Pfizer

Psychological symptom reports

Male, 90 - 110 years

Age Reported Symptoms Notes
90 2021-01-16 abnormal behaviour PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD ... Read more
PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD BEEN SICK FOR A COUPLE OF DAYS. HAD NAUSEA AND VOMITTING DURING THIS TIME AS WELL. ON 1/3 THE CARE GIVER WENT TO CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE TIME. EMS RECORDED THAT THEY THOUGHT DIAGNOSIS WOULD BE STROKE, PNEUMONIA OR SEPSIS. AFTER ARRIVAL AT THE HOSPITIAL DETERMED THAT SHE HAD A STORKE, ACUTE KIDNEY INJURY, ABNORMAL LFTS.
90 2021-01-18 poor quality sleep Dizziness - was dizzy earlier, didn't sleep well last night. B/P checked, on discharge b/p was 116/... Read more
Dizziness - was dizzy earlier, didn't sleep well last night. B/P checked, on discharge b/p was 116/57. Encouraged to hydrate and given some water. Denies dizziness on discharge
90 2021-02-02 mental status changes Abnormal chest x-ray; Altered mental status, unspecified altered mental status type; Arrhythmia; Bra... Read more
Abnormal chest x-ray; Altered mental status, unspecified altered mental status type; Arrhythmia; Bradycardia; CHF (congestive heart failure); Cardiac arrhythmia, unspecified cardiac arrhythmia type; Essential hypertension; Heart failure with preserved ejection fraction, unspecified HF chronicity; Hypothermia, initial encounter; Pneumonia of right middle lobe due to infectious organism; Right middle lobe pneumonia
90 2021-02-09 memory impairment, confusional state Vaccine on Jan 25, 2021 Minor seizure on Jan 31. 2021- 4:35pm talking, then staring, "blank stare... Read more
Vaccine on Jan 25, 2021 Minor seizure on Jan 31. 2021- 4:35pm talking, then staring, "blank stare", didn't recognize either daughter for about 10 minutes. Daughter did stroke tests, all normal. called 911, they saw no stroke symptoms, EKG normal. Within 15 minutes, he was coherent but lethargic. Could not remember 15 minutes prior. Did NOT take to ER. Saw cardiologist next day and then had head CT later that week.
90 2021-02-24 confusional state emergency Room HPI This is a 90 y.o. male who presents presents in the emergency room by ambulance f... Read more
emergency Room HPI This is a 90 y.o. male who presents presents in the emergency room by ambulance from local nursing home for complaint of fall with no localized pain but was said to have low blood pressure of 80/40 and low O2 sat of 77%. PCP said to send patient to the ER for evaluation. Patient is COVID positive but is said to have completed the vaccine on 19th of January 2021. In the ER blood pressure is 122/71, respiration 18, pulse is 68, temperature 98.7° F and O2 sat of 95% on 4 L. Patient is confused and not answering questions which is his baseline.
90 2021-03-01 disorientation unable to stand or walk; Legs no longer able provide support; mentally increased disorientation at t... Read more
unable to stand or walk; Legs no longer able provide support; mentally increased disorientation at times; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 01Feb2021 at 15:00 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 05Feb2021 4 days after vaccine, patient was unable to stand or walk with rolling walker. Prior to vaccine, patient was able to ambulate slowly with rolling walker. Legs no longer able provide support. Also mentally increased disorientation at times. Patient visited doctor office due to the events considered as disabling. At the time of the reporting the patient had not yet recovered from the events.
90 2021-03-07 mental status changes Patient began feeling ill the evening after receiving the 2nd dose of the Pfizer COVID vaccine on 3/... Read more
Patient began feeling ill the evening after receiving the 2nd dose of the Pfizer COVID vaccine on 3/3/21. He woke the next morning with AMS and was admitted to the ED with a fever of 103F. He was initially unresponsive to stimulus but no other symptoms. After arrival, given tylenol and ice packs placed. Awoke upon examination. Admitted for management of UTI with acute metabolic encephalopathy and need for cardiopulmonary monitoring. Discharged to SNF with no complaints on 3/8 for continued PT.
90 2021-03-08 insomnia Severe abdominal pain unable to eat or sleep for 36 hours. He went by ambulance to the Hospital emer... Read more
Severe abdominal pain unable to eat or sleep for 36 hours. He went by ambulance to the Hospital emergency room. They tried to pump his stomach but he aspirated and and went into cardiac arrest. He was revived but never regained consciousness. (The ICU Dr said that he had blood clots in his abdomen from a recent stroke. We were unaware of him having a stroke other than in 2026. The same Dr. said that he had necrosis in his lungs from aspirating. The necrosis was from his bowel dying) He was put on a ventilator and given drugs to increase his heart rate. On 3-5-21 the heart drugs were reduced and he died. I was with him when he recieved the vaccination and he was healthy, just old. I think that the shot killed him.
90 2021-03-16 feeling abnormal 3/17/21 ER Nurses' Triage note: "To Er via EMS for eval of AMS and low oximetry as reported by nur... Read more
3/17/21 ER Nurses' Triage note: "To Er via EMS for eval of AMS and low oximetry as reported by nurse at the rehab and long-term care facility. States he has not been his "normal " self the last few days. Upon arrival here patient is alert and verbal. Laughing with staff, poor extremity circulation shows varying oximetry, but after warm blanket applied oxi 99-100% 2lpnc. Is bradycardic with cardiac monitor showing 3rd degree block"
90 2021-03-28 mental status changes ALTERED MENTAL STATUS Bradycardia Elevated troponin Non-traumatic rhabdomyolysis Death
90 2021-04-15 loss of personal independence in daily activities, sleep disorder Total body aches - especially joints; feeling extremely tired. Impacted ADL - Significant Mobility i... Read more
Total body aches - especially joints; feeling extremely tired. Impacted ADL - Significant Mobility impact. S&S started early morning 4/12, unable to sleep due to pain. c/o S&S 4/13 - 4/16, unresolved as of this submission. Son is a physician and advised to take Aspirin for pain.
90 2021-04-23 confusional state After the second shot, my father began coughing worse and it appeared his COPD exacerbated, as well ... Read more
After the second shot, my father began coughing worse and it appeared his COPD exacerbated, as well as progression in memory loss and confusion. His oxygen levels decreased and his blood work showed low platelets, so he was admitted to hospital on March22-23. Discharged with recommendations to see hematologist. Bone marrow biopsy indicated a very rare form of leukemia (Hairy Cell ). Cancer likely not a cause of vaccine of course, but suspected low blood platelets and exacerbation of COPD?
