chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Upper respiratory tract congestion
Clinical narrative: Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; Fever; sore throat; head congestion; body aches; cough (less severe); 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), in Feb2021 as dose 1, single (Batch/Lot number: unknown, Expiry date: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown, Expiry date: unknown), in left arm and on 23Sep2021 at 08:00 as dose 3 (booster), single (Batch/Lot number: unknown, Expiry date: unknown) at the age of 62 years, in left leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19"; PYREXIA (non-serious), outcome "not recovered", described as "Fever"; OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat"; UPPER RESPIRATORY TRACT CONGESTION (non-serious), outcome "not recovered", described as "head congestion"; PAIN (non-serious), outcome "not recovered", described as "body aches"; COUGH (non-serious), outcome "not recovered", described as "cough (less severe)". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of pyrexia, oropharyngeal pain, upper respiratory tract congestion, pain, cough.  Clinical course: The patient received Paxlovid as COVID 19 Treatment from Apr2022 to 30Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Extra dose administered, Off label use, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Dose Number: 5; Dose Number: 5; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2022 at 09:00 as dose 5 (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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Penicillin, reaction(s): "Known allergies: Penicilin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; OFF LABEL USE (non-serious), EXTRA DOSE ADMINISTERED (non-serious), outcome "unknown" and all described as "Dose Number: 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (05May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Other medication in two weeks was No. Product: COVID 19 Treatment, treatment start date was 25Apr2022 and treatment stop date was 30Apr2022. Vaccine lot unknown reason is Misplaced/discarded. Reoccurence of Covid positive antigen tests 5 days after negative test and 6 days after last dose of 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 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  lack of efficacy cannot be ruled out.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Depression." (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Unknown Manufacturer), for COVID-19 Immunization. Patient had no known allergies. 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: Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: No real change in symptoms except when I would eat a meal right afterwards I would feel sick (sometimes I did throw up) and really dizzy. Patient received paxlovid as treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
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) (Other HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 13:00 as dose 5 (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), as dose 2 single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: Penecilian" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Negative, notes: Tested negative on rapid test five days after starting Paxlovid; (08May2022) Negative, notes: On day eight from first negative test symptoms returned tested negative twice on rapid tests; (08May2022) Negative, notes: On day eight from first negative test symptoms returned tested negative twice on rapid tests. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient did not taken any other medication within two weeks of vaccination. Paxlovid in COVID 19 Treatment.  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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 12May2021 as dose 1, single (Batch/Lot number: unknown), in left arm 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), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2 weeks reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm, on 22Feb2021 as dose 2, single (Lot number: en6203) at the age of 67 years and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive; (06May2022) Unknown result, notes: Covid symptoms returned after 5 days of feeling better and symptom free. Adverse event start time: 01:00 PM. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid, treatment start date: 26Apr2022, treatment stop date: 30Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; VALACYCLOVIR [VALACICLOVIR]; MITOCOR. Past drug history included: Known allergies: sulfa drugs, reaction(s): "Allergies". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Negative, notes: Felt better 24 hours after taking Paxlovid. Tested negative 3 days later; (01May2022) Positive, notes: About 5 days later felt worse and tested positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. On 27Apr2022, the patient started Paxlovid for the treatment of covid-19 and stopped on 01May2022. Felt better 24 hours after taking Paxlovid. Tested negative 3 days later. About 5 days later felt worse and tested positive. Other concomitant medications in two weeks included: Probono and Orthomolecular.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 05Jan2021 as dose 2, single (Lot number: EK9321), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: 3014584) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MIRENA, start date: 01Dec2020. Patient received the other medication in 2 weeks. Other medication in 2weeks product included Mirena intrauterine device. