Pfizer

02/10/2021: Weakness, fatigue, headache, myalgia, bilateral bleeding from ears. 02/28/2021: Weakness that I had to use a walker to ambulate (normally ambulate independently), dizziness/vertigo, sore gums, weakness more pronounced in lower extremities below knees.

Experienced very severe tinnitis after 2nd shot. Continuing from beginning March until now. We participate in Vsafe, but did not report this because we did not realize it might be related to the 2nd shot. Therefore, reporting through this systen,

The pain went down his left shoulder and back/he developed pain down his right side of his shoulder, and down in his hips/His left ankle, right side heel, and shoulders also hurt.; The pain went down his left shoulder and back; he was having problems breathing/difficulty breathing; possibly a swollen lymph node on his trachea; His left ankle, right side heel, and shoulders also hurt.; He has had pains in different parts of his body that last for 2-3 days and then some place else starts to hurt.; chills; His wife took his temperature and it was 100.3./He has weird fevers for one day with no other symptoms.; jaw pain; Dates for COVID vaccine: (Start: 5Feb2021 Stop: 16Feb2021), first dose on 5Feb2021 and second dose on 16Feb2021; Dates for COVID vaccine: (Start: 5Feb2021 Stop: 16Feb2021), first dose on 5Feb2021 and second dose on 16Feb2021; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 (Lot Number: EL9267) (at age of 90-year-old) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included ongoing atrial fibrillation, stent placement from 19Jun2020 and ongoing (successful in the descending aorta), and ongoing Heart problems. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2, administered in Arm Right on 05Feb2021(Lot: EL9263) (at age of 89-year-old) for covid-19 immunisation. The patient would like to talk to an individual regarding his side effects he has been having since his two COVID vaccinations in Feb 2021. Ten days after the second inoculation on 26Feb2021, he woke in the middle of the night with jaw pain. He was in great pain. The pain went down his left shoulder and back . His wife said that morning that those were signs of heart problems. He does have Atrial Fibrillation, and he had a stent placed 19 Jun 2020. He went to the emergency room where they checked him out for heart problems. He had a clean bill of health. They sent him home, and told him to take Tylenol for the pain. The Tylenol certainly helps. It took whatever number of days for it to subside. It subsided for 2 weeks, but then he developed pain down his right side of his shoulder, and down in his hips. Once again they figured they better get back to the ER. They did EKG and a X-ray. There was absolutely nothing wrong with his stent. They told him just to continue with Tylenol to control the pain. He went a third time to the emergency room because he was having problems breathing. The emergency room put him through the COVID entry at Kaiser because of the difficulty breathing. They re did all the previous work, and did a scan of his lung to check for blood clots. He thinks they did that because 6 people died from blood clots from Johnsons and Johnson. They wanted to see if there were blood clots, but there were no blood clots. They told him he needed to make an appointment with his primary who then referred him to a Cardiologist. On 11May2021, he saw his primary doctor who ordered another scan because they found possibly a swollen lymph node on his trachea. The doctor measured that, and said to wait a month to do that again. To see any change in it. On the 26 May 2021, he has his next appointment to get that rechecked. He hasn't had a comfortable day since this started. He has had pains in different parts of his body that last for 2-3 days and then some place else starts to hurt. His left ankle, right side heel, and shoulders also hurt. The pain was under control if he takes ibuprofen, but his doctor advised him against too much of that because of his kidneys. It was very effective. The Tylenol works to some extent, but not like the Ibuprofen. He is just living with it day to day. He can play tennis some days. One day he played tennis and came home with chills. His wife took his temperature and it was 100.3. In the last week and half this has happened two times. After the second shot this has happened probably four times. He has weird fevers for one day with no other symptoms. Ever since 26Feb2021, it has been on a daily basis that some place else hurts. One subsides , but another pain starts up elsewhere. If that is not happening, then his whole demeaner is dead. He is just not comfortable and sitting around he feels like he was wasting what life he has left. He used to be a PE teacher. He has always been in good physical condition. He was 5k and walking 5ks every 4th of Jul. He would compete. He prepared for this 90 birthday/ His goal was to do a 5k in under 60 minutes. He worked out like always , and played tennis 3 days a week to prepare. He also played ball. He likes to walk run 2-3 miles most days. He did his 5k in 52minutes, and he was celebrating. Then ten days later this all started happening. The patient/caller has been tested for COVID, and it was negative. The aches and pains were moving around. He was still having breathing difficulties. Sometimes he can't talk because of the breathing. It just goes away. If it is something like the tumor or a node on the trachea wouldn't it be happening all the time? Sometimes he can't talk because the breathing is bad. It comes and goes. It is more often recently. It is like all the sudden he can't breath and can't talk. That started right at the beginning. It has gotten progressively worse. He took Tylenol to help the pain in his body. Nothing has helped his breathing. He tried antihistamines to see if maybe it was hay fever or something , but there was no difference. He didn't know where to go from here. He was feeling horrible. He was just waiting on 26 May2021, for the second scan without color of thorax to see those results. The patient said he didn't have questions. The outcome of events was unknown.

