chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Overdose
Clinical narrative: No adverse event; 1 ml dose received for dose 1; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (1 ml dose received for dose 1) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 prophylaxis.     It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included Drug allergy (Chloroquine allergy), Penicillin allergy (Penicillins allergy), Anxiety, Hypertension, Eye disorder and Pain. Concomitant products included ALPRAZOLAM for Anxiety, CARVEDILOL for Hypertension, IBUPROFEN and ACETAMINOPHEN for Pain.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 28-Jan-2021, the patient experienced OVERDOSE (1 ml dose received for dose 1). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (1 ml dose received for dose 1) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for OVERDOSE (1 ml dose received for dose 1).    Patient concomitant medication included Vit C/Vit E Lutein Minerals with indication of eye health, oral, 1 capsule.  No treatment information provided.   This case was linked to MOD-2022-630494, MOD-2022-628728 (Patient Link).
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 18-Jul-2022 and administration of vaccine was on 18-Aug-2022; No adverse event; Received second dose one day after 30-days by used date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received second dose one day after 30-days by used date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2022 and administration of vaccine was on 18-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received second dose one day after 30-days by used date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2022 and administration of vaccine was on 18-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received second dose one day after 30-days by used date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2022 and administration of vaccine was on 18-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received second dose one day after 30-days by used date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2022 and administration of vaccine was on 18-Aug-2022).    No concomitant medications were reported. It was reported that the second dose of Moderna COVID-19 vaccine was one day beyond 30 days refrigerated on 18-Aug-2022. The vaccine was taken from the frozen container and out into the refrigerator. The 0.25 ml dose was pulled out of the dark blue cap vial with a magenta boarder label then administered. The vial had not undergone any temperature excursions.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2022: Follow up received includes non-significant information: Reporter information was added and narrative updated. On 18-Aug-2022: Follow up received includes non-significant information: Narrative updated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Overdose
Clinical narrative: No adverse event; 1 ml dose received for dose 2; Dose 1 received on 20-Jan-2021 and Dose 2 received on 12-Feb-2021; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (1 ml dose received for dose 2), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 20-Jan-2021 and Dose 2 received on 12-Feb-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 042L20A) for COVID-19 prophylaxis.     Patient did not had any allergies.  Concurrent medical conditions included Chronic kidney disease since 22-Apr-2015, Hypertension, Pre-diabetic since 22-Apr-2015, High cholesterol, Pain and Diabetes mellitus. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METFORMIN for Diabetes mellitus, ATORVASTATIN for High cholesterol, METOPROLOL SUCCINATE for Hypertension, IBUPROFEN for Pain.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter. On 12-Feb-2021, the patient experienced OVERDOSE (1 ml dose received for dose 2) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 20-Jan-2021 and Dose 2 received on 12-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (1 ml dose received for dose 2), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 20-Jan-2021 and Dose 2 received on 12-Feb-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OVERDOSE (1 ml dose received for dose 2) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 20-Jan-2021 and Dose 2 received on 12-Feb-2021).    No treatment drug information was provided.   This case was linked to MOD-2022-630516, MOD-2022-628730 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Overdose
Clinical narrative: No Adverse event; 1 ml dose received for dose 1; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (1 ml dose received for dose 1) and NO ADVERSE EVENT (No Adverse event) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic kidney disease since 22-Apr-2015, Hypertension, Pre-diabetic since 22-Apr-2015, High cholesterol, Pain and Diabetes mellitus. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METFORMIN for Diabetes, ATORVASTATIN for High cholesterol, METOPROLOL SUCCINATE for Hypertension, IBUPROFEN for Pain.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 20-Jan-2021, the patient experienced OVERDOSE (1 ml dose received for dose 1). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, OVERDOSE (1 ml dose received for dose 1) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered OVERDOSE (1 ml dose received for dose 1) and NO ADVERSE EVENT (No Adverse event) to be not related.    