chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Dermatitis psoriasiform, Paraesthesia, Rash, Skin exfoliation
Clinical narrative: atopic dermatitis; psoriatic dermatitis; skin parasthesia; my skin is disfigured with itchy/painful scales; 2 skin infections; Broke out in a rash all over my legs/The rash never subsided and, since then, gradually worsened and spread to my arms, trunk, and neck, and jawline; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 10:30 as dose 1, single (Lot number: PAA156052) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "GAD" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Mild excema" (unspecified if ongoing); "Penicillin: Allergy" (unspecified if ongoing); "Allergy:Sulfa" (unspecified if ongoing). Concomitant medication(s) included: RALOXIFENE; SIMVASTATIN; AMBIEN; MELATONIN. Past drug history included: Ciproloxacin, reaction(s): "Allergy:ciproloxacin"; Zolpidem, reaction(s): "Allergy: zolpidem".  The following information was reported: RASH (medically significant) with onset 12Feb2021 at 21:30, outcome "unknown", described as "Broke out in a rash all over my legs/The rash never subsided and, since then, gradually worsened and spread to my arms, trunk, and neck, and jawline"; SKIN INFECTION (medically significant), outcome "unknown", described as "2 skin infections"; DERMATITIS ATOPIC (medically significant), outcome "unknown", described as "atopic dermatitis"; DERMATITIS PSORIASIFORM (medically significant), outcome "unknown", described as "psoriatic dermatitis"; PARAESTHESIA (non-serious), outcome "unknown", described as "skin parasthesia"; SKIN EXFOLIATION (non-serious), outcome "unknown", described as "my skin is disfigured with itchy/painful scales". Therapeutic measures were taken as a result of skin infection, rash.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Skin infection
Clinical narrative: atopic dermatitis; psoriatic dermatitis; skin parasthesia; my skin is disfigured with itchy/painful scales; 2 skin infections; Broke out in a rash all over my legs/The rash never subsided and, since then, gradually worsened and spread to my arms, trunk, and neck, and jawline; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 10:30 as dose 1, single (Lot number: PAA156052) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "GAD" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Mild excema" (unspecified if ongoing); "Penicillin: Allergy" (unspecified if ongoing); "Allergy:Sulfa" (unspecified if ongoing). Concomitant medication(s) included: RALOXIFENE; SIMVASTATIN; AMBIEN; MELATONIN. Past drug history included: Ciproloxacin, reaction(s): "Allergy:ciproloxacin"; Zolpidem, reaction(s): "Allergy: zolpidem".  The following information was reported: RASH (medically significant) with onset 12Feb2021 at 21:30, outcome "unknown", described as "Broke out in a rash all over my legs/The rash never subsided and, since then, gradually worsened and spread to my arms, trunk, and neck, and jawline"; SKIN INFECTION (medically significant), outcome "unknown", described as "2 skin infections"; DERMATITIS ATOPIC (medically significant), outcome "unknown", described as "atopic dermatitis"; DERMATITIS PSORIASIFORM (medically significant), outcome "unknown", described as "psoriatic dermatitis"; PARAESTHESIA (non-serious), outcome "unknown", described as "skin parasthesia"; SKIN EXFOLIATION (non-serious), outcome "unknown", described as "my skin is disfigured with itchy/painful scales". Therapeutic measures were taken as a result of skin infection, rash.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CIALIS, start date: Jan2018; FAMOTIDINE, start date: Jan2021; FEXOFENADINE, start date: Jan2020; FINASTERIDE, start date: Jan2011; FLUTICASONE, start date: Jan2021; SIMVASTATIN, start date: Jan2005; TEMAZEPAM, start date: Jan2020; AZELASTINE nasal, start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (13May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: If vaccine received: Yes; Other medication in 2weeks: Yes; Known allergies: No. Adverse event: 3 days after completing 5-day treatment of Paxlovid tested negative for Covid without any symptoms. 5 days after completing treatment of Paxlovid rebounded with a sinus congestion and sore throat and tested positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EW6202), in left arm, on 01Apr2021 as dose 2, single (Lot number: FR5130), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 13Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FK9896) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE; SYNTHROID; ESTRADIOL; PROGESTERONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Day 10 after taking drug, felt better, tested negative. Then cold symptoms started Day 12, tested strong positive again Day 13 & Day 15; congestion, phlegm, cough; fever Day 16; finally tested negative again Day 19: Rebound lasting full week. Probably contagious again during rebound. People taking Paxlovid should quarantine 14 full days and test again before ending isolation. Also, had extreme fatigue, constipation and muscle soreness/weakness while taking drug; not sure if side effect or caused by virus. Rebound completely different symptoms - more like bad cold.