chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 62-year-old male patient received the 3rd dose (booster) of BNT162B2 (Comirnaty, batch/lot# FF8841), at the age of 61, in left arm, on Oct 7, 2021, single dose, for COVID-19 immunization. Vaccination history included the 2nd dose of BNT162B2 (Comirnaty, batch/lot# ER8730), in left arm, on Mar 31, 2021, and the 1st dose of BNT162B2 (Comirnaty, batch/lot# EN6203), in left arm, on Mar 10, 2021; both single dose, for COVID-19 immunization. No  medical history. Concomitant medications not reported. The patient experienced vaccination failure (medically significant) and COVID-19/COVID-19 treatment (medically significant), with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul 2022) positive, notes: Still tested positive 5 days after last dose. Therapeutic measures were taken as a result of vaccination failure and COVID-19. Clinical course: Antiviral drug Paxlovid given from Jul 6, 2022 to Jul 10, 2022.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "pulmonary emboli" (unspecified if ongoing); "obesity" (unspecified if ongoing); "herniated discs cervical and thoracic" (unspecified if ongoing). Concomitant medication(s) included: CLONIDINE; ELIQUIS; METOPROLOL; SPIRONOLACTONE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LOSARTAN; HYDROCHLOROTHIAZIDE; PREVACID; TYLENOL; SYMBICORT. Past drug history included: Ativan, reaction(s): "Known allergies: Ativan", notes: Known allergies: Ativan.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, 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: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with Paxlovid for COVID-19 (Treatment start date: 08Jul2022 Treatment stop date: 13Jul2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 06Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ5683) at the age of 77 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: "DJD" (unspecified if ongoing); "HBP" (unspecified if ongoing); "Reflux" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Past drug history included: Daypro, reaction(s): "Allergy"; Voltaren, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Jul2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Positive, Rapid Covid test on 13Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Recurrence of symptoms 5 days after finishing five days of Paxlovid (sinus, congestion, cough sneezing) Positive Rapid Covid test on 13Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Immunisation, Off label use, Product use issue
Clinical narrative: have administered second booster dose of the Pfizer  COVID vaccine (Gray cap) to a 15 years old female that was not eligible to get it.; have administered second booster dose of the Pfizer  COVID vaccine (Gray cap) to a 15 years old female that was not eligible to get it.; have administered second booster dose of the Pfizer  COVID vaccine (Gray cap) to a 15 years old female that was not eligible to get it.; Asthma; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (2nd booster), single (Batch/Lot number: unknown) at the age of 15 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (1st BOOSTER); Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), PRODUCT USE ISSUE (non-serious) and all described as "have administered second booster dose of the Pfizer  COVID vaccine (Gray cap) to a 15 years old female that was not eligible to get it."; ASTHMA (non-serious).  Additional information: It was reported that she had Asthma but not immunocompromised. She was fully immunized and 2nd booster dose was not needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: Rheumatoid arthritis flareup after 2nd and 3rd doses. Flareups keep getting worse causing me to start Orencia from an unspecified date to 02Jul2022; Flareups keep getting worse causing me to start Orencia from an unspecified date to 02Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 08:15 as dose 2, single (Lot number: EL8982) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Linear IGA Dermatosis" (unspecified if ongoing). Concomitant medication(s) included: DAPSONE; HYDROXYCHLOROQUINE. Past drug history included: Enbrel, reaction(s): "Known allegy: Enbrel". Vaccination history included: BNT162b2 (Vaccine administration time: 09:15 AM, Vaccine lot number: EL3247,, Vaccine lot unknown: False,, Vaccine dose number: 1, Vaccine dose number unknown: False, Vaccine location: Left arm), administration date: 19Jan2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Covid-19 Treatment", "Covid-19 Treatment". The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flareup after 2nd and 3rd doses. Flareups keep getting worse causing me to start Orencia from an unspecified date to 02Jul2022"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "Flareups keep getting worse causing me to start Orencia from an unspecified date to 02Jul2022". The patient underwent the following laboratory tests and procedures: Body temperature: (04Jul2022) 102, notes: tested positive 04Jul2022 with 102 fever; SARS-CoV-2 test: (04Jul2022) Positive, notes: tested positive 04Jul2022 with 102 fever; (13Jul2022) Negative, notes: Tested Covid negative on antigen test 13Jul2022; (14Jul2022) Positive, notes: tested positive on antigen test 14Jul2022. Therapeutic measures were taken as a result of rheumatoid arthritis, condition aggravated.  Clinical course: The patient received other medication within 2 weeks of vaccination. The patient received the Anti-viral drug (Plaxovid) as COVID 19 treatment from 05Jul2022 to 10Jul2022. Rheumatoid arthritis flareup after 2nd and 3rd doses. Flareups keep getting worse causing patient to start Orencia. COVID symptoms began 03Jul2022 and tested positive 04Jul2022 with 102 fever. Tested COVID negative on antigen test 13Jul2022. Respiratory symptoms began evening of 13Jul2022 and tested positive on antigen test 14Jul2022.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966412 Same patient and event, different dose;US-PFIZER INC-202200960651 Same product, patient, different AEs, different dose;
