, severe dizziness with hallucinations and fever was recovered in 06Mar2021; while the other events was recovering. No treatment was received for the events. The patient was not tested for COVID post vaccination.
66 2021-03-24 feeling abnormal I have never passed out prior; 1 in.laceration above the right eye along; food is less flavorful and... Read more
I have never passed out prior; 1 in.laceration above the right eye along; food is less flavorful and does not excite me; Feeling queasy; bruising to my upper arm, leg and back; don't feel right; About 10 hours after the second injection began to have chills and a low grade fever.; About 10 hours after the second injection began to have chills and a low grade fever.; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route of administration (on left arm) on 06Mar2021 12:00 (at the age of 66 -years-old), single dose for COVID-19 immunisation. Medical history included Diabetes Type 2 (Doctor stated that I really do not fit either profile. Concomitant medications included pioglitazone, metformin, lisinopril, ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). Patient stays away from all Opioids they make him very nauseous. Patient typically gets a low grade fever (100-101) and chills 4 hours after a Flu Vaccine that last almost exactly 24 hours. The patient had the first dose of covid vaccine on 11Feb2021 for covid-19 immunisation and experienced only minor soreness at the injection site with the first dose. Experience only minor soreness at the injection site with the first dose. About 10 hours after the second injection began to have chills and a low grade fever. Sunday morning 07Mar2021 started feeling queasy. Patient thought that if I took a shower that I might feel better. As Patient was getting toward the end of his shower Patient just thought, Patient don't feel right. The next thing Patient remember Patient was picking himself of the floor of the shower. Patient have never passed out prior to this episode. Patient received a 1 in. laceration above the right eye along with bruising to his upper arm, leg and back. Patient basically ate nothing the remainder of Sunday nor Monday. It is as if the food is different. Even though he is a Diabetic and keep his blood sugar under control. Patient knows that this may sound weird, but it is as if the food is less flavorful and does not excite him. As 09Mar2021, he still does not feel together. The outcome of the events was not recovered. No treatment for any adverse event. No Covid prior vaccination, not Covid tested post vaccination.
66 2021-03-25 anxiety The patient's wife noted he began to experience: 101F temperatures, muscle aches, headache, feelings... Read more
The patient's wife noted he began to experience: 101F temperatures, muscle aches, headache, feelings of impending doom or that everyone is out to kill him, mumbled to himself (not normal)
66 2021-03-25 loss of personal independence in daily activities, sleep disorder at first it was pain across my shoulders and to my wrists, next added pain in my legs (not my feet) ... Read more
at first it was pain across my shoulders and to my wrists, next added pain in my legs (not my feet) and light headedness. I could hardly sleep all night from pain and aches. The next morning I had a hard time using my legs and could hardly lift anything, that lasted all day wednesday into thursday. Thursday the pain lessened and the weakness became less but I started getting pain in my hips and heavy painful bloating feeling in my intestinal area. That lasted all day and into Friday (today). Today (Friday) the pain in my arms subsided, legs got better (no pain but still weak) but the intestinal issues are keeping me incapacitated and the top of my hips ache.
66 2021-03-30 confusional state high fever; high heart rate; low oxygen; high blood pressure; chills; he was confused and out of it;... Read more
high fever; high heart rate; low oxygen; high blood pressure; chills; he was confused and out of it; did not have as much confusion as he did with the first dose; weak; This is a spontaneous report from a contactable consumer reported for her father. A 66-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 11: 00 am for covid-19 immunisation. Medical history included sleep apnea from 2010 and ongoing, hypertension from 2011 and ongoing, polycythemia vera from 2015 and ongoing, two strokes (both in 2016), myasthenia gravis from 2019 and ongoing, mass on kidney (right kidney, Found in 2020 and being monitored), COVID-19 from Dec2020. The patient was negative for COVID as of "13Jan2013" (as reported). The patient was hospitalized for COVID for about a week in Dec2020. Concomitant medications included levothyroxine from 2019 and ongoing for Thyroid maintenance, azathioprine from Aug2020 and ongoing for myasthenia gravis, clopidogrel from 2016 and ongoing for Stroke prevention/ blood thinner, hydrochlorothiazide from 2019 and ongoing for hypertension, nifedipine from 2015 (maybe) and ongoing for hypertension, bisoprolol from maybe like 2015 and ongoing for hypertension, atorvastatin from an unspecified date and from Mar2020 and ongoing at new dosage (unspecified) for blood cholesterol, hydroxycarbamide (HYDROXYUREA) from 2015 and ongoing for polycythaemia vera. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6201) via an unspecified route of administration in the left arm on 11Feb2021 for covid-19 immunisation, experiencing tested for COVID and he tested positive at that time with symptoms on 12Feb2021, unresponsive like he could answer he questions but he was unable to get up to get out to the car to go to the hospital on 12Feb2021 at 14: 00, muscular weakness and confused and out of it/confusion on an unspecified date. The patient got flu shot in Oct2020 and that was the last vaccine prior to COVID shot. The patient had both doses of the COVID vaccine, and both times he ended up in the hospital with a reaction. The reporter stated that the doctors were not calling the patient's reaction an allergic reaction, but the patient had a high fever, a high heart rate, low oxygen, high blood pressure and he would have chills and he was confused and out of it. Caller stated that the patient was currently in the hospital. For the second dose, the patient got the reaction occurred a little quicker, it started around 10 pm yesterday, but it was not really bad until today at 10am, and so that was when the caller called 911 again. Caller stated that today, the patient did not have as much confusion as he did with the first dose, but he was weak, had a high fever, high blood pressure, high heart rate and low oxygen. Caller stated that the patient was sent home after the first dose with a nasal cannula and oxygen but his oxygen was low. Caller reported that the patient went to the ER this morning, he had not yet been discharged but he also had not been admitted to the hospital at the time of this phone call. The patient had covid test on 12Mar2021 with positive result. The reporter stated that she didn't really think anything had been abnormal, other than, she knew the vaccine did not cause someone to get COVID, but the week before his first does, the patient was tested for COVID, and he was negative. The reporter reported that the day the patient went to the hospital on 12Feb2021, he was tested for COVID and he tested positive at that time. Caller reported that she took the patient to his primary care doctor a few days later, and the patient had two tests, both the mouth and nasal swabs and those were both negative. Caller stated that everything else that the hospital tested the patient for, looked good. Caller stated that he had bloodwork done, and cultures and a Chest Xray and everything looked clear and normal. Caller reported that the only thing abnormal was that one COVID test on 12Feb2021, and the caller had him tested again a few days after that, and 10 days after that, and those tests were all negative. The patient was not admitted to the hospital after the first dose, only was in the ER. The patient was currently in the ER and it was unclear if he will be admitted to the hospital or not at the time of this call. Outcome of the events was unknown.