90 2021-04-23 loss of personal independence in daily activities Significant drop in blood pressure, nausea, dizziness, significant decline in functional capacity- f... Read more
Significant drop in blood pressure, nausea, dizziness, significant decline in functional capacity- fell x 2 , was independent now requires full hands on assist for Balance and fall prevention
90 2021-05-06 amnesia, confusional state Confusion Lethargic In mobile Memory loss Motor skill loss
90 2021-05-07 feeling abnormal dizzy; the whole room began to spin/he was still wobbly; This is a spontaneous report from a contact... Read more
dizzy; the whole room began to spin/he was still wobbly; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration Date: 31May2021) via intramuscular on 31Jan2021 16:15 on right arm as single dose for covid-19 immunisation. Medical history included mesothelioma from Aug2019 and ongoing. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) reported as none. Patient took the first dose of the Pfizer covid vaccine shot yesterday at 4:15 pm. Everything was fine till about 10:30 at night when he was ready to go to bed. patient got up from his recliner, patient was dizzy and the whole room was spinning so he sat down again and tried again 5 minutes later, and he was still wobbly on 31Jan2021 22:30. Then after he sat there for a while, he was ok. patient did not have an immediate reaction. Patient asks if his reaction was serious what would they have treated him with for the dizziness. Patient asks if he should take the second dose and if the dizziness is normal. Last night patient was thinking about going to the hospital since he got panicky but then it passed. patient did not go to the hospital since there was a snowstorm. Patient did not visit emergency room and physician office. Treatment was declines any, he was drinking plenty of fluids. The outcome of the event dizzy was recovered on 31Jan2021 and unknown for another event.
90 2021-05-13 mental status changes N17.9 - Acute kidney failure, unspecified ALTERED MENTAL STATUS
90 2021-05-28 confusional state I get all sorts of pain; Fever of 101.3F; Slight shortness of breath; Confusion; Extreme fatigue and... Read more
I get all sorts of pain; Fever of 101.3F; Slight shortness of breath; Confusion; Extreme fatigue and weakness.; Extreme fatigue and weakness.; This is a spontaneous report from two contactable consumers (one is the patient). This 90-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6200), via an unknown route in the left arm, on 20Feb2021 at single dose for COVID-19 immunization, administered at Public Health Clinic/(Name) facility. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262) as single dose on 30Jan2021 for COVID-19 immunization. No other vaccine was received in four weeks. Relevant medical history included melanoma, lung cancer, peripheral neuropathy, arthritis and heart failure. Past drug history included allergy to penicillin. Relevant concomitant medications included spironolactone and bumetanide. On 22Feb2021, the patient experienced extreme fatigue and weakness, confusion and slight shortness of breath. He had fever of 101.3F five days after second dose of vaccine. The patient stated, 'I get all sorts of pain'. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the events. The outcome of the event 'I get all sorts of pain' was unknown while the outcome of the remaining events was not recovered. No follow-up attempts are needed. No further information is expected.
90 2021-06-11 sleep disorder, anxiety, disturbance in attention Patient was a healthy, active man, walked the dog 2x a day, wrote about classical music, etc. until ... Read more
Patient was a healthy, active man, walked the dog 2x a day, wrote about classical music, etc. until 02/23-26/2021: Atrial fibrillation episodes that would not resolve themselves; 03/03/2021: Cardioversion at Hospital which did not work; medications were changed or adjusted over the next weeks, Metoprolo tartrate 25mg was added 03/10/2021. Patient was anxious, napped during the day, couldn't sleep at night, couldn't concentrate on anything for any length of time, breathing irregular, had no energy to walk; 03/11-16/2021: in Hospital 04-10-14/2021: in Medical Center, for ablation and pacemaker. Great improvement, had more energy, was ale to drive again but was not back to his active self pre- 02/23/2021. Medications as of 04/27/2021 were Allopurinal 300mg daily; Atorvastatin 10mg, daily; Eliquis 5mg 2x a day; Furosemide 20mg daily; Melatonin 10mg, daily; Metoprolol succinate ER 50mg daily; Valsartan 40mg, daily; Adult 50+ Eye Health, daily; multivitamin, 1 daily; Docusate sodium 50mg as needed. By 05/26/2021, the patient is once again sleeping off and on during the day, has no energy, coughs more, can't concentrate, has lost his appetite, is anxious and discouraged. His speech is often muffled instead of clearly enunciated as is his wont. The medications have been adjusted again: as of 06/07/2021, Metoprolol 200mg, daily; Furosemide 40mg daily; the other medications remain the same. The patient, over the more than 3 months, has had xrays, electrocardiagrams, CT scans; bloodwork done. The question is: is it possible that these seemingly uncontrolable atrial fibrillation episodes are an adverse reaction to the second Pfizer vaccine? Has research been done on the vaccine and cardiac problems?
90 2021-06-24 feeling abnormal Pretty much been in bed most of the time; Body aches; Chills; Headache; Sheer exhaustion; Feels like... Read more
Pretty much been in bed most of the time; Body aches; Chills; Headache; Sheer exhaustion; Feels like he got hit by a Truck; This is a spontaneous report from a contactable consumer reporting for father. A 90-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 28Jan2021 as 1st dose, single (at the age of 90-years-old) for COVID-19 immunization. Vaccination Facility Type was reported as Clinic. Vaccine was not administered at another Facility. Patient medical history and concurrent conditions included: Ongoing prostate cancer with onset at least 15 years ago, extraction of 2 molar teeth which was done last week on an unspecified date in 2021, height shrunk. The concomitant medications included ongoing leuprorelin acetate (LUPRON) injection about every 4 months taken for prostate cancer with last dose administered last week. On 28Jan2021, patient was pretty much been in bed most of the time, had body aches, chills, headache, sheer exhaustion, felt like he got hit by a truck. The patient was administered his first dose of Pfizer COVID-19 Vaccine on 28Jan2021. The patient is normally incredibly active. He does all of his own lawn moving, snow shoveling and he still works. Starting the night of 28Jan2021 he had pretty much been in bed most of the time ever since. Most of the time since then he has had lots of body aches, chills-but no fever, headache and just sheer exhaustion. The patient went into work at the office for a couple hours Monday (01Feb2021), he pretty much slept all day Tuesday (02Feb2021). They called the patient doctor office, and the nurse gave a not real professional response to the events reported to her, that it is really common to have body aches for 2 weeks. They reported to the nurse that this is not normal for the patient. The nurse told them that this happens all the time; but advised them that if they think it is a problem to take him to the urgent care. They have not heard of people with the first Pfizer COVID-19 Vaccine being so knocked out. Some days he was ok, some days the adverse events were incredibly bad. A day before (03Feb2021) he was fine for a couple of hours, on Monday (01Feb2021) he was fine for a couple of hours. His usual statement regarding these adverse events was that he felt like he got hit by a truck. The outcome of the events was unknown. Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
90 2021-07-14 mental status changes SUSPECTED CVA; BRADYCARDIA; FACIAL DROOP; SLURRED SPEECH; WEAKNESS; DYSARTHRIA; ALTERED MENTAL STATU... Read more
SUSPECTED CVA; BRADYCARDIA; FACIAL DROOP; SLURRED SPEECH; WEAKNESS; DYSARTHRIA; ALTERED MENTAL STATUS; HYPERTENSION;HYPOKALEMIA; ISCHEMIC CARDIOMYOPATHY; LEFT BRANCH BUNDLE BLOCK; RHEUMATOID ARTHRITIS; RIGHT SIDED WEAKNESS; TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHY STARTED ON 7/4/21 AND PATIENT WAS HOSPITALIZED UNTIL 7/8/21. CARDIAC ARREST; ACUTE ENCEPHALOPATHY; ALTERED MENTAL STATUS STARTED ON 7/9/21 AND PATIENT WAS HOSPITALIZED UNTIL 7/12/21.
