chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral swelling, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: SARS-COV-2, qPCR: Positive; SARS-COV-2, qPCR: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 01Apr2021 as dose 2, single (Lot number: EN6205), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy: Latex" (unspecified if ongoing), notes: Reaction. Concomitant medication(s) included: MULTIVITAMINS [VITAMINS NOS]. Past drug history included: Aspirin for known allergies: aspirin, notes: Reaction. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Dec2021, outcome "unknown" and all described as "SARS-COV-2, qPCR: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2021) Positive, notes: Other.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SARS-COV-2, qPCR: Positive; SARS-COV-2, qPCR: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 01Apr2021 as dose 2, single (Lot number: EN6205), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy: Latex" (unspecified if ongoing), notes: Reaction. Concomitant medication(s) included: MULTIVITAMINS [VITAMINS NOS]. Past drug history included: Aspirin for known allergies: aspirin, notes: Reaction. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Dec2021, outcome "unknown" and all described as "SARS-COV-2, qPCR: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2021) Positive, notes: Other.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "blood clot". The patient date of death was unknown. Reported cause of death: "blood clot". It was not reported if an autopsy was performed. As reported: Her friend that was 44 had 2 kids and she died all of a sudden with a blood clot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: blood clot
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clots left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 2, single (Lot number: FD0810) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FD0810 BUD, Location of injection: Arm Left), administration date: 14Oct2021, when the patient was 46-year-old, for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 02Apr2022, outcome "recovering", described as "Blood clots left arm". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of thrombosis.  Clinical information: The patient was treated with Xarelto. Patient did not received any other vaccine in four weeks and other medications in two weeks. Patient did not have any COVID prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Blood clots left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 2, single (Lot number: FD0810) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FD0810 BUD, Location of injection: Arm Left), administration date: 14Oct2021, when the patient was 46-year-old, for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 02Apr2022, outcome "recovering", described as "Blood clots left arm". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of thrombosis.  Clinical information: The patient was treated with Xarelto. Patient did not received any other vaccine in four weeks and other medications in two weeks. Patient did not have any COVID prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 1, single (Lot number: FD0810 BUD), in left arm and on 04Nov2021 as dose 2, single (Lot number: FD0810 BUD) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  Clinical course: The patient did not have any previous vaccines. The patient did not have other medications in two weeks. The patient did not have covid prior to vaccination. The patient was tested for covid-19 post vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 1, single (Lot number: FD0810 BUD), in left arm and on 04Nov2021 as dose 2, single (Lot number: FD0810 BUD) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  Clinical course: The patient did not have any previous vaccines. The patient did not have other medications in two weeks. The patient did not have covid prior to vaccination. The patient was tested for covid-19 post vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: Chills; headache; muscle pain; tired; feel bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 15:30 as dose 4 (booster), single (Lot number: FL3209) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FL3182, Location of injection: Arm Left), administration date: 26Sep2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL9266, Location of injection: Arm Left), administration date: 11Feb2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Arm Left), administration date: 21Jan2021, when the patient was 74-year-old, for COVID-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022); FEELING ABNORMAL (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022), described as "feel bad"; HEADACHE (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022); MYALGIA (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022), described as "muscle pain"; FATIGUE (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022), described as "tired". Therapeutic measures were not taken as a result of chills, headache, myalgia, fatigue, feeling abnormal.  Additional information: No other vaccine in four weeks. Patient had no known allergies. No covid prior vaccination. The patient was not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Symptom recurrence