66 2021-03-31 confusional state muscular weakness; he was confused and out of it/confusion; he was unresponsive like he could answer... Read more
muscular weakness; he was confused and out of it/confusion; he was unresponsive like he could answer he questions but he was unable to get up to get out to the car to go to the hospital; tested for COVID and he tested positive at that time with symptoms; This is a spontaneous report from a contactable consumer reporting for her father. A 66-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 13:45 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation . Medical history included sleep apnoea syndrome from 2010 and ongoing , hypertension from 2011 and ongoing , polycythaemia vera from 2015 and ongoing , cerebrovascular accident on 2016 , myasthenia gravis from 2019 and ongoing , renal neoplasm from 2020 to an unknown date , covid-19 from Dec2020 to an unknown date (Hospitalized for COVID for about a week in Dec2020) , thyroid disorder from an unknown date. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder from 2019 and ongoing; azathioprine (AZATHIOPRINE) taken for myasthenia gravis from Aug2020 and ongoing; clopidogrel (CLOPIDOGREL) taken for prophylaxis, anticoagulant therapy from 2016 and ongoing; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension from 2019 and ongoing; nifedipine (NIFEDIPINE) taken for hypertension from 2015 and ongoing; bisoprolol (BISOPROLOL) taken for hypertension from 2015 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from Mar2020 and ongoing; hydroxycarbamide (HYDROXYUREA) taken for polycythaemia vera from 2015 and ongoing. The patient experienced he was unresponsive like he could answer questions but he was unable to get up to get out to the car to go to the hospital on 12Feb2021 14:00 with outcome of unknown , he was confused and out of it/confusion on an unspecified date with outcome of unknown , tested for covid and he tested positive at that time with symptoms on 12Feb2021 with outcome of unknown. The event Unresponsive to stimuli was considered an Important Medical Event. The patient underwent lab tests and procedures which included blood test: everything looks clear and normal , chest x-ray: everything looks clear and normal , culture: everything looks clear and normal, Sars-cov-2 test: positive on 12Feb2021, Sars-cov-2 test: negative on 22Feb2021. Course of the event Caller reports that her father had the first dose of the COVID vaccine on 11Feb2021, at 1:45PM, and about exactly 24 hours later, his reaction started at 2pm on 12Feb2021. Caller reported that after the first dose, her father had muscle weakness and confusion, he was unresponsive like he could answer he questions but he was unable to get up to get out to the car to go to the hospital, so the caller had to call 911. Caller reported that her father was not actually admitted to the hospital, he was taken to the ER and was there for maybe 6 hours before his body just snapped out of the reaction, and he was discharged home that same day. Follow up information has been requested.
66 2021-04-03 impaired work ability Five days after my second vaccine, at about 8 am, I developed fairly diffuse abdominal pain, and ret... Read more
Five days after my second vaccine, at about 8 am, I developed fairly diffuse abdominal pain, and retching. I left work and went home. This lasted for about 3 to 4 hours, then let up, but then developed about 45 minutes of profound rigors, which then let up, then my temperature (had been normal) went up to less than 102 F. For the next six days I continued to run fever, never higher than 103, chills, and some migrating abdominal pain, no diarrhea, normal stools, constipated if anything. Stayed home from work obviously. On Sunday, and Monday am, still running fevers, my pain seemed to settle into my right lower quadrant. My wife, a family physician, helped arrange a CT scan Abdomen and Pelvis, as we were concerned about appendicitis, maybe an abscess. The scan revealed normal appendix, but several lesions in the right side of the liver thought highly suspicious for "metastatic disease." MRI recommended, and had this Wednesday that week, and it confirmed the lesions, with characteristics suspicious for metastatic tumors. By Monday afternoon, my fever abated, and I felt much better. Able to return to work. The abdominal discomfort was improved, maybe due to constipation. Friday of that week, I was able to get to see my primary provider, who is in Omaha, NE to review the situation, and we agreed a liver biopsy was needed. A week later, Friday, Jan. 29, I had CT guided liver biopsy at hospital in Omaha. 16 cores taken, and no malignancy found, but significant inflammatory cells, especially lymphocytes. Meanwhile I have felt fine. Decided to do a follow up MRI of liver, which was done Friday, April 2, and all the areas have resolved. There is an entity called "Inflammatory pseudotumors" of the liver, and my condition fits with this. It is very rare. A consideration would be whether it would be possible to stain the biopsy to see if the lymphocytes carry antibodies to the corona virus.
66 2021-04-08 mental status changes Symtoms: headache, loss of vision in left eye, vertigo. Stroke took time to diagnos, I thought it ... Read more
Symtoms: headache, loss of vision in left eye, vertigo. Stroke took time to diagnos, I thought it was a vision problem. Long time delays occurred while scheduling further testing (CT and MRI). Summary from MRI: "Study Result Impression: There is diffusion restriction along the left thalamus consistent with subacute ischemia, greater than 6 hours in etiology but less than 2 weeks." Outcome: Vision is slowly improving, headache is mostly gone, vertigo & mental status slowly improving.
66 2021-04-15 mental status changes, confusional state Ischemic stroke. Presented to ER with confusion and altered mental status at Hospital. Transferred t... Read more
Ischemic stroke. Presented to ER with confusion and altered mental status at Hospital. Transferred to another hospital for possible CVA
66 2021-04-15 mental status changes Last seen normal 9pm on 4/14; on 4/15 patient had altered mental status, fever (105.3 F), and hypogl... Read more
Last seen normal 9pm on 4/14; on 4/15 patient had altered mental status, fever (105.3 F), and hypoglycemia. Presented as a sepsis-like picture. Patient required D10% infusion for hypoglycemia. Diagnostics did not reveal any source of infection (CTA negative for PE and pneumonia, CT abd/pelvis negative, head CT negative, urinalysis unremarkable, chem port site did not appear infected). Troponin was elevated (up to 10.8) with bedside echo showing EF=35% with severe apical wall hypokinesia (previous echo was 60%); EKG was similar to baseline. Patient went to cath lab; coronary vessels were not occluded.
