chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "He recently tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive for Covid. Therapeutic measures were taken as a result of Covid-19, drug ineffective. Additional information: Caller has received his primary series of Covid vaccinations plus one booster. He stated he received the Pfizer Covid vaccines. He recently tested positive for Covid. He was prescribed Paxlovid which he has been taking. His tongue has turned a rusty brown color. He wants to know if this is a reported side effect of the medication. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalopathy, Fatigue, Magnetic resonance imaging, Memory impairment, Nasopharyngitis
Clinical narrative: various spots on brain; Fatigue; sixty pound weight loss; memory issues; tachycardia; cold like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4388298-00.  A 49-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose-1, Intramuscular), administration date: 03Aug2021, when the patient was 49-year-old, for Covid-19 Immunization, reaction(s): "Suspected COVID-19"; BNT162b2 (Dose-1, Intramuscular), administration date: 03Aug2021, when the patient was 49-year-old, for COVID-19 Immunization, reaction(s): "Drug ineffective". The following information was reported: ENCEPHALOPATHY (medically significant), outcome "unknown", described as "various spots on brain"; FATIGUE (non-serious), outcome "unknown"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "sixty pound weight loss"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memory issues"; TACHYCARDIA (non-serious), outcome "unknown"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold like symptoms". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown; Weight: weight loss, notes: sixty pound weight loss. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "various spots on brain", "fatigue", "sixty pound weight loss", "memory issues", "tachycardia" and "cold like symptoms" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.  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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Weight, Weight decreased
Clinical narrative: various spots on brain; Fatigue; sixty pound weight loss; memory issues; tachycardia; cold like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4388298-00.  A 49-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose-1, Intramuscular), administration date: 03Aug2021, when the patient was 49-year-old, for Covid-19 Immunization, reaction(s): "Suspected COVID-19"; BNT162b2 (Dose-1, Intramuscular), administration date: 03Aug2021, when the patient was 49-year-old, for COVID-19 Immunization, reaction(s): "Drug ineffective". The following information was reported: ENCEPHALOPATHY (medically significant), outcome "unknown", described as "various spots on brain"; FATIGUE (non-serious), outcome "unknown"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "sixty pound weight loss"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memory issues"; TACHYCARDIA (non-serious), outcome "unknown"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold like symptoms". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown; Weight: weight loss, notes: sixty pound weight loss. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "various spots on brain", "fatigue", "sixty pound weight loss", "memory issues", "tachycardia" and "cold like symptoms" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.  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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 48-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: FH8027), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 29Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 that included Paxlovid.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 18-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 24Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 17 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "heart murmur" (unspecified if ongoing), notes: other medical history: heart murmur; "known allergies: Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts; "known allergies: tree nuts" (unspecified if ongoing), notes: known allergies: tree nuts. Concomitant medication(s) included: ALLEGRA taken for hypersensitivity; FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course included: The patient received Paxlovid for the treatment of COVID-19 from 7May2022 to 11 May2022. He tested negative on day 6 or so after going through all of Paxlovid but he was testing positive again on day 9. He felt completely fine from around day 3-8 but on day 9 he had a slight sore throat/shortness of breath. He may have started tested positive again earlier but didn't take a test between days 6 and 9. The adverse event started on 16MAy2022 at 8:45 AM. The patient was recovering. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 12:00 as dose 1, single (Lot number: En6200), in left arm, on 20Mar2022 at 12:00 as dose 2, single (Lot number: Er2613), in right arm and on 15Oct2021 at 12:00 as dose 3 (booster), single (Lot number: Fh8020) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing); "Open heart to treat birth defect ALCA" (unspecified if ongoing); "Open heart to treat birth defect ALCA" (unspecified if ongoing); "Open heart to treat birth defect ALCA" (unspecified if ongoing); "possible auto immune" (unspecified if ongoing), notes: possible auto immune. Concomitant medication(s) included: VIVELLE [ETHINYLESTRADIOL;NORGESTIMATE], start date: 02Mar2018, stop date: 16May2022; METOPROLOL, start date: 02Feb2019, stop date: 16May2022; PROGESTERONE, start date: 01Mar2019, stop date: 16May2022. Past drug history included: Known allergies: augmentin ct dye, reaction(s): "Known allergies: augmentin ct dye". The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 01Sep2021 as dose 2, single (Batch/Lot number: unknown) and on 05Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Heart disease - stent." (unspecified if ongoing); "Hypoactive thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical information of the events: Adverse event: Rebound COVID symptom 5 days after last dose of PAXLOVID. Runny nose, fever, chills, sneezing and cough. patient recovered: Not Recovered. No treatment received. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EL9265), in right arm, on 03Mar2021 as dose 2, single (Lot number: EN6206), in right arm and on 08Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Alopecia" (unspecified if ongoing), notes: other medical history: alopecia. Concomitant medication(s) included: TYLENOL, start date: 27Apr2022, stop date: 29Apr2022; FINASTERIDE, start date: 01Sep2021. Past drug history included: Prednisone, reaction(s): "Known allergies: prednisone", notes: known allergies: prednisone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (2022) Negative, notes: I tested negative about 10 days after my first positive test; (2022) Positive, notes: I tested negative about 10 days after my first positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid antiviral treatment for COVID 19 were started from 28Apr2022 to 03MAy2022, Lot number NDC:0069-1085-30, the patient taking other medications/products within 2 weeks of starting COVID-19 treatment of multivitamins. Patient tested negative about 10 days after her first positive test and about 5 days after her last Plaxovid then tested positive 2 days later on 09May2022 at 08:00 AM.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3249), in right arm, on 17Feb2021 at 14:00 as dose 2, single (Lot number: WL9269), in right arm and on 24Sep2021 at 14:00 as dose 3 (booster), single (Lot number: 301308A) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 01Feb2021, stop date: 02May2022; PLAVIX, start date: 01Feb2022; PROTONIX [OMEPRAZOLE], start date: 01Feb2021; METOPROLOL, start date: 01Feb2021; METFORMIN, start date: 01Feb2021; JARDIANCE, start date: 01Feb2021, also these were medications taken in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID -19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Negative; (12May2022) Positive; (30Apr2022) Positive, notes: Symptoms much worse than initial positive test from April 30th. Therapeutic measures were taken as a result of sars-cov-2 test positive included Paxlovid, treatment start date: 02may2022, treatment stop date: 06may2022.  Clinical course: Covid relapse occurred about 4 days after treatment with Paxlovid ended. Treatment start on 02May and ended on 06May. Tested negative with rapid antigen test on 06May. Started feeling bad on 10May with a positive Covid antigen test on 12May. Symptoms much worse than initial positive test from 30April.  Follow-up attempts completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 45-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 01Feb2021 as dose 2, single (Lot number: EL9262), in left arm and on 29Sep2021 as dose 3 (booster) single (Lot number: FF2588) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight/obesity" (unspecified if ongoing); "hyperlipidemia (Untreated)" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN oral, start date: 06May2022, stop date: 09May2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) positive, notes: Tested on binaxnow positive on day of symptoms (day 0) and 2 days after known exposure; (13May2022) negative, notes: Tested on binaxnow day 6 negative and symptoms improved; (17May2022) positive, notes: Retested, positive on rapid antigen I health test and symptomatic (worsening congestion/sore throat) on day 10 of covid after taking Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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 the reported events cannot be totally excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 at 12:00 as dose 1, single (Lot number: ERE734), in left arm, on 24Apr2021 at 12:00 as dose 2, single (Lot number: EW0175), in left arm and on 12Dec2021 at 12:00 as dose 3 (booster), single (Lot number: 330308D) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 09May2022 at 12:00, outcome "unknown", COVID-19 (medically significant) with onset 09May2022 at 12:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 8 days after finishing 5 day Paxlovid course; Positive, notes: initially testing positive; Positive, notes: Still testing Covid positive 15 days after initially testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: The patient did not receive other medication in 2weeks. Anti-viral details: COVID 19 Treatment, Treatment start date=03May2022 and stop date=08May2022. Adverse event: Still testing Covid positive 15 days after initially testing positive and 8 days after finishing 5-day Paxlovid course. Symptoms mild after Paxlovid course. Sore throat. Runny nose. Adverse event start date: 09May2022 at 12:00 AM. If patient is Recovering. If the patient was not received treatment. The patient had no known allergies. Other medical history None.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: Fever; Terrible fatigue; Join pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "I have arm pain". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; FATIGUE (non-serious), outcome "unknown", described as "Terrible fatigue"; ARTHRALGIA (non-serious), outcome "unknown", described as "Join pains".  Additional information: The patient took their second shot and for now a few months the patient had arm pain. The patients brother experience the same pain. The patient took the first booster a couple of days ago and hoped that this will not happen. With the 1st booster, the patient was experiencing fever and a terrible fatigue and join pains. The patient wanted to know if there was a medical solution for this problem.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19,testing positive; Treatment of COVID-19,testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "not recovered" and all described as "Treatment of COVID-19,testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive. Therapeutic measures were not 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 10:00 as dose 1, single (Lot number: EN6204), in left arm and on 02Apr2021 as dose 2 , single (Lot number: ER8734) at the age of 63 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 08Nov2021 as dose 3 (booster), single (Lot number: 032F21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Mild/moderate depression" (unspecified if ongoing); "Known allergies: Iodine contrast" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, start date: 01May2021. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin", notes: Known allergies: erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Anti-viral details: Product: Product: COVID-19 Treatment, brand: Paxlovid, treatment start date: 07May2022, treatment stop date: 11May2022, indication: Treatment of COVID-19. Adverse event: Covid symptoms initially improved then on 14May flared up again sore throat, fatigue and congestion, Adverse event start date: 14May2022, Adverse event start time: 06:00 AM. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: EW0150), in left arm and on 02May2021 as dose 2, single (Lot number: ER8735), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Jan2022 as dose 3 (booster), single (Lot number: 008F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "IBS" (unspecified if ongoing). Other medication in 2weeks: Concomitant medication(s) included: FLUOXETINE, start date: May2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Anti-viral details COVID 19 Treatment. Paxlovid Treatment start date: 13May2022. Treatment stop date: 14May2022. After 2nd Paxlovid dose, started seeing cloud-like shapes, which were moving and blurring vision. This occurred in right eye only but it impaired total vision. Reaction took place for 15-20 minutes. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for Covid-19 immunisation; enalapril maleate (ENALAPRIL MALEATE), (Batch/Lot number: unknown); latanoprost (LATANOPROST), (Batch/Lot number: unknown). The patient had no relevant medical history. Concomitant medication(s) included: TIMOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Product: COVID-19. Treatment, Brand: Paxlovid, Treatment start date: 04May2022, Treatment stop date: 08May2022, Indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Negative; positive. 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.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), on 16Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Oct2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Mar2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 38 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), from 19Mar2021 (Lot number: 180525) to 19Mar2021 at 1 single (dose 1, single) for Covid-19 immunisation. The patient's relevant medical history included: "Hyperprolactinemia" (unspecified if ongoing). Concomitant medication(s) included: Zyrtec [Cetirizine Hydrochloride]; Flonase [Fluticasone Propionate]; Cabergoline. The following information was reported: DRUG INEFFECTIVE (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. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), on 16Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Oct2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Mar2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 38 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), from 19Mar2021 (Lot number: 180525) to 19Mar2021 at 1 single (dose 1, single) for Covid-19 immunisation. The patient's relevant medical history included: "Hyperprolactinemia" (unspecified if ongoing). Concomitant medication(s) included: Zyrtec [Cetirizine Hydrochloride]; Flonase [Fluticasone Propionate]; Cabergoline. The following information was reported: DRUG INEFFECTIVE (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. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EJ1685), in right arm, on 09Jan2021 as dose 2, single (Lot number: EJ1686), in right arm and on 27Sep2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "autoimmune gastritis" (unspecified if ongoing); "Known allergies: beer" (unspecified if ongoing). Concomitant medication(s) included: MODAFINIL; SERTRALINE; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Oxygen saturation: (May2022) normal, notes: entire time; SARS-CoV-2 test: (04May2022) Positive; (12May2022) Positive; (16May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Adverse event: Consumer developed congestion on 03May2022, tested positive the morning of 04May2022 and began paxlovid the evening of 04May2022. Consumer took all doses as prescribed and had few symptoms of covid she noted an unpleasant taste in her mouth during the treatment. She finished paxlovid on the morning of 09May2022. She continued to improve and on the AM of 12May2022 retested herself to go back to work- her test was strongly positive. In the afternoon, she started to develop all of the symptoms of covid again: congestion, sore throat, cough, fatigue, muscle aches and had fever and chills overnight - the next day she was more ill than she had been the entire time and since then have slowly improved (today is May2016) -  now she still testing positive but only have a cough and congestion, some fatigue - none of this return of symptoms was subtle and it truly felt like she was starting all over with the infection; Her O2 sats were normal the entire time. Other medication in 2weeks product included Modafinil, Sertraline and Levothyroxine.