chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a 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 27Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 18May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 13Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN], start date: 01Jul2022, stop date: 02Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering", 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: Covid-19 treatment; (01Aug2022) Positive, notes: Testing positive for Covid again on 01Aug2022 at home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid, started on 20Jul2022 and stopped on 25Jul2022.  Clinical information: The patient had received vaccine and also had administered another medication within 2 weeks of vaccine administration. No additional symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: 012A21A), in right arm, in Apr2021 as dose 2, single (Lot number: 044B21A), in left arm and in Dec2021 as dose 3 (booster), single (Lot number: 067H21B) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Sulphur drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 25Jul2022 to 29Jul2022. Clinical course: Patient has received other medication in 2 weeks were Synthroid, Hydrocodone. Tested Positive again on 4th day after stopping Paxlovid. Some symptoms including congestion and headache.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Off label use
Clinical narrative: States that she had Covid right before she got that vaccine; Extremely sick after first dose of vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "States that she had Covid right before she got that vaccine"; ILLNESS (non-serious), outcome "unknown", described as "Extremely sick after first dose of vaccine".  Additional information: Consumer stated that she did not know if she has the right person to speak with. Stated she has been to a couple of doctors and went to neurology. The neurology office gave her this number to call Pfizer. Consumer stated that she had her first dose of the vaccine 27Feb of last year.  Stated that she had Covid right before she got that vac-cine. Stated she understands that now they tell you to wait 90 days after Covid to get the vaccine, but at that time, they were just telling you to get the vaccine. Consumer stated that she felt extremely sick after that first vaccine, by the time she started to feel better; it was time for her second vaccine. Consumer stated that in Sep she started having a weird feeling in her left arm. Did any AE(s) require a visit to: Physician Office: Yes
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Inflammation, Limb discomfort, Ultrasound scan, X-ray
Clinical narrative: Started having a weird feeling in her left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Lot number: EN6208) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Had Covid right before having the first dose of the vaccine" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose, NDC/Expiry Date: Unknown; Lot Number: EN6203; Vaccine given in the left arm), administration date: 27Feb2021, when the patient was 43-year-old, for COVID-19 immunization, reaction(s): "felt extremely sick", "Had Covid right before having the first dose of the vaccine". The following information was reported: LIMB DISCOMFORT (non-serious) with onset Sep2021, outcome "unknown", described as "Started having a weird feeling in her left arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states that she had her first dose of the vaccine 27Feb of last year. States that she had Covid right before she got that vaccine. States she understands that now they tell you to wait 90 days after Covid to get the vaccine, but at that time, they were just telling you to get the vaccine. Caller states that she felt extremely sick after that first vaccine, by the time she started to feel better; it was time for her second vaccine. Caller states that in Sep she started having a weird feeling in her left arm. She received her booster dose of the vaccine on 22Oct2021. Caller states that a week after that, from her wrist up to her forearm on her left arm, looked like an elephant leg. Over 10 days later it was still inflamed, she went to the doctor and they sent her to orthopedics. Orthopedics did x-rays and said it was inflamed. Caller states that she hadn't gotten hurt. Orthopedics didn't know what it was so they sent her for an ultrasound to check for blood clots; there was no blood clots. They said she had calcification in her left arm. They started her on pain management. Caller states that her thumb, small finger, and fingertips on her left hand are all completely numb. The area from her wrist to her elbow is still inflamed. She takes unspecified pain medications. Caller states she cannot just keep going with this, she owns a preschool. Caller says that the CT Scan that was done by neurology showed the calcification. Caller states that she has heard some other people have this reaction in their arms and legs; She doesn't know if it is swollen up against a nerve and that's why she has the numbness in her fingers, or what.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