66 2021-04-17 sleep disorder Evening day of injection: Fatigue, chills and muscle aches. Mild headache. Night: Muscle aches worse... Read more
Evening day of injection: Fatigue, chills and muscle aches. Mild headache. Night: Muscle aches worse, very little sleep all night. Next day: Whole body aches, all muscles, bad headache, hot then cold chills off and on all day. Spent the entire day in bed. Slept better at night finally. Second day a little less severe and mostly gone by the third day.
66 2021-04-18 insomnia After the second vaccination on April 3, 2021, I started having a low-grade fever on Tuesday, April ... Read more
After the second vaccination on April 3, 2021, I started having a low-grade fever on Tuesday, April 6. The fever was oscillating between 97 and 99.8°. On April 10 the fever got worse and went as high as 101.8°, and I started to develop a cough. I called my local general practitioner for advice on Monday, April 12. Should recommended A Covid test. Over the course of the week I continue to have symptoms of fever oscillating between high and low temperatures (chills and fever) and an increasing development of the cough. Over the course of the illness mornings seem to be better and the temperature with spike in the afternoon. Sleeping was difficult because of the persistent cough. It is currently April 19, 2021 and I still have the persistent cough and intermittent low-grade fever. I had an appointment with my my doctor Dr., she indicated that although the duration is longer than a normal lease see that this would appear to be an adverse effect two of the Covid vaccination. She requested that I report the symptoms that I was having.
66 2021-04-19 feeling abnormal Female who presents to the office today stating last Thursday on 2/25/2021 she received her first Co... Read more
Female who presents to the office today stating last Thursday on 2/25/2021 she received her first Covid vaccine which was Pfizer. She reports premedicating herself before the vaccination with 1 Pepcid and 2 Benadryl. However unfortunately within 13 minutes of receiving the vaccine she started to experience a and irritation of the tongue/throat with tingling sensation followed by throat hoarseness, a cough and a red face. She was experiencing a little bit of chest tightness in addition to a little bit of shortness of breath and therefore used her albuterol inhaler. Shortly thereafter her red face improved. EMS was called to the scene however by the time they arrived she was improving and was sent home. She took a Benadryl at home later in the evening and the following day on Friday she started Pepcid daily since that time. She states since the vaccine she has felt poorly describing exhaustion and feeling achy all over with continued raw throat. She has not warranted use of her albuterol inhaler since last Thursday and ran out of Benadryl Thursday evening only utilizing Pepcid daily and continues on her other medications. She reports a history of allergies to petroleum products including polyethylene glycol which is suspected to be the cause of her allergic reaction
66 2021-05-03 loss of personal independence in daily activities Neurologist agreed that the vaccine has attacked nervous system; They thought he was having a stroke... Read more
Neurologist agreed that the vaccine has attacked nervous system; They thought he was having a stroke because the left side of his body was twitching and numbness all the way from the arm to the feet; He had some kind of palsy where his face was not reacting bilaterally; Got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms; He hasn't been able to work since 25th; He cannot coordinate his thoughts and fantasies; Dizziness; He felt his head was spinning; Nausea; He couldn't stand up without falling; Pressure in his brain; Pain in the rear of his head between the neck and the cranium; Inability to speak/Slurring his speech; twitching and numbness all the way from the arm to the feet; twitching and numbness all the way from the arm to the feet; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 2 via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The Reporter stated, her husband had the Pfizer vaccine and the second dosage he got really sick 18 hours after it and it lasted for like two days where he was really, really sick, all sorts of symptoms. He got very sick. the Reporter stated, there was a problem and it's recurring and the vaccine was affecting people neurologically and if they have had something like concussion or any neurological damaging the path was attacking their nervous system. So, this was major, and this was happening not just 3 people we know and the doctors were agreeing that this was happening from the Pfizer vaccine. The Reporter stated, the patient had been in emergency 3 times, patient thought he was going to die. He hasn't been able to work since 25th and he has been in emergency 3 times they have done MRI's and CT scans. And he was very sick, he cannot coordinate his thoughts and fantasies. He was not dead; he was very sick. On Mar2021, the Reporter stated that, Everything CT scans, MRI, ear exams, audiology test was done it. On Mar2021, the reporter stated that, the patient was hospitalized 1 night in emergency for observation. He was hospitalized about three days ago. He was discharged the next day, but he was in emergency overnight. He was hospitalized for the vaccine he took, and the neurologist agreed that the vaccine has attacked nervous system. The Reporter again stated that the patient had some of the symptom's dizziness, he felt his head was spinning, they thought he was having a stroke because the left side of his body was twitching and numbness all the way from the arm to the feet, he thought he was having a stroke. He had some kind of palsy where his face was not reacting bilaterally, he had nausea, he couldn't stand up without falling, pressure in his brain, pain in the rear of his head between the neck and the cranium and inability to speak, he was slurring his speech. The outcome of the events was reported as unknown No follow-up attempts are needed; information about lot/batch number cannot be obtained.
66 2021-05-04 disturbance in attention 2nd shot received 2/1/2021. Shingles seen 02/18/2021. Blisters broke 02/19/2021. Visited doc 02/20/2... Read more
2nd shot received 2/1/2021. Shingles seen 02/18/2021. Blisters broke 02/19/2021. Visited doc 02/20/2021. Rx Valacyclovir (7 days). Pain lasted 2 weeks. Fatigue since then has caused me to have to nap almost every afternoon, 1.5-2 hours. Unable to concentrate for as long as I used to. Shortness of breath and inability to walk as far as normal (regular 1.5m walk now a challenge). Worsening tinnitus.
66 2021-05-13 disturbance in attention I have been sick since the day after the first the first Pfizer shot. 24 hour head ache, drowsy, los... Read more
I have been sick since the day after the first the first Pfizer shot. 24 hour head ache, drowsy, lost concentration, ringing in my ears and just cant seem to wake up. I have been to the doctor three times and had mutable blood labs, and am now seeing a neurologist who has ordered a MRI of my brain. The problem is none of the doctors have any experience dealing with these adverse symptoms from the injection, does anybody? So who is going to help me before the lights go completely out?????
