chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: en6205), in left arm, on 02Apr2021 as dose 2, single (Lot number: er8734), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: fh8020), in left arm and on 10May2022 as dose 4 (booster), single (Lot number: fj4991) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing); "occasional asthma" (unspecified if ongoing); "gluten intolerant" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Known Allergy: penecillan" (unspecified if ongoing); "Known Allergy: dust" (unspecified if ongoing); "Known Allergy: grass" (unspecified if ongoing); "Known Allergy: trees" (unspecified if ongoing); "Known Allergy: Lidocain" (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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: Home test; (30Jun2022) Negative, notes: 4 days after stopping Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. From 21Jun2022 to 26Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. The patient took nirmatrelvir; ritonavir for 5 days after testing positive using at home test. Symptoms were mild: headache and nasal congestion, sneezing and sore throat.Tested was negative on 30Jun2022 (4 days after stopping Paxlovid).  On 04Jul202 02:00 (8 days after stopping Paxlovid), the same symptoms returned and were much worse than my initial symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: six months ago after second shot, it was 150/85-88.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "six months ago after second shot, it was 150/85-88.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states that another friend who has taken "maybe two" vaccines, not sure of booster, now discovered she has high blood pressure. Caller states his most recent blood pressure 140/80, and six months ago after second shot, it was 150/85-88. Caller asks for any association with the Covid vaccine and carpal tunnel syndrome or high blood pressure, and guidance for treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 at 04:00 as dose 1, single (Lot number: EL9262), in left arm, on 11Feb2021 at 03:00 as dose 2, single (Lot number: EM9810), in left arm, on 01Sep2021 at 09:00 as dose 3 (booster), single (Lot number: EW0186), in left arm and on 13May2022 at 09:00 as dose 4 (booster), single (Lot number: Fj4991) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Recurring indigestion" (unspecified if ongoing), notes: Recurring indigestion; "Have taken medication for cholesterol previously but discontinued over 6 months ago." (unspecified if ongoing), notes: Have taken medication for cholesterol previously but discontinued over 6 months ago.; "Have taken medication for cholesterol previously but discontinued over 6 months ago." (unspecified if ongoing), notes: Have taken medication for cholesterol previously but discontinued over 6 months ago. Concomitant medication(s) included: OMEPRAZOLE, start date: 14Jul2021. Past drug history included: Formaldehyde, reaction(s): "Known allergies: Formaldehyde", notes: Known allergies: Formaldehyde. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (2022) Normal temperature, notes: Normal temperature both instances; SARS-CoV-2 test: (2022) positive; (24Jun2022) positive; (29Jun2022) Negative; (04Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID-19 was 24Jun2022. Stop date of treatment for COVID-19 was 29Jun2022. After testing positive for COVID 24Jun2022 began Paxlovid immediately for 5 days. Symptoms were very mild. Tested negative 29Jun. On 04Jul2022 I tested positive again for COVID. Started with very runny nose which I thought was allergies, next day chest had mild congestion which caused me to test that afternoon. Normal temperature both instances. Second time I'm feeling more congestion and coughing with sneezing. Second day i'm still testing positive. Normal temp.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 10:00 as dose 1, single (Lot number: 011J20A), in right arm, on 17Feb2021 at 10:00 as dose 2, single (Lot number: 022M20A), in right arm, on 20Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 011D21A), in right arm and on 13Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 005M21) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "retinal vein occlusion" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies Amoxicillin", notes: known allergies Amoxicillin; Codeine, reaction(s): "known allergies Codeine", notes: known allergies Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical curse: Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a Covid-19 Vaccine. Covid rebound after Paxlovid. I tested Negative on a home test on day 10 and after completing 5 days of Paxlovid. Paxlovid was started on day 2. On day 14, I tested positive on a home test, with no symptoms.   No follow-up attempts are possible. No further information is expected
Age: 64.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left 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's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: dietary latex" (unspecified if ongoing); "Known allergies: avocados, water chestnuts, bananas and kiwi" (unspecified if ongoing), notes: avocados, water chestnuts, bananas and kiwi. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.patient previously receive a COVID-19 Vaccine.Rebound symptoms and positive testing. Completed Paxlovid course, tested negative for 5 days in a row, then symptoms recurred and tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 51-year-old female patient received BNT162b2 (BNT162B2), on 13May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm 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 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 26Jun2022 to 01Jul2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. Metallic taste in mouth starts 2-3 h after taking Paxlovid. On Jul2022 (Day 10-11),  fatigue came back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. From 23Jun2022 to 28Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 14Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 06Oct2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ana postive speckled" (unspecified if ongoing), notes: Other medical history: Ana positive speckled. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "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 course: The patient received other medication within 2 weeks of vaccination and also received Paxlovid as a treatment of COVID-19 from 26May2022 to 30May2022. Other medication included Sulfate, Pernsdione. No known allergies were reported.  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 known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, SARS-CoV-2 test, Vomiting
