Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Blood pressure measurement, Brain oedema, Cerebral haemorrhage, Cerebral thrombosis
Clinical narrative: Brain swelling and emergency craniotomy; Paralysis on his right side; he was disoriented; slurring his speech; Brain bleed; Hospitalized for a stroke; Blood clot in brain; Was supposed to go for surgery on 18Jan2022 to repair a hernia mesh that was removed in 2009 and had started causing him problems; some aphasia; Selected Report Type: Initial Is report related to a study or programme? No Is the patient also the reporter? No Reporter type: Consumer or other non health professional Specify Consumer or other non health professional: Wife of the Patient  Primary / Prescribing Healthcare Professional Info HCP postal address: Regulatory Authority  Dates for Was supposed to go for surgery on 18Jan2022 to repair a hernia mesh that was removed in 2009 and had started causing him problems: (From: Unspecified To: Unspecified) Reporter seriousness for Was supposed to go for surgery on 18Jan2022 to repair a hernia mesh that was removed in 2009 and had started causing him problems: Unspecified  Dates for Paralysis on his right side, he was disoriented, slurring his speech: (From: 12Jan2022 To: Unspecified) Reporter seriousness for Paralysis on his right side, he was disoriented, slurring his speech: Unspecified  Dates for Hospitalized for a stroke: (From: 12Jan2022 To: Unspecified) Reporter seriousness for Hospitalized for a stroke: Hospitalization Dates when patient was in hospital for Hospitalized for a stroke: 12Jan2022 to 27Jan2022  Dates for Brain bleed: (From: 12Jan2022 To: Unspecified) Reporter seriousness for Brain bleed: Unspecified  Dates for Brain swelling and emergency craniotomy: (From: 15Jan2022 To: Unspecified) Reporter seriousness for Brain swelling and emergency craniotomy: Unspecified  Dates for Never received second dose of vaccine: (From: Unspecified To: Unspecified) Reporter seriousness for Never received second dose of vaccine: Unspecified  Dates for Transferred to Neuro-Rehab facility: (From: 27Jan2022 To: Unspecified) Reporter seriousness for Transferred to Neuro-Rehab facility: Unspecified  Dates for Blood clot in brain: (From: 12Jan2022 To: Unspecified) Reporter seriousness for Blood clot in brain: Hospitalization Dates when patient was in hospital for Blood clot in brain: 12Jan2022 to 27Jan2022  Is Pfizer Covid Vaccine a Pfizer product? Yes Pfizer Covid Vaccine manufacturer: Unspecified Dates for Pfizer Covid Vaccine: (Start: 10Aug2021 Stop: Unspecified) NDC number of Pfizer Covid Vaccine: Unknown Reason for no lot number: of Pfizer Covid Vaccine: Other: Caller reported that Lot Number is either PD8448 or FD8448. Expiry Date of Pfizer Covid Vaccine: Unknown  Other Products: No  Additional Context: Caller states that she is calling about the Pfizer Product: The first dose of the Pfizer Covid Vaccine.  States she is calling for her husband who is currently hospitalized. Her husband received the first dose of the vaccine in August.   Her husband was supposed to go for surgery on 18Jan2022 to repair a hernia mesh that was removed in 2009 and had started causing him problems. Her husband had to go and have extensive testing prior to this surgery. Her husband previously had stents placed after a heart attack, also around 2009.  Caller states that her husband only has to see his cardiologist about once a year and has always passed all of his tests. Leading up to the hernia surgery, they were aware of all his medications. States that her husband was on the same hypertension medication, blood thinners and cholesterol medication that he had been on since his heart attack, over a decade ago.  Caller states that her husband went through an echogram and all kinds of screening. He had an advanced echo and was cleared for his surgery for 18Jan2022.  On 12Jan2022 her husband was hospitalized for a stroke. She states he is in Neuro-Rehab now and recovering, going through therapy. He has been seen by a cardiologist and pulmonologist who say that her husband is fine on their end after he had to have three brain surgeries over a three day period.  Caller says that on 12Jan2022 around 2000 at night her husband started having paralysis on his right side, he was disoriented, slurring his speech. He went to the neighbors for help. When he got to the hospital via ambulance he didn't know how to pronounce his name and didn't know his date of birth. Since he had no identification on him he was treated as a withheld at first.  Caller states that they ran something up her husbands groin to dissolve the blood clot in his brain. While doing that they had to give him blood thinners. A couple of hours later he experienced a brain bleed and had to go back into emergency surgery to address the brain bleed. He was placed into ICU for a couple of days. The pulmonologist said her husband was fine, no issues with his lungs, his Oxygen level was fine. Her husband was extubated and weaned from the Oxygen. The cardiologist said there was no concerns with his heart. Within 2 days the caller's husband developed some brain swelling. On 15Jan2022 he had to have an emergency operation, craniotomy, to remove half of his skull and relieve the pressure.  Caller states that on 27Jan2022 her husband was transferred to a highly rated Neuro-Rehab in withheld. He is there now and is doing fine.  Caller states that she was reading about how when a patient has a blood clot the doctor should try to pinpoint where it came from; the hear, lungs, legs, so they can address the cause. Caller states that none of her husbands doctors can say where the clot came from.  