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 19:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 09Mar2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Nov2021 at 16:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05May2022, outcome "not recovered", COVID-19 (medically significant) with onset 05May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I tested negative one day after finishing Paxlovid with only symptom being a slight cough; (unspecified date) Positive, notes: 2 days after finishing Paxlovid, I started testing positive again. Cough became more persistent. ; (unspecified date) Positive, notes: Cough became more persistent. Day 3 I began experiencing fatigue. I have been testing positive everyday; (unspecified date) Positive, notes: Day 4 fatigue got worse. I have been testing positive everyday; (unspecified date) Positive, notes: Day 5 (after finishing Paxlovid) woke up with a sore throat, cough and headache. Feeling very tired. Feeling COVID symptoms again and testing positive; (05May2022) Positive, notes: I tested positive for COVID in Thursday 05May. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Believe patient was rebounding. Patient tested positive for COVID in thursday 05May and began treatment on Friday 06May. Last day of treatment was Tuesday 10May. Patient tested negative one day after finishing Paxlovid with only symptom being a slight cough. 2 days after finishing Paxlovid, patient started testing positive again. Cough became more persistent. Day 3 patient began experiencing fatigue. Day 4 fatigue got worse. Patient has been testing positive everyday. Day 5 (after finishing Paxlovid) woke up with a sore throat, cough and headache. Feeling very tired. Feeling COVID symptoms again and testing positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 04Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 30 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: "Known Allergies: Penicillin" (unspecified if ongoing); "Known Allergies: Sulfa" (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 "unknown" and all described as "Treatment of COVID-19".  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. No follow-up attempts are possible. No further information is expected.
Age: 44.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing); "known allergies: wheat" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE, start date: 06Jan2020; LITHIUM, start date: 09Nov2020; OMEPRAZOLE, start date: 04Apr2022; TYLENOL, start date: 02May2022 were other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (12May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Symptomatic Rebound positive antigen test after 5 days after concluding Paxlovid and 6 days after first negative antigen test.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech: 22Dec2020, 13Jan2021, 13Oct2021; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: 22Dec2020, 13Jan2021, 13Oct2021; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 02:00 as dose 1, single (Lot number: EH9899), in left arm, on 13Jan2021 at 02:00 as dose 2, single (Lot number: EL0142), in left arm and on 13Oct2021 at 01:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 38 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: COVID-19 (medically significant) with onset 13May2022 at 07:00, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: 22Dec2020, 13Jan2021, 13Oct2021; Paxlovid: Treatment of COVID-19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Fatigue; body aches; Soreness in the arm around injection area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 12May2022 at 10:30 as dose 3 (booster), single (Lot number: FL3197) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 04May2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Apr2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13May2022 at 06:00, outcome "recovering", described as "Soreness in the arm around injection area"; FATIGUE (non-serious) with onset 14May2022, outcome "recovering"; PAIN (non-serious) with onset 14May2022, outcome "recovering", described as "body aches". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient had received no other vaccines within 4 weeks prior to COVID vaccine. The patient had not diagnosed with COVID prior vaccination and the patient had not tested to COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
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 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 16Dec2021 as dose 3 (booster) single (Lot number: 7J8762) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hodgkin's lymphoma", start date: Oct2013, stop date: Apr2014, notes: Hodgkin's Lymphoma - diagnosis Oct2013, complete remission as of Apr2014 - no known relapse; "Allergy" (unspecified if ongoing); "cold" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA taken for hypersensitivity, start date: 01Aug2015; NYQUIL taken for nasopharyngitis, start date: 12May2022, stop date: 13May2022.  The following information was reported: 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 vaccination failure, covid-19.  Clinical course: The patient received treatment anti-viral Product Brand Pfizer Paxlovid, Treatment start date- 14May2022, Lot number- GA5120, Indication- Treatment of COVID-19. About 30 minutes after taking first dose, patient experienced a bitter taste in mouth/on tongue that has not gone away with eating or drinking. It tastes similar to the bitterness of BC Powder. It is not unmanageable, and she will continue taking the medication even if she continue to experience this AE.