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Drug ineffective, COVID-19 and the administration of the vaccine cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". 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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 12Feb2021 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (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: now testing positive; Negative, notes: Continue to test negative till day 14. Clinical course: Paxlovid work great seven days later patient tested negative, continue to test negative till day 8 after the symptoms. Continue to test negative till day 14 now testing positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each; diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each; This is a spontaneous report received from contactable reporter(s) (Physician).  A 61-year-old female 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 immunization. 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), outcome "unknown" and all described as "diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Information: The reporter reported that his neighbors were diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each. The date of vaccination was not known. It was also reported that the treatment prescribed was Paxlovid to them.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200722911 same reporter/drug/event, different patient
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 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: "stroke", start date: 2015 (unspecified if ongoing), notes: Prior stroke in 2015. Concomitant medication(s) included: XARELTO taken for anticoagulant therapy, start date: 05Aug2015, stop date: 26Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "recovered" (16May2022) and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) positive; (02May2022) negative, notes: Took 3 more antigen tests over the next 5 days (all negative); (10May2022) positive, notes: Antigen test positive again for an additional 6 days; (16May2022) negative, notes: Finally negative again on Day 20. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: If vaccine received: Yes, Other medication in 2weeks: Yes. Adverse event: Rebound of symptoms and positive COVID test on Day 14. Initially tested positive (antigen plus PCR) on 26Apr. Took Paxlovid for 5 days. Tested negative on antigen test on 6th day (02May). Took 3 more antigen tests over the next 5 days (all negative). Symptoms returned on Day 14 (10May). Antigen test positive again for an additional 6 days. Finally negative again on Day 20 (16May). Known allergies: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), (SARS-COV-2 TEST POSITIVE) COVID-19.(medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, (sars-cov-2 test positive). COVID-19. Clinical course: The patient received treatment anti-viral product brand Paxlovid, treatment start date 06may2022, treatment stop date 10may2022. The patient experienced rebound symptoms after five-day course of Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "Inflammatory bowel disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, sars-cov-2 test positive. 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 provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2021 at 13:00 as dose number unknown . single (Lot number: 331308A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 03Apr2021 as dose 2, single (Lot number: EW0150), in right arm, on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Apr2022 at 18:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "depression" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Diclofenac, reaction(s): "Known allergies: Diclofenac"; Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Recurrence. Therapeutic measures were taken as a result of vaccination failure, Covid-19. No other medication in 2weeks. Treatment of COVID-19 with Paxlovid (Lot number : FY5657) from 04May2022 to 09May2022. Recurrence of Covid symptoms on day 3 after finishing 5-day treatment of Paxlovid. Chest tightness and congestion, cough, runny nose, sore throat, and headache. Exhaustion continued. Also nausea is a new symptom. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Off label use, Vaccination failure
Clinical narrative: off label use; Booste; 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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Mar2000, stop date: 11May2022; ANASTROZOLE, start date: Aug2017.  The following information was reported: OFF LABEL USE (medically significant), outcome "unknown"; IMMUNISATION (medically significant), outcome "unknown", described as "Booste"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19 treatment". Therapeutic measures were taken as a result of off label use, immunisation, vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.