Treatment information was not provided.   This case was linked to MOD-2022-630508, MOD-2022-628730 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Doses were given 21 days apart; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given 21 days apart) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given 21 days apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given 21 days apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given 21 days apart).    No concomitant product use was provided.  The patient has not experienced any symptoms. No additional doses, medications, or treatments have been administered at this point in time.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: COVID-19 SHOTS CAUSED BREAKOUT ON NECK FOR BOTH SHOTS; This spontaneous case was reported by a consumer and describes the occurrence of RASH (COVID-19 SHOTS CAUSED BREAKOUT ON NECK FOR BOTH SHOTS) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced RASH (COVID-19 SHOTS CAUSED BREAKOUT ON NECK FOR BOTH SHOTS). At the time of the report, RASH (COVID-19 SHOTS CAUSED BREAKOUT ON NECK FOR BOTH SHOTS) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) and mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the event of COVID-19 SHOT CAUSED BREAKOUT ON NECK FOR BOTH SHOTS was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Weight decreased
Clinical narrative: reports having no appetite starting after her first Primary Series Dose, and this continues to this day; Patient has lost 20 pounds; This spontaneous case was reported by an other health care professional and describes the occurrence of DECREASED APPETITE (reports having no appetite starting after her first Primary Series Dose, and this continues to this day) and WEIGHT DECREASED (Patient has lost 20 pounds) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included CROMOGLICATE SODIUM (NASALCROM), LEVOTHYROXINE and ALPRAZOLAM for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced DECREASED APPETITE (reports having no appetite starting after her first Primary Series Dose, and this continues to this day) and WEIGHT DECREASED (Patient has lost 20 pounds). At the time of the report, DECREASED APPETITE (reports having no appetite starting after her first Primary Series Dose, and this continues to this day) had not resolved and WEIGHT DECREASED (Patient has lost 20 pounds) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2022-630610, MOD-2022-630614 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pigmentation disorder, Rash
Clinical narrative: Stated her arm was purple; Stated her arm was red; Stated her arm was red, purple, swollen; Her entire body looked like road rash; This spontaneous case was reported by a consumer and describes the occurrence of PIGMENTATION DISORDER (Stated her arm was purple), ERYTHEMA (Stated her arm was red), PERIPHERAL SWELLING (Stated her arm was red, purple, swollen) and RASH (Her entire body looked like road rash) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Pain, Relapsing-remitting multiple sclerosis (Relapsing remitting multiple sclerosis), Gastroparesis, Depression and Anxiety. Concomitant products included OCRELIZUMAB (OCREVUS), BUPROPION HYDROCHLORIDE (WELLBUTRIN), BACLOFEN, DOCUSATE SODIUM (COLACE), LUBIPROSTONE (AMITIZA), OXYCODONE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), GABAPENTIN, SPIRONOLACTONE, DULOXETINE, ALPRAZOLAM (XANAX), BUPRENORPHINE HYDROCHLORIDE (BELBUCA), VITAMIN D NOS and ASCORBIC ACID, BIOTIN, TOCOPHERYL ACETATE (BIOTIN GUMMY) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PIGMENTATION DISORDER (Stated her arm was purple), ERYTHEMA (Stated her arm was red), PERIPHERAL SWELLING (Stated her arm was red, purple, swollen) and RASH (Her entire body looked like road rash). At the time of the report, PIGMENTATION DISORDER (Stated her arm was purple), ERYTHEMA (Stated her arm was red), PERIPHERAL SWELLING (Stated her arm was red, purple, swollen) and RASH (Her entire body looked like road rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's concomitant medication included hair, skin and nails gummies with biotin.  Treatment information was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received an expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine).    No concomitant medications were reported. Reporter stated that she still had vaccine that have been expired and she wanted to know how to dispose of it.  She stated that it was their 1st booster and the vaccine had expired a few days ago and a patient receiving it did not make a difference. That the patient was still getting the benefit from the vaccine.  No treatment medications were reported.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received a  full dose instead of a half a dose for the first booster/Received 0.5ml from Red Cap Vial instead of 0.25ml for first booster dose) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022, the patient experienced ACCIDENTAL OVERDOSE (Received a  full dose instead of a half a dose for the first booster/Received 0.5ml from Red Cap Vial instead of 0.25ml for first booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Received a  full dose instead of a half a dose for the first booster/Received 0.5ml from Red Cap Vial instead of 0.25ml for first booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Received a  full dose instead of a half a dose for the first booster/Received 0.5ml from Red Cap Vial instead of 0.25ml for first booster dose).    