66 2021-05-14 anger, feeling abnormal, insomnia, impaired work ability I am angry and it is effecting my sleep, it's effecting my job and my sleep; I am angry and it is ef... Read more
I am angry and it is effecting my sleep, it's effecting my job and my sleep; I am angry and it is effecting my sleep, it's effecting my job and my sleep; Could not sleep last night/ It is effecting my sleep; It felt like someone socked me in the head/ Feel bad; Neck pain/ right side of my neck is painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head/ Strained Neck, Neck Pain; Headaches/ it is like a crown headache; Nauseated; Flu-like symptoms; Kidney Stones 2-3 weeks after Vaccine; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 28Feb2021 (Batch/Lot Number: EN6203) at the age of 66-year-old, as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Feb2021 (Batch/Lot Number: EL9264). Medical history included, nephrolithiasis from Dec2020 to Dec2020, ongoing sleep disorder, pain from an unknown date and unknown if ongoing. Concomitant medication included eszopiclone (LUNESTA) taken for sleep disorder from an unspecified start date and ongoing; tamsulosin hydrochloride (FLOMAX RELIEF) taken for nephrolithiasis from Dec2020 to an unspecified stop date; hydrocodone bitartrate, paracetamol (NORCO) taken for pain, sleep disorder from Dec2020 and ongoing. The patient reported that he received his 2nd Pfizer vaccine dose on 28Feb2021 and after 10 - 12 hours it felt like someone socked me in the head. The patient has had neck pain and headaches ever since the 2nd dose on 28Feb21. He stated: 'I am angry, and it is effecting my sleep, it's effecting my job and my sleep. Somedays the neck pain may go away a little, but never completely and the headaches are terrible. I have tried applying ice and applying heat, I have been to the chiropractor to treatments.' Patient is a self-employed and this was affecting his ability to work. He stated that the left side ok and the right side of my neck was painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head. It is like a crown headache. I have never had problems with headaches before this vaccine. The reported adverse events were: kidney stones 2-3 weeks after vaccine (nephrolithiasis) on 2021 with outcome of unknown , neck pain on 28Feb2021 with outcome of not recovered, headache on 28Feb2021 with outcome of not recovered , nausea on 28Feb2021 with outcome of recovered, flu-like symptoms on 28Feb2021 with outcome of recovered, insomnia on 02May2021 with outcome of unknown, feeling abnormal on 28Feb2021 21:00 with outcome of unknown, anger on an unspecified date with outcome of unknown , and impaired work ability on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of neck pain and headache. Information on Lot/Batch number was available. Additional information has been requested.
66 2021-05-14 insomnia Muscle and joint pain; Muscle and joint pain; headache; extreme fatigue; sore arm; chills; unable to... Read more
Muscle and joint pain; Muscle and joint pain; headache; extreme fatigue; sore arm; chills; unable to sleep; Overall just don't feel well; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on left arm on 08Feb2021 (at the age of 66-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history included pacemaker, replacement knees and left hip. The patient had known allergy with cipro and vancomycin. The patient had COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. The patient was not tested COVID-19 post vaccination. On 09Feb2021 at 02:00, the patient experienced muscle and joint pain, headache, extreme fatigue, sore arm, chills, unable to sleep. Overall, the patient just did not feel well. The patient did not receive any treatment for the event. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
66 2021-05-25 disturbance in attention SEVERE HEADACHE, TINITUS, DROWSY/GROGGY FEELING ( all day ) , LOW CONCENTRATION, FORGETTING ALOT OF ... Read more
SEVERE HEADACHE, TINITUS, DROWSY/GROGGY FEELING ( all day ) , LOW CONCENTRATION, FORGETTING ALOT OF COMMON THINGS. He states he has been taking Motrin 800mg 1 TAB, PRN. HE STATES HE HAS GONE TO SEVERAL DOCTORS FOR THESE ISSUES. THE FIRST DR. VISIT WAS ON 05/03/21 PCP- Dr. referred him to a neurologist... Dr. visit with neurologist was on 05/13/2021- MRI, LABS .. on 05/24/2021 - conclusion , MRI/LABS (normal). Dr. recommended B3 vitamin and B12, states he started taking both of the vitamins yesterday.
66 2021-05-28 feeling abnormal He did not feel good the next day; Woke up with sweats; fatigue; Swelling of lymph nodes in neck in ... Read more
He did not feel good the next day; Woke up with sweats; fatigue; Swelling of lymph nodes in neck in opposite side of injection; scratchy throat; Pain; Bruising on left arm; He can still see a little discoloration in his arm; had no energy; he felt worse; This is a spontaneous report from a contactable consumer. A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL3248), via intramuscularly, administered in left arm muscle on 15Jan2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunization at School/Student Health Clinic. Patient's medical history included asthma (diagnosed many years ago as a child) and blood cholesterol. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) 60 units 100/50 two puffs daily, acid reducer and cholesterol medication, uses inhaler (unspecified) for Asthma. The patient previously took fluticasone propionate (FLOVENT). Patient had no vaccines administrated prior to covid 19 vaccine no additional Vaccines were administered on same day of the vaccine. On 16Jan2021, at 06:00 (reported as after the first few days) patient had had bruising on arm, not out of the ordinary. On 21Jan2021, at 06:00 patient started getting pain and swelling in lymph nodes in neck and a scratchy throat. That has been on for a while now. It was reported that last Friday, he felt worse and had fatigue at 10:00, did not feel well and in the middle of night, woke up with sweats on 30Jan2021 at 01:00. He did not feel good the next day. Now, he was back to swelling in lymph nodes and sore throat. There was a couple of days where he did not notice it at all and was supposed to get next vaccine on Wednesday and was not sure if he should or not. He provided his weight as 140ish. There was no prescriber. Patient still had a little discoloration in his arm, but it was not tender. Last Wednesday and Thursday, he felt good and could feel a little swelling in his lymph nodes, and on Friday, he felt more fatigued. Patient was always felt fatigued, but on Friday, he had no energy. The scratchy throat this morning was not as bad, but by this afternoon, it is least as sore or more of the same. He is still fatigued, but he can work. When he gets done with work, he was much more tired and fatigued and even during the day, he felt he was not quite right. The outcome events were not recovered for swollen lymph nodes, scratchy throat, fatigue, bruising on left arm and night sweats, and unknown for the rest of the events. Follow-up attempts are completed. No further information is expected.
66 2021-05-29 amnesia 48 hours after the second dose he began running a high fever with body aches. His fever lasted almos... Read more
48 hours after the second dose he began running a high fever with body aches. His fever lasted almost 3 weeks using Ibuprofen and Tylenol twice a day ever day with his fever rarely breaking. I took him to the ER at Hospital on Monday, May 10th. They diagnosed him with Colitis after reviewing a CT scan of his abdomen. He was discharged back home later that evening where he continued on to oral antibiotics: Flagil and Levaquin for 10 days. He was in bed for over 4 weeks with no appetite and lost approximately 15 pounds. It made his chronic vertigo worse with increased memory loss and loss of dexterity in fingers.