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (30Apr2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Symptoms worse than COVID symptoms in the first 5days while on paxlovid; (30Apr2022) Negative, notes: Tested negative on home COVID antigen test on day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound symptoms. Developed URI symptoms - sneezing, nasal congestion, sinus pressure, body aches, sore throat 11 days after initial positive COVID test. Symptoms worse than COVID symptoms in the first 5 days while on Paxlovid. Tested negative on home COVID antigen test on day 7. Patient received the treatment Paxlovid start from 24Apr2022 and treatment stop on 28Apr2022 for event COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive on home; Tested positive on home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVIL 12 HOUR, start date: 27Apr2022, stop date: 28Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06May2022, outcome "not recovered" and all described as "Tested positive on home". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (02May2022) Negative; (06May2022) Positive; (08May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested positive on home and PCR tests and took Paxlovid on 27Apr. Covid symptoms alleviated within a few hours. Tested negative 02May. 06May, woke with renewed symptoms, tested positive on rapid home test. Still positive with symptoms today, 08May. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: dose number: 4 date: 11Apr2022; COVID 19 Treatment; dose number: 4 date: 11Apr2022; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FK9846) at the age of 38 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: "Ankylosing spondylitis" (unspecified if ongoing); "exercise induced asthma" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: 24Apr2022, stop date: 24Apr2022; CELECOXIB, start date: 25Apr2022, stop date: 25Apr2022. Past drug history included: Compazine, reaction(s): "known allergies: Compazine".  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "cdose number: 4 date: 11Apr2022; COVID 19 Treatment"; COVID-19 (medically significant), outcome "unknown", described as "dose number: 4 date: 11Apr2022; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19  which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: dose_number=4 date=20/Apr/2022; COVID 19 Treatment; dose_number=4 date=20/Apr/2022; 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 female patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 28Mar2021 as dose 2, single (Lot number: ER8733), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Sleep Apnea" (unspecified if ongoing), notes: Other medical history: Sleep Apnea. The patient's concomitant medications were not reported. No Known allergies. No Other medication in 2weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05May2022, outcome "unknown", COVID-19 (medically significant) with onset 05May2022, outcome "recovering" and all described as "dose_number=4 date=20/Apr/2022; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Negative, notes: Tested negative with PCR on 04May2022; (unspecified date) Positive; (06May2022) Positive, notes: Testing positive with antigen tests May 6, 7 & 8th so far..; (07May2022) Positive, notes: Testing positive with antigen tests May 6, 7 & 8th so far..; (08May2022) Positive, notes: Testing positive with antigen tests May 6, 7 & 8th so far... Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have been experiencing rebound Covid symptoms after my five day treatment with Paxlovid. I felt pretty good, during and shortly after. About the second day post treatment I started having the same s; I have been experiencing rebound Covid symptoms after my five day treatment with Paxlovid. I felt pretty good, during and shortly after. About the second day post treatment I started having the same s; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Past history of Lyme carditis, with several bouts of heart block since." (unspecified if ongoing); "Past history of Lyme carditis, with several bouts of heart block since." (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer / biontech (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04May2022, outcome "not recovered" and all described as "I have been experiencing rebound Covid symptoms after my five day treatment with Paxlovid. I felt pretty good, during and shortly after. About the second day post treatment I started having the same s". Therapeutic measures were not taken as a result of covid-19, drug ineffective. Adverse event: Patient has been experiencing rebound Covid symptoms after his five day treatment with Paxlovid. Patient felt pretty good, during and shortly after. About the second day post treatment he started having the same symptoms as before treatment. On day 11, today he was feeling much worse. We need direction from the manufacturer and the CDC as to how to go about dealing with these current symptoms. There is nothing published as of yet, besides several news media coverage of this happening. Should I seek a different treatment, or a repeat dose of Paxlovid?. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (the patient). A 43-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 42, on Oct 7, 2021, single dose, for COVID-19 immunisation. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (batch/lot#unknown); both single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medication included: levothyroxine and Paxil (piroxicam). Past drug history included: Keflex, notes: known allergies Keflex. The patient experienced ineffective drug (medically significant) and COVID-19 (medically significant), with outcome of unknown. Therapeutic measures were taken as a result of ineffective drug and COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: have had 5 of my wife's friends who had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2, Solution for injection), 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: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "have had 5 of my wife's friends who had miscarriages".  Clinical course: Caller started referring to a document that was regarding breast feeding and pregnant women. Caller spoke for a while and then summarize by asking about information regarding breastfeeding and pregnancy with the Pfizer COVID19 vaccine. He mentioned both he and his wife were not vaccinated. The reporter had 5 of his friends' wife who had miscarriages.They had the COVID vaccine. All of our friends who had no COVID vaccine had a normal, healthy baby. So 5 out of 5 that were vaccinated had miscarriages in their third trimester and then one had a still born birth so he guessed that was 4 out of 5. No doctor linked any of that to the COVID vaccine and all those doctors- all those women were told, cause we actually they were in the same church and they were obviously were very mentally upset, but all their doctors, OBGYN, all of them recommended that they get the COVID vaccine because they said their baby was gonna get COVID or they could get COVID during it and their baby would die. They didn't give any data and that scared those women into getting the shot. They didn't provide anything.   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-202200677408 mother/baby case
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (the patient). A 52-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 51, in left arm, Dec 2021, single dose, for COVID-19 immunization. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunization. Medical history not reported. No concomitant medications. Patient received the other medication in 2 weeks. The patient experienced ineffective drug (medically significant) and suspected COVID-19/treatment of COVID-19 (medically significant), with outcome of unknown. Therapeutic measures were taken as a result of ineffective drug and suspected COVID-19. Clinical course: Antiviral details: COVID-19 treatment started May 7, 2022 for both events. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Evening of 08May I tested positive via rapid; Evening of 08May I tested positive via rapid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP7534 7/21), in right arm and on 12Apr2021 as dose 2 , single (Lot number: ER8731 7/21), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high-blood pressure" (unspecified if ongoing); "Sulfa Allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ADVAIR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "not recovered" and all described as "Evening of 08May I tested positive via rapid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Negative, notes: I tested negative via rapid test 03May, 04May, and 05May; (04May2022) Negative, notes: I tested negative via rapid test 03May, 04May, and 05May; (05May2022) Negative, notes: I tested negative via rapid test 03May, 04May, and 05May; (08May2022) Positive, notes: Evening of 08May I tested positive via rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had other medication in 2 weeks. Anti viral details: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 27Apr2022, treatment stop date 02May2022, indication: Treatment of COVID-19. Covid vaccine details : Vaccine brand: Other, vaccine brand other: Moderna, vaccine brand unknown: False, vaccine administration date: 18Nov2021, vaccine lot number: 033F21A, vaccine lot unknown: False, vaccine dose number: 3, vaccine dose number unknown: False, vaccine location: Right arm, vaccine brand: Pfizer / BioNTech, vaccine brand  unknown: False, vaccine administration date: 12Apr2021, vaccine lot number: ER8731 7/21, vaccine lot unknown: False, vaccine dose number: 2, vaccine dose number unknown False, vaccine location: Right arm, vaccine brand: Pfizer / BioNTech, vaccine brand unknown: False, vaccine administration date: 22Mar2021, vaccine lot number: EP7534 7/21, vaccine lot unknown: False, vaccine dose number: 1, vaccine dose number unknown: False, vaccine location: Right arm. Other medication details: Other medication in 2weeks product: Advair Diskus, other medication in 2weeks product: Lisinopril. Adverse event: Rebound case. The patient tested negative via rapid test 03May, 04May, and 05May. Did not test on 06May. On the evening of 07May he developed a sore throat and sinus congestion. Evening of 08May he tested positive via rapid test. The patient had sulfa allergy.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; 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 15Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Adhd" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; CYMBALTA; VYVANSE; OMEPRAZOLE; ALLEGRA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was received other medication in 2 weeks. Patient did not  had any Known allergies. Treatment start date- 01May2022, Treatment stop date- 06May2022.  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 lack of efficacy cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Fatigue, Oropharyngeal pain