90 2021-07-27 sleep disorder I received two Covid-19 injections, dated: 3/26/21 (Lot Number EN6202) (I can't be certain whether ... Read more
I received two Covid-19 injections, dated: 3/26/21 (Lot Number EN6202) (I can't be certain whether it is EN6202 or FN6202 -- tiny font) 5/1/21 (Lot Number EP6955) (font is clear in this case) In May, my right thumb became stiff. It sticks when I try to bend or straighten it (whenever I need to go from bent to straightened or from straightened to bent). My arm bothers me at night when I sleep but as soon as I get up and start moving around, it's OK. But it bothers me when I am trying to sleep.
91 2021-02-09 mental status changes DIAGNOSIS: #1. CVA #2. Aphasia, acute Number 3. Change in mental status, acute ASSESSMENT/PLAN/DE... Read more
DIAGNOSIS: #1. CVA #2. Aphasia, acute Number 3. Change in mental status, acute ASSESSMENT/PLAN/DECISION MAKING: Spoke with radiologist informed me that patient had a deep ischemic or infarct change in his corona radiata area which is common in patients with covid 19 infection or vaccination, which patient had a day and a half ago after lengthy discussion with wife, she informed me that patient would not want CPR and he had a stroke in the past and does not want to go to another city as he is 91 years old and therefore not a candidate for thrombolysis and also this was a wakeup stroke and so we do not know his exact time of onset, and she states that they simply want to be treated here for comfort care.
91 2021-02-11 mental status changes RECEIVED COVID VACCINES ON 01/20/21 AND 02/10/21. 2/11/21 EMS CALLED BY FAMILY FOR ALTERED MENTAL ST... Read more
RECEIVED COVID VACCINES ON 01/20/21 AND 02/10/21. 2/11/21 EMS CALLED BY FAMILY FOR ALTERED MENTAL STATUS AND ACCUCHECK OF 40 AND TAKEN TO ER HAD NEGATIVE COVID PCR ON 02/11/21 DIAGNOSED IN ER ADMITTED TO HOSPITAL INPATIENT WITH HYPOGLYCEMIA DUE TO DMII, AMS, UTI, AND PLEURAL EFFUSION
91 2021-03-16 confusional state 91 y.o. Male with diabetes, pacemaker, hypertension, history of DVT on anticoagulation, who had his ... Read more
91 y.o. Male with diabetes, pacemaker, hypertension, history of DVT on anticoagulation, who had his second dose of Covid vaccine on 2/17. After that, he experienced left arm swelling then developed a diffuse rash on his trunk and groin, and went to urgent care on 2/25 at that time noting blisters forming in multiple areas. At that time he was started on a 10-day prednisone taper from 40 mg down and referred to dermatology. However, he then came to the ED on 3/13 complaining of worsening of this blistering rash he described as itchy, not painful, and not associated with fevers or chills. Per his daughter he was mildly confused and complaining of fatigue. In the ED, he was afebrile with normal vital signs. WBC 13.4 with neutrophil predominance, mild anemia, acute kidney injury with creatinine of 1.7, CRP 16, lactate 2.1, Covid PCR negative. No imaging was done. Blood cultures were obtained but no antibiotics were started. He was started on high-dose Solu-Medrol and topical steroids and antihistamines as well. ID consult requested for further recommendations.
91 2021-03-18 hallucination hallucinations; headache; hearing disturbing noises; nausea; stomach pain; diarrhea; vision became w... Read more
hallucinations; headache; hearing disturbing noises; nausea; stomach pain; diarrhea; vision became worse; This is a spontaneous report from a contactable consumer (patient himself). A 91-year-old male patient received the second (2nd) dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200, expiration date was not reported), via an unspecified route of administration, administered in the right arm on 23Feb2021 at 12:30 PM as a single dose for COVID-19 immunization. Relevant medical history included high blood pressure, severe anemia, diabetes, vision problems/poor vision, and spinal stenosis; all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bimatoprost (LUMIGAN) and insulin aspart (NOVOLOG) with "Bd Nano," and hydrochlorothiazid; all taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had other vaccine in four weeks, but not specified. Following the 2nd dose on 25Feb2021 at 01:00 AM, the patient suffered headache, hallucinations, hearing disturbing noises, nausea, stomach pain, and diarrhea. Additionally, he has had poor vision, but following the shot, his vision became worse. The adverse events (AE) resulted in hospitalization for 3 days on an unspecified date. It was unknown if the patient received any treatment for the events. The patient was not recovered from all the events.
91 2021-03-28 sleep disorder pt notes prolonged left arm pain after second covid vaccination. pain is shooting/deep, worse at nig... Read more
pt notes prolonged left arm pain after second covid vaccination. pain is shooting/deep, worse at night, waking him from sleep. starts at injection site, radiates downward. exam = benign, from shoulder, no weakness, no sign for impingement. rounded 2cm soft tissue nodule which is soft, is palpated. xray neg for bony abn. very bothersome trialling gabapentin, as tylenol rtc and topical nsaids= ineffective and pain seems to be neuropathic
91 2021-05-04 feeling abnormal Felt a little off; Pneumonia; This is a spontaneous report from a contactable consumer (patient's da... Read more
Felt a little off; Pneumonia; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 16Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history included deaf. Concomitant medications were not reported. Reporter stated that a week and a half after his first vaccine he had pneumonia (Mar2021); but that they didn't think it was related to the vaccine. The patient also felt a little off on 16Mar2021 and required a visit to the emergency room and physician office. The facility where the vaccine was administered was in a clinic. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no family medical history relevant to events and no relevant tests done. Outcome of the event pneumonia was unknown while not recovered for the other event. The reporter mentioned that they didn't think that pneumonia was related to the vaccine. Information about the Lot/batch number has been requested.; Sender's Comments: Based on available information, pneumonia is assessed as unrelated to BNT162B2, this is an intercurrent medical condition. Potential contributors include patient's advanced age as the risk for infections is higher in this population. Case will be reassessed if additional information is received
91 2021-05-31 memory impairment, abnormal behaviour After the first dose my father got what the eye doctor thought was pink eye. After treating him it d... Read more
After the first dose my father got what the eye doctor thought was pink eye. After treating him it didn't clear up. It was later diagnosed as herpes of the eye and he became blind in one eye. Shortly afterwards I read an article from researchers who stated they had found fragments of the herpes virus in the vaccine. After the second vaccine he was fine one day and 2 days later started having seizures. He was hospitalized for the seizures. His personality totally changed. He no longer recognized my sister. He also became hostile which is not the person he was. He was released from the hospital and brought to a new facility. Then the lights went out. he just stared off into space. A day later he was dead.