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) (Physician).A 72-year-old female patient received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years 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 included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Barretts oesophagus" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCT [HYDROCHLOROTHIAZIDE;LISINOPRIL] oral; ATORVASTATIN oral; OMEPRAZOLE oral; MELOXICAM oral.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (02Aug2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive, at home test,; (25Jul2022) Negative, notes: negative at home test on 25Jul2022; (28Jul2022) Positive, notes: positive at home test on 28Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: covid rebound, tested positive, at home test, 16Jul2022 treated with paxlovid x 5 days (atorvastatin held x 14 days), negative at home test on 25Jul2022. Symptom recurrence on 28Jul2022 with positive at home test on 28Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 15May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (unspecified if ongoing), notes: Other medical history: Mild intermittent asthma; "interchange of vaccine products" (unspecified if ongoing), notes: Moderna on 15May2022, dose 4. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, 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: Patient experienced rebound covid-19; Unknown results, notes: Symptoms returned 5 days after completing Paxlovid. Symptoms included + Rapid antigen testing, fever, chills, malaise, rhinorrhea, and sore throat. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient experienced rebound covid-19. Symptoms improved while taking Paxlovid. Symptoms returned 5 days after completing Paxlovid. Symptoms included + Rapid antigen testing, fever, chills, malaise, rhinorrhea, and sore throat.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension, controlled; hyperlipidemia, arthritis; "controlled hyperlipidemia" (unspecified if ongoing), notes: Other medical history: Hypertension, controlled; hyperlipidemia, arthritis; "arthritis" (unspecified if ongoing), notes: Other medical history: Hypertension, controlled; hyperlipidemia, arthritis. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, 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) Unknown results, notes: COVID 19 Treatment; (30May2022) Positive, notes: about 5 days after the end of the Paxlovid, the symptoms began again, and I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment with Paxlovid started on 21May2022 and stopped on 25May2022. After completing the course of Paxlovid and having my symptoms resolve, about 5 days after the end of the Paxlovid, the symptoms began again, and I tested positive again. These symptoms consisted primarily of significant congestion, fatigue, and low-grade fever, and resolved in about a week. Adverse event started on 31May2022 and recovered on 05Jun2022. Treatment taken for adverse events ephedrine, Afrin nasal spray, rest. No known allergies. No other medication taken in 2weeks.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test, Systemic lupus erythematosus
Clinical narrative: SLE; Death; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 2, single (Lot number: EP7534) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged Prostrate" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 20Feb2021, when the patient was 69-year-old, for Covid-19 Immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (hospitalization, disability, life threatening) with onset 17Mar2021, outcome "not recovered", described as "SLE"; DEATH (death), outcome "fatal". The patient was hospitalized for systemic lupus erythematosus (hospitalization duration: 60 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2021) unknown. Therapeutic measures were taken as a result of death, systemic lupus erythematosus. The date and cause of death for the patient were unknown. Patient had not received any other vaccine in four weeks. Patient not had covid prior vaccination and was tested to covid post vaccination. Treatment of events was reported as multiple. Patient had no known allergies.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Reported Cause(s) of Death: unknown cause of death
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). It was reported that the patient had no known allergies. Concomitant medication(s) included: LEXAPRO, start date: 01Jan2019, stop date: 02Aug2022; WELLBUTRIN, start date: 01Jan2019, stop date: 02Aug2022; VALTREX, start date: 01Jan2019, stop date: 02Aug2022; TREMFYA, start date: 01Jan2021, stop date: 02Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, 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 covid-19. COVID 19 Treatment was received with Paxlovid from 24Jul2022 to 28Jul2022 for treatment of COVID-19. The clinical course was reported as After recovering from all symptoms, the following systems reappeared: nasal congestion, cough, sore throat. but no fever. The patient has never tested negative after Paxlovid but the test line was very faint. When the symptoms restarted on the day of reporting, the antigen test showed a bright red test line.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Influenza like illness, Lethargy