No concomitant medication reported. No treatment medication details reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough; Body aches; Low grade fever; This serious initial spontaneous safety report was received by  on 15-AUG-2022 from a consumer.  A female of 69 years was vaccinated at a pharmacy with intramuscular Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 09-AUG-2022 at 11am CST via the left side.  The following medical history was reported as COVID-19 (FEB-2021) and Pain in extremity with the Flu vaccine.  The following concomitant medications were reported as "NO."  On an unspecified day in AUG-2022, after suspect Covid-19 vaccine dose 1, the individual had a low grade fever (PT: Pyrexia), cough (PT: Cough) (Serious: Hospitalization), and body aches (PT: Pain). On the morning of 15-AUG-2022, the individual went to the hospital where her HCP (health care provider) prescribed an inhaler and something for her cough.  Relevant lab tests included: SARS-CoV-2 test (Result: Positive ; FEB-2021).  At the time of reporting, the event outcomes of Pyrexia, Cough, and Pain was recovering/resolving (diminishing).  Additional information is expected in this case.; Sender's Comments: This 69  year-old female experienced: Cough, Pain and Pyrexia after vaccination with Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Cough was reported as serious. The events Pain and Pyrexia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted and the reported events were assessed as Possible.
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, COVID-19, Computerised tomogram, Drug ineffective, Electrocardiogram
Clinical narrative: He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR; He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR; This is a literature report from a sales representative for the following literature source(s):   A 63-year-old male patient received BNT162b2 (BNT162B2), 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: "type 2 diabetes mellitus" (unspecified if ongoing); "hospitalization" (unspecified if ongoing); "tachycardia" (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 latency 2 days after the suspect product(s) administration, outcome "recovering" and all described as "He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide (2-100): less than 35.0; Computerised tomogram: demonstrating bilateral pulmonary emboli, notes: without evidence of parenchymal involvement from SARS-CoV-2; Electrocardiogram: without changes to suggest ischemia, notes: or right ventricular strain; Fibrin D dimer: 2.26 ug/ml, notes: was 4.5 times above the upper normal limit. Reference range less than or equal to 0.48; Haemoglobin: 11.8 %; Oxygen saturation: 91 %; Polymerase chain reaction: Positive, notes: On day 2; Positive, notes: On day 8 Repeat Test; Pulmonary embolism: demonstrating bilateral pulmonary embol, notes: without evidence of parenchymal involvement from SARS-CoV-2; Troponin T: less than 2.50, notes: High Reference range: less than or equal to 39.0. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Haemoglobin, Oxygen saturation, Polymerase chain reaction, Pulmonary embolism
Clinical narrative: He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR; He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR; This is a literature report from a sales representative for the following literature source(s):   A 63-year-old male patient received BNT162b2 (BNT162B2), 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: "type 2 diabetes mellitus" (unspecified if ongoing); "hospitalization" (unspecified if ongoing); "tachycardia" (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 latency 2 days after the suspect product(s) administration, outcome "recovering" and all described as "He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide (2-100): less than 35.0; Computerised tomogram: demonstrating bilateral pulmonary emboli, notes: without evidence of parenchymal involvement from SARS-CoV-2; Electrocardiogram: without changes to suggest ischemia, notes: or right ventricular strain; Fibrin D dimer: 2.26 ug/ml, notes: was 4.5 times above the upper normal limit. Reference range less than or equal to 0.48; Haemoglobin: 11.8 %; Oxygen saturation: 91 %; Polymerase chain reaction: Positive, notes: On day 2; Positive, notes: On day 8 Repeat Test; Pulmonary embolism: demonstrating bilateral pulmonary embol, notes: without evidence of parenchymal involvement from SARS-CoV-2; Troponin T: less than 2.50, notes: High Reference range: less than or equal to 39.0. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Troponin T