91 2021-07-22 mental status changes 91 y/o male, BMI 38, PMHx CHF, dementia, HTN, and paroxysmal Afib, admitted for acute onset altered ... Read more
91 y/o male, BMI 38, PMHx CHF, dementia, HTN, and paroxysmal Afib, admitted for acute onset altered mental status, SOB, Covid19, and pulmonary edema on 4/12/21. No reports of fever but tested positive for Covid19. Chest x-ray presents cardiomegaly with bibasilar opacities suggesting atelectasis and/or pneumonia. Covid treated with supportive care. Discharged home with hospice on 4/14/21.
92 2021-02-02 agitation, hallucination, excessive sleepiness, mental status changes Since receiving the COVID-19 vaccine, patient has been sleeping 20 hours a day with decreased oral i... Read more
Since receiving the COVID-19 vaccine, patient has been sleeping 20 hours a day with decreased oral intake. On 1/30, his mobility began decreasing and he was no longer able to use the walker he normally uses. He is also usually alert and oriented x 4, altered (including hallucinations) when admitted to the ICU on 2/1/21. Also with hypertension and AKI. Management: precedex for agitation, labetalol for hypertension, fluids and foley for AKI
92 2021-02-03 anxiety anxious; This is spontaneous report from a contactable consumer (patient's niece). A 92-year-old mal... Read more
anxious; This is spontaneous report from a contactable consumer (patient's niece). A 92-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 18Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's niece reported that her uncle had the Pfizer vaccine yesterday and now was acting really anxious. She was wondering if this is normal. Outcome of the event was unknown. Information on lot/batch number has been requested.
92 2021-03-01 mental status changes 92 year-old male with PMHx of vascular dementia, BPH, MDD, sleep disturbance , basal cell carcinoma ... Read more
92 year-old male with PMHx of vascular dementia, BPH, MDD, sleep disturbance , basal cell carcinoma of neck, osteoarthritis, BLE edema, Guillain-Barre syndrome 30 years prior, s/p COVID positive on 1/11/21 and received IV Bamlanivimab. Sent to hospital on 2/2/21 for altered mental status, generalized weakness with inability to lift bilateral UE and difficulty moving his BLE. He was treated for UTI with 7 days of Cefepime for Morganella Morganii. He was followed by neurology with MRI of the brain and CT of the spine without acute findings. Lumbar puncture unable to be obtained. He received 5 day course of IVIG for presumed Guillain-Barre . EMG showed generalized sensory motor polyneuropathy both axon loss and demyelinating type severe in degree. However, he did not recover from his GBS symptoms, was transferred back to the nursing home and died on 2/15/2021.
92 2021-04-23 feeling abnormal Shoulder pain/right shoulder is bothering him a little; Unstable feeling; unstable on his feet; back... Read more
Shoulder pain/right shoulder is bothering him a little; Unstable feeling; unstable on his feet; back is bothering him; mild tiredness/ he is very tired; weakness/ weak; periods of dizziness/ lightheaded; sleepy; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3246, expiration date not reported) via an unspecified route of administration in right arm on 30Jan2021 at 10:00 am (at the age of 92-year-old) as a single dose for COVID-19 immunisation in other type vaccination facility: park. Patient's Medical History (including any illness at time of vaccination) was none. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. There was no history of any previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no other additional Vaccines Administered on Same Date of the Pfizer Suspect. On an unknown date in 2021 patient experienced dizziness, weakness, tiredness, was sleepy, lightheadedness, unstable feeling. On 30Jan2021 patient had shoulder pain (arthralgia). It was reported that patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine 9 days ago. However, he said he was still experiencing mild tiredness, weakness, and dizziness. He wants to know if these side effects are still associated to the vaccine and if it is normal that he is still experiencing it 9 days after his 1st dose. He also mentioned that he has no temperature and his pulse and blood pressure was normal. It was then reported that patient was still suffering some side effects 2-1/2 weeks after getting the COVID-19 Vaccine. He said the side effects come and go. He said the side effects will last 4-5 hours, and then go away, and come back the next day. He said he has checked his blood pressure and pulse, and they are both OK. He said he uses an oximeter to check his oxygen level, and his oxygen is good. He said he sleeps well at night. He said he is having periods of dizziness, weakness, and feeling tired and sleepy. He said he feels lightheaded and unstable on his feet, also. He said he feels fine now. He said his right shoulder is bothering him a little, too. He said his right shoulder was uncomfortable and bothered him if he laid on it at night. Reported his back was bothering him, so he bent over a little, but if he stands up straight, he was about 5'10". He stated his side effects started a day or so after he received his COVID-19 Vaccine, and he can't remember the exact day. He said the side effects lasted continuously for several days, or about a week. He said now his side effects are sporadic. He said in the morning he will wake up and feel OK, and then after a while the side effects start. He said some days his side effects will start in the morning, and other days his side effects won't start until the afternoon. Patient declined any treatment. He said he read that any side effects from the COVID-19 Vaccine only last 2-3 days. Reporter wants to know if it is a problem that he is still having side effects after 2-1/2 weeks or is there some action he should be taking. He said he figured Pfizer is the expert, so he would ask Pfizer directly. He said otherwise, he was thinking of going to an urgent care to see what the urgent care thinks of his side effects. There was no emergency room or physician office visit. There were no relevant tests. Reported his second COVID-19 Vaccine dose was scheduled on 26Feb2021 at 9:30AM and asked if still can get the 2nd dose Vaccine after having a reaction to the 1st dose. No PQC was present. Outcome for the events weakness, periods of dizziness, tiredness, lightheadedness, sleepy, unstable feeling was not recovered, outcome for shoulder pain was recovering and for unstable on his feet, back discomfort was unknown.