66 2021-05-31 sleep disorder After 1st and 2nd shot Mild flush face sore arm same night no other problems Until on or about 5/... Read more
After 1st and 2nd shot Mild flush face sore arm same night no other problems Until on or about 5/1/21 Headaches dry throat rapid heart beat legs angels swelling cold not flashes can not sleep every night and sometimes in morning
66 2021-06-01 insomnia Erythema multiforme; Hives over parts of the body growing and changing shapes; itchy; painful to tou... Read more
Erythema multiforme; Hives over parts of the body growing and changing shapes; itchy; painful to touch; high fever 104.5; intense night sweats; chills; cough; wheezing; fatigue; body weakness; muscle pain; headache; cannot sleep; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 19Mar2021 19:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Diabetes type 2, CAD (coronary artery disease), BPH (benign prostatic hyperplasia), osteoarthritis, gall stones. Concomitant medications included metformin; eicosapentaenoic acid ethyl ester (VASCEPA); ezetimibe (ZETIA); fenofibrate; ursodiol. The patient previously took morphine and known allergies to morphine, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 26Feb2021 18:45 (Batch/Lot number was not reported) as 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. The patient experienced Covid-like symptoms (high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep) from 18Apr2021 and had a covid test (Nasal Swab) on 22Apr2021: negative. The patient also experienced hives over parts of the body growing and changing shapes, itchy, painful to touch - erythema multiforme on 29Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events and included amoxicillin sodium, clavulanate potassium (AUGMENTIN), azithromycin (Z-PACK), ibuprofen (ADVIL), paracetamol (TYLENOL), diphenhydramine hydrochloride (BENADRYL), cetirizine hydrochloride (ZYRTEC). The outcome of the events high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep was recovered on 27Apr2021, of the other events was not recovered. Information about lot/batch number has been requested.
66 2021-06-02 anxiety Pt is a resident in a SNF. He went for dose 2 of his Pfizer Covid series at 950am on 6/2. At 12:30am... Read more
Pt is a resident in a SNF. He went for dose 2 of his Pfizer Covid series at 950am on 6/2. At 12:30am on 6/3 he became weak, anxious, SOB and required oxygen supplementation. He was shaking and weak and transferred to hospital via ambulance.
66 2021-06-13 sleep disorder, insomnia, anxiety I got the vaccine in the morning. That night I was unable to fall asleep the whole night. A few we... Read more
I got the vaccine in the morning. That night I was unable to fall asleep the whole night. A few weeks went by and then I started experiencing occasional insomnia. I would wake up in the middle of the night and be unable to go back to sleep. It kept getting worse such that I could not fall asleep without taking a sleeping pill. What happens is that when I lay down after about 10 to 15 minutes I start to feel a surge of energy. My body gets hot. It is not a fever. My heart seems to beat faster and my mind is racing. My doctor prescribed both Ambien and Lunesta. I take one or the other and eventually I go to sleep. I am averaging about 4 hours of sleep at night after I take the drug. The stress of not being able to sleep well has given me some anxiety issues. In addition, the anxiety has led me to develop high blood pressure. I am now taking high blood pressure medicine. I am not the kind of person who has anxiety normally. I believe the vaccine introduced something into my system that is triggered every night now preventing me from natural sleep.
66 2021-06-16 nervousness I'm thinking... I'm having covid; chills; body malaise; fever/100.4 temperature; worse in the evenin... Read more
I'm thinking... I'm having covid; chills; body malaise; fever/100.4 temperature; worse in the evening Friday; I'm scared; feeling cold; This is a spontaneous report received from a contactable consumer (Patient). A 66-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER2613, expiration date date: Jul2021), via an unspecified route of administration in left arm on 18Mar2021 at 14:15 as single dose for COVID-19 immunization. Medical history included Gout. Concomitant medications included Febuxostat for uric acid. On 19Mar2021 at 01:00 pm (Friday) at lunch time, the patient felt cold and had chills, around lunch time, body malaise all over later in the day. The patient had fever around that time, which worsened in the evening of Friday. On Saturday in the morning, the patient stated that fever was a little bit better around lunchtime to the evening and the same thing happened on Sunday and Monday too. The patient stated that fever gets worse in the lunchtime also in the evenings. The patient stated that fever had been the same for the past 3 days. The patient stated that he felt ok in the morning and as It was only 9am in Hawaii, he doesn't know how he will feel today. The patient stated that in the first 2 to 3 days he was not sure if he really had a fever or not because he didn't had a thermometer. The patient stated that yesterday he had a fever of 101.4. The patient stated that he did not take any ibuprofen or Tylenol. The patient stated that he can always bear with it. The patient stated that he was scared to get the 2nd dose as it was scheduled on 08Apr2021. The patient stated that he has been healthy all this time and now after he got the shot, he was thinking that he had covid. The patient wanted to know whether this was normal and what he could do to make it better. The caller stated that he was bearing it for now. The patient did not receive any treatment medication for the events. The outcome of the event thinking that he had covid was unknown and not recovered for other events. No follow-up attempts are needed. No further information is expected.