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2022 as dose 4 (booster), single (Lot number: FF2587) at the age of 58 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 on 14Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "latex" (unspecified if ongoing); "sulfa" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ESTRACE; HUMIRA; HYDROXYCHLOROQUINE; METHOTREXATE. Past drug history included: Sodium thiosulfate, reaction(s): "known allergies: sodium thiosulfate". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Positive; (06Jul2022) Negative; (13Jul2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Adverse event: Rebound COVID infection. tested positive 01Jul, negative by antigen test 06Jul, rebound symptoms 13Jul with positive antigen test that day.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flareup after 2nd and 3rd doses; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 23:15 as dose 3 (booster), single (Lot number: FJ8757) at the age of 70 years, in left arm for covid-19 immunisation. Patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "linear IGA dermatosis" (unspecified if ongoing). Concomitant medications included: DAPSONE; HYDROXYCHLOROQUINE. Past drug history included: Enbrel, reaction: "Known allergies: Enbrel". Vaccination history included: BNT162b2 (Dose: 1, Administration time: 09:15 AM, Lot number: EL3247, Vaccine location: Left arm), administration date: 19Jan2021, when the patient was 69-year-old, for Covid-19 immunization, reaction: "COVID 19 Treatment"; BNT162b2 (Dose: 2, Administration time: 08:15 AM, Lot number: EL8982, Vaccine location: Left arm), administration date: 09Feb2021, when the patient was 69-year-old, for Covid-19 immunization, reactions: "Rheumatoid arthritis flareup", "COVID 19 Treatment". It was reported that rheumatoid arthritis flared up after 2nd and 3rd doses. Flareups keep getting worse causing patient to start abatacept (ORENCIA) from an unspecified date to 02Jul2022. Outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966407 same patient and event, different dose;US-PFIZER INC-202200960651 same patient, different AEs, different dose;
Age: 39.0
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 40-year-old male patient received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RISPERIDONE, start date: 01Jun2019; BABY ASPIRIN; ZYRTEC ALLERGY; FLONASE ALLERGY RELIEF; MELATONIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient was given antiviral drug Paxlovid from 07Jul2022 to 11Jul2022 as a treatment for Covid-19. It was reported that the patient does not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: DEXILANT; FINASTERIDE; SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (unspecified date) Negative; (13Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: patient received other medication in 2weeks. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 06Jul2022, Treatment stop date: 11Jul2022, Indication: Treatment of COVID-19. AE: had a rebound in symptoms and tested positive again after testing negative for a period of time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6202), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 30Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CARDIAC PATIENT" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 01Jul2022; ZETIA, start date: 01Jul2022; METFORMIN, start date: 01Jul2022; ASPIRIN (E.C.), start date: 01Jul2022; ROSUVASTATIN, start date: 01Jul2022, stop date: 04Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid test positive; (Jul2022) Negative, notes: Paxlovid 5 days, then Covid negative; (Jul2022) Positive, notes: Symptoms returned 3 days later Covid tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid treatment from 05Jul2022 to 09Jul2022 for covid-19. Covid symptoms sore throat, cough, mucous in throat build up, covid test positive. Paxlovid 5 days, then covid negative, symptoms returned 3 days later covid tested positive. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
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 a contactable reporter(s) (Physician).  A 61-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENICAR; AMLODIPINE; PHENERGAN [PROMETHAZINE]; BACTRIM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 treatment of oral paxlovid from 04Jul2022 till 09Jul2022 (Lot number=1111111111). Symptoms recurred 4 days after finishing course. Known allergies and other medical history reported as no.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 27Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT, start date: Jan2018, stop date: 15Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: newly positive with return of symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: No known allergies. The patient received Paxlovid from 04Jul2022 to 08Jul2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Patient had an anaphylactic reaction to the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE:1, Unknown manufactured), for covid-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Patient had an anaphylactic reaction to the second dose". Clinical course: Patient had an anaphylactic reaction to the second dose. When we try to order rituximab, an interaction appeared between an inactive ingredient in the Pfizer vaccine and rituximab. We would like some support or insight on what it can possibly be.  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: Feeling abnormal