Clinical narrative: He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR; He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR; This is a literature report from a sales representative for the following literature source(s):   A 63-year-old male patient received BNT162b2 (BNT162B2), 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: "type 2 diabetes mellitus" (unspecified if ongoing); "hospitalization" (unspecified if ongoing); "tachycardia" (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 latency 2 days after the suspect product(s) administration, outcome "recovering" and all described as "He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide (2-100): less than 35.0; Computerised tomogram: demonstrating bilateral pulmonary emboli, notes: without evidence of parenchymal involvement from SARS-CoV-2; Electrocardiogram: without changes to suggest ischemia, notes: or right ventricular strain; Fibrin D dimer: 2.26 ug/ml, notes: was 4.5 times above the upper normal limit. Reference range less than or equal to 0.48; Haemoglobin: 11.8 %; Oxygen saturation: 91 %; Polymerase chain reaction: Positive, notes: On day 2; Positive, notes: On day 8 Repeat Test; Pulmonary embolism: demonstrating bilateral pulmonary embol, notes: without evidence of parenchymal involvement from SARS-CoV-2; Troponin T: less than 2.50, notes: High Reference range: less than or equal to 39.0. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Antinuclear antibody, Blood albumin, Blood creatinine, Blood urine
Clinical narrative: IgA nephropathy; This is a literature report for the following literature source: Kidney Med, 2021; pgs:10.1016/j.xkme.2021.05.0023427, DOI:10.1016/j.xkme.2021.05.00234278290. The Full Publication has been requested.  A 30-year-old male patient received BNT162b2 (BNT162B2), as DOSE 2, SINGLE (lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (first dose (manufacturer unknown) via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 immunization. The following information was reported: IgA NEPHROPATHY (medically significant), 1 day after the suspect product administration, outcome "recovering." The patient underwent the following laboratory tests and procedures: ANCA (Antineutrophil cytoplasmic antibody): Negative; Antinuclear antibody: Negative; Serum albumin (Blood albumin): unknown results; Serum creatinine (Blood creatinine): 1.02; 1.03, notes: follow up; Blood urine: Positive, notes: Hematuria; Protein urine: 4+, notes: proteinuria. Therapeutic measures were taken as a result of IgA nephropathy.  Additional information: Treatment: RAASi (renin-angiotensin-aldosterone system inhibitor); Follow-up: 6 weeks; Recovery: Partial.  Follow-up attempts are completed. 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. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: IgA nephropathy, Protein urine
Clinical narrative: IgA nephropathy; This is a literature report for the following literature source: Kidney Med, 2021; pgs:10.1016/j.xkme.2021.05.0023427, DOI:10.1016/j.xkme.2021.05.00234278290. The Full Publication has been requested.  A 30-year-old male patient received BNT162b2 (BNT162B2), as DOSE 2, SINGLE (lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (first dose (manufacturer unknown) via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 immunization. The following information was reported: IgA NEPHROPATHY (medically significant), 1 day after the suspect product administration, outcome "recovering." The patient underwent the following laboratory tests and procedures: ANCA (Antineutrophil cytoplasmic antibody): Negative; Antinuclear antibody: Negative; Serum albumin (Blood albumin): unknown results; Serum creatinine (Blood creatinine): 1.02; 1.03, notes: follow up; Blood urine: Positive, notes: Hematuria; Protein urine: 4+, notes: proteinuria. Therapeutic measures were taken as a result of IgA nephropathy.  Additional information: Treatment: RAASi (renin-angiotensin-aldosterone system inhibitor); Follow-up: 6 weeks; Recovery: Partial.  Follow-up attempts are completed. 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. 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: 50.0
Sex: F
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) from product quality group. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 12:00 as dose 1, single (Lot number: EP7534), in left arm, on 01Apr2021 at 13:00 as dose 2, single (Lot number: ER8734), in left arm and on 09Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FM9992) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Sulfa drug" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 01May2021, stop date: 15Aug2022; LOSARTAN POTASSIUM, start date: 01May2021, stop date: 17Aug2022; GABAPENTIN, start date: 01May2021, stop date: 17Aug2022; DICLOFENAC, start date: 01May2021, stop date: 17Aug2022; CYCLOBENZAPRINE, start date: 01May2021, stop date: 17Aug2022; FOLIC ACID, start date: 01May2021, stop date: 17Aug2022; LEVOTHYROXINE, start date: 01May2021, stop date: 17Aug2022; SETLAKIN, start date: 01Apr2019, stop date: 17Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: After positive test, Paxlovoid started 30 hours after  positive results. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was started on Paxlovid treatment from 16Aug2022 to 17Aug2022 (lot number: GE8716).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 13Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 29Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 12Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TRIAMTERENE/HYDROCHLOROTHIAZIDE, start date: 01Jan2000; EZETIMIBE, start date: 01Jan2020. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient was started with antiviral treatment Paxlovid (Lot 2815223) on 30Jul2022. The patient had adverse event of headache, sore throat, fever, stuffy nose and cough on 30Jul2022 01:00 AM which were resolved on 04Aug2022. The treatment of Paxlovid was stopped on 04Aug2022. Other medication in 2weeks includes:Triamterene/Hydrochlorothiazide and Ezetimibe  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