Clinical narrative: After shot #2, my period cramps caused me to vomit from the severity of the pain; After shot #2, my period cramps caused me to vomit from the severity of the pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2021 as dose 2, single (Lot number: EW0198) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: gluten" (unspecified if ongoing); "known allergies: sulfa-based antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "known allergies:ibuprofen". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0196, Location of injection: Arm Right, ), administration date: 24Jun2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "Loss of consciousness", "Dysmenorrhoea", "COVID-19". The following information was reported: VOMITING (non-serious), DYSMENORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "After shot #2, my period cramps caused me to vomit from the severity of the pain". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200931829 same patient, same drug, different dose/event;
Age: 36.0
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 36 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID Vaccine Details: vaccine brand: Pfizer / BioNTech, vaccine brand unknown: false, vaccine lot unknown: false, vaccine dose number: 3 vaccine dose number unknown: false. Reported Event: Rebound infection of COVID. After completion of my course of paxlovid, I tested negative for COVID I continued testing negative for 6 days, after which point I began having symptoms again, and testing positive with antigen tests
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid_test_result=Positive; covid_test_result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2021 as dose 1, single (Lot number: EW0196), in right arm, on 15Jul2021 as dose 2, single (Lot number: EW0198), in right arm and on 03Mar2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MURO 128; ELDERBERRY [SAMBUCUS NIGRA]; MAGNESIUM; VITAMIN D [COLECALCIFEROL]; TYLENOL. Past drug history included: Gluten, reaction(s): "Known allergies: Gluten", notes: Known allergies: Gluten; Sulfa-based antibiotics, reaction(s): "known allergies: sulfa-based antibiotics", notes: Known allergies: sulfa-based antibiotics; Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: known allergies: ibuprofen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "covid_test_result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Negative, notes: Nasal Swab; (05Jul2022) Positive, notes: Nasal Swab; (21Oct2021) Negative, notes: BioFire Respiratory 2.1-EZ Panel RT-PCR. Nasal Swab.  Clinical course: It was reported that, got the COVID vaccine shot 1 and shot 2 right before her period was due. Her cramps were so much more horrible than normal. After shot 1, her period cramps caused her to nearly pass out from the severity of the pain. After shot 2, her period cramps caused her to vomit from the severity of the pain. There were no other obvious changes in her meds, work, sicknesses, diet, exercise, stress, etc. that could have affected her cycle. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 51.0
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) (Other HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 13:00 as dose 1, single (Lot number: EWO151), in left arm and on 27Apr2021 at 12:00 as dose 2, single (Lot number: EWO171) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Nov2021 at 10:00 as dose 3 (booster), single (Lot number: 027H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing); "DVT (factor V Leiden mutation)" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ATORVASTATIN; WARFARIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had anti viral treatment included COVID 19 Treatment, Brand was Paxlovid started on 23Jun2022 to 28Jun2022. Other medication in 2 weeks included Zoloft, Atorvastatin, Claritin and Warfarin. Covid rebound six days after end of paxlovid treatment (including testing negative by lateral flow antigen assay). No known allergies were reported.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
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) (Nurse). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), 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's relevant medical history was not reported. The patient took 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; Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received Anti-viral treatment for COVID 19 in 2 weeks after vaccine administration.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single, in left arm, on 18Mar2021 as dose 2, single, in left arm and on 05Oct2021 at 13:00 as dose 3 (booster), single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood clot disorder many years ago." (unspecified if ongoing), notes: Other medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 01Jul2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), 2022 min after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive, notes: Tested positive on 02Jul - one day after rebound symptoms began. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical Course: Patient did not received other medication in 2weeks:.Treatment start date: 21Jun2022. Treatment stop date: 26Jun2022. Vaccine administration date: 05Oct2021. Vaccine administration time: 01:00 PM. reporter stated that Covid rebound after taking Paxlovid. Rebound symptoms occurred 5 days after finishing your medication and had continue for 5 days now. They were still ongoing. Tested positive on 02Jul2022 one day after rebound symptoms began. If treatment ae: No. patient did not had any known allergies.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: ~~~
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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'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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks: No. Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=28Jun2022, Treatment stop date=30/Jun/2022. Vaccine administration date=18Dec2019. Took paxlovid, now have rebound COVID 4 days after stopping medication. No Known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 05Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 14Jan2022 as dose 3, (booster), single (Lot number: FF2590) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "prediabetic" (unspecified if ongoing), notes: prediabetic, no meds/acute bronchitis (breathing treatment at the hospital on 28Jun2022); "acute bronchitis" (unspecified if ongoing), notes: prediabetic, no meds/acute bronchitis (breathing treatment at the hospital on 28Jun2022). Concomitant medication(s) included: LISINOPRIL AND HYDROCHLOROTHIAZIDE, start date: Jan2014; ATORVASTATIN, start date: Jan2020; METHYLPREDNISOLONE, start date: 28Jun2022, stop date: 03Jul2022. Past drug history included: Demerol, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 82.0