Around 15 minutes after receiving vaccine, patient started to stare off into space(blank stare). He was sweating, pulse was very weak, and he started to drool at the mouth. Wife kept stating that he did this at home sometimes and it was not related to the shot. Epi was administered and ambulance was called. Before ambulance arrived, patient started to respond to wife and HD personnel. EMT's evaluated him and wife did not want him to go to the hospital. EMT's agreed.

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.

Face turned extremely red. Right eye almost swelled shut, nose, lips, ear swelled and very red on Friday, March 5, 2021. Swelling began to subside somewhat on Monday, March 6 after taking Benadryl.

Two days after receiving second dose of the Pfizer COVID 19 vaccine, I began having blurred vision with irritation and inflammation in both left and right eyes, with the left eye being worse. These symptoms get worse as the day progresses.

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.

Felt like his throat was closing. He was given 25mg benadryl and then developed dizziness, heart racing, chest pain, shortness of breath, jaw pain. Was in SVT on arrival to ED

cranial nerve 3 palsy. Ptosis of the left eye, it was completely shut; cannot hear; This is a spontaneous report from a contactable physician. A 93-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation, hypertension, hyperlipidaemia, diabetes, and chronic kidney disease. Concomitant medications were not reported. No additional vaccines administered on the same date of the vaccine and no prior vaccinations within 4 weeks. The reporter is the family's physician, who stated that the patient received the first dose of the Pfizer COVID vaccine on 22Jan2021 and three days later (25Jan2021), his left eye had ptosis - he was unable to open his left eye and it was completely shut. The patient came to him and when he would try to lift the eyelid up, it would just drop down. He then called a neuro ophthalmologist, he thought to himself that the patient could be having a stroke. The patient was sent to the Emergency Room and kept overnight to do CT of brain, MRI of brain, CT of orbits and MRI of neck. All tests came back normal, there was no stroke. The patient was discharged and was told to go see an ophthalmologist; the eye doctor diagnosed him with Cranial Nerve 3 Palsy. The reporter had read the consultation notes; the eye doctor "wrote 1-2 days after he had COVID and had this happen". The reporter clarified that the patient never had COVID, maybe this was a misunderstanding or typo with the doctor, but the patient just had the vaccine. The point is that the patient was diagnosed. The reporter further added that the patient can't hear, and so he will provide the patient's son's phone number. The reporter would like to know if this is a possible side effect of the vaccine and if he should receive the second dose of the vaccine as he is due in two days (Friday at 8:30AM on 12Feb2021). It was also reported that the ptosis has not gotten worse and has not resolved. The reporter added that the patient was admitted to the hospital for a full day. The patient underwent lab tests and procedures which included computerized tomography (CT) of the brain, CT of the neck, magnetic resonance imaging (MRI) of the brain and MRI of the orbits-all of which resulted normal in Feb2021. The events cranial nerve 3 palsy and 'Ptosis of the left eye, it was completely shut' had not resolved while the outcome of the rest of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: By close temporal relationship, the company cannot completely exclude that the reported cranial nerve 3 palsy' is related to BNT162b2 administration, even though medical history including atrial fibrillation, hypertension, hyperlipidemia, diabetes, and chronic kidney disease, in the setting of elderly age, can be considered confounding factors in the overall clinical evaluation of this event occurred three days after the vaccination. Conversely, even though cannot be excluded as reportable event based on the information provided, the company deems there is not a reasonable possibility that the reported deafness is related to BNT162b2 administration, but, at the present time, evaluated as an intercurrent condition that cannot be also excluded as already present before the vaccination. The impacts 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.

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.

Decrease of vision in left eye/decreased vision in his right eye; This is a spontaneous report from a contactable consumer or other non hcp from a sponsored program. A 93-years-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration number were not reported), via an unspecified route of administration, administered in right arm on 12Jan2021 at 16:30 (at the age of 93-years) as single dose fore COVID-19 immunization. Medical history included ongoing renal disorder , hypertension and macular degeneration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with COVID-19 infection prior to vaccination and has not been tested for the infection since the vaccination.On 13Jan2021 at 05:30, the patient experienced decrease of vision in the left and right eye. The outcome of event was recovering. Follow-up (01Feb2021): New information included clinical course. Information on the lot/batch number has been requested.