66 2021-06-17 anxiety I was not feeling good; cold sweats; the cramp started from dehydration in every muscle of my body; ... Read more
I was not feeling good; cold sweats; the cramp started from dehydration in every muscle of my body; could not walk; muscles cramps; He lost 15 pounds in 3 weeks or less since he has had the vaccine; shaking; Nauseated; I got sick; Vomiting; Muscles were dehydrated and had cramps in fingers and toes cramped with his left arm going straight out.; Muscles were dehydrated and had cramps in fingers and toes cramped with his left arm going straight out.; Muscles were dehydrated and had cramps in fingers and toes cramped with his left arm going straight out.; Diarrhea; Cold, sweaty feeling; Cold, sweaty feeling; Dizziness; Fell off a ladder; both legs feel weak/Arms weak; anxiety worse; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EP7533), intramuscular, administered in arm right on 03Apr2021 as 1st dose, single dose for covid-19 immunisation. Medical history included gastroparesis from Jan2010 to an unknown date, helicobacter pylori from Aug2020 to an unknown date and Cdiff. The patient's concomitant medications were not reported. On an unknown date, the patient experienced not feeling good, cold sweats, the cramp started from dehydration in every muscle of his body, could not walk, muscles cramps, lost 15 pounds in 3 weeks or less since he has had the vaccine, shaking and nauseated. On 03Apr2021, the patient experienced anxiety worse. On 04Apr2021, the patient fell off a ladder and both legs feel weak/arms weak. On 05Apr2021, the patient experienced, cold, sweaty feeling and dizziness. On 06Apr2021, the patient experienced, vomiting, muscles were dehydrated and had cramps in fingers and toes cramped with his left arm going straight out and diarrhea. On 06May2021, the patient got sick. Patient stated: he got sick on 06May2021 in the middle of the night, at 2:30 AM and he layed on the floor for almost 6 hours vomiting and finally he didn't have anything left, then the cramp started from dehydration in every muscle of my body, luckily not his heart, and that was with cold sweats, he could not get warm he kept trying he did everything. Also it was so uncontrollable that he could not walk either, the muscles cramps, he finally did - he fought that at 66 years of age, which sounds young but he was old, that he couldn't control number 2 either, because it was fully out of control and peeing, everything was just going out of his body, he could not stop it, there was no blood. He didn't know where he was. He finally fell asleep. He got up after that, got my cane and got into the kitchen I got a Water with nutrients and vitamins, that night he went to bed, everything was back to normal he was still having cold sweats and then eventually that went away, and he was not feeling well until the first week of May, not feeling himself. He received second dose late because he live by himself, he getting dizzy he need to go back and sit down, this is weird, he already disabled, he been disabled like this he forgetting things like this too, his daughter was a Nurse and told him he forgetting things, his mouth was getting dry ,one more question that's all how long? he have nausea a lot, he is on on medication for nausea - it crosses blood-brain barrier and he don't like it, but That's not even working anymore. How long does this nausea effect, what he felt wasn't all the time but now it's all the time, it's not a heavy nausea it's not like he going to throw up, it just feels like he have it all the time. He have systemic sporosis, he have raynaud's (disease), he have gastroparesis and an implant (stomach). He was been sick a long time, he used to being sick, nothing he can do about the headache and nausea, but he want to do this to help everybody with disability and children, his disabilities make it all worse. He was having symptoms and wants to know if they are normal. He does not see if on the paperwork. He feels bad. He was disabled and has gastroparesis, which was prior to getting the vaccines. He has nausea and everything else from the gastroparesis, but the cold, sweaty, and cold feeling occurred since the first shot. First shot was on 03Apr2021. He could not get another shot because he was too sick with his illnesses that he has. He has a Pacemaker for his stomach. All were prior to getting vaccine. He stated he was in the hospital twice for his dizziness but later clarified that he was only kept overnight once. They originally thought he had benign postural vertigo. They did the emily movements in physical therapy to move the crystals in your ears. It seemed to work ok, but today, it feels the same. He walks around and won't go too far. He is hoarse, but does not have a temperature and is not sore. No further details provided. He goes from being soaking wet to soaking and freezing. He said he is in a good mood, just does not feel good. He lost 15 pounds in 3 weeks or less since he has had the vaccine. He was not trying to. He was laying on the floor and a bunch of other things. On 06Apr2021, at 02:30, he woke up and was so sick. He had to vomit and could not get to the bathroom and had a trashcan. He was soaking wet with sweat, shaking and could hardly walk if at all and then not at all. He was on all fours. He grabbed nearest blanket and sat on top of that with a trash can on all fours. He had a heating blanket and threw it over the top to warm up and was shaking. He could not control anything. He was too shaky. Finally, he layed down on the floor, covered up and stayed warm. He kept wiping sweat off. People that have gastroparesis are immunosuppressed and he was scared of what would happen when he got the shot. He got first shot on 03Apr2021. 0n 04Apr2021, he fell off a ladder. On 05Apr2021, he started getting dizzy during the day. He was nauseated most of the time and still is up until now. He had prior hospitalizations on 23Feb2021, and 24Feb2021. No further details provided. He stated that he is not too "with it." This started after the vaccine. No further details provided. He later stated he feels he is having Dementia since COVID lockdown. The other reason he got the vaccine is he was disabled and has an autoimmune condition and wanted to be safer. It changes day to day and he can catch anything. The second hospitalization he was not kept overnight. He found out Meclizine worked. It was not benign positional vertigo. No further details provided on Meclizine. Dizziness came back at the time of report and was persisting with walking. He can walk ok, but still feels woozy. His legs feel weak today and were not previous day. His arms also feel weak. He used wheelchair for first two days after receiving the first dose. Then it improved. His arms stayed the same. Vomiting started 02:30 am. It was the worse that he had in his life. He could not catch his breath and started having diarrhea after that. He had complete muscle dehydration. His fingers and toes were cramped and his left arm was going out straight. He layed there an tried to untie everything. He drank Essential water to get everything back in his body. The cramps went away later that day. He was feeling good by the end of 06Apr2021. During that time, he thought he was going to have a heart attack because all of his muscles were cramping. He gets dehydrated quite often. This was prior to taking the vaccine because of his gastroparesis. He said he got C-Diff because the antibiotics they gave him for helicobacter pylori killed everything off. He only remembers the name of one of the antibiotics that did that, flagyl. He does not remember the names of the other one. He does not have the dose, manufacturer, lot or expiration. He tried two and the third one worked. That one that worked was divicid. He was unsure of the spelling. Transcribed as provided. This was all prior to receiving the vaccinations. He did not have a manufacturer, lot or expiration for any of them. He has had anxiety all of his life. He was on medication for the anxiety and he has had to take more of it since getting the vaccine. He takes clonazepam and has been taking it since 2016. They are 1mg tablets and he takes 1 1/2 tablets by mouth twice daily. He would not be willing to send a sample. Count size is 90. They are in a pharmacy vial with no lot or expiration. He would like to know if it is normal for dizziness and his eyes being blurred. How long will it last. The clinical outcome of the events got sick, not feeling good, cold sweats, the cramp started from dehydration in every muscle of his body, could not walk, muscles cramps, fell off a ladder, he lost 15 pounds in 3 weeks or less since he has had the vaccine, shaking and nauseated was unknown. The clinical outcome of the event dizziness was recovered on an unspecified date of Apr2021 and recovering for other events. Information on Lot/Batch number was available. Additional information has been requested. No follow-up attempts completed. No further information is expected.
