Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, No adverse event
Clinical narrative: Test done and found out zero antibodies; This case is considered as invalid as there is no indication that the patient experienced an event under BNT162b2.  This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that:  Serious: No  Patient characteristics: Sex: Female  Reaction(s)/Event(s): MedDRA version for reaction/event term LLT: N/A   Reaction/event in MedDRA terminology (LLT): Medical Information Potential AE    Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: Pfizer-Biontech Covid-19 Vaccine  Identification of the country where the drug was obtained: US (United States) Country of authorization/application:  Active Substance Information:  Active Drug substance names: Pfizer-Biontech Covid-19 Vaccine  Narrative case summary and further information: Case narrative: Date Received: 11Feb2021 17:47:57 Originating AE Request: REQ-# Attachments: 1 Patient Age: 76 Reporter Subtype: Patient PQC Present: No AE Present: Yes PQC Details:   Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Call transferred, spoke with (Name) sign on # Reportum # Caller (female, age 76) is a liver transplant patient and is part of a study to see the efficacy of the vaccine. She received the Pfizer covid vaccine, first dose on Monday 01Feb2021 and had an antibody test done on 18Feb2021 and had zero antibodies after the first dose. This is after the first dose of the vaccine is this common? She received her second dose today. The husband got on the phone (recorded call disclaimer given) and stated, "She goes to the (Clinic name) and they stated Pfizer should tell you what to do next? It's been a long process. She 76 years old, getting a liver was not easy. She's in the (University name) program. I wasn't happy with them telling us she had zero antibodies. (Clinic name) told us to find out what to do. She got her 2nd dose today. Wondering if you have any other transplant people.  There were zero antibodies and I want to know weather she is protected. I want Pfizer to know people are reaching out they don't have anything to share. We should be transferred to someone and find what are they doing to transplant patients who have zero antibodies after vaccination? Transplant people are wondering and feeling they are not protected if there are zero antibodies."   e-transmitting potential duplicate AE Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller (female, age 76) is a liver transplant patient and is part of a study to see the efficacy of the vaccine. She received the Pfizer covid vaccine, first dose on Monday 01Feb2021 and had an antibody test done on 18Feb2021 and had zero antibodies after the first dose. This is after the first dose of the vaccine is this common? She received her second dose today. The husband got on the phone (recorded call disclaimer given) and stated, "She goes to the (Clinic name) and they stated Pfizer should tell you what to do next? It's been a long process. She 76 years old, getting a liver was not easy. She's in the (University name) program. I wasn't happy with them telling us she had zero antibodies. (Clinic name) told us to find out what to do. She got her 2nd dose today. Wondering if you have any other transplant people.  There were zero antibodies and I want to know weather she is protected. I want Pfizer to know people are reaching out they don't have anything to share. We should be transferred to someone and find what are they doing to transplant patients who have zero antibodies after vaccination? Transplant people are wondering and feeling they are not protected if there are zero antibodies."  Caller asked about antibody test and type of test.  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller stated, "I want Pfizer to know people are reaching out they don't have anything to share. We should be transferred to someone and find what are they doing to transplant patients who have zero antibodies after vaccination? Transplant people are wondering and feeling they are not protected if there are zero antibodies."  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller (female, age 76) is a liver transplant patient and is part of a study to see the efficacy of the vaccine. She received the Pfizer covid vaccine, first dose on Monday 01Feb2021 and had an antibody test done on 18Feb2021 and had zero antibodies after the first dose. This is after the first dose of the vaccine is this common? She received her second dose today. The husband got on the phone (recorded call disclaimer given) and stated, "She goes to the (Clinic name) and they stated Pfizer should tell you what to do next? It's been a long process. She 76 years old, getting a liver was not easy. She's in the (University name) program. I wasn't happy with them telling us she had zero antibodies. (Clinic name) told us to find out what to do. She got her 2nd dose today. Wondering if you have any other transplant people.  There were zero antibodies and I want to know weather she is protected. I want Pfizer to know people are reaching out they don't have anything to share. We should be transferred to someone and find what are they doing to transplant patients who have zero antibodies after vaccination? Transplant people are wondering and feeling they are not protected if there are zero antibodies."   