chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM; dose administered past manufactures expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM).    Concomitant medications details were not reported by the reporter. There was not any other potential caused. It was unknown if patient experienced similar adverse event in the past. Dose administered after 30-day Use by Date or after manufacturer date of expiry. The vial was initially stored in the refrigerator. Was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM.  Dose were administered between 2-3 PM on 03May2022 5. The vial did not 6undergo any temperature excursions. Treatment details was not reported by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM; dose administered past manufactures expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient had no known allergies.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 03-May-2022 at 2:50 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:50 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was put in refrigerator on 03-May-2022 until 1:45 PM and administered on 03-May-2022 between 2-3 PM).    No Concomitant medication was reported  The vaccine vial was initially pulled from freezer at 10 AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM. All 12 doses were administered between 2-3 PM on 03-May-2022.The vial did not undergo any temperature excursions. No Treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain, our arms both hurt so bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain, our arms both hurt so bad). At the time of the report, PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain, our arms both hurt so bad) had not resolved. No concomitant were reported. No treatment were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 25 doses of expired Moderna Covid-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint lock, Muscle fatigue, Muscular weakness, Pain
Clinical narrative: Aches / Pains; Arms were extremely tired; Knees and ankles got lock; Arms were weak; Felt extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches / Pains), MUSCLE FATIGUE (Arms were extremely tired), JOINT LOCK (Knees and ankles got lock), MUSCULAR WEAKNESS (Arms were weak) and FATIGUE (Felt extremely tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Ulcerative colitis and Crohn's disease.    Patient had no known allergies. Patient had no relevant medical history.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Aches / Pains), MUSCLE FATIGUE (Arms were extremely tired), JOINT LOCK (Knees and ankles got lock), MUSCULAR WEAKNESS (Arms were weak) and FATIGUE (Felt extremely tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (Aches / Pains) had not resolved, MUSCLE FATIGUE (Arms were extremely tired) outcome was unknown and JOINT LOCK (Knees and ankles got lock), MUSCULAR WEAKNESS (Arms were weak) and FATIGUE (Felt extremely tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  Dosage text was reported as Booster (1 in 1 Once) for Moderna COVID-19 Vaccine  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with HUMIRA(ADALIMUMAB) for the events of Knees and Ankles got lock and Arms were extremely tired and weak was a reasonable possibility, for the events of Arms were extremely tired and weak was not provided, and for the events of were extremely tired and Aches / Pains was no reasonable possibility.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Muscle pain; Cramping in legs; Cramping in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 03May2022 at 11:15 as dose 4 (booster), single (Lot number: FK9894) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Rotator cuff surgery", start date: 09Feb2022 (unspecified if ongoing), notes: Verbatim: Rotator cuff surgery, Rotator cuff surgery on 09Feb2022. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FJ1620, Location of injection: Arm Right), administration date: 23Nov2021, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left), administration date: 19Apr2021, when the patient was 61-year-old; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 04May2022 at 15:30, outcome "recovered", described as "Cramping in hands"; MUSCLE SPASMS (non-serious) with onset 04May2022 at 15:30, outcome "recovered", described as "Cramping in legs"; MYALGIA (non-serious) with onset 04May2022 at 15:30, outcome "recovered", described as "Muscle pain". Therapeutic measures were not taken as a result of myalgia, muscle spasms, muscle spasms.  Additional information: If other vaccine in four weeks: No No other vaccine was administered in four weeks. Prior to vaccination patient was not diagnosed with COVID and was not tested positive since vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Magnetic resonance imaging, Myelitis transverse
Clinical narrative: Worsened with second vaccine.; transverse myelitis; L-sided hemisensory numbness from torso at level of ~T4 to toes; developed over course of weeks after COVID vaccine. Worsened with second vaccine. MRI findings showing demyelinating process, concernin; This is a spontaneous report received from a contactable reporter (Physician).  A 30-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 04Mar2022 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in left arm and on 25Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Allergy", notes: known allergies: Penicillin. The following information was reported: HYPOAESTHESIA (hospitalization) with onset 11Mar2022, outcome "recovering", described as "L-sided hemisensory numbness from torso at level of ~T4 to toes; developed over course of weeks after COVID vaccine. Worsened with second vaccine. MRI findings showing demyelinating process, concernin"; MYELITIS TRANSVERSE (hospitalization, medically significant) with onset 11Mar2022, outcome "recovering", described as "transverse myelitis"; CONDITION AGGRAVATED (hospitalization, medically significant), outcome "recovering", described as "Worsened with second vaccine.". The events "transverse myelitis" and "l-sided hemisensory numbness from torso at level of ~t4 to toes; developed over course of weeks after covid vaccine. worsened with second vaccine. mri findings showing demyelinating process, concernin" required emergency room visit. L-sided hemisensory numbness from torso at level of ~T4 to toes; developed over course of weeks after COVID vaccine. Worsened with second vaccine. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: transverse myelitis, notes: MRI findings showing demyelinating process, concerning for transverse myelitis. Therapeutic measures were taken as a result of myelitis transverse, hypoaesthesia, condition aggravated.  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 information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 05Jan2021 as dose 2, single (Lot number: EK9231), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 3d458A) at the age of 44 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: HUMALOG, start date: Jun2017; OZEMPIC, start date: May2019; PANTOPRAZOLE, start date: May2014; ATORVASTATIN, start date: Jan2019; HYDROCHLOROTHIAZIDE, start date: Jan2019; LOSARTAN, start date: Feb2020; INVOKANA [CANAGLIFLOZIN], start date: Feb2016; VITAMIN D NOS, start date: Jan2014; VITAMIN C [ASCORBIC ACID], start date: Feb2009. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 10:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, Covid-19. The patient received Paxlovid Anti-viral details: product=COVID-19 Treatment, from 02May2022 to 06May2022 for treatment of COVID-19. 24 hrs. after patient stopped taking Paxlovid patient became more congested than while on treatment, running nose and more loose cough, body ache also was new since starting the treatment. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 at 11:30 as dose 3 (booster), single (Lot number: FF2587) in left arm, on 27Mar2021 at 03:00 as dose 2 , single (Lot number: ER8730), in left arm and on 04Mar2021 at 03:00 as dose 1, single (Lot number: EN6202), at the age of 73 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "pulmonary fibrosis" (unspecified if ongoing); "cirrhosis" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Jan2000, stop date: 30Apr2022; ROSUVASTATIN, start date: Jan2000, stop date: 30Apr2022; VITAMIN D [VITAMIN D NOS], start date: 01Dec2013, stop date: 30Apr2022; FAMOTIDINE, start date: 01Dec2013, stop date: 30Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound after taking the 30 tablets of Paxlovid/Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Sender's Comments: Based on the information available a possible contributory role of the suspect  BNT162b2 cannot be excluded for the reported events of drug ineffective, Covid-19.
Age: 57.0
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 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 25Jan2021 at 12:15 as dose 1, single (Lot number: FJ5683), in left arm, on 15Feb2021 at 12:00 as dose 2, single (Lot number: EN5318), in left arm, on 07Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 08Jan2022 as dose 4 (booster), single (Lot number: EL9262) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022 at 14:30, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound covid. Tested negative for three days then tested positive again; Positive, notes: Rebound covid. Tested negative for three days then tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Other medication in 2weeks. Adverse event: Rebound covid. Tested negative for three days then tested positive again. Patient took Anti-viral Pfizer product for COVID 19 Treatment, Treatment start date was 27Apr2022 and Treatment stop date was 02May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 at 12:15 as dose 1, single (Lot number: FJ5683), in left arm, on 15Feb2021 at 12:00 as dose 2, single (Lot number: EN5318), in left arm, on 07Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 08Jan2022 as dose 4 (booster), single (Lot number: EL9262) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022 at 14:30, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound covid. Tested negative for three days then tested positive again; Positive, notes: Rebound covid. Tested negative for three days then tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Other medication in 2weeks. Adverse event: Rebound covid. Tested negative for three days then tested positive again. Patient took Anti-viral Pfizer product for COVID 19 Treatment, Treatment start date was 27Apr2022 and Treatment stop date was 02May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 56 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), 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: "high blood pressure (controlled)" (unspecified if ongoing), notes: controlled; "high cholesterol (controlled)" (unspecified if ongoing), notes: controlled. Concomitant medication(s) included: LOSARTAN, start date: 01Apr2022, stop date: 25Apr2022; CHLORTHALIDONE, start date: 01Apr2022, stop date: 25Apr2022; ATORVASTATIN, start date: 01Apr2022, stop date: 25Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) positive; (02May2022) Negative, notes: rebound congestion on day 13 and positive COVID test, after negative COVID test on day 7; (08May2022) Positive, notes: rebound congestion on day 13 and positive COVID test, after negative COVID test on day 7. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical Information: The patient had no Known allergies. Anti-viral COVID-19 Treatment details included Paxlovid from 25Apr2022 to 30Apr2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am vaccinated (2 Pfizer) and boosted (Moderna). I tested positive and developed minor symptoms; I am vaccinated (2 Pfizer) and boosted (Moderna). I tested positive and developed minor symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-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; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "I am vaccinated (2 Pfizer) and boosted (Moderna). I tested positive and developed minor symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: tested positive and developed minor symptoms; tested negative; started testing positive and Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient have not taken any other medication in two weeks. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 26Apr2022, Treatment stop date: 01May2022. Patient was vaccinated (2 Pfizer) and boosted (Moderna). He tested positive and developed minor symptoms. That night he started paxlovid. He took all 10 doses. During the course he fleet fine and tested negative on rapid tests. A few days after the course he started testing positive and Covid again. He was isolating so it's unlikely that he was reinfected. Symptoms developed.