chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) . The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6199), on 07Apr2021 as dose 2, single (Lot number: EP7633), in left arm and on 01Apr2022 as dose 3 (booster), single (Lot number: FK9729), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: having a negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19: treatment with Paxlovid from 02Feb2023 to 06Feb2023.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications within 2 weeks. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: rebound covid on day 8 after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with with Paxlovid (treatment start date: 30Jan2023 treatment stop date: 04Feb2023).  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure, low thyroid; "low thyroid" (unspecified if ongoing), notes: other medical history: High blood pressure, low thyroid; "Strawberries" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Postive, notes: Tested positive again on Day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PAXLOVID.  Clinical Course:if vaccine received: Yes, other medication in 2 weeks: Yes, product=COVID 19 Treatment, brand=Paxlovid, treatment start date=01Feb2023, treatment stop date=06Feb2023, other medication details:other medication in 2 weeks product=Levothyroxine, other medication in 2 weeks product=Amlodipine, adverse event: Rebound covid. Tested positive again on Day 13 after feeling well from day 7-12 after initial symptom onset. Tired, headache, cough, fever. Milder than the first set of symptoms.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Caller is asking if there is any clinical trials for patients that have symptoms of long Covid/the Pfizer BioNtech Covid-19 vaccine gray cap bivalent along with a seizure drug help with her tremors; 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 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neurological symptoms." (unspecified if ongoing), notes: has neurological symptoms. She is experiencing shaking of her hands.; "Shaking of her hands" (unspecified if ongoing), notes: has neurological symptoms. She is experiencing shaking of her hands.; "Tremors" (unspecified if ongoing); "compression fractures" (unspecified if ongoing), notes: She also reported 2 compression fractures from her Covid due to excessive cough.; "Cough" (unspecified if ongoing), notes: She also reported 2 compression fractures from her Covid due to excessive cough. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Caller is asking if there is any clinical trials for patients that have symptoms of long Covid/the Pfizer BioNtech Covid-19 vaccine gray cap bivalent along with a seizure drug help with her tremors".  Additional information : Caller is asking if there is any clinical trials for patients that have symptoms of long Covid. She states her and her husband are experiencing symptoms post Covid diagnosis and they both feel better after taking the Pfizer BioNtech Covid-19 vaccine gray cap bivalent.Symptoms described by caller: 66 year old female, has neurological symptoms. She is experiencing shaking of her hands. She states that the Pfizer BioNtech Covid-19 vaccine gray cap bivalent along with a seizure drug help with her tremors. She also reported 2 compression fractures from her Covid due to excessive cough. Caller also reported symptoms experienced by her husband: 62 year old male experiencing fatigue and neuropathy. Lies on the couch for a month, doesn't have the strength to do anything. He can't take a shower without a chair and is now on permanent dsability. States that the Pfizer BioNtech Covid-19 vaccine gray cap bivalent gives him energy and helps alleviate the fatigue. After a few days after taking his booster he has a lot of energy and feels better for a couple of month.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: rapid heart rate; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 9-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (orange cap), 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: HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was presented as a consumer but already had a file here which registered her as an HCP Caller is asking if Pfizer BioNtech Covid-19 orange cap monovalent has been associated with rapid heart rate in children. case is non-serious. Caller was asking if Pfizer BioNtech Covid-19 orange cap monovalent has been associated with rapid heart rate in children.   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: Thrombosis
Clinical narrative: three patients that had clots after the covid vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: THROMBOSIS (medically significant), outcome "unknown", described as "three patients that had clots after the covid vaccine". Therapeutic measures were taken as a result of thrombosis.  Clinical Course: Report about the unexpected outcome/effect of bivalent covid 19 Pfizer vaccine outcome after treatment. Patient gender was unknown (3 patients not one- she works in Cardiology -hospital also). It was also stated that "I am vaccinated myself with the bivalent and booster. I believe in the vaccine, however I got recently three patients that had clots after the covid vaccine and they had to be in heparin for 6 months) I would like studies about this problem from the scientific point". It was clear the adverse event took place AFTER Pfizer Product USE. On Sunday, 12Feb2013 at 4:15pm mst (yes, I confirm the visit actually took place on Sunday at a Urgent care facility)  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 NOS and the reported event thrombosis. 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.,Linked Report(s) : US-PFIZER INC-PV202300028560 Different patients, Same reporter, drug, event.;US-PFIZER INC-202300067082 Different patients, Same reporter, drug, event.;