Age: 44.0
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 a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE, start date: 13Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 66-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension controlled by meds" (unspecified if ongoing), notes: hypertension controlled by meds; "high cholesterol controlled by meds" (unspecified if ongoing), notes: high cholesterol controlled by meds. Concomitant medication(s) included: DIOVAN; TADALAFIL; AMLODIPINE; PROTONIX [OMEPRAZOLE]; FAMOTIDINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I have a "rebound case" of covid-19. I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information- It was reported that patient  took paxlovid for the prescribed 5 days from 05-09May2022. He started taking it within one day of the onset of covid 19 symptoms. He felt great for about 4-5 days after he finished the 5-day course of paxlovid, but now he believe Ihe had a "rebound case" of covid-19. He was still testing positive and now have runny nose and postnasal drip and scratchy throat, just 5 days after finishing the paxlovid. He believed this is what is being investigated as a "rebound" case of covid despite taking paxlovid on the same day of testing positive. (I am also fully vaccinated with four shots).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 31-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". 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, covid-19 with Paxlovid from 05May2022 to 10May2022. Clinical course: No other medications were received in two weeks. It was reported that there was full return of symptoms and positive rapid antigen testing after testing negative day after completion of treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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 was not reported. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient started experiencing symptoms two weeks ago but tested negative on a rapid test. Later, the patient got a PCR test the next morning (day 1) and it came back positive. The patient  doctor started the medicine on Paxlovid the next day (day 2). Later, had a few days of unpleasant symptoms but started feeling better and testing negative on rapid tests on day 6, and finished course of Paxlovid on day 7. Per CDC guidelines, the patient continued masking (including at home) through day 10, and then dropped precautions at home. Later, the patient woke up on day 12 with slightly swollen lymph nodes and decided to take a rapid test. It came back positive. Facility where the most recent COVID-19 vaccine was administered was Other. The patient received any other vaccines within 4 weeks prior to the COVID vaccine. There was list of any other medications the patient received within 2 weeks of vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovad/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovad/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: Ff2593) at the age of 45 years, on 23Mar2021 as dose 2, single (Lot number: Er8727) and (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "known allergies Ibuprofen". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Negative; (13May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Anti-viral details product=COVID 19 treatment (brand=Paxlovid). treatment start date=30Apr2022 and stop date=04May2022, indication is use for treatment of COVID-19. adverse event 11May2022 she started coughing and sneezing, then headache and heartburn. Muscle pain specifically in hips started 12May. 13May rapid test showed a strong positive result while rapid test was already negative by 06May. if patient is Recovering. The patent was not received treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), first regimen from 12Mar2021 (Lot number: 001B21A) to 12Mar2021 at single (dose 1, single) and second regimen from 09Apr2021 (Lot number: 030B21A) to 09Apr2021 at single (dose 2, single) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACYCLOVIR HCL taken for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) positive; (11May2022) Negative; (13May2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BENAZEPRIL, start date: May2022; VITAMIN D NOS, start date: May2022; VITAMIN C [ASCORBIC ACID], start date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks was reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Dizziness, Multiple allergies, Muscle spasms
Clinical narrative: + rapid Ag/Test: Home Ag Result: Positive; + rapid Ag/Test: Home Ag Result: Positive; Allergies; dizziness; cramping; bones ached; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), on 25Feb2021 as dose 2, single (Lot number: EL3247) and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. If patient had Covid prior to vaccination was unknown. If Covid tested post vaccination was yes. The following information was reported: MULTIPLE ALLERGIES (non-serious) with onset 10May2022, outcome "unknown", described as "Allergies"; BONE PAIN (non-serious) with onset 10May2022, outcome "unknown", described as "bones ached"; MUSCLE SPASMS (non-serious) with onset 10May2022, outcome "unknown", described as "cramping"; DIZZINESS (non-serious) with onset 10May2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "unknown" and all described as "+ rapid Ag/Test: Home Ag Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11May2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: + rapid Ag/Test: Home Ag Result: Positive; + rapid Ag/Test: Home Ag Result: Positive; Allergies; dizziness; cramping; bones ached; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), on 25Feb2021 as dose 2, single (Lot number: EL3247) and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. If patient had Covid prior to vaccination was unknown. If Covid tested post vaccination was yes. The following information was reported: MULTIPLE ALLERGIES (non-serious) with