Clinical narrative: had rashes spreading over body, rashes came from injection site and spread to hands, feet, and lower extremities; had rashes spreading over body, rashes came from injection site and spread to hands, feet, and lower extremities; nausea, felt like caller was going to vomit,; general lethargicness; fatigue; low grade fever.; no energy at all; Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 28Jul2022 as dose 3 (booster), single (Lot number: FP7150) at the age of 24 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, SINGLE, Lot number: EW0171), administration date: 20May2021, when the patient was 22-year-old, for COVID-19 immunization, reaction(s): "Flu like symptoms", "Fatigue"; BNT162b2 (Dose: 02, SINGLE, Lot number: EC3180), administration date: 11Aug2021, when the patient was 23-year-old, for COVID-19 immunization, reaction(s): "Flu like symptoms", "Fatigue". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "Flu like symptoms"; FATIGUE (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022); LETHARGY (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "general lethargicness"; PYREXIA (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "low grade fever."; NAUSEA (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "nausea, felt like caller was going to vomit,"; ASTHENIA (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "no energy at all"; VACCINATION SITE RASH (non-serious), RASH (non-serious) all with onset 31Jul2022, outcome "recovering" and all described as "had rashes spreading over body, rashes came from injection site and spread to hands, feet, and lower extremities". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that had rashes spreading over body, rashes came from injection site and spread to hands, feet, and lower extremities. Indication: To have more sustained immunity for going back and forth from work and to not get caller's fiance sick, caller's fiance was susceptible to getting very sick from Covid. No any other event require a visit to emergency room, physician office. Prior Vaccinations (within 4 weeks) no any other list of vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Just besides feeling general fatigue and flu like symptoms which caller stated everyone experiences. Reporter confirmed he had general fatigue and flu like symptoms with the 1st and 2nd doses of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash, Vaccination site rash
Clinical narrative: had rashes spreading over body, rashes came from injection site and spread to hands, feet, and lower extremities; had rashes spreading over body, rashes came from injection site and spread to hands, feet, and lower extremities; nausea, felt like caller was going to vomit,; general lethargicness; fatigue; low grade fever.; no energy at all; Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 28Jul2022 as dose 3 (booster), single (Lot number: FP7150) at the age of 24 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, SINGLE, Lot number: EW0171), administration date: 20May2021, when the patient was 22-year-old, for COVID-19 immunization, reaction(s): "Flu like symptoms", "Fatigue"; BNT162b2 (Dose: 02, SINGLE, Lot number: EC3180), administration date: 11Aug2021, when the patient was 23-year-old, for COVID-19 immunization, reaction(s): "Flu like symptoms", "Fatigue". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "Flu like symptoms"; FATIGUE (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022); LETHARGY (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "general lethargicness"; PYREXIA (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "low grade fever."; NAUSEA (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "nausea, felt like caller was going to vomit,"; ASTHENIA (non-serious) with onset 29Jul2022, outcome "recovered" (30Jul2022), described as "no energy at all"; VACCINATION SITE RASH (non-serious), RASH (non-serious) all with onset 31Jul2022, outcome "recovering" and all described as "had rashes spreading over body, rashes came from injection site and spread to hands, feet, and lower extremities". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that had rashes spreading over body, rashes came from injection site and spread to hands, feet, and lower extremities. Indication: To have more sustained immunity for going back and forth from work and to not get caller's fiance sick, caller's fiance was susceptible to getting very sick from Covid. No any other event require a visit to emergency room, physician office. Prior Vaccinations (within 4 weeks) no any other list of vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Just besides feeling general fatigue and flu like symptoms which caller stated everyone experiences. Reporter confirmed he had general fatigue and flu like symptoms with the 1st and 2nd doses of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product administered at inappropriate site, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 on 31Jul2022; 0.2ml in left thigh/vastis lateralis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID: (159558).  An 1-year-old male patient received BNT162b2 (BNT162B2), on 23Jul2022 as dose 1 (maroon cap), 0.2 ml single (Lot number: FT9142, Expiration Date: Sep2022) at the age of 1 years, in left thigh for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 23Jul2022, outcome "unknown", described as "0.2ml in left thigh/vastis lateralis"; COVID-19 (non-serious) with onset 31Jul2022, outcome "not recovered", described as "tested positive for COVID-19 on 31Jul2022". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was a physician on behalf of a 1-year-old male patient. The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine (6 months to 4 years formulation, maroon cap) on 23Jul2022. Then the patient had a COVID exposure and tested positive for COVID-19 on 31Jul2022. Caller asked for more information on the timing of the second and third doses. She was aware that the CDC considers the second dose to be valid when given up to 8 weeks apart from the first dose, but she wanted to know if she should continue with the vaccination schedule or restart it if the parents wanted to vaccinate their child after more than 8 weeks. Caller states she doesn't think he got COVID from the vaccine, contracted virus after coming in contact with someone with COVID, tested positive a week after getting his first dose. Caller was seeking information about when to give the subsequent doses of the vaccine since the patient tested positive.