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 46-years-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EP6955),  at the age of 46, on Apr 13, 2021, in left arm, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (batch/lot# EP6955, location of injection: left arm, manufacturer: Pfizer), on Mar 22, 2021, for COVID-19 immunization. The patient developed injection site pain and symptom recurrence, onset Apr 2021, with outcome of unknown. Patient  described "recurring pain at injection site in left arm only/periodic and mild pain." No therapeutic measures/treatment taken as a result of injection site pain or symptom recurrence. Additional information: The patient had recurring pain at injection site in left arm only. Periodic and mild pain. She had no other vaccines in 4 weeks. She did not have COVID-19 prior to vaccination and it was unknown if she tested for COVID-19 post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Myalgia
Clinical narrative: he slept for 15 hours woke up at 5:00pm high temp 37.1 Celsius/in the afternoon the temperature increased to 38.4 Celsius; a little muscle pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 14:15 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I contracted Covid-19", start date: 16Dec2021, stop date: 16Dec2021, notes: On 16Dec, I contracted Covid-19, and recovered, I don't know if I am covered and immunity. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 09Apr2022 at 17:00, outcome "unknown", described as "a little muscle pain"; BODY TEMPERATURE INCREASED (non-serious) with onset 09Apr2022 at 17:00, outcome "unknown", described as "he slept for 15 hours woke up at 5:00pm high temp 37.1 Celsius/in the afternoon the temperature increased to 38.4 Celsius". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Batch/lot number, NDC number and Expiry Date of Pfizer vaccine were not Provided. Other Products, Other Conditions and Investigations were not Provided. The reporter is a physician who took the first dose of the Pfizer Covid vaccine on 08Apr at 2:15 pm. Stated that for the next 15 hours that he was fine then slept. He states he had some issues, he slept for 15 hours woke up at 5:00 pm with a high temperature 37.1 degrees Celsius, and had a little muscle pain, and later on in the afternoon the temperature increased to 38.4 Celsius. He wanted to know if he should take the fever reducer. He was fine until very early in the morning like 5:00 am, He had a slight increase in temperature, and he thought it would improve, but then during the day, it increased to 38 degrees, and then 38.4. What my concern is that if I take Tylenol, I know it will reduce the fever, but my concern is, how will it affect the vaccine's performance? Can I take a Tylenol, or do I wait it out. The reporter wanted to know, "How does taking Tylenol, affect the action and efficacy of the Pfizer Covid vaccine? "On 16Dec, he contracted Covid-19, and recovered, he doesn't know if he is covered and immunity for life, Pfizer should know. Due to the fact that the vaccine needs mediators, but if you take medicine will it affect the vaccine's effectiveness, because its effectiveness depends on the mediators to generate antibodies. How does taking fever medicine affect the vaccine's ability to generate antibodies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: Ep6955), on 12Apr2021 as dose 2, single (Lot number: Ep6955) and on 04Nov2021 as dose 3 (booster), single (Lot number: fh8027) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Apr2022, outcome "recovered" (2022) and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she got COVID-19 the first two weeks of Janaury of this year; she got COVID-19 the first two weeks of Janaury of this year; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she got COVID-19 the first two weeks of Janaury of this year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive.  Clinical course: caller wants to know if it is to soon for her to receive the second booster dose of the vaccine if she already received two doses of the Pfizer´s COVID-19 vaccine and she got COVID-19 the first two weeks of January of this year.  During the call patient mentioned that she was unable to review in a web page if her vaccination schedule was complete, she stated that the website did not work properly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Ear discomfort, Eustachian tube dysfunction, SARS-CoV-2 test
Clinical narrative: I developed hearing loss; dizziness; Eustachian tube dysfunction; fullness in my ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2021 at 13:00 as dose 2, single (Lot number: EW0168) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot number=EW0167,, administration time=12:00PM,, vaccine location=Left arm), administration date: 02May2021, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: EUSTACHIAN TUBE DYSFUNCTION (hospitalization, disability) with onset 15Jun2021 at 08:00, outcome "not recovered"; DEAFNESS (hospitalization, disability, medically significant) with onset 15Jun2021 at 08:00, outcome "not recovered", described as "I developed hearing loss"; DIZZINESS (hospitalization, disability) with onset 15Jun2021 at 08:00, outcome "not recovered"; EAR DISCOMFORT (hospitalization, disability) with onset 15Jun2021 at 08:00, outcome "not recovered", described as "fullness in my ears". The patient was hospitalized for deafness, dizziness, eustachian tube dysfunction, ear discomfort (hospitalization duration: 2 day(s)). The events "i developed hearing loss", "dizziness", "eustachian tube dysfunction" and "fullness in my ears" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Aug2021) Negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of deafness, dizziness, eustachian tube dysfunction, ear discomfort.   Clinical course: In Jun2021 shortly after 2nd vaccine in May, patient developed hearing loss, Eustachian tube dysfunction, fullness in ears and dizziness. Currently the dizziness was occasional, but the fullness in ears and hearing loss persists. The patient received Dose 3 (booster) dose on 09Dec2021 at 12:00, on left arm (lot number=33030BD) for covid-19 immunization administered at Pharmacy or Drug Store. No other vaccine were received in four weeks. No covid prior vaccination. And tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Temporomandibular joint syndrome