66 2021-06-18 confusional state, agitation, loss of personal independence in daily activities Patient had an acute cognitive decline less than 24 hours post 1st vaccination. This includes: weigh... Read more
Patient had an acute cognitive decline less than 24 hours post 1st vaccination. This includes: weight loss, confusion, loss of ADLs (inability to dress, shower without assistance, with urinary and bowel incontinence), agitation, personality change, and impulse control issues. Unable to determine if patient will recover from this decline and may end up in hospice.
66 2021-06-21 hallucination, confusional state Patient's wife stated Husband 2021/03/12 muscle pain in legs, fever 2021/03/14 (100.4), chills (Trea... Read more
Patient's wife stated Husband 2021/03/12 muscle pain in legs, fever 2021/03/14 (100.4), chills (Treated temp down 99.8), stomach/muscle pains. Contact with Dr. 2021/03/17 (Fever 100.7) phoned. No treatments for nausea, headache, muscle pains. Hospital visit ER with confusion/hallucinations. Temp 100.4 BP 136/110, *8:30am 2021/03/19. Home incident of falling, EMS called (vitals normal) admitted in Hospital. Transferred to another Hospital (Covid Neg.), stated bad infections. Death 2021/03/21
66 2021-06-30 insomnia I would fell asleep for three hours and wake up and not able to go back to sleep again; I would get ... Read more
I would fell asleep for three hours and wake up and not able to go back to sleep again; I would get in to bed every evening and not able to sleep at all, not even for one minute; I have the energy so I am thinking the vaccine somehow affected my adrenal glands I guess; insomnia; This is a spontaneous report received from a contactable consumer or other non hcp. A 66-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Left on 03 Mar 2021 (at the age 66-year-old) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 vaccine on 10Feb2021, experienced sore arm for couple of days and few days a little bit tired on an unspecified date. The patient experienced insomnia on 21 Mar 2021, "i would fell asleep for three hours and wake up and not able to go back to sleep again; i would get in to bed every evening and not able to sleep at all, not even for one minute on an unspecified date, i have the energy so i am thinking the vaccine somehow affected my adrenal glands i guess". Consumer stated, "I am calling about Pfizer-BioNTech COVID-19 Vaccine. I was told and I have been waiting for close to an hour and this was the the number given to report the vaccine symptoms. I have some symptoms. I was fine, I had really no symptoms after the first vaccine just there was sore arm for couple of days and for a few days a little bit tired more than I normally would be. I got the second vaccine and then around the beginning of the third week like on Sunday 21Mar2021, I started which would be beginning of the third week after the vaccine, I don't know which I have never had before, I started getting every single day insomnia. I would fell asleep for three hours and wake up and not able to go back to sleep again and then that happened for two days. Then every two days, I would get in to bed every evening and not able to sleep at all, not even for one minute and then for another one or two days maximum of two to four hours of sleep when I usually get eight to nine. So, for next couple days not one minute of sleep and since last night, I didn't sleep for 1 minute and I still haven't slept at all." When paraphrased the concern, consumer stated, "I have got insomnia but I have the energy so I am thinking the vaccine somehow affected my adrenal glands I guess. I have no issues, I take medicines for nothing, no adrenal gland issues, nothing at all. I am in perfect health. I don't take any medicines for anything. I just have coffee whenever and didn't sleep well and and never have I had insomnia. Also, I am grateful for having both first and second shots of the vaccine. I hope that it ends, this insomnia." Consumer further stated, "I want to report the symptom and also I would like to know how many people have reported the insomnia and what would be the reason. I haven't slept, so I would like to know some of the factors affecting my adrenal glands or whatever something is wrong." Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
66 2021-07-01 nervousness The next day after vaccine, I experienced all symptoms of COVID 19 except for sore throat. I went in... Read more
The next day after vaccine, I experienced all symptoms of COVID 19 except for sore throat. I went in to see my family practice doctor, got tested for COVID 19. It came back negative. These symptoms lasted for a month. I thought I was going to die. I still have fatigue, wheezing and a cough. I have been shaky and have fallen several times. I have lost 40 pounds since I received this vaccine. My family practice sent me to a GI doctor. I have also been referred to an oncologist and cardiologist to do CT scan and figure out why I still experience fatigue. Cardiologist appt on 07/13/2021.
66 2021-07-12 feeling abnormal About 4 hours after my 2nd dose, I was driving on my way home and all of a sudden I felt like I was ... Read more
About 4 hours after my 2nd dose, I was driving on my way home and all of a sudden I felt like I was hallucinating. I saw what looked like a bug infestation coming across my vision line. It was a swarm of black spots. I had to stop and re-evaluate my situation on the way home. When I gained control again, I realized it wasn't a hallucination. It was my actual vision. When I got home I basically crashed for the rest of the day. The next day I contacted my optometrist and I went in for an evaluation. They said it was a cloud of floaters. I asked if there was any chance that it was a side effect of the vaccine. They told me no. They sent me to an ophthalmologist. He told me that it will never go away. I went back to my optometrist and they said it would go away. All that they could come up with is that it is a coincidence. I have also had dizzy spells. They weren't strong, but it was like a constant dizziness. I still have all of the symptoms going on. The floaters in my eye seem like they are starting to dissipate. I have had some mild nausea. I can take a nap and it seems like it dissipates. This all came on at one time. I have been extremely tired lately. I take 2-3 naps a day and that is just not like me. It's like the feeling of being hungover, but I haven't had a drink in months.
66 2021-07-15 amnesia Progressive neurological issues, including short-term memory loss, and hand trembling. Tingling mor... Read more
Progressive neurological issues, including short-term memory loss, and hand trembling. Tingling more often from the foot up to the knee has diabetic neuropathy. Symptoms have progressively worse since the vaccine.
66 2021-07-22 excessive sleepiness Very very Tired.; Approx. 11 hours of sleep; This is a spontaneous report from a contactable consume... Read more
Very very Tired.; Approx. 11 hours of sleep; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, pneumonia and minor case of epilepsy. The patient did not have any allergies to medications, food or other products. Concomitant medications included carbamazepine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. Prior to the vaccination, 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 21Mar2021, the patient experienced very very tired and would go to bed as soon as got home from work, and slept until got up the next day for work. Approx. 11 hours of sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events very very tired and would go to bed as soon as got home from work, and slept until got up the next day for work were resolved on 28Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
66 2021-07-25 amnesia Patient states he awoke on 7/22/21 with complete memory loss; didn't know his wife or even who he wa... Read more
Patient states he awoke on 7/22/21 with complete memory loss; didn't know his wife or even who he was. Memory returned after 15 minutes. He did not seek medical care.