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 contactable reporter(s) (Physician). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2020 at 13:00 as dose 1, single (Lot number: EL0140), in left arm, on 13Jan2021 at 12:00 as dose 2, single (Lot number: EL3249), in left arm, on 02Oct2021 at 11:45 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02May2022 at 10:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 82 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLOFT, start date: 01Nov2017; LIPITOR, start date: 05Jul2016; PREVACID, start date: 04Aug2014; ZETIA, start date: 20Jun2017; ALTACE, start date: Aug1979; IRON SULFATE, start date: Jan2001; FISH OIL, start date: Apr1978; VITAMIN D3, start date: Jul2000.The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: a rebound of symptoms and recurrence of a positive antigen test after taking 7 doses of Paxelovid (I skipped 24 hours between the 5th dose and 6th dose, and I did not complete the full 10 doses, because my antigen test became negative and my symptoms totally subsided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: sars-cov2 infection; 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 73-year-old male patient received BNT162b2 (BNT162B2, Vaccine brand unknown and Vaccine dose number unknown: False, Vaccine lot unknown: True, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Vaccine brand unknown and Vaccine dose number unknown: False, Vaccine lot unknown: True, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion), on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic kidney disease stage 3B" (unspecified if ongoing), notes: Other medical history: chronic kidney disease stage 3B; "asthma" (unspecified if ongoing), notes: Other medical history: asthma; "COPD" (unspecified if ongoing), notes: Other medical history: COPD. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), outcome "not recovered", described as "sars-cov2 infection"; VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Treatment of COVID-19". Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer Paxlovid, Treatment start date: 16Jun2022, Treatment stop date: 20Jun2022, Indication: Treatment of COVID-19. Adverse event: five days after stopping the medicine, COVID symptoms came back, Adverse event start date: 02Jul2022, Adverse event start time: 03:00 PM. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19, vaccination failure. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 76.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left 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's relevant medical history included: "Coronary artery disease" (unspecified if ongoing), notes: Other medical history: Coronary artery disease; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: two negative antigen tests; Negative, notes: two negative antigen tests; Positive, notes: I experienced a positive antigen test; Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 Treatment from 24Jun2022 to 29Jun2022. Adverse event: After full course Paxlovid and two negative antigen tests, patient experienced a positive antigen test and recurrence of symptoms.  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: 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), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid cancer" (unspecified if ongoing), notes: other medical history: thyroid cancer/ take synthroid. Concomitant medication(s) included: SYNTHROID taken for thyroid cancer. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: The patient had no other medication in 2 weeks. The patient has anti-viral product Plaxlovid for COVID 19 Treatment from 23Jun2022 to 27Jun2022. No known allergies were reported.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive, notes: grandson tested positive for COVID through a home kit in February.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 16May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Oct2021, outcome "recovered" and all described as "positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Oct2021) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing). There were no concomitant medications. There were no other medications in 2weeks. There were no Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with onset 2022, 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) Unknown results, notes: product: COVID 19 Treatment; (29Jun2022) Negative, notes: on the sixth day tested negative and symptoms went away. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as COVID 19 Treatment from 23Jun2022 for five days. Came back 02Jul2022 with extreme symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected 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: Linked Report(s) : US-PFIZER INC-202200934657 Same patient, different drug, different event;
Age: 66.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Topical Steroid Withdrawal" (unspecified if ongoing). Concomitant medication(s) included: CEFDINIR, start date: 16Jun2022, stop date: 06Jul2022; GABAPENTIN, start date: Jul2018; METFORMIN, start date: Nov2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". 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: Linked Report(s) : US-PFIZER INC-202200935085 Same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Jun2022 at 13:00 as dose 3 (booster), single (Lot number: 058a22-2a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 01Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Additional information: patient received anti viral product for Treatment of COVID-19 from 26Jun2022 to 01Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200935280 same reporter/patient, different product/AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-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), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Rebound Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left 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's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Rebound Covid-19 5 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Drug ineffective.