chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Full blood count, Hepatic enzyme increased, Inflammatory marker test
Clinical narrative: liver enzymes are a little bit high/high liver enzymes; diarrhea; fatigue; stiffness; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM). The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Remicade, notes: we did have to increase the dose of your Remicade in the past. The following information was reported: HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "liver enzymes are a little bit high/high liver enzymes"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for methotrexate sodium was unknown.  Additional information: Age: 55-59 years. PT has high liver enzymes, diarrhea, fatigue, stiffness after receiving COVID vaccine, methotrexate. Um, now, we did have to increase the dose of your Remicade in the past. Um, I don't, uh, I mean, you're doing so well I'm not so sure it's worthwhile checking it. Your recent labs, your vitamin D looks great. Your blood counts look good. Your inflammatory markers are normal. Um, now your liver enzymes are a little bit high.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vitamin D
Clinical narrative: liver enzymes are a little bit high/high liver enzymes; diarrhea; fatigue; stiffness; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM). The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Remicade, notes: we did have to increase the dose of your Remicade in the past. The following information was reported: HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "liver enzymes are a little bit high/high liver enzymes"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for methotrexate sodium was unknown.  Additional information: Age: 55-59 years. PT has high liver enzymes, diarrhea, fatigue, stiffness after receiving COVID vaccine, methotrexate. Um, now, we did have to increase the dose of your Remicade in the past. Um, I don't, uh, I mean, you're doing so well I'm not so sure it's worthwhile checking it. Your recent labs, your vitamin D looks great. Your blood counts look good. Your inflammatory markers are normal. Um, now your liver enzymes are a little bit high.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 such as fever, cough, and feeling of tiredness. Rapid antigen test turned positive.; COVID-19 such as fever, cough, and feeling of tiredness. Rapid antigen test turned positive.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old male patient received BNT162b2 (COMIRNATY), in Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 such as fever, cough, and feeling of tiredness. Rapid antigen test turned positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rapid antigen test turned positive.  Clinical information: It was reported that on Friday, 03Jun, the patient reported as having developed symptoms of COVID-19 such as fever, cough, and feeling of tiredness. Rapid antigen test turned positive. He received 1st booster dose back in Dec 2021. Response: Please take note that out of the 4 reports that were submitted yesterday, only the 22 and 12 year old males are the only ones that the reporter was certain of the vaccination status, although the reporter does not know what manufacturer brand of COVID-19 vaccine they received.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 20Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 28Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FH8028) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lastacaft, reaction(s): "Known Allergy:Lastacaft". The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid 19 treatment".  Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical course: Started treatment Friday (03Jun2022) evening. Will finish Wednesday (07Jun2022) morning. Leaves metallic/tinny taste in the mouth. Woke up with severe headache Monday (06Jun2022) morning. Treatment taken includes ibuprofen.  Investigation report: The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8028, FF8841 and EN5318 the bulk formulated drug product. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Nervous system disorder
Clinical narrative: hospitalized for 3 weeks and was having neurological problem; having problems to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: NERVOUS SYSTEM DISORDER (hospitalization), outcome "unknown", described as "hospitalized for 3 weeks and was having neurological problem"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "having problems to walk". The patient was hospitalized for nervous system disorder (hospitalization duration: 21 day(s)).  Clinical course: 1 week after receiving the second dose, the patient was hospitalized for 3 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica, SARS-CoV-2 test
Clinical narrative: Polymyalgia rheumatica; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 at 12:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, other vaccine same date product= Pfizer,, other vaccine same date lot number= 5318,, other vaccine same date vaccine location= Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 2, other vaccine same date product=Pfizer,, other vaccine same date lot number= 6199,, other vaccine same date vaccine location= Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 3, other vaccine same date product= Pfizer,, other vaccine same date lot number= 3182,, other vaccine same date vaccine location=Right arm), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant) with onset 20Apr2022, outcome "recovering". The event "polymyalgia rheumatica" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Negative, notes: Nasal swab. Therapeutic measures were taken as a result of polymyalgia rheumatica.  Clinical Course: The patient did not receive any other vaccine in four weeks. No other medications received in two weeks. Prior vaccination, the patient not had covid vaccination. Post vaccination, the patient had tested for covid.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Batch/Lot number: unknown), on 15Mar2021 as dose 2, single (Batch/Lot number: unknown), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (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, notes: covid rebound on day 12 after initial covid symptoms / day 5 after completing paxlovid treatment; Unknown results, notes: covid rebound on day 12 after initial covid symptoms / day 5 after completing paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : The event covid rebound on day 12 after initial covid symptoms / day 5 after completing Paxlovid treatment with outcome as recovering. Anti viral details: The drug paxlovid started on 27May2022 and stopped on 01Jun2022 was taken for indication as treatment of COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EP7533), in right arm and on 01May2021 as dose 2, single (Lot number: ER8736) at the age of 47 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: 037F21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 26May2022, stop date: 08Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication: Covid-19 immunization; (04Jun2022) Negative; (08Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: the second COVID19 Side effects: similar to the first, pain in my right arm and fatigue; the second COVID19 Side effects: similar to the first, pain in my right arm and fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 01), administration date: 21Mar2021, for COVID-19 Immunization, reaction(s): "pain in my right arm"; BNT162b2 (DOSE: 01), administration date: 21Mar2021, for COVID-19 immunization, reaction(s): "Fatigue". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Mar2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "the second COVID19 Side effects: similar to the first, pain in my right arm and fatigue".  Clinical course: On the onset patient would like to express her appreciation for receiving her call last week. She had listed the schedule when her COVID19 vaccines were administered and side effects to give us an understanding of her personal experience. 21Mar2021 patient's first Pfizer Vaccine was given through the (withheld), the injection was administered in her right arm. Side effects: pain in my right arm and fatigue. 28Mar2021 Again through the (withheld), She received the second COVID19 Vaccine injection in her right arm. Side effects: similar to the first, pain in my right arm and fatigue. 28May2022 she was scheduled to take the second Pfizer COVID19 Booster injection, due to the onset of the Tinnitus, put it on temporary hold until she got more information. Currently, She was seeking medical attention to explore treatment options to address her Tinnitus.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: CETIRIZINE HCL; MAGNESIUM L-THREONATE. (Other medications in two weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive, notes: first tested positive for covid on 25May2022; (02Jun2022) Negative, notes: First tested negative on 02Jun2022; (05Jun2022) Negative, notes: tested negative again on 05Jun2022; (07Jun2022) Positive, notes: Tested positive again on 07Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course includes covid 19 rebound. She first tested positive for covid on 25May2022. First tested negative on 02Jun2022, tested negative again on 05Jun2022. Tested positive again on 07Jun2022. Am experiencing nasal congestion, sneezing, and very mild fatigue. The patient had anti-viral details includes COVID 19 treatment started from 26May202 to 31May2022, Lot number (GC0466)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound Covid 6 days after negative test, 4 days after completing the antiviral drug; Rebound Covid 6 days after negative test, 4 days after completing the antiviral drug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65 year old male patient received BNT162b2 (BNT162B2), on 25Mar2021 at 13:15 as dose 1, single (Lot number: ER8727), in left arm, on 15Apr2021 at 16:30 as dose 2, single (Lot number: EW0161), in right arm and on 26Oct2021 at 14:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 64 years, in right arm for covid-19 immunization. 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), outcome "unknown" and all described as "Rebound Covid 6 days after negative test, 4 days after completing the antiviral drug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient had no known allergies and no other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: he is immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient. A 31-year-old male 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: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "he is immunocompromised". Caller also asked if the second booster dose is available for the general population.  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
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result Positive; covid test result Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 13:00 as dose 1, single (Lot number: el3247), in right arm and on 02Apr2021 at 14:00 as dose 2, single (Lot number: er8732) at the age of 54 years, in right arm, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Mar2022 at 17:00 as dose 3 (booster), single (Lot number: 029h21b) intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; DAILY VITAMINS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "not recovered" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Negative, notes: Covid test type post vaccination: Nasal swab; (01Jun2022) Negative, notes: Covid test type post vaccination: Nasal swab; (08Jun2022) Positive, notes: Covid test type post vaccination: Nasal swab.  Clinical course: No covid prior vaccination. the patient had covid tested post vaccination. No other vaccine in four weeks. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have had 3 doses of the pfizer covid vaccine/ I started testing RAT positive again; I have had 3 doses of the pfizer covid vaccine/ I started testing RAT positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) 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 "not recovered" and all described as "I have had 3 doses of the pfizer covid vaccine/ I started testing RAT positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested PCR positive for COVID-19; Negative, notes: I started testing RAT negative; Positive, notes: My symptoms returned and I started testing RAT positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I was prescribed Paxlovid the day I tested PCR positive for COVID-19. My symptoms gradually improved and I started testing RAT negative. Three days later, my symptoms returned and I started testing RAT positive again. My doctor said to report this to Pfizer so that it would be counted. I didn't see anywhere else to report, so I am reporting it here. For context, I have had 3 doses of the Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Jan2020 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "HL" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: negative PCR test. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was under treatment for COVID-19 with Paxlovid from 29May2022 to 02Jun2022. Covid rebound occurred after completing five day paxlovid course and negative PCR test. He had minor symptoms of nasal congestion, headache and malaise.  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 and covid 19 cannot be ruled out.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication: Covid-19 immunization; (07Jun2022) Positive, notes: Tested positive for COVID19 with an at home rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Anti-viral details included product for COVID 19 Treatment (Brand: Pfizer), treatment start date was on 24May2022 and treatment stop date was on 29May2022. Tested positive for COVID19 with an at home rapid antigen test because I woke with a headache, stuffy nose and laryngitis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter consumer or other non HCP from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Lot number: Fg3527) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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 Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical information: Patient had no known allergies. The patient received COVID 19 Treatment paxlovid on 06Jun2022.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE, start date: 27May2022, stop date: 05Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (25May2022) positive; (08Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound Covid after Paxlovid 25May2022. Initial symptoms 24May2022 with positive test 25May2022.Pt had improved symptoms and negative test in between. Then followed by worsened symptoms and positive Covid PCR test 08Jun2022. Prescribed 2nd Paxlovid course.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Return of Covid symptoms and positive test; Unknown Results. 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: 67.0