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 10Jan2021 as dose 2, single (Lot number: EH9899), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: 3302680), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "cardiac dysrrhythmia - both controlled with medications" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL, start date: 29Jun2018, stop date: 02Aug2022; ATORVASTATIN, start date: 20Jun2018, stop date: 02Aug2022; TERAZOSIN, start date: 20Jun2018, stop date: 02Aug2022; LISINOPRIL, start date: 20Jun2018, stop date: 02Aug2022; TESTOSTERONE, start date: 20Jun2018, stop date: 02Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), 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, notes: Covid-19 treatment; (unspecified date) Negative, notes: home test negative; (unspecified date) Positive, notes: Home Covid test positive; (unspecified date) Positive, notes: Covid test is positive again; (28Jul2022) Negative, notes: tested negative 28Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medications in two weeks: Brand: Paxlovid, start date: 22Jul2022, stop date: 26Jul2022, Indication: Treatment of COVID-19. Other medication in 2weeks product: Verapamil, start date=20Jun2018, stop date=02Aug2022; atorvastatin, start date=20Jun2018, stop date=02Aug2022; Terazosin, start date=20Jun2018, stop date=02Aug2022; Lisinopril, start date=20Jun2018, stop date=02Aug2022; Testosterone, start date=20Jun2018, stop date=02Aug2022. First Covid symptoms 21Jul22; home test negative. Significant cough, muscle aches, lassitude 22Jul. Home Covid test positive. Paxlovid prescribed and started on 22Jul. Took all 10 doses through 26Jul. Felt much improved and tested negative 28Jul. No symptoms at all for 3 days then, evening of 01Aug developed nasal congestion and dry coughing. This am (02Aug) have severe, frequent bouts of coughing, heavy nasal congestion, lassitude and Covid test is positive again.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association reported between the events and the suspect drug BNT162B2
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 25Jun2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE; BUPROPION HCL XL; FINASTERIDE; TADALAFIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment, treatment start date was 18Jul2022, treatment stop date was 23Jul2022 and indication was treatment of COVID-19. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: they both tested positive; they both tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: His wife takes Clonidine for her high blood pressure. Concomitant medication(s) included: CLONIDINE taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they both tested positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High, notes: His wife takes Clonidine for her high blood pressure; Reduce, notes: the medication he knows brings down high blood pressure; 207/115, notes: blood pressure sky rocketed to over 200 and registered 207/115; 205/112, notes: go her blood pressure down to 205/112; SARS-CoV-2 test: Positive, notes: 3 days later got COVID; Positive, notes: they got Covid back from him; Negative, notes: both tested positive and negative 3 time's; Positive, notes: both tested positive and negative 3 time's. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She said previous to this her husband and her contacted Covid because they were silly and went where people were and 3 days later got Covid. Was a very mild reaction if anything and they went about their daily business and they are retired and not going to work. They confined their activities to walking in the park away from people for exercise and fresh air until they tested negative. Their son lives with them and he got Covid from them and then they got Covid back from him. They don't want to keep passing Covid back and forth forever and she said they don't build up antibodies and they can get as many times as exposed and they are healthy and her husband and her are in their 70's and their son is in his 50's and they are active and healthy. She didn't want to get Covid back and she said the more times getting Covid can then get lung Covid and said who wants lung Covid. Her husband said they are both vaccinated and boosted all with Pfizer vaccines and received two vaccines and two boosters and the second issue is they both tested positive and negative 3 time's and by the third time they decided to try this antiviral drug and at that point they were in desperation. The third piece of information is his wife did do five days of medication and and stopped on Friday evening at bedtime. Patient received Paxlovid for the treatment of COVID-19.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 39.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 39 years 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 included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: SIMPONI; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Negative, notes: Negative test 4 days after starting Paxlovid; (30Jul2022) Positive, notes: Positive test 12 days after starting treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received antiviral treatment for COVID 19 .Treatment start date was 18Jul2022.Treatment stop date was22Jul2022. Patient received other medication in 2weeks: Simponi and Plaquenil.