Clinical narrative: Psoriasis,; TMJ; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 at 16:00 as dose 2, single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 04Oct2021, when the patient was 25-year-old, for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 03Dec2021 at 08:00, outcome "not recovered", described as "Psoriasis,"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 03Dec2021 at 08:00, outcome "not recovered", described as "TMJ". The events "psoriasis," and "tmj" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of psoriasis, temporomandibular joint syndrome. Additional information: The patient was administered the most recent COVID-19 vaccine at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient tested for COVID-19 was Unknown. The patient received Medication as a Ae treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, SARS-CoV-2 test
Clinical narrative: Chest pains and tightening; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2021 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 30Dec2021, outcome "not recovered"; CHEST DISCOMFORT (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Chest pains and tightening". The events "chest pains and tightening" and "chest pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest discomfort, chest pain. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: No other vaccine in four weeks, no information patient received treatment for event, no vaccination prior covid vaccination. Patient received covid test post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: i had a stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 28May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sofa for Allergies, notes: Known allergies. No covid prior to vaccination and not tested post vaccination. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 16Aug2021, outcome "not recovered", described as "i had a stroke". The event "i had a stroke" required emergency room visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable reporter (Other healthcare professional). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2022 at 12:45 (Lot number: FK9893) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: JUNEL taken for contraception. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7534, Anatomical location: Left arm), administration date: 01Jul2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EP7534, Anatomical location: Left arm), administration date: 23Jul2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Apr2022, outcome "recovering", described as "Left supraclavicular lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy.   Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she tested Home Ag positive 4/7; she tested Home Ag positive 4/7; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Apr2022, outcome "recovering" and all described as "she tested Home Ag positive 4/7". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Family sick with COVID started 4/5 son daughter and husband. Then she got sx ST cough runny nose started on 4/6 and then she tested Home Ag positive 4/7. It was unknown if the patient received other vaccine in four weeks and covid prior vaccination. The patient was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events VACCINATION FAILURE, COVID-19 and suspect drug BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Myalgia, Pain in extremity
Clinical narrative: both of my arms start hurting; muscle ache, arm ache on both shoulders even the one I take it in and also on the other side; muscle ache, arm ache on both shoulders even the one I take it in and also on the other side; sometime I have back pain and ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; ibuprofen (IBUPROFEN), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE:1, MANUFACTURER: UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE:2, MANUFACTURER: UNKNOWN), for Covid-19 immunization; Bnt162b2 (DOSE:3), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "both of my arms start hurting"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "muscle ache, arm ache on both shoulders even the one I take it in and also on the other side"; BACK PAIN (non-serious), outcome "unknown", described as "sometime I have back pain and ache". The action taken for ibuprofen was unknown.  Additional information: Patient had the Pfizer booster the second booster on 31Mar2022 and that was fourth dose, in other words, Pfizer shot. The others were very easy like it was on the third day or the second day patient took an Ibuprofen and patient was okay but both of the arms start hurting and this time patient felt to have some muscle ache, arm ache on both shoulders even the one patient took it in and also on the other side and patient did not have any kind of joint pain, sometime had back pain and ache anyway.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Dysphagia, Oropharyngeal pain, Suspected COVID-19
