chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUDESONIDE, start date: 22Mar2022, stop date: 06May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Clinical course includes Patient received vaccine and other medications in 2 weeks. No Known allergies. Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=07May2022, treatment stop date=11May2022, indication=Treatment of COVID-19, administrator route=Other, Adverse event: Paxlovid induced rebound. Worsening, SX 2 days after completion of therapy. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 29.0
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 29-year-old male patient received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient 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 21May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of Covid-19. Clinical course includes, adverse event: Horrible metallic taste in mouth. Occurred less than an hour from initial dose of medication. And continued through course of treatment. Taste would decrease in intensity between doses. No known allergies. treatment start date: 26May2022, treatment stop date: 26May2022 (antivirals). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma. Concomitant medication(s) included: XYZAL, start date: 30Mar2022, stop date: 16May2022. Past drug history included: Yes, reaction(s): "Allergy", notes: known allergies: yes. The following information was reported: VACCINATION FAILURE (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: Unknown results; Positive, notes: recurrent positive rapid ag test. Therapeutic measures were taken as a result of covid-19. Clinical information: On 16May2022 the therapeutic measures taken was oral Paxlovid a result of covid-19 treatment. On 20May2022,the treatment with Paxlovid was discontinued.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: hiving COVID in Jan2022; hiving COVID in Jan2022; 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 female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "hiving COVID in Jan2022".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
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) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 09:45 as dose 1, single (Lot number: EK9231), in left arm, on 03Feb2021 at 13:15 as dose 2, single (Lot number: EL9264), in left arm and on 08Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroditis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "known allergies: lots of foods sensitivities/intolerance" (unspecified if ongoing), notes: known allergies: lots of foods sensitivities/intolerances-gluten, corn, dairy, etc.; "sensitivities/intolerances-gluten" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: diary" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 11Apr2009. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: COVID setback- return of (very mild) symptoms and a positive test result. Intermittent sore throat from a scratch to sandblasted, thick post-nasal drip with mucous expectoration, occasional sneeze (allergies?), some rhinitis.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "recovered" and all described as "COVID 19".  Clinical course: Patient had allergy for unknown past drug. No other medication in 2weeks. Reported as COVID 19 Treatment, brand: Paxlovid via oral from 04May2022 to 07May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported Drug ineffective / COVID-19 cannot be ruled out
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter (consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Jan2021 as dose 1, single (batch/lot number: EL3303), in left arm, on 16Feb2021 as dose 2, single (batch/lot number: EM9810), in left arm and on 19Nov2021 as dose 3 (booster), single (batch/lot number: FY1620) at the age of 54 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medications included: OMEPRAZOLE; SIMVASTATIN; EFFEXOR; VITAMIN D [VITAMIN D NOS]. Past drug history included: Codeine, reaction(s): "allergy". 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: Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old patient received BNT162b2 (BNT162B2), on 24Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Drug Allergy", notes: Known allergies = Ceclor.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 antibody test: negative, notes: symptoms went away after 4 or 5 days; positive, notes: Positive again in exactly 10 days after starting the Medication. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was not revived other medication in past 2 weeks , Device timestamp 26May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Nervousness, Pyrexia, SARS-CoV-2 test
Clinical narrative: strange shaking feeling inside my head; flu like symptoms; low grade fever; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Insulin resistance" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ALDACTONE [SPIRONOLACTONE]; ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 23May2022, outcome "recovered with sequelae" (2022), described as "flu like symptoms"; PYREXIA (non-serious) with onset 23May2022, outcome "recovered with sequelae" (2022), described as "low grade fever"; NERVOUSNESS (non-serious) with onset 23May2022, outcome "recovered with sequelae" (2022), described as "strange shaking feeling inside my head". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nervousness, influenza like illness, pyrexia. Additional information: The facility type vaccine was, Pharmacy or Drug Store. No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination. No known Allergies. This was her 4th Covid shot (second booster). She was perfectly fine after the initial first three vaccines. After this most recent one, she got flu like symptoms and low-grade fever but what was weird was that inside her head when she got up from sitting or laying down, she got this strange shaking feeling inside her head. Never had that before. She was healthy for her age.