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: three patients that had clots after the covid vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: THROMBOSIS (medically significant), outcome "unknown", described as "three patients that had clots after the covid vaccine". Therapeutic measures were taken as a result of thrombosis.  Clinical course: Reported as, 3 patients not one- Reporter works in Cardiology - hospital also). Reporter stated "I am vaccinated myself with the bivalent and booster. I believe in the vaccine, however I got recently three patients that had clots after the covid vaccine and they had to be in heparin for 6 months. I would like studies about this problem from the scientific point." The adverse event took place after Pfizer product use. Date Reported: Sunday, 12Feb2013 at 4:15 pm mst (yes, I confirm the visit actually took place on Sunday at a Urgent care facility).  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 available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 NOS and the reported event thrombosis. 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.,Linked Report(s) : US-PFIZER INC-PV202300028560 Different patients, Same reporter, drug, event.;US-PFIZER INC-202300067081 Different patients, Same reporter, drug, event.;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; vaccine brand other=Moderna; vaccine dose number=4/ vaccine brand=Pfizer / BioNTech; vaccine dose number=5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 14Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ongoing treatment for bladder cancer (BCG instillations)" (ongoing), notes: other medical history: Ongoing treatment for bladder cancer (instillations). Concomitant medication(s) included: LISINOPRIL, start date: Jan2019; TAMSULOSIN, start date: Sep2022. Patient had no known allergies.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Oct2022, outcome "unknown", described as "vaccine brand other=Moderna; vaccine dose number=4/ vaccine brand=Pfizer / BioNTech; vaccine dose number=5"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "not recovered"; COVID-19 (medically significant) with onset 2023, outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 04Feb2023 to 09Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Aches; Tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: ACE inhibitor which has managed my blood pressure for the last 3 years. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for COVID-19 Immunization, reaction(s): "Tiredness", "Aches", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Aches"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional information: Patient reported "I am not comfortable using the form you sent to add personally identifiable information under your stated confidentiality policy. However, I will try to provide information about my situation in an effort to help with reporting possible adverse events. I am (word not legible) female and have not had COVID. I had an original 2 dose regimen of Pfizer vaccine and then 2 Pfizer boosters. Aside from general reactions (fever, aches, tiredness). I had no other symptoms. At the end of Sep, I received the Moderna bivalent booster. Seven days later, my symptoms started. I began having severe visual auras, sight disturbances and dizziness. After consultation with my primary care provider, I had a thorough exam from my ophthalmologist who indicated that there were no changes to my eyes. My doctor then ordered an MRI of my brain. Unfortunately it was not scheduled until early Dec. I was surprised to learn that I had several subacute ischemic strokes, probably in mid Oct or early Nov. Prior to this, i had no symptoms. I am on the lowest dose of an ACE inhibitor which has managed my blood pressure for the last 3 years. My primary care doctor ordered several additional MRI tests, multiple ultrasounds, a heart monitor, EKG, and echocardiogram, All results indicated that i am healthy. At this point, I saw that Pfizer was found to have an increased stroke risk for adults over 65, Since I had kept a diary of my symptoms. I went back and realized that all my symptoms were the most intense in the 3 weeks following my Moderna booster. Since we have ruled out almost everything else, I wanted to report my adverse event in the hope that it will further your research."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): PFIZER INC-PV202300028832 same patient/event, different vaccine dose number;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Aches; Tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: ACE inhibitor which has managed my blood pressure for the last 3 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever"; Bnt162b2 (Dose: 02), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Aches"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional information: the patient had an original 2 dose regimen of Pfizer vaccine and then 2 Pfizer boosters. Aside from general reactions (fever, aches and tiredness). The patient not had other symptoms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): PFIZER INC-PV202300028832 same patient/event, different vaccine dose number;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Aches; Tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever"; Bnt162b2 (Dose 2, single), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever"; Bnt162b2 (Dose 3 (booster), single), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Aches"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional information: The patient have not had COVID. She had an original 2 dose regimen of Pfizer vaccine and then 2 Pfizer boosters. Aside from general reactions (fever, aches, tiredness), she had no other symptoms. At the end of Sep, she received the Moderna bivalent booster. Seven days later, her symptoms started. She began having severe visual auras, sight disturbances and dizziness. After consultation with her primary care provider, she had a thorough exam from her ophthalmologist who indicated that there were no changes to her eyes. Her doctor then ordered an MRI of her brain. Unfortunately, it was not scheduled until early Dec. She was surprised to learn that she had several subacute ischemic strokes, probably in mid Oct or early Nov. Prior to this, she had no symptoms. She was on the lowest dose of an ace inhibitor which had managed her blood pressure for the last 3 years. Her primary care doctor ordered several additional MRI tests, multiple ultrasounds, a heart monitor, EKG, and echocardiogram. All results indicated that she was healthy. At this point, she saw that Pfizer was found to have an increased stroke risk for adults over 65, Since she had kept a diary of her symptoms, she went back and realized that all her symptoms were the most intense in the 3 weeks following her Moderna booster. Since they had ruled out almost everything else, she wanted to report her adverse event in the hope that it would further their research.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): PFIZER INC-PV202300028832 same patient/event, different vaccine dose number;