Clinical narrative: He states he had Pfizer one and two but no booster and recently got the booster, and he has a sore throat side effect from Covid; He states he had Pfizer one and two but no booster and recently got the booster, and he has a sore throat side effect from Covid; pills are extra big can't swallow with sore throat.; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "problem swallowing pills my whole life" (unspecified if ongoing), notes: problem swallowing pills my whole life; "rash" (unspecified if ongoing), notes: weak and didn't feel good and got a rash after chewing antibiotic pill; "weak and didn't feel good" (unspecified if ongoing), notes: weak and didn't feel good and got a rash after chewing antibiotic pill. Patient states that one time he took antibiotics and chewed the pill then was weak and didn't feel good and got a rash because it came on too quick it was supposed to be time released. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He states he had Pfizer one and two but no booster and recently got the booster, and he has a sore throat side effect from Covid"; DYSPHAGIA (non-serious), outcome "unknown", described as "pills are extra big can't swallow with sore throat."; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". Therapeutic measures were taken as a result of dysphagia, oropharyngeal pain. Patient states he had Pfizer one and two but no booster and recently got the booster, and he had a sore throat side effect from Covid so can't swallow pills and was not going to take them if he can't swallow them. patient states he had a problem swallowing pills his whole life and from the virus he had a sore throat it hurts and pills were extra big can't swallow with sore throat. He was prescribed Paxlovid and had a problem with swallowing pills because it was too big. He chewed the first three doses but then read the package warning that says do not crush or chew and he took no more.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Myalgia, Pain in extremity
Clinical narrative: leg (muscles); muscle pain in legs; leg (muscles); muscle pain in legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Anal Cancer", start date: 1999, stop date: 1999, notes: Pertinent details: Laser surgery; "TIA", start date: 2001, stop date: 2001, notes: Pertinent details: Rest d recuperate; "Hysterectomy uterus removed Pre cancer" (unspecified if ongoing), notes: Pertinent details: Surgery removed uterus; "SUT", start date: 2007, stop date: 2007, notes: Pertinent details: ablation for irregular heartbeats; "dryness of vagina" (ongoing); "Pain" (ongoing); "Gerd" (ongoing); "Inflammation" (ongoing); "supplements" (ongoing). Concomitant medication(s) included: ESTRADIOL taken for vulvovaginal dryness, pain (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); HYDROCHLOROTHIAZIDE taken for inflammation (ongoing); VITAMIN D [COLECALCIFEROL] taken for supplementation therapy (ongoing); VITAMIN B 12 [CYANOCOBALAMIN] sublingual taken for supplementation therapy (ongoing); METAMUCIL [PLANTAGO OVATA] taken for supplementation therapy (ongoing); MAGNESIUM taken for supplementation therapy (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "leg (muscles); muscle pain in legs". The event "leg (muscles); muscle pain in legs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, myalgia. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vertigo positional
Clinical narrative: Recurrence of some BPPV; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 31Mar2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: FORTEO taken for osteoporosis, start date: 06Jan2022. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed., Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose: 03), for COVID-19 Immunization, reaction(s): "a tooth broke out", "BPPV began in Dec2021". The following information was reported: VERTIGO POSITIONAL (non-serious) with onset 2022, outcome "not recovered", described as "Recurrence of some BPPV". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that tried submitting this through your website form, but I had trouble using your form. When I tried to put in my list of medications on your form, that's where the trouble started, so I did not submit the information through your web page, and I am sending you this letter instead. Here is the information regarding my second booster shot was had second Booster shot of the Pfizer vaccine at 5:00 PM on 31Mar2022, and it triggered a recurrence of some BPPV I had a few times over the past few months. BPPV history: The BPPV began in Dec2021 after a visit to the dentist where a tooth broke out and he had to rebuild a tooth for about an hour. The symptoms would be "a little room spinning for a short time in the morning and then I would be fine the rest of the day. It would go away after a few days. I don't recall the start of the second episode of BPPV. The 3rd episode of BPPV started after an MRI exam where they put ear plugs in ears. And now after the second booster shot, it started again. Had checked on the web and Yes, patients have reported vertigo after the Pfizer shot. I will let you know if the BPPV continues or gets worse. I have also been taking a daily injection of Forteo for Osteoporosis, since 06Jan2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (159558). The reporter is the patient. A male patient received the 4th (second booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 8, 2022, single dose, for COVID-19 immunisation. The patient's medical history included allergies (unspecified if ongoing), notes: he had allergies previously. The patient's concomitant medications not reported. Vaccination history included the COVID-19 vaccine (primary series complete, manufacturer unknown), for COVID-19 immunization; and the 3rd (first booster) dose of BNT162B2. The patient had pain in extremity/arm was a bit aching after the shot, onset Apr 8, 2022, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Pneumonia