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After a full course of Paxlovid, I began to experience COVID symptoms again and test positive on an at-home test.; After a full course of Paxlovid, I began to experience COVID symptoms again and test positive on an at-home test.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2021 at 16:15 as dose 3 (booster), single (Lot number: ER8730) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE, start date: 01Nov2020, stop date: 08May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022 at 22:00, outcome "not recovered" and all described as "After a full course of Paxlovid, I began to experience COVID symptoms again and test positive on an at-home test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: I began to experience COVID symptoms again and test positive on an at-home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient was treated with Antiviral drug for Covid 19 from 27th April 2022 to 02 May 2022).  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 23:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Jan2021 at 20:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 28Aug2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "mild cardiovascular disease" (unspecified if ongoing), notes: mild cardiovascular disease; "sulfa" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course : The patient did not receive Other Medication in 2weeks.The Anti-Viral Details included Brand: Paxlovid Treatment Start Date: 29Apr2022 Treatment Stop Date: 03May2022 Indication: Treatment of COVID-19. Resurgence of COVID symptoms 5 days after completing course.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19/I had with COVID; indication=Treatment of COVID-19/I had with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: F31611) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Minor anxiety" (unspecified if ongoing), notes: Minor anxiety; "infrequent migraines" (unspecified if ongoing), notes: infrequent migraines; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE HCL, received in 2 weeks of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19/I had with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: when taking a rapid COVID test, I had a barely visibly positive line. Yesterday (a week after ending paxlovid) COVID symptoms began to resurge. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID 19 Treatment, Brand=Paxlovid, Treatment start date: 24Apr2022, Treatment stop date: 30Apr2022, Indication: Treatment of COVID-19. Symptoms of COVID subsided relatively soon after taking paxlovid to the point where the day following my last dose, he felt almost back to normal and when taking a rapid COVID test, he had a barely visibly positive line. Yesterday (a week after ending paxlovid) COVID symptoms began to resurge. For him, that included sore throat, runny nose, and sort of a tingling sensation in his nose similar to what one would normally had with a cold. These were the same noticeable symptoms he had with COVID. Symptoms had worsened over the past 24 hours but remain the same, only increased in intensity.  A final statement is not entered.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive 7 days after completing course of paxlovid; tested positive 7 days after completing course of paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "not recovered" and all described as "tested positive 7 days after completing course of paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive 7 days after completing course of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Developed COVID 19 symptoms and tested positive 7 days after completing course of paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient previously received a COVID-19 Vaccine. The patient did not have any no Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, latency 5 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details were product-COVID 19 Treatment, brand-Paxlovid, Treatment start date-03May2022, Treatment stop date-08May2022. Reported Event: Explosive diarrhea and GI symptoms after ending full course of Paxlovid. Adverse events start date was 08May2022 if patient recovered was Recovering. If treatment ae was no. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid today 08May2022; I tested positive for Covid today 08May2022; 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 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Dec2021 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "unknown" and all described as "I tested positive for Covid today 08May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: tested positive for covid.  Clinical course: Patient Wants to report that Patient had tested positive for Covid today 08May2022. Patient was double vaccinated and boosted with Pfizer vaccine. Booster was on Dec2021. Currently Patient has no symptoms, just reporting the positive case.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: daughter with COVID 02May then sx mild started 02May and then PCR test positive 07May and Ag positive 06May; daughter with COVID 02May then sx mild started 02May and then PCR test positive 07May and Ag positive 06May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. The reporter is the parent.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0151), on 05May2021 as dose 2, single (Lot number: EW0171) and on 16Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 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) with onset 02May2022, outcome "unknown", COVID-19 (medically significant) with onset 02May2022, outcome "recovering" and all described as "daughter with COVID 02May then sx mild started 02May and then PCR test positive 07May and Ag positive 06May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive, notes: daughter with COVID; (06May2022) Positive, notes: Other; (07May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19. Clinical course included that unknown if other vaccine is administered within 4 weeks. daughter with COVID 02May then sx mild started 02May and then PCR test positive 07May and Ag positive 06May feeling better now.  No follow-up attempts are possible. No further information is expected.; 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 serious events vaccination failure and COVID-19 cannot be totally excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test, Vaccination failure