Reviewed  EUA PI (LAB-# Revised: Jan2021) and no information regarding transplant patients  Follow-up (22Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that:  Patient characteristics:  Age at time of onset of reaction/event: 76 Age at time of onset of reaction/event (Unit): Year Weight (kg): 90.72 Height (cm): 168 Sex: Female  Relevant medical history and concurrent conditions:  Structured information(Patient episode name): Liver transplant Patient Medical start date: 18Apr2021 Patient Medical comments: Verbatim: Liver transplant    Relevant medical history and concurrent conditions:  Structured information(Patient episode name): Diabetes Patient Medical continuing: Yes Patient Medical comments: Verbatim: Diabetes    Reaction(s)/Event(s): Reaction/event as reported by primary source: Test done and found out zero antibodies   Date of start of reaction/event: 18Feb2021  Results of tests and procedures for investigation of the patient: Date: 18Feb2021 Test: Antibody test Result: Zero antibodies    More information available (Y/N): No  Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: COVID Vaccine    Batch/lot number: EN5318 Dosage text: administered in right upper arm; unknown dose Date of start of drug: 01Feb2021 Action(s) taken with drug: UNKNOWN  Drug(s) Information Characterization of drug role: CONCOMITANT Proprietary medicinal product name: Tacrolimus   Dosage text: 1.5mg capsule twice a day by mouth    Drug(s) Information Characterization of drug role: CONCOMITANT Proprietary medicinal product name: CellCept    Dosage text: 2mg capsule twice a day by mouth     Narrative case summary and further information: Case narrative:  Submitted by Call Centre 1 Ref: #; ININ:#  Selected Report Type: Initial Is the patient also the reporter? Yes Reporter consent to contact given: Yes Reporter type: Consumer or other non health professional Reporter telephone: # Reporter email: #  Primary / Prescribing Healthcare Professional Info HCP Occupation/Specialty: Liver Transplant Coordinator  Dates for Test done and found out zero antibodies: (From: 18Feb2021 To: Unspecified)  Is COVID Vaccine a Pfizer product? Yes COVID Vaccine manufacturer: Unspecified Dates for COVID Vaccine: (Start: 01Feb2021 Stop: Unspecified) NDC number of COVID Vaccine: Unknown Expiry Date of COVID Vaccine: May2021 Why was the patient taking COVID Vaccine (Verbatim): So would protect self; was told and recommended by doctors  Other Products: Yes Dates for Concomitant Products Tacrolimus: (Start: Unspecified Stop: Ongoing) Why was the patient taking Concomitant Products Tacrolimus (Verbatim): Anti-Rejection  Dates for Concomitant Products CellCept: (Start: Unspecified Stop: Ongoing) Why was the patient taking Concomitant Products CellCept (Verbatim): Anti-rejection Patient History: Yes Patient history: Liver transplant (From: 18Apr2020 To: Unspecified) Patient history: Diabetes (From: Unspecified To: Ongoing) Additional Information for Other Conditions: Diagnosed about 20 something years ago  Investigation Assessment: Yes Additional Context: Caller on the line calling about the COVID Vaccine. She had a liver transplant in April. She had the first Pfizer COVID vaccine three weeks ago. She is part of a study with (University name) to see the efficacy of the COVID vaccine on transplant patients. She also mentioned since she is on heavy duty drugs she had an antibody test done Thursday which was 2 weeks and 3 days after the first shot and the results  showed she had zero antibodies. Today, while on hold she got the second dose of the COVID Vaccine. She was wondering if there is a chance she won't be protected at all? She wanted to see if it was common.   Caller did not have full contact details to provide for the Liver Transplant Coordinator.  Caller's husband also on the line to help provide details at times during interaction.   Vaccine Supplemental Form  Patient Last Name: See reporter details Patient First Name: See reporter details Address: See reporter details  City: See reporter details  State: See reporter details  Zip Code: See reporter details  Patient age at time of vaccination: 76 years  Time the vaccination given: 5pm Anatomical Location of Administration of the Pfizer vaccine considered as suspect: Right upper arm  Vaccination Facility Type- Pharmacy/drug store Vaccine Administered at Military Facility- No  Vaccination Facility Address  History of all previous immunizations with the Pfizer vaccine considered as suspect:  First Dose: See formal field  Second dose:  Vaccine Name: COVID Vaccine Lot Number: EL9266/Exp Date: May2021 Anatomical Location: Left arm  Date: 22Feb2021   Additional vaccines Administered on the Same Date of the Pfizer suspect: None  Additional Information:  Did any AEs require a visit to:  Emergency Room-No Physician's Office- No  Stated, she did not have to go anywhere, she was just provided with a written result.   Prior vaccinations within 4 weeks: None  AEs following prior vaccinations: None  Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Caller on the line calling about the COVID Vaccine. She had a liver transplant in April. She had the first Pfizer COVID vaccine three weeks ago. She is part of a study to see the efficacy of the COVID vaccine on transplant patients. She also mentioned since she is on heavy duty drugs she had an antibody test done Thursday which was 2 weeks and 3 days after the first shot and the results  showed she had zero antibodies. Today, while on hold she got the second dose of the COVID Vaccine. She was wondering if there is a chance she won't be protected at all? She wanted to see if it was common.  First dose lot/exp details in formal field.  Lot Number: EL9266/Exp Date: May2021. Received second dose today, 22Feb2021.