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I got a COVID positive test result 24May2022; I got a COVID positive test result 24May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 16:00 as dose 1, single (Batch/Lot number: unknown) and on 05May2021 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "HypoThyroid" (unspecified if ongoing); "I lost my sense of smell near the start of the pandemic", start date: 2021, stop date: 2022, notes: lost my sense of smell near the start of the pandemic. I have my sense of smell back. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "I got a COVID positive test result 24May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: I got a COVID positive test result 24May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported patient had sense of smell back which was a very positive result. It had been gone for over a year. she was given the Paxlovid from 24May2022 to 26May2022, because got a COVID positive test result 24May2022. However, she lost sense of smell near the start of the pandemic and never got it back. Maybe she had COVID back in then and didn't know it. After day 1 of the Paxlovid treatment, she was suddenly inundated with smells and scents she thought she'd never smell again. It has been so surprising and weird felt she needed it o share this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Recurrent Covid symptoms and test one week after stopping Paxlovid and 3 days after testing negative.  My wife caught Covid from me so I did have ongoing exposure.  Relapse or reinfection? I am a reti; Recurrent Covid symptoms and test one week after stopping Paxlovid and 3 days after testing negative. My wife caught Covid from me so I did have ongoing exposure. Relapse or reinfection?; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 at 13:00 as dose number unknown, single (Lot number: 301358A) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22May2022, outcome "not recovered", described as "Recurrent Covid symptoms and test one week after stopping Paxlovid and 3 days after testing negative.  My wife caught Covid from me so I did have ongoing exposure.  Relapse or reinfection? I am a reti"; COVID-19 (medically significant) with onset 22May2022, outcome "not recovered", described as "Recurrent Covid symptoms and test one week after stopping Paxlovid and 3 days after testing negative. My wife caught Covid from me so I did have ongoing exposure. Relapse or reinfection?". Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.The case will be reevaluated should additional information become available.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 30Mar2021 at 08:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 27Sep2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 16Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: Synthroid; Zoloft; Sumatriptan. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 26May2022, outcome "unknown", described as "Pfizer / BioNTech dose / COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 26May2022, outcome "unknown", described as "Pfizer / BioNTech dose/ COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical information: Other medication in 2weeks product: Claritin. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Completion of course on 21May2022 and on 25May2022 developed sore throat again, and rapid antigen positive; after 2 negative rapid antigen tests; Completion of course on 21May2022 and on 25May2022 developed sore throat again, and rapid antigen positive; after 2 negative rapid antigen tests; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing); "asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "migraines" (unspecified if ongoing); "sulfa" (unspecified if ongoing). Concomitant medication(s) included: DYMISTA; HYDROXYCHLOROQUINE; METFORMIN; NORVASC; PROAIR [SALBUTAMOL SULFATE]. Past drug history included: Amoxacillin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "recovering" and all described as "Completion of course on 21May2022 and on 25May2022 developed sore throat again, and rapid antigen positive; after 2 negative rapid antigen tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. A 36-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 36 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), FATIGUE (non-serious) all with onset 25May2022, outcome "unknown" and all described as "Traveled to Wedding and then exposed 21May & 22May then ST cough and fatigue HA 25May2022 and then + Ag test 26May2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "Traveled to Wedding and then exposed 21May & 22May then ST cough and fatigue HA 25May2022 and then + Ag test 26May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: Nasal Swab. It was unknown if patient had Covid-19 previous to vaccination. Investigation conclusion for lot FF2589: The complaint for 'Lack of Effect' of the PFIZER BIONTECH COVID-19 VACCINE lot FF2589 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/Rebound COVID-19 symptoms; COVID 19 Treatment/Rebound COVID-19 symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not pregnant at time of vaccination. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment/Rebound COVID-19 symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (May2022) negative, notes: home rapid test; (26May2022) positive, notes: home rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2weeks Lipitor, Alendronate start date=Sep2020, stop date=17May2022. Rebound COVID-19 symptoms after completing Paxlovid course. Patient completed Paxlovid treatment, symptoms resolved and patient had a negative at home rapid test. Patient developed similar URI type symptoms. Repeat at home rapid test was positive. Anti viral details COVID 19 Treatment Start date=18May2022, stop date=22May2022, Indication: Treatment of COVID-19, administrator route=Oral. The patient known allergies was sulfa, erythromycin. The patient other medical history osteoporosis, hyperlipidemia.  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, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Clinical course: The patient wanted to know how long she needs to wait to get the Pfizer COVID-19 Vaccine 2nd booster dose after she had Covid 2 weeks ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: mild arm pain/injection site pain; Mild redness/swelling at injection site; Mild redness/swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 at 17:00 as dose 3 (booster), single (Lot number: FL8095) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). Concomitant medication(s) included: GARDASIL, on 09May2022 as single dose; MENINGOCOCCAL VACCINE, on 09May2022 as single dose; TDAP, on 09May2022 as single dose; DAILY MULTIVITAMIN. Vaccination history included: Bnt162b2 (dose number 2, product: COVID 19,, brand: Pfizer-BioNTech COVID-19 Vaccine,, lot number FK5127,, administration date Nov2021,), administration date: Nov2021, when the patient was 10 years old, for COVID-19 immunization; Bnt162b2 (dose number 1, product COVID 19,, brand Pfizer-BioNTech COVID-19 Vaccine,, lot number FK5127,, administration date Nov2021,), administration date: Nov2021, when the patient was 10 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 27May2022, outcome "not recovered", INJECTION SITE ERYTHEMA (non-serious) with onset 27May2022, outcome "not recovered" and all described as "Mild redness/swelling at injection site"; VACCINATION SITE PAIN (non-serious) with onset 27May2022, outcome "not recovered", described as "mild arm pain/injection site pain". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, injection site erythema.  Additional information: Adverse event: Very mild arm pain/injection site pain reported by patient when asked 24.5 hours post-dose. Mild redness/swelling at injection site 24.5 hours post-dose. No other AEs or reactogenicity events occurred at the time of reporting (24.5 hours post-dose). Adverse event start date: 27May2022. Adverse event country. Ae resulted in: None of the above. If patient recovered: Not recovered. If treatment ae: No. If covid prior vaccination: No. if covid tested post vaccination: No. Known allergies: NKA Other medical history: Eczema.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2022 as dose 1, single (Lot number: EP7533) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21May2022, outcome "unknown", COVID-19 (medically significant) with onset 21May2022, outcome "not recovered" and all described as "COVID-19". 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: The vaccine was received. Patient received other medication in 2weeks: product- Albuterol inhaler, brand- ProAir. Anti-viral details product- Paxlovid, COVID 19 Treatment, treatment start date was 18May2022, treatment stop date was 22May2022 for indication Treatment of COVID-19. Symptoms returned after taking Paxlovid. Took Paxlovid on Day 2, and symptoms resolved shortly after. Tested negative on Day 9, then tested positive again on Day 12. Symptoms include runny nose, sore throat and some chills. No known allergies.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 28Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain" (unspecified if ongoing); "TBI" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "recovering from surgery of hand" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: MS CONTIN, start date: 01Mar2022. Past drug history included: Keflex, reaction(s): "known allergies: Keflex"; Codeines, reaction(s): "known allergies: codeines"; Nickel, reaction(s): "known allergies: nickel". 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: (unspecified date) Unknown results; (25May2022) Negative, notes: I tested negative on 25May-4 days after I completed the full doses of placovid; (27May2022) Positive, notes: This morning I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound case of covid. She tested negative on 25May-4 days after she completed the full doses of placovid. On Day 7, she started having symptoms of congestion and fever last night. That morning, she tested positive again. Fever, cough, congestion, body aches and headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 at 10:00 as dose 1, single (Batch/Lot number: Not available/provided to reporter at the time of report completion), in left arm, on 10Apr2021 at 10:00 as dose 2, single (Batch/Lot number: Not available/provided to reporter at the time of report completion), in left arm, on 05Feb2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: Not available/provided to reporter at the time of report completion), in left arm and on 26Feb2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: Not available/provided to reporter at the time of report completion) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Chronic Inflammatory Demyleating Polyneuropathy" (unspecified if ongoing); "Attention Deficit" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Menieres Disease" (unspecified if ongoing); "Known allergies: blood thinners." (unspecified if ongoing), notes: Known allergies: Ibuprofen, blood thinners. The patient took concomitant medications. Other medication in 2weeks product- other medication in 2weeks product-Several routine prescription medicines. Past drug history included: Ibuprofen, reaction(s): "allergies: Ibuprofen", notes: Known allergies: Ibuprofen, blood thinners. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Adverse event: Paxlovid relieved Covid symptoms, but not entirely. Continued slow improvement for multiple days after completing the five day regimen. Five days later, symptoms worsened and have continued unrelieved. Adverse event start date: 25May2022 12:00 AM, If patient recovered: Not recovered. Report about Covid treatment: Yes. If vaccine received: Yes. Anti-viral details: Product-COVID 19 Treatment, Brand- Paxlovid, Treatment start date- 15May2022. Treatment stop date- 20May2022, Indication- 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 covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 17Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). 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 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient had no other medication in 2weeks. No Known allergies were reported. Anti-viral details included Paxlovid for COVID 19 Treatment starting from 17May2022 to 22May2022. Paxlovid rebound 3 days after completing treatment. Zero symptoms after treatment. 3 days later runny nose, congestion, fever, fatigue, sore throat, and sneezing.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 35-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 29Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; magnesium oxide heavy, sodium bicarbonate (ANTACID C), from 16May2022 (Batch/Lot number: unknown) to 25May2022. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "overweight" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (unspecified date) Negative, notes: three home rapid tests on 25May and 26May; (25May2022) Negative, notes: three home rapid tests on 25May and 26May; (26May2022) Negative, notes: three home rapid tests on 25May and 26May; (27May2022) Positive, notes: tested positive again on two home rapid antigen tests on 27May; (27May2022) Positive, notes: tested positive again on two home rapid antigen tests on 27May. 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: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive on 27May; Tested positive on 27May; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 03Dec2020; VYTORIN, start date: 03Dec2020, stop date: 13May2022. Past drug history included: Levaquin, reaction(s): "Knonwn allergies: Levaquin"; Macrobid, reaction(s): "Knonwn allergies: macrobid"; Benicar, reaction(s): "Knonwn allergies: benicar". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "Tested positive on 27May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) positive, notes: Tested positive on 27May, two days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses: Anti viral details product: COVID 19 Treatment, brand: Pfizer, treatment start date: 19May2022, treatment stop date: 25May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech: Dose number 1, 2, 3; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose number 1, 2, 3; Paxlovid: 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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 at 17:00 as dose 1, single (Lot number: EN6201), in left arm, on 11Mar2021 at 17:00 as dose 2, single (Lot number: EN6208), in left arm and on 15Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing); "anemia" (unspecified if ongoing); "hyocellular bone marrow" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "paroxysmal afib" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Pfizer / BioNTech: Dose number 1, 2, 3; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) negative, notes: Tested negative on 13May2022 and negative on 15May and had no symptoms; (15May2022) negative, notes: Tested negative on 13May2022 and negative on 15May and had no symptoms; (24May2022) positive, notes: Tested on 24May and was positive; (27May2022) negative, notes: Symptoms went away on 25May and tested on 27May and was negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient did not received any other medications in two weeks.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 17:45 as dose 1, single (Lot number: EL9261), in left arm, on 09Feb2021 at 17:00 as dose 2, single (Lot number: EM9809), in left arm and on 27Aug2021 at 16:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Buckwheat" (unspecified if ongoing), notes: known allergies Codeine and Buckwheat. There were no concomitant medications, reported as no other medication in 2weeks. Past drug history included: Codeine, reaction(s): "known allergies Codeine", notes: known allergies Codeine.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (treatment start date: 27May2022, treatment stop date: 27May2022, lot number: 300691085301). Clinical course was reported as, vaccine lot was unknown, unable to locate or read the details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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: "DM" (unspecified if ongoing), notes: DM; "HTN" (unspecified if ongoing), notes: HTN; "h/o breast cancer" (unspecified if ongoing), notes: h/o Breast cancer. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical closure: Anti-viral details: Paxlovid from 18May2022 to 22may2022, oral route for Treatment of COVID-19. Adverse event: Relapse in covid-19 symptoms 48 hours after completion of Paxlovid treatment for covid-19 infection.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.