chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Child who was given second dose of primary of 6 months to 5 years vaccine that was missed when it should have been pulled February 11, 2023, when it expired. It was given this morning by accident; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Child who was given second dose of primary of 6 months to 5 years vaccine that was missed when it should have been pulled February 11, 2023, when it expired. It was given this morning by accident) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Child who was given second dose of primary of 6 months to 5 years vaccine that was missed when it should have been pulled February 11, 2023, when it expired. It was given this morning by accident). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Child who was given second dose of primary of 6 months to 5 years vaccine that was missed when it should have been pulled February 11, 2023, when it expired. It was given this morning by accident) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Child who was given second dose of primary of 6 months to 5 years vaccine that was missed when it should have been pulled February 11, 2023, when it expired. It was given this morning by accident).    No concomitant information was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2023: Live follow up information received reporter details updated.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use
Clinical narrative: Potential revaccination with Bivalent vaccine as the first dose in the primary series; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Potential revaccination with Bivalent vaccine as the first dose in the primary series) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Bone marrow transplant.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Potential revaccination with Bivalent vaccine as the first dose in the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Potential revaccination with Bivalent vaccine as the first dose in the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for OFF LABEL USE (Potential revaccination with Bivalent vaccine as the first dose in the primary series).    The concomitant medication was not reported by reporter. It was reported that patient need of revaccination of primary series, potential revaccination with Bivalent vaccine as the first dose in the primary series. Patient who had a Bone Marrow Transplant and needed to restart the COVID vaccine series. Patient had not been able to find the monovalent vaccine locally and patient's doctor said she could repeat the series using the bivalent booster vaccine. The treatment medication was not reported by reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Drainage, Inappropriate schedule of product administration, Influenza like illness, Nasopharyngitis
Clinical narrative: has a cold; flu like symptoms; throat drainage; cough; Patient received dose 1 on 03-Mar-2021 and dose 2 on 21-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (has a cold), INFLUENZA LIKE ILLNESS (flu like symptoms), DRAINAGE (throat drainage), COUGH (cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 03-Mar-2021 and dose 2 on 21-Mar-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 058H21A, 021B21A and 024M20A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 03-Mar-2021 and dose 2 on 21-Mar-2021). On 26-Feb-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DRAINAGE (throat drainage) and COUGH (cough). On an unknown date, the patient experienced NASOPHARYNGITIS (has a cold). The patient was treated with CAFFEINE, CODEINE PHOSPHATE, DOXYLAMINE SUCCINATE, PARACETAMOL (SYNDOL [CAFFEINE;CODEINE PHOSPHATE;DOXYLAMINE SUCCINATE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (has a cold), INFLUENZA LIKE ILLNESS (flu like symptoms), DRAINAGE (throat drainage), COUGH (cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 03-Mar-2021 and dose 2 on 21-Mar-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had cold and had symptoms of throat drainage, cough, and flu like symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Wrong technique in device usage process
Clinical narrative: shivering; After the 4th shot the dose was given with a longer 23 needle than a 25 inch needle; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (shivering) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (After the 4th shot the dose was given with a longer 23 needle than a 25 inch needle) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A and 939909) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Nurse told the Agent that she has a history of a clotting disorder and that she does have a Cardiologist. Nurse did not want to provide any additional information about her Medical History. Nurse did not provide permission for Safety to follow up with her.  The patient's past medical history included Clotting disorder (she is consulting a cardiologist).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced CHILLS (shivering) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (After the 4th shot the dose was given with a longer 23 needle than a 25 inch needle). On 18-May-2022, CHILLS (shivering) had resolved. At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (After the 4th shot the dose was given with a longer 23 needle than a 25 inch needle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient did not have any adverse events after the first, second and third dose of vaccines. The patient feels that the deeper injection into her muscle may have contributed to her Adverse Reaction. It was reported that she had shivering for and a half hours after 4th dose. No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "M.S." (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", 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: (28Feb2023) Positive, notes: COVID 19 Treatment; (28Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, Body temperature increased, Fatigue, Pain, Pain in extremity
Clinical narrative: aches; soreness in the arm; a mild temperature of 99.2 degree F; fatigue; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Feb2023 as dose 4 (booster), single (Lot number: GL1990) 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; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the arm"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "a mild temperature of 99.2 degree F"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was asking which vaccine he received and if the vaccine with LOT GL1990 was the RNA vaccine, and said he thought it's stronger. Reporter stated Pfizer GL1990, all its written down is Pfizer, and it looks like GL1990, it could be CL1990 that's why he was calling he was wondering which vaccine is this." Reporter shared that this was his "third one", received on Saturday 25Feb2023. He is experiencing mild side effects, including aches, soreness in the arm, a mild temperature of 99.2degree F, and fatigue. The reporter said also that he has had two boosters and two regular doses of the Pfizer covid 19 vaccines. The reporter asked how long the side effects last.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 81 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid nodule" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Simvastatin, reaction(s): "known allergies Simvastatin", notes: known allergies Simvastatin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 [nirmatrelvir tablets (300mg) and 1 ritonavir tablet (100mg), oral, from 17Feb2023 to 22Feb2023].  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She did not have any bad reactions to the previous COVID-19 vaccines other than soreness; 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.  