Clinical narrative: slight coughing; sore throat; slight chest tightness; tiredness; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP6955), on 16Apr2021 as dose 2, single (Lot number: EP6955) and on 24Nov2021 as dose 3 (booster), single (Lot number: 330308D) 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 06May2022 at 19:30, outcome "unknown" and all described as "tested positive for COVID-19"; COUGH (non-serious), outcome "unknown", described as "slight coughing"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "slight chest tightness"; FATIGUE (non-serious), outcome "unknown", described as "tiredness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: slight coughing; sore throat; slight chest tightness; tiredness; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP6955), on 16Apr2021 as dose 2, single (Lot number: EP6955) and on 24Nov2021 as dose 3 (booster), single (Lot number: 330308D) 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 06May2022 at 19:30, outcome "unknown" and all described as "tested positive for COVID-19"; COUGH (non-serious), outcome "unknown", described as "slight coughing"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "slight chest tightness"; FATIGUE (non-serious), outcome "unknown", described as "tiredness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Headache, Malaise, Nasal congestion
Clinical narrative: coughing; congestions; headache; not feeling very good; he tested positive for covid infection last Friday; he tested positive for covid infection last Friday; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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 included: "BNT162B2" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 06May2022, outcome "unknown", described as "fever"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 06May2022, outcome "unknown" and all described as "he tested positive for covid infection last Friday"; MALAISE (non-serious) with onset 06May2022, outcome "unknown", described as "not feeling very good"; COUGH (non-serious), outcome "unknown", described as "coughing"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestions"; HEADACHE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive. Clinical Course: Caller, 38-year-old male, said he and his wife (30+ y/o) already received 3 shots of Pfizer covid vaccine, then he tested positive for covid infection last Friday, while his wife has been testing positive for over a week now. Caller stated that they are having a medium flu-like symptom; fever, coughing, congestions, headache. Caller said they do not feel the need of being hospitalized as he described the symptoms to be just mild, he is just wondering why the vaccine shots didn't work. Caller states he received the Pfizer Covid Vaccine 3 times and he is 38 years old and he has had the worst weekend ever after testing positive for Covid last Friday. Caller states he has a fever and he is not feeling very good. Caller states the vaccine is not working well, he has got it in his system, but it is not doing anything for him. Caller states the reason he is calling is because he is wondering why it is not working? Caller states they advertised everyone needs to get the shots, its been tested and it works but he doesn't know why it didn't work for him. Caller states he got the Omicron Variant and he is not seeing that the vaccine is working.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: coughing; congestions; headache; not feeling very good; he tested positive for covid infection last Friday; he tested positive for covid infection last Friday; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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 included: "BNT162B2" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 06May2022, outcome "unknown", described as "fever"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 06May2022, outcome "unknown" and all described as "he tested positive for covid infection last Friday"; MALAISE (non-serious) with onset 06May2022, outcome "unknown", described as "not feeling very good"; COUGH (non-serious), outcome "unknown", described as "coughing"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestions"; HEADACHE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive. Clinical Course: Caller, 38-year-old male, said he and his wife (30+ y/o) already received 3 shots of Pfizer covid vaccine, then he tested positive for covid infection last Friday, while his wife has been testing positive for over a week now. Caller stated that they are having a medium flu-like symptom; fever, coughing, congestions, headache. Caller said they do not feel the need of being hospitalized as he described the symptoms to be just mild, he is just wondering why the vaccine shots didn't work. Caller states he received the Pfizer Covid Vaccine 3 times and he is 38 years old and he has had the worst weekend ever after testing positive for Covid last Friday. Caller states he has a fever and he is not feeling very good. Caller states the vaccine is not working well, he has got it in his system, but it is not doing anything for him. Caller states the reason he is calling is because he is wondering why it is not working? Caller states they advertised everyone needs to get the shots, its been tested and it works but he doesn't know why it didn't work for him. Caller states he got the Omicron Variant and he is not seeing that the vaccine is working.