92 2021-07-06 nervousness diabetic; He didn't eat much last night and didn't eat this morning.; temperature was 100.3.; Nausea... Read more
diabetic; He didn't eat much last night and didn't eat this morning.; temperature was 100.3.; Nausea; feeling dizzy; Rash; face real red; shaky and jittery; shaky and jittery; This is a spontaneous report from a contactable consumer. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0167), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 92-years-old) as unknown, single dose for COVID-19 immunization. Medical history included patient first diagnosed as pneumonia, reporter was unsure pulmonary lung infection and pneumonia are the same and treated 3-4 weeks ago for a pulmonary lung infection and type 2 diabetes mellitus. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No adverse event prior vaccinations. Patient did not perform any relevant test. Patient took a lot of medications after being in rehab but concomitant medication was not reported. Vaccine was not administered at (Privacy)Facility. On 30Apr2021, the patient experienced nausea, feeling dizzy, temperature, developed rash, red face and shaky and jittery. Patient had been bringing up stuff from lungs some of the stuff bothers and makes patient nauseated, didn't eat much last night and this morning. Patient was diabetic so she thought it might be related to a sugar thing. Patient won't drink any water and temperature was 100.3. She put a cold towel on face and it came to normal color and face was real red before, on 30Apr2021. Diabetic on an unspecified date. Reporter asks would that condition aggravate the side effects of the vaccine. Patient did not visit to physician office and emergency room. The patient underwent lab tests and procedures which included body temperature: 100.3 on 30Apr2021. The outcome of the event nausea was recovered and rest of the events are unknown. Follow-up attempts completed. No further information expected.
93 2021-01-04 abnormal behaviour The resident received is vaccine around 11:00 am and tolerated it without any difficulty or immediat... Read more
The resident received is vaccine around 11:00 am and tolerated it without any difficulty or immediate adverse effects. He was at therapy from 12:36 pm until 1:22 pm when he stated he was too tired and could not do anymore. The therapist took him back to his room at that time and he got into bed himself but stated his legs felt heavy. At 1:50 pm the CNA answered his call light and found he had taken himself to the bathroom. She stated that when he went to get back into the bed it was "abnormal" how he was getting into it so she assisted him. At that time he quit breathing and she called a RN into the room immediately. He was found without a pulse, respirations, or blood pressure at 1:54 pm. He was a DNR.
93 2021-01-16 confusional state at about 36 hrs post vaccine developed severe chills, fatigue, confusion. Chills lasted several hour... Read more
at about 36 hrs post vaccine developed severe chills, fatigue, confusion. Chills lasted several hours and after warming blanket and extra blankets they went away. Severe weakness lasted most of the following day until evening. Temp. under 100 degrees all day.
93 2021-02-03 confusional state, anxiety, disturbance in attention anxious; cognition has degraded; wounded; his confusion was the worst I've ever seen. He was totally... Read more
anxious; cognition has degraded; wounded; his confusion was the worst I've ever seen. He was totally inattentive; totally inattentive; This is a spontaneous report from a contactable consumer (patient's daughter). A 93-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 16Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes, CHF, impaired kidney function, atrial fibrillation, multiple strokes, dementia/memory issues, confusion. Concomitant medications were not reported (unspecified 15 meds). The patient previously took blood thinners. It was reported that the patient suffered from memory loss and dementia, and on 19Jan2021 his confusion was the worst the reporter had ever seen. He was totally inattentive - like, he kept tuning out until she said, Dad, Dad. Then he'd listen and it was as if he couldn't remember the sentence from 2 minutes ago. He was having difficulty putting together a coherent thought. He was not in any pain. The patient still functioned well. She said since receiving the 1st dose of the vaccine, she noticed that her dad's cognition has degraded in a very concerning way. He was very confused and anxious. She said this was all new behavior, and just started to happen after her dad received the vaccine. Then last night on 19Jan2021, apparently he wandered, which he never does, and he tried to push a nurse or aide, and tried to go into a neighbor's room, a friend, so he was looking for a safe place, and he was hitting a doorknob, and he is on a blood thinner, so he wounded himself and bled, he is on blood thinners, he didn't bleed out, she wrapped his wrist and it's fine. No treatment was received for the events 'his confusion was the worst I've ever seen. He was totally inattentive'. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was in a facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event 'his confusion was the worst I've ever seen. He was totally inattentive' was not recovered while unknown for the other events.
93 2021-02-04 mental impairment general malaise , Fatigue, poor interest in activities , hypoactivity, pulmonary embolism Narrative:... Read more
general malaise , Fatigue, poor interest in activities , hypoactivity, pulmonary embolism Narrative: Patient transferred to ER for evaluation. Physician at facility reported marked deterioration, hypoactivity and slow mentation s/p COVID vaccine second dose 1/8/21. Cough also reported x 1 week. Patient evaluated at ER on 1/20/21 and admitted to internal medicine ward with diagnosis impression pulmonary emboli, aspiration pneumonia and urinary tract infection.
93 2021-02-14 mental status changes Patient received his second dose of the Pfizer vaccine. He was accompanied by his daughter. Per da... Read more
Patient received his second dose of the Pfizer vaccine. He was accompanied by his daughter. Per daughter prior to receiving his vaccine he was his "normal" self. He was sitting in a chair next to the vaccinator. He did walk in with a walker and minimal assistance from his daughter. He did have a gait belt on around his waist. When I came to patient he was looking straight ahead with his left eye open - right eye s/p surgery to his right eye per daughter. He did not respond to questions asked. His daughter stated mentally he is normally intact. His pulse was faint but palpable. His color was pale with slight dusky skin to hands. 911 was called. Undetectable blood pressure initially with his faint pulse. Initially his heart rate was 105. He was shallow breathing. BP was undetectable sitting - with oxygenation low 80's on room air. He was lifted to a bed/cart with legs elevated. He was given supplemental oxygen. After laying down with legs up he started to look around. He was able to tell me his name and respond to questions. His blood pressure was 117/68 with heart rate 55 and oxygenation on 6L nasal cannula 87-88%. Patient's daughter stated that patient was recently at hospital with low blood pressure and questionable seizure activity. No obvious seizure activity noted today. Parametics - updated with patient history and events. Blood sugar checked at 183. Patient neurologically improved with ability to state name, his daughters name and his age. No injury noted. Dr phoned and updated on patient condition and events. Patient transported without injury on oxygen. Two daughters with patient to emergency room. Pt being evaluated by cardio on admission for sycope/possible seizure. Still admitted
93 2021-02-16 disorientation Disorientated; in a lot of pain in his chest and rib area; in a lot of pain in his chest and rib are... Read more