Clinical narrative: brain fog; 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 female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLINTSTONES. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog".  Additional information: Stated she wanted to know if it was okay to get the 2nd booster if she had somewhat of a reaction to third dose, she was scared to get 4th dose. The caller clarified she wanted to know what her options are, not so much if she can take it. She stated she would have taken the 2nd booster if it was not for the reaction she had.  She wanted someone to give her half a shot. She wanted to know if she would be able to take a smaller dose or a children's dose?  She stated she was not ill and was very healthy. She only takes flintstone vitamins and was extremely active. She does not want brain fog again. She did notice when she was reading with Pfizer and Moderna no one lists brain fog as a symptom, there was nothing about that. She stated, "I do not fall in same category as someone that is 200-300 pounds, or someone with a lot of medical issues, so I do not know why I am getting the same dose as them." She wants to be able to take a smaller dose. The caller wanted to know what the dosage was of the booster dose and whether all the doses of the Pfizer vaccine are the same. The caller stated she believes Moderna booster was a half dose, but is 0.5. However, she was not sure what units they are measuring in.  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: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications, also reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Unknown results, notes: Covid Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 03Jul2022 for COVID 19 Treatment and stopped on 08Jul2022. Clinical course was reported as, patient had Covid rebound started in Jul2022. and no treatment received for Covid rebound.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old male patient received BNT162b2 (BNT162B2, Vaccine brand unknown, vaccine lot unknown: False), on 11Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FMO698) at the age of 56 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 had no relevant medical history. Known allergies: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022 at 13:30, outcome "not recovered" and all described as "COVID-19". Report about COVID treatment: Yes. If vaccine received: Yes. Other medication in 2weeks: Unknown. Anti viral details: product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 01Jul2022, Treatment stop date: 05Jul2022.Adverse event: Tested negative on 08Jul2022 and then positive again for Covid-19 again on 14Jul2022. Adverse event start date: 14Jul2022, 01:30 PM. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Report about COVID treatment: Yes; (08Jul2022) Negative, notes: Tested negative on 08Jul2022; (14Jul2022) Positive, notes: then positive again for Covid-19 again on 14Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Both my husband and I took Paxlovid. This is our first case of Covid; (2022) Positive, notes: first positive test; (Jul2022) Negative, notes: day 5; (Jul2022) Negative, notes: day 7; (Jul2022) Positive, notes: day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: COVID 19 Treatment with Paxlovid from 06Jul2022 to 11Jul2022.  Adverse event: Both patient husband and she took Paxlovid. This was their first case of Covid. They had both experience Covid rebound. They improved after 5 days of isolation, got sick again on the 10th day after symptoms/first positive test, and have tested positive again. Her husband never tested negative, but she tested negative for Covid by home test on day 5 and 7 after first positive test, and she was feeling very well. Day 9 she started feeling like she was getting a cold, and day 10 she have tested positive again on home test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19 positive; Covid 19 positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EL19266), on 10Mar2021 as dose 2, single (Lot number: EN6206) and on 27Oct2021 as dose 3 (booster), single (Lot number: EH8020) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "not recovered" and all described as "Covid 19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was reported as no. If other vaccine in four weeks was reported as no. If COVID prior vaccination was reported as no. If COVID tested post vaccination was reported as yes. If treatment AE was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN6203) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications. No other medication in 2weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Anti-viral details product COVID 19 Treatment, brand Pavlovid, treatment start date 06Jul2022, treatment stop date 10Jul2022.