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Aug2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 02Aug2022, outcome "not recovered", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient received the Prevnar 20 vaccine yesterday and today had a fever of 101 degrees Fahrenheit. She did check for COVID and that was negative.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, 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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6204), on 11Apr2021 as dose 2, single (Lot number: EP7533) and on 09Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type-2 Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN, start date: 19Jul2022, stop date: 24Jul2022; LIRAGLUTIDE; LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 102.8, notes: temperature (102.8); SARS-CoV-2 test: (20Jul2022) positive, notes: Officially tested positive 20Jul; (26Jul2022) Negative, notes: Had negative antigen test on 26Jul and 30Jul; (30Jul2022) Negative, notes: Had negative antigen test on 26Jul and 30Jul; (02Aug2022) positive, notes: Positive antigen test as of the morning of 02Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course includes, adverse event: Officially tested positive 20Jul at a (facility) and was prescribed Paxlovid. Started regimen the evening of 20Jul. Expressed metallic taste throughout 5-day regimen with temperature (102.8) and many symptoms. Had negative antigen test on 26Jul and 30Jul, after completing Paxlovid as of the morning of 25Jul. Limited congestion continued through 27Jul but no fever. No symptoms from 28Jul through the morning of 30Jul. Running nose and sneezing started afternoon of 30Jul, increasing through 02Aug. Positive antigen test as of the morning of 02Aug. Reconfirmed positive with second antigen test on 02Aug. Symptoms worsened from 30Jul but remain largely a head cold at this time, no fever.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 4 (booster), single (Lot number: FL3209) at the age of 41 years, in right arm 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative on Ag test on day 5 post-dose; Negative, notes: I tested negative on Ag again on day 9 post-dose; Positive, notes: I tested positive by home Ag on day 11; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The had no known allergies. The patient was treated with Paxlovid from 23Jul2022 to 27Jul2022 for COVID-19. The patient completed his course of Paxlovid and tested negative on Ag test on day 5 post-dose, with complete resolution of symptoms. He tested negative on Ag again on day 9 post-dose. On day 10 post-dose he developed sneezing and nasal congestion. He tested positive by home Ag on day 11.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The Patient receives vaccine and the patient receive other medications in two weeks of vaccinations and she has no known allergies ,Patient Received (Paxlovid) From 27Jul2022 Treatment stop date- 30Jul2022 For the Treatment of 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: Based on available information , there is reasonable possibility of causal association between the events Vaccination failure and COVID-19  and the suspect drug BNT162b2 .
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-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 included: "Hypertension" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Ischemic Stroke" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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, notes: COVID-19 Treatment; (19Jul2022) Negative, notes: Tested negative 3 days after finished paxlovid; (23Jul2022) Positive, notes: Test positive 7 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not receive any medications within two weeks. Anti viral details: Product COVID 19 Treatment, brand Paxlovid, Treatment start date 12Jul2022, Treatment stop date 16Jul2022. Adverse event: Rebound Covid after taking paxlovid. Tested negative 3 days after finished paxlovid. Test positive 7 days later.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Sleep disorder
Clinical narrative: Chills; headache; vomiting; fever; fatigue; sleep disruption; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "High blood pressure" (ongoing), notes: High blood pressure. Concomitant medication(s) included: LISINOPRIL. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. Vaccination history included: Covid-19 vaccine (Dose number: 3), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2), for COVID-19 immunization; Covid-19 vaccine (Dose number: 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering"; FATIGUE (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering"; PYREXIA (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering"; SLEEP DISORDER (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering", described as "sleep disruption"; VOMITING (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering". Therapeutic measures were not taken as a result of chills, headache, vomiting, pyrexia, fatigue, sleep disorder.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Also since vaccination, she had not been tested for COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 2 weeks of vaccination, she received Lisinopril. She reported event such as chills, headache, vomiting, fever, fatigue, and sleep disruption.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.