Disorientated; in a lot of pain in his chest and rib area; in a lot of pain in his chest and rib area; hurt to breathe and move; shaken up; Short of breath/It hurt to breathe; Concomitant medication:ongoing prednisone for immunotherapy; Concomitant medication:ongoing prednisone for immunotherapy; This is a spontaneous report from a contactable nurse. A 93-year-old male patient (reporter's father) received first does of BNT162B2 (Lot#: EN5318), via intramuscular on 28Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included ongoing prostate cancer metastatic diagnosed a few years ago and immunotherapy. Concomitant medication included ongoing abiraterone acetate (ZYTIGA) at 1g, once a day for prostate cancer and ongoing prednisone at 5 mg, tablet, twice a day, by mouth for immunotherapy. The caller stated she is reporting a reaction her father had to Pfizer's COVID-19 vaccine. The patient experienced disorientated, in a lot of pain in his chest and rib area, hurt to breathe and move and short of breath/it hurt to breathe on 29Jan2021. The reporter seriousness for the events was medically significant. The events didn't require a visit to emergency room or physician office. The patient did go to urgent care. The caller explained her father became disoriented. He received the first vaccine on 28Jan2021. The next day, her father began to move his car around 12 pm and he became disoriented and stated he wasn't going to drive. Caller stated they were not aware of this disorientation until Friday, 29Jan2021. Her father was not sleeping and was up the night before because he was in a lot of pain in his chest and rib area. It hurt to breathe. He was short of breath. It hurt to move. Caller clarified further her woke up feeling so bad he thought he was going downhill. He thought his cancer got worse over night. He told the caller's brother after he became so disorientated that he was no longer going to drive because he was so shaken up. He was taken to urgent care on Friday, 29Jan2021. He was prescribed Naproxen, 500 mg Friday evening and he slept all night for the first night in years. He usually gets up in the middle of the night to use the bathroom. He woke up on Saturday morning, 30Jan2021, and he was feeling 100% better. He recovered completely. He was up moving around and in no pain. Caller verified she has no NDC, Lot number and expiry date for the Naproxen her father was prescribed. She didn't see any of that written on the discharge papers, that may be with the pharmacy. She wanted to put a chest x-ray was done. He has Metastatic Prostate Cancer and the pain was coming from the lesions on his lung and rib. Caller explained the Chest X-Ray showed the mets (metastasis) but no new lesions, no infiltrates or anything. It showed nothing related to the COVID-19 vaccine.The patient underwent lab tests and procedures which included Chest X-ray: showed the mets (metastasis) but no new lesions, no infiltrates or anything on 29Jan2021 and EKG: essentially normal on 29Jan2021. The outcome of the events disorientated, in a lot of pain in his chest and rib area, hurt to breathe, shaken up and move and short of breath/it hurt to breathe was recovered on 30Jan2021. The reporter's assessment for all the events was related.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to all events disorientation, chest pain, musculoskeletal chest pain, movement disorder, shaking, and shortness of breath cannot be excluded. The ongoing prostate cancer metastatic status and immunotherapy may be major cofounders. 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.
93 2021-03-22 excessive sleepiness Sleeping more than usual and off balance. He fell and split his head on right side. Called rescue an... Read more
Sleeping more than usual and off balance. He fell and split his head on right side. Called rescue and brought to hospital. Had a hematoma and was sent to rehab for two weeks. Lost hearing to the right ear which was his better ear. Had second shot on March 15th and tired sleeping most of day. Two days after shot, he went to get up and fell cuttiing his head in the back. We were able to stop bleeding, applied ice and facility gave us bandaging material. Still healing and sleeping most of the day and night.
93 2021-04-14 delirium K62.89 - Rectal pain R42 - Dizziness R41.0 - Delirium R55 - Syncope R77.8 - Elevated troponin M25.55... Read more
K62.89 - Rectal pain R42 - Dizziness R41.0 - Delirium R55 - Syncope R77.8 - Elevated troponin M25.552 - Left hip pain Z86.2 - Hx of thrombocytopenia M79.662 - Pain in left lower leg
93 2021-04-29 confusional state Brain Bleed Brain Damage Severe Confusion
93 2021-05-31 sleep disorder, confusional state, loss of personal independence in daily activities fatigue; unable to get up on his own; heavy breathing; thick mucus; increased confusion; Weakness; s... Read more
fatigue; unable to get up on his own; heavy breathing; thick mucus; increased confusion; Weakness; severe muscle weakness; unable to sleep; aches and pains; arm was sore; This is a spontaneous report from a contactable consumer (patient's son). A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration date: Unknown) via an unspecified route of administration in the left arm on 24Jan2021 at 13:30 (at the age of 93-year-old) as 1st dose, single dose for COVID-19 immunization in hospital. Medical history included muscle relaxant, blood pressure or cholesterol and broken neck from 1978 to an unknown date and unknown if ongoing. Concomitant medications included ongoing atorvastatin calcium 10mg taken once daily by mouth for blood pressure or cholesterol taking for a while, ongoing propafenone hydrochloride 150mg taken one twice daily by mouth, taking for a while, ongoing baclofen 10mg taken one five times daily by mouth as muscle relaxant taking for years, ongoing diltiazem HCL 180mg taken once daily by mouth, taking for long time, ongoing mirtazapine 30mg taken one at bedtime by mouth, taking for a while, ongoing citalopram HBR 20mg take once daily by mouth, taking for a while. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jan2021, the patient experienced unable to sleep, aches and pains, arm was sore, on 25Jan2021, experienced weakness, severe muscle weakness, on 26Jan2021, experienced increased confusion and on an unspecified date, experienced fatigue, unable to get up on his own, heavy breathing and thick mucus. But his father has tremendously decreased. Mentions his father was previously independent, using a walker, going to exercise class by himself and totally fine. Now after receiving the vaccine his father is unable to sleep, has aches and pains, was experiencing increased confusion and profound weakness. Adds his father can't get up on his own and has to be guided to use the walker if he can get up. They did call his HCP and were advised not to get the second dose and to make sure patient was eating and drinking. He was scheduled to receive the second dose on 14Feb2021 but he was unsure if he will get it. Adds his father had been water walking everyday and this wasn't like him. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
93 2021-07-12 feeling abnormal, loss of personal independence in daily activities Pt received both doses of the Pfizer COVID-19 vaccine, on 2/18/2021 and 3/10/2021. On 7/12/2021, pt... Read more
Pt received both doses of the Pfizer COVID-19 vaccine, on 2/18/2021 and 3/10/2021. On 7/12/2021, pt presented to our ED for "feeling crumy" with a decline in ADLs. Pt tested positive for COVID 19 via PCR. Chest Xray positive for pneumonia, suspected UTI also contributing. Pt admitted to inpatient due to weakness and suspected underlying infection.
94 2021-02-06 incoherent I received my first COVID 19 Pfizer Vaccination on Jan. 21, 2021 from clinic about 2:30 pm. I am ag... Read more
I received my first COVID 19 Pfizer Vaccination on Jan. 21, 2021 from clinic about 2:30 pm. I am age 94. My wife brought me home about 3:30 pm and I was tired and went to bed and to sleep. I slept soundly until about 8 pm, and my wife awoke me to eat. I was too weak to sit up or stand, my legs felt like rubber. I didn?t feel like eating, and I couldn?t answer her questions coherently. My wife was worried and called the 911. They checked me and found my vital signs were normal, so they helped my wife get me settled in bed. The next few days I still felt weak and had to use a cane or walker. My second dose is scheduled for February 11, 2021 at 2 pm. Will I likely have worse side affects? What precautions should I take.