Age: 33.0
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) (Nurse).  A 33-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in left arm and on 21Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) positive, notes: tested positive for COVID on antigen testing today; (06Jul2022) positive, notes: tested positive for COVID-19 on 06Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Treated with Paxlovid orally Treatment start date: 05Jul2022 and Treatment stop date: 10Jul2022. The reporter stated that patient became symptomatic and tested positive for COVID-19 on 06Jul2022, and was prescribed Paxlovid. He took his first dose that evening, and completed the course. He noticed quick and profound symptom improvement. Today, he felt sudden return of COVID symptoms (sinus pain, pressure, headache, fatigue) and tested positive for COVID on antigen testing today. This appears to be an instance of COVID rebound post Paxlovid therapy. The patient received no other medication in 2 weeks.; 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: M
Vaccine: COVID19
Symptoms: Antibody test, Magnetic resonance imaging head, Myasthenia gravis, Nerve stimulation test, Serology test
Clinical narrative: Immune Mediated Bulbar Myasthenia Gravis; This is a literature report.  A 32-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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization, reaction(s): "Immune Mediated Bulbar Myasthenia Gravis". The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant), outcome "recovering", described as "Immune Mediated Bulbar Myasthenia Gravis". The patient underwent the following laboratory tests and procedures: Antibody test: non-reactive; without explanatory pathological findings; Magnetic resonance imaging head: without explanatory pathological findings; without explanatory pathological findings; Nerve stimulation test: decrement in facial nerve-nasalis CMAPs with low f, notes: repetitive stimulation, consistent with a post-synaptic neuromuscular disorder; post-exercise and, notes: repetitive stimulation-induced decrements in median-abductor policus brevis and spinal accessory trapezius CMAPs, confirming a systemic post-synaptic neuromuscular disorder; Serology test: non-reactive; without explanatory pathological findings; AChR binding and blocking antibodies were, notes: ultimately detected. Therapeutic measures were taken as a result of myasthenia gravis.  No follow up attempts are needed. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event myasthenia gravis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200023773 Same article/ drug/patient and different event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis, SARS-CoV-2 test, Sjogren's syndrome, Thrombosis
Clinical narrative: blood clots; Sjogren's syndrome; rheumatoid arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular, Primary immunization series completed but manufacture unknown.), administration date: Apr2021, for COVID-19 Immunization; Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular, Primary immunization series completed but manufacture unknown.), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: SJOGREN'S SYNDROME (hospitalization, medically significant) with onset Mar2022, outcome "recovering"; THROMBOSIS (hospitalization, medically significant) with onset Mar2022, outcome "recovering", described as "blood clots"; RHEUMATOID ARTHRITIS (hospitalization, medically significant) with onset Mar2022, outcome "recovering". The events "blood clots", "sjogren's syndrome" and "rheumatoid arthritis" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive; Thrombosis: (Mar2022) lupus markers, notes: March and Apr2022 timeframe-labs showed evidence of lupus markers. Therapeutic measures were taken as a result of thrombosis, sjogren's syndrome, rheumatoid arthritis.  