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tetanus toxoid (Caller mentioned she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid.), for immunisation, reaction(s): "Allergies". The following information was reported: PAIN (non-serious), outcome "unknown", described as "She did not have any bad reactions to the previous COVID-19 vaccines other than soreness".  Additional information: The female patient wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and how often elderly female patients experienced side effects. Caller mentioned that her doctor recommended her to get it. Caller mentioned she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid. She reacted before to Tetanus toxoid. There's other vaccines she cannot take because they contain the diphtheria toxoid. No other product names provided. She wanted to confirm if the vaccine is still being studied and under emergency use. Pfizer's 4th vaccine shot, the COVID-19 vaccine, the latest vaccine for the Omicron. She wanted to know what are the adverse. She was 82 years old and was leery of taking this vaccine. She worked as a medical secretary. She had a hard time hearing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300088187 same patient/event, different vaccine dose;US-PFIZER INC-202300088188 same patient/event, different vaccine dose;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Condition aggravated, Product administered at inappropriate site
Clinical narrative: developed a large lump in the right armpit; developed a large lump in the right armpit; After my second booster, I have noticed it has gotten larger; dose administration date=17Feb2023; dose vaccine location=Right leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Feb2023 at 13:00 as dose number unknown (booster), single (Lot number: GL0446) at the age of 61 years, in right leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First booster dose, COVID 19 Pfizer, lot number: FO7139, administration time: 01:00 PM, vaccine location: Right arm), administration date: 22Aug2022, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "have developed a large lump in the right armpit. first noticed it after my first booster."; Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 17Feb2023 at 13:00, outcome "unknown", described as "dose administration date=17Feb2023; dose vaccine location=Right leg"; AXILLARY MASS (non-serious), outcome "unknown", described as "developed a large lump in the right armpit"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "developed a large lump in the right armpit; After my second booster, I have noticed it has gotten larger".  Additional information: Patient was not pregnant at the time of vaccination.  Facility type vaccine was Doctor's office/urgent care. No other vaccine in four weeks. Patient developed a large lump in the right armpit. First noticed it after first booster, event started on 29Aug2022 02:30 PM (no treatment received and not recovered). After second booster, noticed it had gotten larger. No covid prior vaccination and covid not tested post vaccination. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300088529 Same patient, different drug and different event.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Dec2021 as dose 3 (booster), single (Lot number: FJ8757) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Thrombocytopenia" (unspecified if ongoing); "known allergies: mango" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Sep2018; THORNE, start date: Sep2022; NORDIC NATURALS DHA, start date: Sep2022. Past drug history included: Ceclor, reaction(s): "known allergies: Ceclor". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Negative, notes: negative test 4 days after final dose of Paxlovid; (Feb2023) Positive, notes: positive COVID-19 test 7 days after final dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 10:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 19Apr2021 at 16:45 as dose 1, single (Lot number: 032L20A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 022M20A), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 11May2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "Pacemaker for sick sinus syndrome due to undiagnosed and untreated Lyme disease." (unspecified if ongoing), notes: Pacemaker for sick sinus syndrome due to undiagnosed and untreated Lyme disease.; "sick sinus syndrome" (unspecified if ongoing), notes: Pacemaker for sick sinus syndrome due to undiagnosed and untreated Lyme disease.; "Lyme disease" (unspecified if ongoing), notes: Pacemaker for sick sinus syndrome due to undiagnosed and untreated Lyme disease.; "known allergies: wheat allergies" (unspecified if ongoing), notes: known allergies: wheat allergies; "Known allergies: nickel" (unspecified if ongoing), notes: Known allergies: nickel. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11May2022, outcome "unknown", described as "vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she did not have any bad reactions to the previous COVID-19 vaccines other than soreness; 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.  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tetanus toxoid (she had allergies before with the tetanus toxoid), reaction(s): "allergies"; Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "She did not have any bad reactions to the previous COVID-19 vaccines other than soreness". The following information was reported: PAIN (non-serious), outcome "unknown", described as "she did not have any bad reactions to the previous COVID-19 vaccines other than soreness". Additional information: Female patient wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and how often elderly female patients experienced side effects. Caller mentioned that her doctor recommended her to get it. Caller mentioned she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid. Caller stated that she did not have any bad reactions to the previous COVID-19 vaccines other than soreness. Caller also wanted to confirm if the vaccine was still being studied and under emergency use. Caller wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and if it contained any tetanus toxoid or diphtheria toxoid. Reason for no lot number: of COVID-19 Vaccine: Caller unwilling to complete the report. Product: Pfizer's 4th vaccine shot, the COVID-19 vaccine, the latest vaccine for the Omicron. She wanted to know what were the adverse effects? She was 82-years-old and is leery of taking this vaccine. She reacted before to Tetanus toxoid. There were other vaccines she cannot take because they contain the diphtheria toxoid. No other product names provided. Asked if the COVID-19 Vaccine had diphtheria toxoid in there and what were the expected side effects in the elderly and how often was that happening. Patient worked as a medical secretary. Asked Pfizer to please not sell her phone number. She had a hard time hearing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300087801 same patient/event, different vaccine dose;
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 11Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient received Paxlovid from 18Feb2023 to 22Feb2023 as treatment of COVID-19. The patient has no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (batch/lot number: GL0448) at the age of 58 years for covid-19 immunization; BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (batch/lot number: FJ4991) for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "chronic migraine" (unspecified if ongoing); "GERD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). 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 "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment Paxlovid on 27Feb2023.