94 2021-05-19 confusional state Pt is 94 yo male with PMH of afib not on anticoagulation, BPH, OA on chronic opioids, and depression... Read more
Pt is 94 yo male with PMH of afib not on anticoagulation, BPH, OA on chronic opioids, and depression. He presented to this institution on 4/19 with aphasia and confusion, concern for stroke. MRI showed no signs of stroke and at discharge 5 days later he was back to baseline. Pt underwent standard inpatient COVID-19 testing: rapid test was positive on 4/19, then PCR test was negative on 4/20. Patient is s/p Pfizer vaccine with his first dose on 1/20 and second dose on 2/10. He was asymptomatic, with no hypoxia and did not starts steroids nor remdesivir. Team decided that presentation is most consistent with false positive, but per ID and epidemiology, pt must remain in isolation for 10 days as a precaution.
94 2021-07-28 emotional distress 4/22/2021 Tested positive for Covid-19 discovered during Universal Swabbing on Specific Unit. Reside... Read more
4/22/2021 Tested positive for Covid-19 discovered during Universal Swabbing on Specific Unit. Resident was asymptomatic. COVID-19 screening were completed every 4 hours. 5/3/2021 COVID-19 screening revealed runny nose, declining meds and combative. Urine tea colored and foul smelling, Poor PO Intake. 5/4/2021 resident appeared uncomfortable and distressed with increased respiratory rate. Morphine and Ativan given for comfort measures. 5/5/2021 Deceased.
95 2021-01-24 excessive sleepiness Does not want to eat; sleeps 20 hours a day
95 2021-01-25 memory impairment he has a hearing and memory problem; he has a hearing and memory problem; Very bad headache; Fatigue... Read more
he has a hearing and memory problem; he has a hearing and memory problem; Very bad headache; Fatigue; Dizziness; This is a spontaneous report from a contactable consumer. A 95-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient has a hearing and memory problem. He later clarified the main thing is he wanted to know if he can continue with getting the second COVID vaccination. He wanted to continue but wanted to know if these symptoms will prevent him from continuing with getting the COVID vaccination. He confirmed he has no problems around the injection site. However, this is the second day and in Jan2021, he had dizziness. On 11Jan2021, last night he had a very bad headache and fatigue. This morning he is feeling better, but he still has slight dizziness. He is still three weeks away from getting the next vaccine. He wanted to know if he would be able to still take it. He wanted to be immune and to know if there would be any reason why he cannot take the second dose of the vaccine. He then mentioned these symptoms that he is speaking of are general symptoms and he assumed other people have reported them along with him because it is listed on the information sheet. Outcome of the events of dizziness, fatigue and headache was recovering, other events was unknown. Information about batch/lot number has been requested.
95 2021-01-26 feeling abnormal OX SATURATION AS LOW AS 74, TEMPERATURE OF 100.5, DYPHORETIC, SHAKING, HOT TO TOUCH, PALE, FEELS TER... Read more
OX SATURATION AS LOW AS 74, TEMPERATURE OF 100.5, DYPHORETIC, SHAKING, HOT TO TOUCH, PALE, FEELS TERRIBLE COUGHING
95 2021-01-30 hallucination, emotional distress 1.28.2021 Dad began having hallucinations the morning of January 28. He seemed not to have them in ... Read more
1.28.2021 Dad began having hallucinations the morning of January 28. He seemed not to have them in the afternoon. 1.29.2021 Dad had hallucinations all day and was very distressed by them. 1.30.2021 The hallucinations stopped.
95 2021-02-05 disorientation, crying Severe Headache, Disorientation, Physical & cognitive impairment, Aphasia / Stroke-like symptoms Det... Read more
Severe Headache, Disorientation, Physical & cognitive impairment, Aphasia / Stroke-like symptoms Details: My dad has been in excellent health and lives independently. He received the Vaccine on THURSDAY, 1/14/21 at 11 pm. FRIDAY(1/15/21 at 11:45 a.m.) The following morning, I went into his home to check on him. He was sitting in his chair with his undershirt and boxers that he wore to sleep. Normally, Dad would have showered and been dressed. He was holding his head in his hands and crying. (CONT'D)
95 2021-03-02 hallucination Hallucinations after both doses; This is a spontaneous report from a contactable consumer. A 95-year... Read more
Hallucinations after both doses; This is a spontaneous report from a contactable consumer. A 95-year-old male patient received bnt162b2 (BNT162B2, lot number unknown), via an unspecified route of administration, first dose on 25Jan2021 10:00, second dose (Lot number=En6021) on 17Feb2021 12:30, both at Left arm, at single dose, for COVID-19 immunisation. Medical history included High cholesterol from an unknown date. No other vaccine in four weeks. There is other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. The patient experienced hallucinations after both doses on 28Jan2021. On 28Jan2021, 3 days after first vaccine he began having hallucinations that lasted for two days. 19Feb2021, 2 days after second vaccine he began having hallucinations. This is being reported at the moment so the reporter cannot say what the end date will be. No treatment AE. The outcome of the event was recovered in Jan2021 for the first time . Information on Lot/Batch number has been requested.
95 2021-03-21 disorientation 3 days after vaccination, person was somewhat disoriented. 4th day after vaccination, patient fell, ... Read more
3 days after vaccination, person was somewhat disoriented. 4th day after vaccination, patient fell, hit head and developed subdural hematoma from which he subsequently died.
95 2021-03-25 incoherent Vomiting, high fever (103.4 F.), chills, uncontrollable shaking, inability to speak coherently, lead... Read more
Vomiting, high fever (103.4 F.), chills, uncontrollable shaking, inability to speak coherently, leading to hospitalization for 3 days
95 2021-03-28 excessive sleepiness Patient seen at my office 3/18/2021 (ambulatory). Had dose 2 on 3/19/21. The next morning around 5... Read more
Patient seen at my office 3/18/2021 (ambulatory). Had dose 2 on 3/19/21. The next morning around 5am (3/20), he had difficulty get to bathroom. Was holding onto the sink because his legs would not work. Family had to help him use bathroom and get him back into bed. Family got him bedside commode that day and even then had severe weakness like a "bowl of jelly". Had mild cough and neighbor listened to lungs and was clear. Cough cleared and had labored breathing intermittently. His breathing became more labored and he slept a lot and then breathing "kind of erratic" and then breathing slowed down and got slower and slower until he stopped breathing altogether. Passed on 3/21/2021.
95 2021-04-12 insomnia loss of hearing two days after vaccine; up for 48 hours after the vaccine; This is a spontaneous rep... Read more
loss of hearing two days after vaccine; up for 48 hours after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 95-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6208) via an unspecified route of administration, administered in Arm Right, at the age of 95-year-old, on 20Mar2021 11:30, as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. Concomitant medications included atenolol; dutasteride; apixaban (ELIQUIS); and methenamine. The patient received amoxcillin and experienced allergy and first dose of of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ENF6200) via an unspecified route of administration, administered in Arm Right on 27Feb2021 11:45, as SINGLE DOSE for covid-19 immunisation. It was reported that the patient received other vaccine (unspecified) four weeks before receiving the COVID vaccine. The patient was up for 48 hours after the vaccine on 22Mar2021, then loss of hearing two days after vaccine on 22Mar2021. The patient did not receive any treatment in response to the events. The event loss of hearing two days required emergency room visit. The patient was not diagnosed with COVID before vaccination and was not tested since vaccination. Outcome of the events was not recovered.