Clinical narrative: the patient experienced COVID; the patient experienced COVID; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till Dec2021 at 40 mg (citrate free, 40 mg (1 in 2 wk)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset 2021, outcome "unknown"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "the patient experienced COVID". The patient was hospitalized for drug ineffective, covid-19, pneumonia (start date: Dec2021, discharge date: Mar2022). The action taken for adalimumab was dosage permanently withdrawn in Dec2021.  The reporter's assessment of the causal relationship of "the patient experienced covid" and "pneumonia" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Additional information: The patient was hospitalized from Dec2021 to Mar2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporter's causality for the event(s) of COVID and PNEUMONIA was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of COVID and PNEUMONIA are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Magnetic resonance imaging, Tooth fracture, Vertigo positional
Clinical narrative: BPPV began in December, 2021; a tooth broke out; a little room spinning for a short time in the morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, Unknown Manufacturer), for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovered", described as "a little room spinning for a short time in the morning"; TOOTH FRACTURE (non-serious) with onset 2021, outcome "unknown", described as "a tooth broke out"; VERTIGO POSITIONAL (non-serious) with onset Dec2021, outcome "unknown", described as "BPPV began in December, 2021". The events "a tooth broke out" and "a little room spinning for a short time in the morning" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Drug ineffective, Joint swelling, Musculoskeletal discomfort
Clinical narrative: Swelling of elbows; Pain in elbow; Hand pain; hand swelling; COVID-19; COVID-19; Discomfort in right elbow; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4265254-00 (Agency).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 31Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at citrate free and second regimen (Batch/Lot number: unknown) at citrate free, all subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovering" and all described as "COVID-19"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2022, outcome "unknown", described as "Discomfort in right elbow"; JOINT SWELLING (non-serious), outcome "not recovered", described as "Swelling of elbows"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Pain in elbow"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Hand pain"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "hand swelling". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. The action taken for adalimumab was dosage permanently withdrawn. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "covid-19" and "discomfort in right elbow" related to BNT162b2. The reporter's assessment of the causal relationship of "swelling of elbows", "pain in elbow", "hand pain" and "hand swelling" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment and causal relationship of "discomfort in joints" and "COVID-19" with the suspect product(s) BNT162b2 was possible.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Swelling in right elbow, Pain in right elbow, Pain in right Hand, Swelling in right hand, Discomfort in right elbow and Covid-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid-19, musculoskeletal discomfort, joint swelling, arthralgia, pain in extremity and peripheral swelling cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Swelling of elbows; Pain in elbow; Hand pain; hand swelling; COVID-19; COVID-19; Discomfort in right elbow; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4265254-00 (Agency).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 31Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at citrate free and second regimen (Batch/Lot number: unknown) at citrate free, all subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovering" and all described as "COVID-19"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2022, outcome "unknown", described as "Discomfort in right elbow"; JOINT SWELLING (non-serious), outcome "not recovered", described as "Swelling of elbows"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Pain in elbow"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Hand pain"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "hand swelling". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. The action taken for adalimumab was dosage permanently withdrawn. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "covid-19" and "discomfort in right elbow" related to BNT162b2. The reporter's assessment of the causal relationship of "swelling of elbows", "pain in elbow", "hand pain" and "hand swelling" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment and causal relationship of "discomfort in joints" and "COVID-19" with the suspect product(s) BNT162b2 was possible.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Swelling in right elbow, Pain in right elbow, Pain in right Hand, Swelling in right hand, Discomfort in right elbow and Covid-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid-19, musculoskeletal discomfort, joint swelling, arthralgia, pain in extremity and peripheral swelling cannot be excluded.