chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive 06Jun2022; Tested positive 06Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 10:00 as dose 1, single (Lot number: Ep7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8743), in left arm and on 25Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Smoke" (unspecified if ongoing). There were no concomitant medications. Patient did not had allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "Tested positive 01Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) positive; (07Jun2022) Negative; (14Jun2022) positive, notes: worse symptoms; (19Jun2022) positive, notes: still. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 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 had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022 at 08:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The patient did not have any known allergies. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date-14Jun2022, treatment end date-17Jun2022, Lot number=GA9630, indication: Treatment of COVID-19. Adverse event: Two mild side effects: 1. A weird metallic taste in my mouth - persistent thru the 4 days so far of dosing. Brushing teeth and Listerine masks the taste for a few minutes, but gradually returns. 2. Diarrhea - or loose bowel - transient, experienced about an hour or two after taking the Paxlovid 3 tabs in the morning and later in the evening. The medication seems to have been very effective. Started taking it within 24 hours of symptoms (sore throat, persistent cough, myalgia-as/arthralgias and low-grade fever) - and within 36 hours of treatment, was almost back to normal. Will complete the 5 days, which ends tomorrow night. I tested COVID antigen positive 2 days prior to symptoms - the test was done as a requirement to enter a Pharmaceutical Trade Meeting. Been in complete isolation since the positive test. Adverse events start date: 07Jun2022. Adverse events start time: 08:00 AM. if patient recovered was not recovered. if treatment ae was no. 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 drug ineffective (LOE) and Covid 19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I was diagnosed with COVID on 13May, this year; I was diagnosed with COVID on 13May, this year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant) with onset 13May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "I was diagnosed with COVID on 13May, this year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information:Patient was diagnosed with COVID, Patient have had 3 vaccinations.My heart rate was low.I was given some heavy chest pain symptoms; I am in pain.Reason for no lot number of Paxlovid Consumer further stated, "Expires Feb2023, number on the pack, Lot number was 6C7457. It is GO07457."Consumer stated, "Well I was diagnosed with COVID on 13May, this year and they give me the medicine Paxlovid and since then I have been feeling fine. The medicine was strong, strong strong. It really helped the symptoms that I had, I never had to go to the full lay in bed, I laid in the bed for couple of day. Well it was the third COVID shot (Pfizer COVID-19 Vaccine) that knocked me out. That COVID shot was so bad that I had a heart attack with it. My heart rate was low and I had a second heart operation and in the past three weeks, four weeks, I was given some heavy chest pain symptoms and I am trying to find out can I get a prescription refill as a preventive measure."Consumer stated, "No, not that long please. I am in pain and I want to lay down well and rest myself."LOT#: Consumer stated, "It was 150 mg. Old white pack 3CL/PFFE. They covered it up."LOT# (Pfizer COVID-19 Vaccine): Consumer stated, "No no I got a card. It knocked my symptoms in a day or two. They advised to take all the medicine which I did too. I have back in 13May. The first dose was on 13Jan2021 the second dose was 11Feb2021 and third dose was 15Nov2021 and the LOT# is 069F look like 2TH. It could be an A or H."  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
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 17Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 31Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Date of last menstrual period: 19Apr2022. The patient is expected to deliver a baby(s) on 24Jan2023. Concomitant medication(s) included: SERTRALINE, start date: 01Sep2015. Past drug history included: Flonase, reaction(s): "Allergy", notes: Known allergies- Yes, Flonase and dextromethorphan; Dextromethorphan, reaction(s): "Allergy", notes: Known allergies- Yes, Flonase and dextromethorphan. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=13Jun2022, Treatment stop date=18Jun2022, Indication=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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EKS730), in left arm, on 14Jan2021 at 12:30 as dose 2, single (Lot number: ELI283), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: TRIAMTERENE HCTZ; ATENOLOL; LISINOPRIL; LEVOTHYROXINE; VITAMIN C [ASCORBIC ACID]; ROBITUSSIN DM; IBUPROFEN; TYLENOL; ABREVA; OFLOXACIN; VISINE ALLERGY [NAPHAZOLINE HYDROCHLORIDE;PHENIRAMINE] taken for eye disorder; VISINE ADVANCED RELIEF taken for eye disorder; ALBUTEROL [SALBUTAMOL]; PINK EYE RELIEF taken for eye disorder. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Unknown results, notes: covid symtoms started. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included took paxlovid a.m. dose at 1700 on 18Jun22.  Clinical course: Patient called pharmacy at (pharmacy name withheld) to ask if this was ok, wanted to take the Paxlovid since started having increased cough. They said it was ok to. Patients covid symptoms started on 14Jun22 in the p.m. After patient took Paxlovid, immediately didn't feel right. Became horribly anxious and BP went up to 165/112, tried to relax. Took BP again and the machine wouldn't even read numbers. The cuff is of appropriate size for arm, so it's not that the cuff is too tight. Patient could feel a slight headache in right eye and became horribly anxious. The BP machine would reach over 200 mm/Hg when trying to read BP, that's when patient knew that she was in trouble. Patient made telehealth appt. NP said to stop taking Paxlovid. Brand was Paxlovid, treatment start date 17Jun2022, treatment top date 17Jun2022, Lot number GA3593, Indication was treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid:Treatment of COVID-19; Paxlovid: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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2 , single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Past Cancer Treatment" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; ENBREL.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid:Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 23Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 18Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FJ6369) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; PRILOSEC [OMEPRAZOLE MAGNESIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were not taken as a result of vaccination failure, covid-19. Patient had no known allergies. Patient did not receive any treatment. The vaccine dates on the review screen are all one day earlier than entered on the data entry screen.