Caller states that her husband never got the second dose or the booster dose of the Pfizer Covid Vaccine. States that she did not want him to get the first dose to begin with. States that her husband is 63 with his heart history. States he got to watching the news and got concerned so he went and got the first vaccine. Caller states that her daughter is a nurse, and very anti-vaccination. Caller says that herself and her daughter were able to convince the caller's husband not to get the second dose of the vaccine. Caller states they live on a farm, and her husband has low interactions; so they were able to convince him he would be fine without it.  Caller states that she has a gnawing feeling. States the blood clot came out of nowhere. Caller mentions that while her husband has been at the Neuro-Rehab he is not even having to take his blood pressure medications, because his blood pressure has been in range without them.  Caller says that she has been married to her husband for 33 years and had only seen him hospitalized twice; once for his hernia and once for his heart attack. States that her husband is 63 years old and had clearance to go under the knife for his hernia surgery because he is healthy. Caller states that she feels like the vaccine could have caused his blood clot.  Caller states that her husband could have lost his life. States he is very healthy. Caller says her husband had his craniotomy on 15Jan2022 and 2 weeks later was released to the rehab because he is doing so well. States they are expecting her husband to make a full recovery; he might just have some aphasia because of where the brain bleed occurred.  Caller states she feels that Pfizer needs to listen to consumer concerns that are coming in. She feels its possible the vaccine caused this. States she has a friend who is a Neuro Doctor in his third year residency who did not think it was the vaccine that caused the blood clot; because blood clots from the vaccine are reported as happening soon after the vaccine. Caller states she realizes that her husband had the vaccine in Aug2021 and this all occurred in Jan2022; but she still wants it to be noted. States she feels like the vaccine had something to do with these events.  Patient Details: Age: Caller states that her husband was 62 years old on 10Aug2021 when he received the vaccine.   Reporter Details: Declines to provide mailing address or alternative phone number.  HCP Information: Caller states that her and her husband have just moved from withheld to a farm in withheld. Her husband is still trying to get set up with new doctors. States that her husband had a team of surgeons and all within the hospital; but he does not currently have a recurring doctor. Declines to provide HCP information.  Suspect Products: Lot Number: Reported by the caller as being either PD8448 or FD8448.  Caller states that her husband was supposed to have his second dose of the vaccine on 31Aug2021; but he did not.  History: Caller states that her husbands original hernia repair was in 2009. States that his heart attack and stents was in 2012.  Denies any other medications, medical conditions, labs, testing or treatments relevant to report.  Caller states that in Jan through Mar2021 her husband went through extensive testing with the cardiologist. States that about every 4 years, whenever his cardiologist would change, the new one would always run her husband through the mill with all kinds of testing. Caller states that her husbands test results have always been fine. He has been on the same medications since his heart attack, no new medications, no changes in medications, states they may have just lowered the doses at some point.  VACCINE SUPPLEMENTAL FORM History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None Additional Vaccines Administered on Same Date of the Pfizer Suspect: None Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: paralysis on his right side, he was disoriented, slurring his speech Time of Onset: 2000 Did any AE(s) require a visit to:  Emergency Room? Yes  If Yes, which AE(s)? paralysis on his right side, he was disoriented, slurring his speech Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to  the first administration date of the suspect vaccine(s): None AE(s) following prior vaccinations: None Patient's Medical History (including any illness at time of vaccination)? See Formal Fields and Additional Context Relevant Tests: None  Caller states that her husband is a chef and owns his own restaurant. States it has been open since May2020 and only closed for about 2 months when the pandemic started. Caller says that her husband has not had any symptoms of any illnesses. No flu, no Covid. States her husband has had to have Covid tests for things like returning to work, and he had to have one to go to the Neuro-Rehab center, they have all been negative.  Caller asks where can she go to find reliable information that has been reported to Pfizer about the associations between the vaccine and blood clots. States the news and media have all kinds of things. She wants to know what Pfizer says about it and the time frames between the vaccine and blood clots.  Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Feels like vaccine caused blood clot. Product strength and count size dispensed: Pfizer Covid Vaccine; First Dose Additional lot numbers: Reported by the caller as being either PD8448 or FD8448.   Follow-Up (04Feb2022): Follow-up attempts are completed. No further information is expected.