95 2021-05-09 confusional state Pt c/o not feeling well and very weak right after receiving injection, and fell less than 3 hours la... Read more
Pt c/o not feeling well and very weak right after receiving injection, and fell less than 3 hours later, would/ could not eat/drink or walk as usual, became confused and bedbound the same day of vaccination and appetite further deteriorated while weakness and confusion increased.
96 2021-04-30 confusional state, memory impairment mild confusion; memory issues; This is a spontaneous report from a contactable consumer (patient's d... Read more
mild confusion; memory issues; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-year-old male patient received first dose of (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) (Lot Number: Unknown) via intramuscularly on Left arm on 25Mar2021 16:00 (at age 96-year-old) as single dose for COVID-19 Immunization. Patient medical history and concomitant medications were unknown.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.Patient experienced mild confusion, memory issues on unspecified date in Mar2021. He received the first dose of the vaccine three weeks ago at the hospital. Two-three days later after receiving the vaccine he had symptoms. He developed mild confusion that has not passed. This was very unusual for her father. It continues today. It was very sudden and abrupt. He had been waking up the last three weeks asking what the hell was he doing. Caller calls her father every morning to say good morning, He forgets that she had called and then he will call her. He had never done anything like this in the ten years of them living together. He had been confused 11-12 times in the past 19 days. He forgot about a big business that he had when he was younger. These were changes or memory issues that her farther has not had in his entire life. Caller stated that her father was scheduled to receive the second dose on Thursday. Caller was hesitant to have her father receive the second dose. Caller was asking what the maximum time for her father was to get the second dose as he has received it 3 weeks ago and experienced an unsolicited side effect. Treatment given to these events were unknown. Outcome of event mild confusion was not recovered and memory issues was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
97 2021-02-17 confusional state Systemic: Confusion-Severe, Additional Details: Although date of ADR is several days from vaccinatio... Read more
Systemic: Confusion-Severe, Additional Details: Although date of ADR is several days from vaccination this occurred with 3 people at the same facility.
97 2021-02-27 loss of personal independence in daily activities, excessive sleepiness Spasms in leg and arm muscles, unable to stand and hard to eat. Symptoms were much diminished at 10:... Read more
Spasms in leg and arm muscles, unable to stand and hard to eat. Symptoms were much diminished at 10:30 pm and he slept from about 12:30 pm to 10:30 pm and then through the night.
98 2021-04-15 confusional state Patient was brought into the ER with weakness, confusion and decreased appetite for days after testi... Read more
Patient was brought into the ER with weakness, confusion and decreased appetite for days after testing positive for COVID19 on 2/6. Patient's wife had a fall on 2/2, patient helped his wife and again had recurrent fall and finally took to hospital on 2/5 where she was tested positive for COVID 19 and passed away on 2/5. Patient received his first dose of COVID-19 vaccine on 1/29/2021. Patient's daughter was concerned about patient's confusion, breathing and decreased energy levels and recommended to come to hospital for evaluation. Daughter report that she noticed mild fever, cough and some diarrhea on 2/6 when she came to check on him after her mother tested positive on 2/5. She thinks he might have symptoms 1-2
98 2021-05-31 confusional state This is a 98y.o. male with past medical history of s/p covid on 4/20/21 and treated with antibodies ... Read more
This is a 98y.o. male with past medical history of s/p covid on 4/20/21 and treated with antibodies and received pfizer x2, dementia, aortic aneurysm, MI s/p AICD, a fib hypothyroidism, presents to ED via EMS. Patient is alert and oriented to person and place but not time. He does not know why he is at the hospital or who called 911 or why they called. Most of history was obtained from son. He states that this morning the facility noticed that he was more confused than usual and that he seemed short of breath. When they checked his vitals his blood pressure was low an his oxygen saturation was low. Per EMS report he was short of breath while walking to the common area and his fingers turned blue. EMS sheet 104/54 and spo2 94% on room air. Patient states that he has no complaints. He denies any shortness of breath currently, chest pain, abdominal pain, diarrhea, melena, hematochezia, palpitations. He does admit to some back pain when laying too long. Son stated that he is supposed to see his cardiologist Dr. for his defibrillator having "weird signals". Son states that he usually aspirates once a meal when asked if patient has been coughing at all.
99 2021-02-19 feeling abnormal Weakness in the body, inability to stand, cannot support the body, inability to eat and swallow. His... Read more
Weakness in the body, inability to stand, cannot support the body, inability to eat and swallow. His face twisted the first day, and he seemed lost in time, and he recovered but after a week he still has no modality, and he began to digest his food. No studies or exams just a checkup with the doctor
102 2021-02-15 confusional state Patient is 102 years old history of hypertension hypothyroidism, patient presenting with altered men... Read more
Patient is 102 years old history of hypertension hypothyroidism, patient presenting with altered mental status, hemoglobin of 4.6 with creatinine of 2.53, patient has lactic acidosis, anion gap metabolic acidosis. Stool Hemoccult is positive, platelet count of 23,000 noted. Patient is awake but confused, patient's son is by the bedside.Patient has diffuse oozing from multiple skin wounds,Patient has received 2 units of blood along with 2 units of platelets and 2 units of FFP. Fibrinogin of 209. Hematology service recommended starting dexamethasone for suspected ITP. Patient is a PMH of  spontaneous subdural > 20 years ago, surgically evacuated, HTN, Hypothyroidism ,pre-diabetes who presented to the ED with CC of AMS and slurred speech x 1 day. History obtained from son at bedside and chart review. At baseline patient is reportedly very independent and able to ambulate in the home without assistive devices. He handles his own ADLs. Patient reportedly received his 2nd dose of the COVID vaccine on Monday and since then has been experiencing fatigue and generalized weakness, in addition to decreased appetite. AMS started yesterday. He reportedly fell out of bed last night around 2 AM and family found him at 7 AM on the floor. Denied loss of consciousness. He was evaluated by Stroke team, CT of the head was un-revealing for an acute process and stable chronic changes, and CTA revealed some mild intracranial stenoses, Stroke team felt was unlikely to be an acute stroke. He was found to have Hb 4.6 on admission. Platelets were 23, He was transfused 1 unit of blood and 1 unit of platelets. Hematology was consulted and recommended dexamethasone 20 mg daily for 3 days. Rectal exam was done and he was found to be Guaiac positive was started on Protonix 40 BID.