93 Male vaccinated Pfizer 1/06/2021 & 1/28/2021. Symptom onset 4/30/2021 - SOA, fatigue. Taken to ER 5/10/2021 for blurry vision. Diagnosed with COVID 4/30/2021. Started dexamethasone. Patient claims left eye problems secondary to dexamethasone. Discharged and final diagnosis at time of death 5/24/2021 - COVID-19 with PNA

Fatigue- started 02/02/2021 morning - currently experiencing muscle ache (shoulders and arms)- started 02/02/2021 - ended 02/06/2021. Teeth hurt when tongue touched their teeth- started 02/05/2021 - ended 02/06/2021 Headache- started 02/05/2021 - ended 02/06/2021 Chills- started 02/05/2021 - currently experiencing Fever- started 02/05/2021 - currently experiencing

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.

sight impairment/did not see very well/unable to read during report; injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; This is a spontaneous report from two contactable consumers. A 95-year-old male patient received 1st dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine ), via an unspecified route of administration in upper right arm on 16Jan2021 11:00 at single dose for vaccination. Medical history included diabetes from 1950 (also reported as 1991) and ongoing. There were no concomitant medications. The patient experienced not in very good shape/terrible reactions on 16Jan2021 12:00. Requested information regarding events relative to the product. Further clarified this event as to include injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment. Patient clarified that all of these events had onset of about 12:00pm-1 hour after Pfizer BioNTech COVID-19 Vaccine administered (16Jan2021 12:00) and had for the most part remained the same since onset, but for sight impairment was on 18Jan2021. The patient did not see very well; caller had to read some of the information provided in this report from forms that patient was unable to read during report. The muscle pain was marginal. The weakness was the same or worse. He wanted a pain reliver or pill. Patient did not plan to get the second dose due to adverse events. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No emergency room/physician office visit. Family medical history relevant to the events was none. The outcome of injection site pain was recovered on 18Jan2021, tiredness, feeling unwell, dizziness was not recovered, muscle pain, frequent urination every 15 minutes was recovering, severe allergic reaction, weakness, sight impairment was unknown. Information on the lot/batch number has been requested.

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.

Within 5 min of injection on 01/16/2021, had slight tongue swelling and tingling feeling in chest and abdomen. Headed to ER but symptoms began to subside within 20 minutes so did NOT go to to ER. Symptoms never recurred so went home and monitored. Never needed epi pen. NO further problems other than slightly sore arm.

tongue began to swell; had a tingling feeling in chest and abdomen; Slightly sore arm; This is a spontaneous report from a contactable consumer. A 96-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number: EL898), via an unspecified route of administration on the right arm on 16Jan2021 12:30 at SINGLE DOSE for COVID-19 immunization at the pharmacy or drug store. Medical history included hypertension, glaucoma, benign prostatic hyperplasia (BPH), skin cancer, gout, and malaria (three times experienced). The patient had also allergies with wasp stings which later manifested of anaphylactic. Patient had unspecified concomitant medications. The patient received vaccine on 16Jan2021 at approximately 12:30 pm. Within 5 minutes (12:35), the tongue began to swell, and patient had a tingling feeling in chest and abdomen. The patient also had slightly sore arm. The patient drove towards emergency room (ER) but within 20 minutes the symptoms had subsided enough to not go to ER and head home. The patient was not diagnosed with COVID-19 prior and since vaccination. No treatment was received for the events. Symptoms disappeared on unknown date in Jan2021 and never recurred.

Headache; Nausea; Eyes are bloodshot red and kind of glaze over; Eyes are bloodshot red and kind of glaze over; He just can't feel real good; This is a spontaneous report from a contactable consumer. A 96-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 as a SINGLE DOSE for COVID-19 vaccination. Medical history included heart problems from an unknown date and unknown if ongoing, he has gone over for a battery replacement, pacemaker, and he has eye problems so, he is taking eye drops for those. Concomitant medications included unspecified eye drops. On unspecified date, the patient experienced headache, nausea and his eyes are bloodshot red and kind of glaze over. He just can't feel real good. His eyes are real red and like glaze over. No treatment was received for the events. Outcome of the events headache, nausea, eyes are bloodshot red and kind of glaze over and he just can't feel real good were unknown. Information on the lot/ batch number has been requested.

Bell's Palsy diagnosis. Following 2nd administration of Pfizer COVID vaccine, 97 year old male found on the floor by housekeeping. Sent to ER due to cuts and bruises. MRI ruled out Stroke. Patient presented with a droopy eye & mouth on one side of face. Complained of ear pain on the same side. Patient also tested positive for COVID without any presenting symptoms via PCR test. Patient's will to live has decreased.

OBJECTIVE: Patient found deceased on March 26, 2021, less than one week post vaccination with Pfizer-BioNTech COVID19 vaccine dose #1. Found by daughter who is also RN and caregiver. Patient found with black tongue protruding slightly from open mouth. Three days post vaccine date and for three days patient found mouth-breathing heavily. When patient?s attention was called to his breathing he immediately resumed normal breathing. Also three days post vaccine date and for three days patient had loosened waist belt and offered complaint of feeling full. Also, Patient was more talkative during the week following vaccination. SUBJECTIVE: Perhaps related to anxiety. OBJECTIVE: Patient had eaten only one avocado per day for his remaining two days of life. Patient had history of stoicism and was known to downplay or deny deviations in physical well-being.