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tinnitus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old male patient received BNT162b2 (BNT162B2), on 31Aug2021 as dose 2, single (Lot number: LC3184) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (Previous dose details , product=COVID 19,, brand=Pfizer,, brand unknown=False,, lot number=LC3181,, lot unknown=False,, dose number=1,, vaccine location=Left arm), administration date: 10Aug2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (medically significant) with onset Oct2021, outcome "not recovered", described as "Acute Tinnitus in both ears diagnosed in Apr2022 after months of suffering". The event "acute tinnitus in both ears diagnosed in Apr2022 after months of suffering" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: (Sep2021) Negative; (Sep2021) Negative; (Dec2021) Negative; (Dec2021) Negative. Therapeutic measures were not taken as a result of tinnitus. Clinical Information: It was reported that patient received no other vaccine in four weeks and patient received other medications in two weeks. No other known allergies. Adverse event start time was provided as 08:00 AM.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Have COVID; Have COVID; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing), notes: Valsartan medication for high blood pressure.; "Interchange of vaccine products" (unspecified if ongoing), notes: He received a Johnson and Johnson COVID vaccine and 2 Pfizer COVID19 vaccines. Concomitant medication(s) included: VALSARTAN taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Have COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (06May2022) Positive; (08May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was a 76-year-old male physician (drug safety expert) and was calling about Paxlovid medication. The patient had no underlying morbidities and was taking Valsartan medication for high blood pressure. He had Covid and was exposed 2 weeks ago and tested positive on day 5 after exposure with PCR and rapid antigen tests. On the last Friday in Apr2022, he prescribed Paxlovid for himself and he completed the course on Wednesday of last week which was 04May2022 and took the complete 5 day course as labeled. His COVID symptoms were mild and he was quarantining. He did a Rapid Antigen test 2 days (last Friday) after finishing treatment with Paxlovid (last Wednesday) and test was still positive. Yesterday, Sunday, he took another rapid antigen Covid test  and it was still positive. He received a Johnson and Johnson COVID vaccine and 2 Pfizer COVID-19 vaccines. He looked at data which stated that after 5 days, there should be a reduction in viral load. He wanted to know what duration of post treatment could he reasonably expect his system to be clear of Covid virus and was asking if Pfizer had any information on a timeframe of complete resolution of Covid infection after Paxlovid treatment.  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 report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 36-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 at 11:30 as dose 1, single (Lot number: EW0161), in left arm, on 08May2021 at 11:45 as dose 2, single (Lot number: EW0173), in left arm and on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRUVADA, start date: Aug2021; FINASTERIDE; WELLBUTRIN; PAXIL [PIROXICAM]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient received Paxlovid indicated for COVID-19 Treatment from 25Apr2022 till 30Apr2022. Patient's infection returned 6 days after completing the course of treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller states that on 29Apr2022, he tested positive for Covid; Caller states that on 29Apr2022, he tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262, Expiration Date: 31May2021), on 12Feb2021 as dose 2, single (Lot number: EN6201, Expiration Date: 30Jun2021) and on 29Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "skipped heartbeats" (unspecified if ongoing); "prostate" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for arrhythmia; GABAPENTIN; AVODART taken for prostate infection. Vaccination history included: Flu vaccine (AE(s) following prior vaccinations: Yes, in terms of the flu vaccine, they give him adverse reactions. His airways start shutting down and it is not very pleasant.), reaction(s): "His airways start shutting down".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "Caller states that on 29Apr2022, he tested positive for Covid". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results, notes: he has had blood tests but clarified there are no relevant details to provide; SARS-CoV-2 test: (09May2022) Positive; (29Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through close contact with another person who has the virus. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. Prior Vaccinations (within 4 weeks) was reported as no. AE(s) following prior vaccinations was reported as yes, in terms of the flu vaccine, they give him adverse reactions. His airways start shutting down and it is not very pleasant. Caller states that it was a few years ago. He had a reaction when he took the flu vaccine one year. He had trouble breathing and the next year he took it and ended up with the paramedics. Patient's Medical History (including any illness at time of vaccination) was reported as none. Family Medical History Relevant to AE(s): Not that he is aware of. His mother had cancer of the liver.