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Sore arm after vaccines.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205), in right arm and on 24Mar2021 as dose 2, single (Lot number: ER8727) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 as dose 3 (booster), single (Lot number: 027C21A), in left arm and on 16May2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL, start date: 31Jan2020; FLAXSEED OIL NATURE MADE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Jun2022 at 06:00, outcome "unknown", described as "Sore arm after vaccines."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022 at 06:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of pain in extremity.  Clinical course: Anti-viral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 26May2022, Treatment stop date: 31May2022, Indication: Treatment of COVID-19. Sore arm after vaccines. Lousy taste with Paxlovid. Rebound 08Jun, 7 days after finishing Paxlovid. Patient had no  Known allergies.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 at 15:30 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 12Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 24Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV+" (unspecified if ongoing). Concomitant medication(s) included: BIKTARVY, start date: 09Jan2009. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022 at 12:00, 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. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no Known Allergies. Other medication in 2 weeks were reported as, yes. Anti-viral details for Covid 19 Treatment with Pfizer Paxlovid, Treatment start date was 13Jun2022 and Treatment stop date was, 18Jun2022. Indication was, Treatment of COVID-19. Adverse Events were, Horrible taste in mouth, diarrhea, muscle and joint pain in back and legs.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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). The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "not recovered" and all described as "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: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 02:30 as dose 1, single (Lot number: EN6203), in left arm, on 21Mar2021 at 02:00 as dose 2, single (Lot number: FR8727), in left arm, on 01Oct2021 at 01:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 08Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing); "highly cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative for Covid after the five day period; Positive, notes: and then when testing a couple of days later I tested positive; Positive, notes: I have now tested positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
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) (Physician). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. 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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Paxlovid: start date: 08Jun2022, stop date: 14Jun2022, administrator route - Oral. Relapse on 19Jun2022, 8 days after completing Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 34.0
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).  A 35-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Rebound covid on 18Jun2022, 4 days after completion of Paxlovid. 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, covid-19 which included Paxlovid, treatment start date=10Jun2022, treatment stop date=14Jun2022, administrator route=Oral.  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 events and suspect drug BNT162B2 cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 13:00 as dose 1, single (Lot number: EL9269), in left arm, on 04Mar2021 at 13:00 as dose 2, single (Lot number: 2N6205) and on 30Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FD8448) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 at 10:00 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 19Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Negative, notes: Paxlovid rebound. After completing the five days of Paxlovid, I tested negative on 13Jun22; (19Jun2022) Positive, notes: On 19Jun22, I tested positive again. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical information: Paxlovid rebound. After completing the five days of Paxlovid, patient tested negative on 13Jun22. On 19Jun22, patient tested positive again.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, 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) (Physician).  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 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: "aspiration pneumonia on admission" (unspecified if ongoing), notes: aspiration pneumonia on admission; hypothyroid; "hypothyroid" (unspecified if ongoing), notes: aspiration pneumonia on admission; hypothyroid. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. No other medication reported in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: both of these people are fully vaccinated and boosted with Pfizer; both of these people are fully vaccinated and boosted with Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, 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 "both of these people are fully vaccinated and boosted with Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Negative, notes: using rapid test; Positive, notes: using rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : Male and Female Consumers (married couple) mentioned they had covid and were prescribed Paxlovid. They stated their symptoms resolved and texted negative (using rapid test), however within less than a week, their covid rebounded - their mild covid symptoms returned (fever, fluish) and they tested positive again (using rapid test). The case meet the seriousness criterion for Drug Ineffective, seriousness criteria updated The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had covid and prescribed Paxlovid; had covid and prescribed Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had covid and prescribed Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: They stated their symptoms resolved and tested negative (using rapid test); Positive, notes: within less than a week, their covid rebounded - their mild covid symptoms returned (fever, flush) and they tested positive again (using rapid test). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Male and female Consumers (married couple) mentioned they had covid and were prescribed Paxlovid. They stated their symptoms resolved and tested negative (using rapid test), however within less than a week, their covid rebounded - their mild covid symptoms returned (fever, flush) and they tested positive again (using rapid test). It was reported that both of these people are fully vaccinated and boosted with Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Prescribed Paxlovid after vaccination; Prescribed Paxlovid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 at 06:30 as dose 4 (booster), single (Lot number: El3249) at the age of 66 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Prescribed Paxlovid after vaccination". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received treatment with Paxlovid for covid-19. start date: 06Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Prescribed Paxlovid after vaccination; Prescribed Paxlovid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 at 06:30 as dose 4 (booster), single (Lot number: El3249) at the age of 66 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Prescribed Paxlovid after vaccination". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received treatment with Paxlovid for covid-19. start date: 06Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, 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 67-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 at 18:30 as dose 4 (booster), single (Lot number: El3249) at the age of 66 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 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.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, 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 67-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 at 18:30 as dose 4 (booster), single (Lot number: El3249) at the age of 66 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 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.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EW0151), in right arm, on 26Apr2021 as dose 2, single (Lot number: ER8735), in right arm, on 03Nov2021 as dose 3 (booster), single (Lot number: 33D26BD), in right arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FP4554), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid+ after stopping treatment (day 11 from start of infection); Negative, notes: two days after testing covid negative; Positive, notes: Covid+ two days after stopping treatment and two days after testing covid negative. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: rapid test positive; rapid test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 21Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: ER8731) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "pre diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; METOPROLOL. Past drug history included: Cephalexin, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "rapid test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive, notes: Positive; (10Jun2022) Positive, notes: Positive; (12Jun2022) Positive, notes: June 12 was very faint; (14Jun2022) Negative, notes: Negative; (18Jun2022) Positive, notes: Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: The patient had other medication in 2 weeks. Covid rebound after completing paxlovid treatment. Tested positive initially 07Jun2022, paxlovid started that date, taken through 12Jun2022. Positive rapid tests on 10Jun2022 and 12Jun2022 (June 12 was very faint). On 14Jun2022, rapid test negative. All symptoms resolved. On 17Jun2022, symptoms returned (runny nose, cough, sore throat), rapid test positive on 18Jun2022. Restarted isolation.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound infection; Rebound infection; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EL3247), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 23Sep2021 as dose 3 (booster), singe (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hx asthma" (unspecified if ongoing); "hx of high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 31Dec2021, stop date: 07Jun2022; SERTRALINE, start date: 31Dec2021, stop date: 07Jun2022. The following information was reported: COVID-19 (medically significant) with onset 18Jun2022 at 09:00, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Rebound infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative; (13Jun2022) Negative; (14Jun2022) Negative; (15Jun2022) Negative; (16Jun2022) Negative; (17Jun2022) Negative; (18Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Rebound infection. Starting from official first symptoms being day 0. Started paxlovid day 2. First negative test day 6. Ended paxlovid day 6. Negative tests from day 6 through 11. Second positive test day 12. Anti-viral treatment included Paxlovid started on 08Jun2022 for COVID 19 Treatment and stopped on 12Jun2022. Other medication in 2weeks products included Levothyroxine and sertraline started on 31Dec2021 and stopped on 07Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: prescribed Paxlovid after vaccination/Treatment of COVID-19; prescribed Paxlovid after vaccination/Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster, single) (Batch/Lot number: unknown) at the age of 27 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), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "prescribed Paxlovid after vaccination/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 09Jun2022 to 13Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Still rapid antigen positive on day 20; Still rapid antigen positive on day 20; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (COMIRNATY), on 18May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years 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 "Still rapid antigen positive on day 20". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (Jun2022) Negative, notes: Negative tests on day 8, 9, 10, maybe; (Jun2022) Positive, notes: Still rapid antigen positive on day 20. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: my COVID-19 symptoms returned; my COVID-19 symptoms returned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 21Apr2021 as dose 2, single (Lot number: EW0170) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), from 05Jan2022 (Lot number: 031H21A) to 05Jan2022 at single (dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Reynaud's Syndrome" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX D, start date: 08Jun2022, stop date: 18Jun2022; ALKA SELTZER PLUS SEVERE COLD AND FLU, start date: 08Jun2022, stop date: 19Jun2022; MUCINEX, start date: 08Jun2022, stop date: 19Jun2022. Past drug history included: Erythromycin, reaction(s): "Allergy:Erythromycin"; Cephalosporin, reaction(s): "Allergy:Cephalosporin"; Fluoroquinalones, reaction(s): "Allergy:Fluoroquinalones". The following information was reported: COVID-19 (medically significant) with onset 16Jun2022, outcome "recovering", VACCINATION FAILURE (medically significant) with onset 16Jun2022, outcome "unknown" and all described as "my COVID-19 symptoms returned". Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that 3 days after finishing Paxlovid course, patient COVID-19 symptoms returned to their initial strength dry cough, runny nose, intermittent fever, sinus and ear congestion and pressure
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech Dose Number: 4 30Mar2022 / Treatment of COVID-19 5Jun2022; Pfizer / BioNTech Dose Number: 4 30Mar2022 / Treatment of COVID-19 5Jun2022; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 76 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 was not reported. Concomitant medication(s) included: LISINOPRIL/HCTZ, stop date: 05Jun2022; SIMVASTATIN, stop date: 05Jun2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech Dose Number: 4 30Mar2022 / Treatment of COVID-19 5Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Negative; (19Jun2022) positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical information: Anti-viral details: Product: Covid-19 treatment, Brand: Paxlovid, Treatment start date: 05Jun2022, Treatment stop date: 09Jun2022, Indication: Treatment of Covid-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the vaccination failure, covid-19 cannot be completely excluded.