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) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 14Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02Apr2022 at 15:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 27May2022 and stopped on 31May2022. Paxlovid rebound on 06Jun2022 at 05:00. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive test; positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number un-known, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Known allergies: No. Other medical history: No. Other medication in 2weeks: Yes. Concomitant medication(s) included: METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Anti-viral details: Product: Covid 19 Treatment Brand: Paxlovid, Treatment start date: 26May2022, Treatment Stop date: 01May2022 and 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive again for covid.; tested positive again for covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (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 "not recovered" and all described as "tested positive again for covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Unknown results, notes: COVID 19 Treatment; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 26May2022 to 30May2022. Clinical course: Paxlovid prescribed. tested negative after taking it for 5 days and isolating. symptoms were gone too. then 5 days: different symptoms (congestion, cold symptoms). She thought it was a cold but tested positive again for covid. was this a rebound effect from taking paxlovid same thing happened to her father.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 24Oct2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: fj9943) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts. Concomitant medication(s) included: PREDNISONE, start date: Mar2020, stop date: 31May2022; METOPROLOL, start date: Mar2018, stop date: Jun2022; VERAPAMIL, start date: 01Sep2019, stop date: 31May2022; HYDROCODONE, start date: Sep2014, stop date: 09Jun2022; REMICADE, start date: Mar2022, stop date: 09Jun2022. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Negative, notes: After testing negative for 3 Days; (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: After testing negative for 3 Days; (unspecified date) Negative, notes: After testing negative for 3 Days; (09Jun2022) Positive, notes: Rebound infection after testing negative for 3 Days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound infection after testing negative for 3 Days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The vaccine doesn't work/I still ended up with Covid; The vaccine doesn't work/I still ended up with Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2021 as dose 1, single (Lot number: FL3197), in left arm and on 07Jan2022 as dose 2, single (Lot number: 3013089) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: other medical history: No. There were no concomitant medications. No known allergies. No other vaccine in four weeks reported. No other medications in two weeks reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "recovered" and all described as "The vaccine doesn't work/I still ended up with Covid". The event "the vaccine doesn't work/i still ended up with covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.Patient took Mulnupiravir treatment for Covid 19.The vaccine did not work. She was not sure how the efficacy was proven in the clinical trials; however, she still ended up with Covid. After talking to her physician she felt it necessary to file a complaint of Ineffective drug because she mentioned all patients, she had seen with Covid had been vaccinated and boosted. Patient had Covid prior vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 31May2021 as dose 1, single (Lot number: EL9264), in left arm, on 30Jun2021 as dose 2, single (Lot number: EN6202), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Early COPD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Failure to empty bladder" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies Codeine", notes: known allergies Codeine. 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. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient also reported as after completion of Paxlovid treatment from 01Jun2022 to 05Jun2022 which was very successful, and after feeling fully recovered with no continuing symptoms other than lower energy level.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Each of us had a Covid infection with light to no symptoms; Each of us had a Covid infection with light to no symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 at 15:00 as dose 1, single (Lot number: En6199), in left arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: Er8734), in left arm and on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE]; NASONEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jan2022, outcome "unknown" and all described as "Each of us had a Covid infection with light to no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive, notes: Nasal Swab.  Clinical information: It was reported that the patient vaccinated at Health Clinic facility. No other vaccine in four weeks. No COVID prior vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828044 same product/event, different patient;US-PFIZER INC-202200828046 same product/event, different patient;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Each of us had a Covid infection with light to no symptoms; Each of us had a Covid infection with light to no symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 at 15:00 as dose 1, single (Lot number: En6199), in left arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: Er8734), in left arm and on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE]; NASONEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jan2022, outcome "unknown" and all described as "Each of us had a Covid infection with light to no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive, notes: Nasal Swab.  Clinical information: It was reported that the patient vaccinated at Health Clinic facility. No other vaccine in four weeks. No COVID prior vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828044 same product/event, different patient;US-PFIZER INC-202200828046 same product/event, different patient;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Each of us had a Covid infection with light to no symptoms; Each of us had a Covid infection with light to no symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 at 15:00 as dose 1, single (Lot number: En6199), in left arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: Er8734), in left arm and on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE]; NASONEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jan2022, outcome "unknown" and all described as "Each of us had a Covid infection with light to no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive, notes: Nasal Swab.  Clinical information: It was reported that the patient vaccinated at Health Clinic facility. No other vaccine in four weeks. No COVID prior vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828044 same product/event, different patient;US-PFIZER INC-202200828046 same product/event, different patient;