onset 10May2022, outcome "unknown", described as "Allergies"; BONE PAIN (non-serious) with onset 10May2022, outcome "unknown", described as "bones ached"; MUSCLE SPASMS (non-serious) with onset 10May2022, outcome "unknown", described as "cramping"; DIZZINESS (non-serious) with onset 10May2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "unknown" and all described as "+ rapid Ag/Test: Home Ag Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11May2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 08Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Apr2022 at 17:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lobectomy for lung cancer" (unspecified if ongoing); "peripheral artery deseasr" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; CYMBALTA; DULOXETINE; COZAAR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FE3594) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Lot number: N31m20a) for 1 day and as dose number unknown, single (Lot number: 045A21A) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "chronic pain/fatigue" (unspecified if ongoing); "chronic pain/fatigue" (unspecified if ongoing); "chronic inflammation" (unspecified if ongoing); "acute/recurring bronchitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Hyoscine, reaction(s): "Known allergies: Hyoscine", notes: Known allergies: Hyoscine. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (08May2022) negative, notes: I had a negative test after finishing the course of this med on 08May2022 and a negative test on 09May2022; (09May2022) negative; (13May2022) positive, notes: I tested positive again on 13May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm 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: "High blood pressure" (unspecified if ongoing); "SI joint dysfunction hence methocarbam" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: METHOCARBAMOL taken for arthropathy, start date: 04Apr2022; HYDROCHLOROTHIAZIDE, start date: 01Aug2020; GABAPENTIN, start date: 25Jan2021; LOSARTAN, start date: 01Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19 which included Paxlovid from 10May2022 to 15May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive/I am fully vaccinated and boosted all with Pfizer; I tested positive/I am fully vaccinated and boosted all with Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 13:15 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "ashtma" (unspecified if ongoing); "copd stage 1" (unspecified if ongoing), notes: copd stage 1. There were no concomitant medications. Past drug history included: Sulfur, reaction(s): "known allergies: none that I am aware of besides sulfur", notes: known allergies: none that I am aware of besides sulfur. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested positive/I am fully vaccinated and boosted all with Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient started the 5 day course of paxlovid the night she tested positive which was 27Apr2022. She was fully vaccinated and boosted all with Pfizer. The only symptom she had was fatigue and possibly some muscle aches. She felt fine until Friday which was 8 days after testing positive and 5 days after completing the paxlovid in which she woke up with flu like symptoms. Stuffed nose and dry cough which turned into a productive cough with yellow thick mucus. Two days later on Sunday she woke up at 1:30 am itching my arms like crazy. Hives developed and were gone by morning. They came on again the next day at work in the afternoon on her lower body. She took Benadryl with no relief. They disappeared again for a whole 24 hours and then came back but mild. Its been 48 hours w/o eventually turned clear with a very stick texture. I am now 8 days past this event and am still having horrible congestion and still coughing up mucus which is causing air hunger upon any activity. Oxygen is still reading in the 90's.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
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) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 at 12:00 as dose 1, single (Lot number: EL9267), in left arm, on 08Mar2021 at 12:00 as dose 2, single (Lot number: EN6198), in left arm and on 10Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Mar2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN, stop date: 05May2022; AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14May2022 at 22:00, outcome "unknown", COVID-19 (medically significant) with onset 14May2022 at 22:00, outcome "not recovered" and all described as "COVID 19 Treatment". Rebound from paxlovid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: I tested negative on day 6; Positive, notes: Symptoms reoccurred on day 10 and tested positive for covid on day 11. Therapeutic measures were taken as a result of vaccination failure, covid-19. Antiviral details: Product- COVID 19 Treatment, brand: paxlovid, treatment start date: 05May2022, treatment stop date: 09May2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing), notes: known allergies Penicillin sulfa erythromycin minocycline; "known allergies sulfa" (unspecified if ongoing), notes: known allergies Penicillin sulfa erythromycin minocycline. The patient took concomitant medications. Past drug history included: Minocycline, reaction(s): "known allergies minocycline", notes: known allergies Penicillin sulfa erythromycin minocycline; Erythromycin, reaction(s): "known allergies erythromycin", notes: known allergies Penicillin sulfa erythromycin minocycline. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: on home test twice; negative, notes: on home test twice; positive, notes: on home and PCR several days after. Therapeutic measures were taken as a result of drug ineffective, covid-19. Other Medication in 2 weeks taken by patient. Patient took Paxlovid on 05May2022 and stopped on 10May2022 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.