Age: 55.0
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 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 09:00 as dose 5 (booster), single (Lot number: C55343) at the age of 55 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 13:00 as dose 1, single (Lot number: EL9263), in right arm, on 11Feb2021 at 13:00 as dose 2, single (Lot number: EM9809), in right arm, on 04Oct2021 at 08:00 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 30Mar2022 at 09:00 as dose 4 (booster), single (Lot number: IK9896), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive on Day 4.  Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: developed a large lump in the right armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Aug2022 at 13:00 as dose number unknown (booster), single (Lot number: FO7139) at the age of 60 years, in right arm 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; unknown manufacturer), for COVID-19 immunization. The following information was reported: AXILLARY MASS (non-serious) with onset 29Aug2022 at 14:30, outcome "not recovered", described as "developed a large lump in the right armpit". Therapeutic measures were not taken as a result of axillary mass.  Additional information: The patient reported that she had developed a large lump in the right armpit. The patient first noticed it after her first booster. After the second booster, noticed it has gotten larger.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300087850 Same patient, different drug and different event.;
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: 01Jan2021; LEVOTHYROXINE, start date: 01Jan2003. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose number unknown (booster), single (Lot number: Gh9694) at the age of 65 years 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 included: "Dormant pancreatic cancer" (unspecified if ongoing); "mild diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eosinophilic oesophagitis" (unspecified if ongoing). 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Moderna, Date:16Apr2022 ; Pfizer / BioNTech, Date: 22Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 09:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Mar2021 at 16:00 as dose 1, single (Lot number: 001b01a), in left arm, on 18Apr2021 at 14:30 as dose 2, single (Lot number: 040a21a), in left arm, on 22Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 061e21A), in left arm and on 16Apr2022 at 12:30 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "I had stage 1 breast cancer 19 years ago, radiation but no chemo" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) in 2 weeks included: BACTRIM, start date: 07Feb2023, stop date: 11Feb2023; AZO URINARY PAIN RELIEF, start date: 07Feb2023, stop date: 07Feb2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022, outcome "unknown", described as "Moderna, Date:16Apr2022 ; Pfizer / BioNTech, Date: 22Sep2022"; DRUG INEFFECTIVE (medically significant) with onset 13Feb2023, outcome "not recovered", COVID-19 (medically significant) with onset 13Feb2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2023) Positive, notes: I tested positive for COVID on 13Feb2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 Treatment including Paxlovid from 14Feb2023 to 19Feb2023.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: other medical history: HTN; "prediabetes" (unspecified if ongoing), notes: other medical history: prediabetes; "A fib" (unspecified if ongoing), notes: other medical history: A fib; "BPH" (unspecified if ongoing), notes: other medical history: BPH. 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included anti viral Paxlovid COVID 19 Treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
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 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Fluoroquinolones, reaction(s): "Known allergies: Fluoroquinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative for two days; Positive, notes: I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used as treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 3/vaccine brand=Pfizer / BioNTech; 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 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: GH9699) at the age of 38 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Lot number: 067F21A), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6207), in left arm and on 07May2021 as dose 2, single (Lot number: EW0162), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Former smoker" (unspecified if ongoing); "known allergies: Allergic to lithium" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Nov2021, outcome "unknown", described as "Moderna Dose Number: 3/vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Negative, notes: symptom-free and tested negative for 3 days after finishing paxlovid,; (Feb2023) positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid treatment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID Virus. Sore throat, runny nose and having trouble taking deep breaths; COVID Virus. Sore throat, runny nose and having trouble taking deep breaths; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), COVID-19 (hospitalization) all with onset Mar2022, outcome "unknown" and all described as "Now she has it again on Saturday-COVID Virus. Sore throat, runny nose and having trouble taking deep breaths. She also confirmed that got all the Pfizer COVID vaccine injections. Got all 5 of them from Pfizer.". The patient was hospitalized for drug ineffective and COVID-19 (start date: 2022, discharge date: 2022, hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2022) positive. Therapeutic measures were taken as a result of drug ineffective and COVID-19 and PAXLOVID. Clinical information: At the end of Mar2022, she got the COVID virus and was in the hospital 5 days (in 2022). She again had sore throat, runny nose and having trouble taking deep breaths. She went in a supermarket instead of medical place (advised not to come if she had symptoms) and did the test there and it was positive. They called the doctor because they gave her medication for a cold and had to change it for the virus instead. She received PAXLOVID as treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.