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 29-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive, notes: (23 days after confirmed infection); (17Aug2022) Positive, notes: Tested positive for Covid again 17 days after completing paxlovid (23 days after confirmed infection). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report was about covid treatment. Patient received vaccine. Anti viral details were product covid 19 Treatment, brand reported Paxlovid, treatment start date was 26Jul2022 and stop date 31Jul2022. Vaccine lot unknown reason was provided as not available/provided to reporter at the time of report completion. Adverse event description provided as tested positive for covid again 17 days after completing paxlovid (23 days after confirmed infection). Adverse event start date was18Aug2022. No treatment taken for adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He had Covid one time and then he got the first vaccine and then he got Covid again.; He had Covid one time and then he got the first vaccine and then he got Covid again.; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: He had Covid one time and then he got the first vaccine. 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 "He had Covid one time and then he got the first vaccine and then he got Covid again.".Clinical course: Is report related to a study or programme was yes. She has a Nurse calling for the Doctor in her office and the patient has been administered the first dose and he has got Covid twice and she is asking should they start the series over or start the second vaccine. Agent said the age group was 5-11 years. The product was the Pfizer Covid-19 vaccine. The caller clarified the details provided by the transfer agent. She clarified the only correction was he had Covid one time and then he got the first vaccine and then he got Covid again and he qualifies for the second dose and the Doctor wanted to clarify she did not need to start the series over or ok to give second dose. Caller asked for USMI number and said she would call back later. Caller declined to complete report. Is there a product complaint to report was yes. Caller said patient had Covid one time and then he got the first vaccine and then he got Covid again. Caller declined to complete a report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test Positive/ Treatment of COVID-19; COVID test Positive/ Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 28Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 06Jan2022 as dose 3 (booster), single (Lot number: 041J21A) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; WELLBUTRIN; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID test Positive/ Treatment of COVID-19". No adverse event from the vaccines. After taking Paxlovid and then testing negative for four days, patient started to get symptoms again and tested positive for Covid again on 14Aug2022. On 18Aug2022, patient still test positive and have mild to moderate symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included COVID 19 Treatment, Paxlovid from 04Aug2022 to 08Aug2022.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient had rebound symptoms with positive test after completion of Paxlovid; patient had rebound symptoms with positive test after completion of Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 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: "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "patient had rebound symptoms with positive test after completion of Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: patient had rebound symptoms with positive test after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and Covid 19 cannot be ruled out.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis acute, SARS-CoV-2 test
Clinical narrative: Acute hepatitis diagnosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, Dose number: 03), for Covid-19 immunization; Covid-19 vaccine (Manufacturer: Unknown, Dose number: 02), for Covid-19 immunization; Covid-19 vaccine (Manufacturer: Unknown, Dose number: 01), for Covid-19 immunization. The following information was reported: HEPATITIS ACUTE (hospitalization, medically significant) with onset 24May2022 at 08:00, outcome "not recovered", described as "Acute hepatitis diagnosis". The patient was hospitalized for hepatitis acute (hospitalization duration: 7 day(s)). The event "acute hepatitis diagnosis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Negative, notes: COVID test post vaccination. Therapeutic measures were taken as a result of hepatitis acute.  Clinical course: No other vaccine in four weeks. Other medications in two weeks included Lisinopril. No COVID prior vaccination. Tested for covid after vaccination. No known allergies and no other medical history. Adverse event included acute hepatitis diagnosis 6 days post vaccination and adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Treatment included Steroids.    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.