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Ag test 13Feb2023; covid test result=Positive; positive Ag test 13Feb2023; covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Feb2023, outcome "unknown" and all described as "positive Ag test 13Feb2023; covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: mild flu like sx 12Feb2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 5: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 at 12:15 as dose 1, single (Lot number: EW6205), in left arm, on 30Mar2021 at 12:15 as dose 2, single (Lot number: Er8732), in left arm, on 15Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FF8028), in left arm and on 30Apr2022 at 12:15 as dose 4 (booster), single (Lot number: FJ4989) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Nov2022 at 12:15 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: SIMVASTATIN, start date: May2005, stop date: 25Jan2023 (Brand: Quallent). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Nov2022 at 12:15, outcome "recovered", described as "Dose 5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: At the conclusion, had no symptoms and a negative antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Jan2023 to 31Jan2023.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer/BioNTech Dose Number: 3 / Moderna Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6205), on 28Mar2021 as dose 2, single (Lot number: EP7534) and on 14Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18May2022 as dose 4 (booster), single (Lot number: 056M21A) and on 10Oct2022 as dose 5 (booster), single (Lot number: AS7145B) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "reflux" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: fentanyl, reaction(s): "Known allergies: Fentanyl"; Known allergies: versed, reaction(s): "Known allergies: Versed". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18May2022, outcome "unknown", described as "Pfizer/BioNTech Dose Number: 3 / Moderna Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: initial positive test; (11Feb2023) negative, notes: tested negative on day 10; (13Feb2023) Positive, notes: retested and was very positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks. On 04Feb2023, patient started treatment with Paxlovid for COVID-19 and stopped on 08Feb2023.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Vitamin D deficient" (unspecified if ongoing), notes: other medical history: Vitamin D deficient; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Amoxicillin, Penicillin, Ceclor, Cephalosporins; "known allergies: Cephalosporins" (unspecified if ongoing), notes: known allergies: Amoxicillin, Penicillin, Ceclor, Cephalosporins. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin, Penicillin, Ceclor, Cephalosporins; Ceclor, reaction(s): "known allergies: Ceclor", notes: known allergies: Amoxicillin, Penicillin, Ceclor, Cephalosporins. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:Treatment, brand=Paxlovid,treatment start date was 03Feb2023, treatment stop date was 08Feb2023, indication=Treatment of COVID-19, Other medication details: other medication in 2weeks product was Flouxetine, other medication in 2weeks brand was Generic, Adverse event: Paxlovid Rebound  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2 NOS), on 18Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: the Pfizer BioNtech Covid-19 vaccine gray cap bivalent gives him energy and helps alleviate the fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "symptoms post Covid" (unspecified if ongoing); "fatigue" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "didn't have the strength to do anything. He couldn't take a shower without a chair" (unspecified if ongoing). The patient's 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "the Pfizer BioNtech Covid-19 vaccine gray cap bivalent gives him energy and helps alleviate the fatigue".  Additional information: Caller stated her, and her husband were experiencing symptoms post Covid diagnosis and they both feel better after taking the Pfizer BioNtech Covid-19 vaccine gray cap bivalent. Caller reported symptoms experienced by her husband were 62-year-old male experiencing fatigue and neuropathy. Lied on the couch for a month, didn't have the strength to do anything. He couldn't take a shower without a chair and is now on permanent disability. Stated that the Pfizer BioNtech Covid-19 vaccine gray cap bivalent gives him energy and helps alleviate the fatigue. After a few days after taking his booster, he has a lot of energy and feels better for a couple of months.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: 6J5342) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Feb2023) Negative, notes: Negative test 2 days after finishing Paxlovid; (11Feb2023) Positive, notes: positive test 4 days after finishing Paxlovid; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Patient received anti viral treatment for COVID-19 from 03Feb2023 to 07Feb2023.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID, start date: 07May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2 weeks was Yes Armour Thyroid. Not sure of any known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023; his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023; his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023; his son has received the Moderna COVID-19 vaccine with his most recent booster shot in Feb2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): US-MODERNATX-MOC20230208000141 (Moderna).