66 2021-07-26 feeling abnormal Breakthrough case after full vaccination. Per report from the prison, patient reported he felt awful... Read more
Breakthrough case after full vaccination. Per report from the prison, patient reported he felt awful and was having trouble breathing. Reports onset 9 days prior. Reports vomiting. Weight loss of 12lbs since 7/8/21. Reported diarrhea x 7 days. Reports cough and chest pain with coughing. Patient was transported to local ER via EMS.
67 2021-01-21 mental status changes Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccina... Read more
Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care.
67 2021-01-25 disorientation, abnormal behaviour vomiting x3 1/8/21 1/9/21 00:34 - called to resident room by CNAs, staff stated resident was "differ... Read more
vomiting x3 1/8/21 1/9/21 00:34 - called to resident room by CNAs, staff stated resident was "different". Vitals taken and 02 sat was low, O2 in room and applied via NC @3L, O2 sat returned to 98 and all other vitals WNL including BS. Resident asked how he felt, stated he felt "okay". Resident exhibiting some shakey movements and clearing throat, states he does not have any phlegm or drainage or trouble swallowing. MD called and updated on situation, voicemail left. 1/9/21 11am- resident has been making a "growling" noise this shift. resident also has tremors. resident alert and answers questions appropriately. when asked if resident wants to go to hospital, resident firmly states "no". vitals wnl. no emesis noted. will continue to monitor resident. 1/9/21 12p- resident not answering questions appropriately. resident only answering yes or no. resident cannot tell me name, or the year, resident cannot state where he is currently or birthdate.
67 2021-01-27 restlessness chills; body aches/aching all over; headaches; tired; not resting well last night/didn't rest well l... Read more
chills; body aches/aching all over; headaches; tired; not resting well last night/didn't rest well last night; a temperature of 99.9F/ fever; where he got the shot was achy; feels like he has a bad case of the flu; tremoring; muscles are achy; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date: unknown), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol since 90s and was taking medication to keep it down, and ongoing neuropathy in the feet back in the 90s. Patient seemed to be okay after the vaccination until he didn't rest well last night on 13Jan2021. The morning of 14Jan2021, he had chills and was aching all over. He has a headache, and he was pretty tired on 14Jan2021. His temperature was 99.9. and wanted to make sure he was okay. They gave him the sheet of side effects but was wondering how long it was going to last. He also had fever and chills on Jan2021. He has been just resting all day long which was all he felt like doing. Patient felt he has a bad case of the flu. When his chills started, he noticed he was tremoring and shaking and his muscles are achy on Jan2021. He usually waits until his temperature is over 100 to take something and noticed where he got the shot was achy on Jan2021. During the night he went to aching more. He was not too excited about getting up and doing anything now. He was tired on 14Jan2021, because he didn't rest well last night and slept in late today. He finally got around, and ate cereal and stuff. He has just been sitting. He would still get the second vaccine, which was not exciting. Outcome of the events aching all over, headaches, and tired are not recovered while for the remaining events was unknown.
67 2021-01-30 feeling abnormal On 01/28/21 at 8pm began feeling: - heavy fatigue - "buzzing" under the skin all over the body - sig... Read more
On 01/28/21 at 8pm began feeling: - heavy fatigue - "buzzing" under the skin all over the body - significant dizziness - Slight nausea - 97.1F Temp This lasted until about 5pm on 01/29/21. On 01/30/21 I felt: - Slight fatigue - Slight dizziness - Slight nausea Then on 01/31/21 awoke feeling feeling: - very heavy fatigue - slight "buzzing" under the skin all over the body - severe dizziness - Significant nausea - 97.0F temp - Slept most the day
67 2021-02-02 anxiety PATIENT WAS IN WAITING AREA AFTER THE VACCINE. HE HAD REDNESS IN HIS EYES, HAD DIFFICULTY BREATHING,... Read more
PATIENT WAS IN WAITING AREA AFTER THE VACCINE. HE HAD REDNESS IN HIS EYES, HAD DIFFICULTY BREATHING, RASH ON BOTH ARMS, AND WAS SLIGHTLY WARM TO TOUCH. WIFE REPORTED PATIENT HAS HISTORY OF ANXIETY ATTACKS, ASTHMA ATTACKS, AND ALLERGIC REACTIONS TO FOOD.
67 2021-02-04 feeling abnormal Patient felt weak and weird, along with nausea. BP 158/89, 135/79, pulse 74, O2 sat 96%. EMS called,... Read more
Patient felt weak and weird, along with nausea. BP 158/89, 135/79, pulse 74, O2 sat 96%. EMS called, Benadryl 25 mg PO given, patient felt better.
67 2021-02-06 anxiety Patient c/o sore throat and feeling anxious
67 2021-02-07 disorientation, confusional state Acute confusion and disorientation muscle aches
67 2021-02-09 disorientation Vax at 1645hrs on 07 Feb 2021. At about 1830hrs starting feeling hot, upper left arm sore, mild shak... Read more
Vax at 1645hrs on 07 Feb 2021. At about 1830hrs starting feeling hot, upper left arm sore, mild shaking, decided to sleep it off. I went deeply under. At various times after I would become aware I was home, alone, on couch, unable even sit up. On one occasion I determined it was 1437hrs, Tuesday, 08 Feb 2021, and sent two text messages with great difficulty just saying HELP. IT was actually 0237hrs, Monday, 08 Feb 2021. Both HELP messages had been replied with questions about what the problem was. At 1200hrs, Tuesday, 09 Feb 2021 I became lucid again though at first I believed it to be Wednesday, 10 Feb 2021.
67 2021-02-09 feeling abnormal 11:30 after receiving vaccine client states he is feeling foggy. Vital signs obtained by EMS: BP 1... Read more
11:30 after receiving vaccine client states he is feeling foggy. Vital signs obtained by EMS: BP 150/83, Pulse 74, O2 sat 97%. 11:30 am client states he if feeling better. Client discharged home by EMS.
67 2021-02-14 confusional state, disorientation, impaired work ability Patient received 2nd dose on 2/2 at 0733. Patient missed worked on 2/3/21 due to "effects from COVI... Read more
Patient received 2nd dose on 2/2 at 0733. Patient missed worked on 2/3/21 due to "effects from COVID vaccine". Patient was unable to go to work due to disorientation, confusion, headache, and chills. The patient's employee health department advised the patient's family to send patient to be seen by ED. Per ED note patient had complaint of intermittent confusion and d