Clinical narrative: exposed eating out and then sx 5/8 head cold and covid positive AG; exposed eating out and then sx 5/8 head cold and covid positive AG; exposed eating out and then sx 5/8 head cold and covid positive AG; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 17Mar2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3(booster) , single (Lot number: FF2589) at the age of 58 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), NASOPHARYNGITIS (non-serious) all with onset 08May2022, outcome "unknown" and all described as "exposed eating out and then sx 5/8 head cold and covid positive AG". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Covid test name post vaccination. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, exposure to sars-cov-2, nasopharyngitis.  No follow-up attempts are possible. No further information is expected.; 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 serious events vaccination failure and COVID-19 cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Dermatitis atopic, Eczema, Rash, SARS-CoV-2 test
Clinical narrative: Developed a rash on my face two days after receiving vaccine; Recent biopsy revealed a form of atopic dermatitis; eczema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN. Vaccination history included: BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose lot number: EN6198 , prev dose number: 2, prev dose vaccine location: Left arm, I also had an adverse event with 2nd dose that I previously reported - gout- occurred the day after vaccine), administration date: 03Mar2021, for Covid-19 immunization, reaction(s): "gout"; BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose lot number: EL9269, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 02Feb2021, for Covid-19 immunization. The following information was reported: RASH (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Developed a rash on my face two days after receiving vaccine"; DERMATITIS ATOPIC (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Recent biopsy revealed a form of atopic dermatitis"; ECZEMA (medically significant) with onset 01Dec2021, outcome "not recovered". The events "developed a rash on my face two days after receiving vaccine", "recent biopsy revealed a form of atopic dermatitis" and "eczema" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: atopic dermatitis/eczema, notes: Recent biopsy revealed a form of atopic dermatitis/eczema; SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of rash, dermatitis atopic, eczema.  Clinical course: No covid prior vaccination. Covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks: Pravistatin. Adverse event: Patient developed a rash on his face two days after receiving vaccine. Multiple visits to dermatologist and treatments with creams, ointments and steroids did not eliminate. Recent biopsy revealed a form of atopic dermatitis/eczema which he has to begin treatment with injectable. This was the first occurrence of any type of this diagnosis at age 62. (Patient also had an adverse event with 2nd dose that he previously reported - gout- occurred the day after vaccine). AE treatment: topical creams, steroid ointments; oral steroids.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid returned after 5 days; Covid returned after 5 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6206), in right arm, on 30Mar2021 as dose 2, single (Lot number: ER8733), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ, start date: 15Dec2021; AMLODIPINE, start date: Jan2011; TAMSULOSIN, start date: Jan2011; EZETIMIBE, start date: Jan2011, stop date: Mar2022; ROSUVASTATIN, start date: Jan2011, stop date: 22Apr2022; QUINAPRIL/HYDROCHLOROTHIAZIDE, start date: Jan2011; FINASTERIDE, start date: Jan2011; CLOPIDOGREL, start date: Jan2011; ELIQUIS, start date: Aug2020; LITHIUM OROTATE, start date: Apr2017. Past drug history included: Peg3350, reaction(s): "Known allergies: PEG3350". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid returned after 5 days". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  If Vaccine received: Yes, Other medication in 2weeks: Yes. Product=COVID 19 Treatment, Brand= Paxlovid; Treatment start date=22Apr2022, Treatment stop date=26Apr2022, Indication=Treatment of COVID-19. Other medication in 2weeks product= Q-urol, Other medication in 2weeks brand= Farr labs, Other medication in 2weeks start date= Nov2021.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, suspected COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive antigen test; positive antigen test; 102.4 fever; 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 30Mar2021 as dose 2, single (Lot number: EP7533), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Minor asthma" (unspecified if ongoing); "minor lung disease" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; TUMS 500 CALCIUM; CENTRUM A TO ZINC. Past drug history included: Known allergies: allergic to midol, reaction(s): "Known allergies: Allergic to midol". The following information was reported: PYREXIA (non-serious) with onset 25Apr2022, outcome "not recovered", described as "102.4 fever"; VACCINATION FAILURE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "not recovered" and all described as "positive antigen test". The patient underwent the following laboratory tests and procedures: Body temperature: (25Apr2022) 102.4, notes: symptom start up to 102.4 fever; SARS-CoV-2 test: (26Apr2022) Positive, notes: positive antigen test- began paxlovid that night never missed a dose for 5 days, symptoms cleared in a couple days; (01May2022) Positive, notes: retest antigen still positive; (05May2022) Negative, notes: retest antigen NEGATIVE; (09May2022) Positive, notes: retest for ultracaution and test very positive. Minimal to no symptoms. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of pyrexia. Clinical Course: It was reported that 25Apr2022 symptom start up to 102.4 fever plus. 26Apr2022 positive antigen test- began paxlovid that night patient  never missed a dose for 5 days, symptoms cleared in a couple days.01May2022 retest antigen still positive, continue isol. 05May2022 retest antigen NEGATIVE. Discontinu isol. 06May2022 visit fiance finally after 12 days 07May2022 fiance becomes sick 09May2022 fiance still sick, patient retested for ultracaution and test very positive. Minimal to no symptoms Which is the reason for this report. Either reinfection from 07May2022 fiance visit or paxlovid rebound.