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Feb2022 as dose number unknown (booster), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Feb2022, outcome "unknown", described as "his son has received the Moderna COVID-19 vaccine with his most recent booster shot in Feb2022"; DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "recovered", DISEASE RECURRENCE (medically significant) with onset Jan2023, outcome "unknown" and all described as "his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023".  Clinical course: Caller states that they all had COVID in May2022 as well. Him and his wife have received the Pfizer COVID-19 vaccine so far but his son has received the Moderna COVID-19 vaccine with his most recent booster shot in Feb2022. Caller states that this was his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent. Other Case identifier(s): MOC20230210000073 (MODERNA).  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: CARDIAC ARREST (death, medically significant) with onset 2022, outcome "fatal". The patient date of death was unknown. Reported cause of death: "Cardiac arrest". It was not reported if an autopsy was performed.  Course of events: Caller called a few weeks ago and one of the things she had mentioned during that call was that her son died this past summer (2022), but she states it had nothing to do with the Moderna COVID-19 vaccine. In fact, her son had received the Pfizer vaccine and was living in another state at the time of vaccination. He was living with her when he had the cardiac arrest and she again claims that it had nothing at all to do with any vaccines. Now, she is getting emails with Moderna thinking that the cardiac arrest was caused by the Moderna vaccine when her son didn't even receive the Moderna COVID-19 vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The reporter considered "cardiac arrest" not related to BNT162b2, BNT162b2 omi ba.4-5. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and known drug safety profile, the event cardia arrest is assessed as unrelated to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. This case will be reassessed should additional information become available.; Reported Cause(s) of Death: Cardiac arrest
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested with covid: Mar2021 / the patient tested positive for covid back in 2021; Tested with covid: Mar2021 / the patient tested positive for covid back in 2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230209000225 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6201) and on 17Mar2021 as dose 2, single (Lot number: EN6206) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Medical History (disease / surgical procedure / etc.): Seasonal allergy. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "allergy", notes: Question: Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor., Answer: Compazine and Augmentin.; Augmentin, reaction(s): "allergy", notes: Question: Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor., Answer: Compazine and Augmentin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2021, outcome "unknown" and all described as "Tested with covid: Mar2021 / the patient tested positive for covid back in 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2021) Positive.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: I lost my brother due to heart attack we both had same vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: MYOCARDIAL INFARCTION (death, medically significant) with onset Feb2023, outcome "fatal", described as "I lost my brother due to heart attack we both had same vaccine". The patient date of death was unknown. Reported cause of death: "I lost my brother due to heart attack we both had same vaccine". No autopsy was performed.  Clinical Information: last week I lost my brother due to heart attack we both had same vaccine he was 49.  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: I lost my brother due to heart attack we both had same vaccine
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, C-reactive protein, COVID-19, CSF test, Computerised tomogram head
Clinical narrative: Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine; Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine; This is a literature report for the following literature source(s): "Concomitant mood disorder and stutter in a post-COVID-19 patient A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "major depressive disorder" (ongoing); "stutter" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Angiogram: revealed no abnormalities; Computerised tomogram head: revealed no abnormalities; C-reactive protein: normal limits; CSF test: an elevated protein level; Fibrin D dimer: normal limits; within normal limit; Laboratory results: unremarkable; Magnetic resonance imaging head: revealed no abnormalities; Protein total (15-45): 73 mg/dl; SARS-CoV-2 test: Positive; Negative; Serum ferritin (26-388): 530 ng/ml.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Fibrin D dimer, Laboratory test, Magnetic resonance imaging head, Protein total
Clinical narrative: Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine; Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine; This is a literature report for the following literature source(s): "Concomitant mood disorder and stutter in a post-COVID-19 patient A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "major depressive disorder" (ongoing); "stutter" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Angiogram: revealed no abnormalities; Computerised tomogram head: revealed no abnormalities; C-reactive protein: normal limits; CSF test: an elevated protein level; Fibrin D dimer: normal limits; within normal limit; Laboratory results: unremarkable; Magnetic resonance imaging head: revealed no abnormalities; Protein total (15-45): 73 mg/dl; SARS-CoV-2 test: Positive; Negative; Serum ferritin (26-388): 530 ng/ml.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".