Additional information: Mar2022, 68 y/o female patient developed blood clots. Patient was hospitalized twice, first time Apr2022 and second time May2022. March and Apr2022 timeframe-labs showed evidence of lupus markers. Per patient's son, pt was given dx of Sjogren's adverse event patient's son, pt was given dx of Sjogren's syndrome and rheumatoid arthritis by her treating physician. Per patient's son-pt was initiated on 10,000 units of vitamin D3 qweek, methotrexate, hydroxychloroquine, and prednisone. On 15Jul2022 patient's son reported that pt had tested positive for COVID. Patient received treatment for ae. Patient had covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: blood clots; Sjogren's syndrome; rheumatoid arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular, Primary immunization series completed but manufacture unknown.), administration date: Apr2021, for COVID-19 Immunization; Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular, Primary immunization series completed but manufacture unknown.), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: SJOGREN'S SYNDROME (hospitalization, medically significant) with onset Mar2022, outcome "recovering"; THROMBOSIS (hospitalization, medically significant) with onset Mar2022, outcome "recovering", described as "blood clots"; RHEUMATOID ARTHRITIS (hospitalization, medically significant) with onset Mar2022, outcome "recovering". The events "blood clots", "sjogren's syndrome" and "rheumatoid arthritis" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive; Thrombosis: (Mar2022) lupus markers, notes: March and Apr2022 timeframe-labs showed evidence of lupus markers. Therapeutic measures were taken as a result of thrombosis, sjogren's syndrome, rheumatoid arthritis.  Additional information: Mar2022, 68 y/o female patient developed blood clots. Patient was hospitalized twice, first time Apr2022 and second time May2022. March and Apr2022 timeframe-labs showed evidence of lupus markers. Per patient's son, pt was given dx of Sjogren's adverse event patient's son, pt was given dx of Sjogren's syndrome and rheumatoid arthritis by her treating physician. Per patient's son-pt was initiated on 10,000 units of vitamin D3 qweek, methotrexate, hydroxychloroquine, and prednisone. On 15Jul2022 patient's son reported that pt had tested positive for COVID. Patient received treatment for ae. Patient had covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis, SARS-CoV-2 test, Sjogren's syndrome, Thrombosis
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: In Mar2022, patient developed blood clots. Patient was hospitalized twice, first time in Apr2022 and second time in May2022. March and Apr2022 timeframe-labs showed evidence of lupus markers. Per patient's son, pt was given dx of Sjogren's adverse event patient's son, pt was given dx of Sjogren's syndrome and rheumatoid arthritis by her treating physician. Per patient's son-pt was initiated on 10,000 units of vitamin D3 qweek, methotrexate, hydroxychloroquine, and prednisone. It was unknown if patient received other vaccine in four weeks. On 15Jul2022 patient's son reported that pt had tested positive for COVID. It was unknown if patient had covid prior vaccination. It was reported that patient tested for covid post vaccination on 15Jul2022 and result as Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: In Mar2022, patient developed blood clots. Patient was hospitalized twice, first time in Apr2022 and second time in May2022. March and Apr2022 timeframe-labs showed evidence of lupus markers. Per patient's son, pt was given dx of Sjogren's adverse event patient's son, pt was given dx of Sjogren's syndrome and rheumatoid arthritis by her treating physician. Per patient's son-pt was initiated on 10,000 units of vitamin D3 qweek, methotrexate, hydroxychloroquine, and prednisone. It was unknown if patient received other vaccine in four weeks. On 15Jul2022 patient's son reported that pt had tested positive for COVID. It was unknown if patient had covid prior vaccination. It was reported that patient tested for covid post vaccination on 15Jul2022 and result as Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.