chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: the product expired last night at 10:32pm and the patient received a dose at 9:22am. Product was diluted and had went past the dilution expiration; the product expired last night at 10:32pm and the patient received a dose at 9:22am. Product was diluted and had went past the dilution expiration; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID: (RA).  A 15-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Lot number: GK0928, Expiration Date: 31Aug2024) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; SINGULAIR. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "the product expired last night at 10:32pm and the patient received a dose at 9:22am. Product was diluted and had went past the dilution expiration".  Additional information: Transferring agent stated, "I have an adverse event to report, I have a caller on the phone that needs to report an adverse event. She is a Licensed practical nurse. The product is the Pfizer BioNTech COVID-19 Vaccine Bivalent for 12 years and older. So, the product was diluted at 10:32 AM yesterday, stored in a refrigerator and would have expired last night at 10:32 PM however a patient was given a dose of that product this morning at 9:22 AM today."
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer - Dose Number: 5; Moderna - Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 07May2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 030L20A), in left arm, on 26Feb2021 as dose 2, single (Lot number: 031M20A), on 31Oct2021 as dose 3 (booster), single (Lot number: 076CYA), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Basel cell cancers" (unspecified if ongoing); "overactive bladder" (unspecified if ongoing); "constipation" (unspecified if ongoing); "Known allergies: Adhesive on tape" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ, start date: 22Dec2022. Past drug history included: Declomycin, reaction(s): "Known allergies: declomycin"; Bacitracin, reaction(s): "Known allergies: bacitracin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "not recovered", described as "Pfizer - Dose Number: 5; Moderna - Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid treatment from 14Aug2023 to 18Aug2023.  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 product to the reported event Drug ineffective and COVID 19 cannot be ruled out considering interchange of vaccine.
Age: 39.0
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 (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in left 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: "Celiac disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Hydronephrosis" (unspecified if ongoing); "Known allergies: grass allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin"; Known allergies: levaquin, reaction(s): "known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included nirmatrelvir; ritonavir (PAXLOVID) from 18Aug2023 to 22Aug2023.  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 available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Temporomandibular joint syndrome
Clinical narrative: Bilateral swelling and stiffness in hands, trigger finger in right hand; Bilateral swelling and stiffness in hands, trigger finger in right hand; TMJ pain; right arm pain from shoulder to wrist; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2022 at 08:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 17Aug2021, when the patient was 50-year-old, for COVID-19 Immunization, reaction(s): "Severe pain in Left knee"; BNT162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 07Sep2021, when the patient was 50-year-old, for COVID-19 Immunization, reaction(s): "Sudden severe pain in Left foot". The following information was reported: PERIPHERAL SWELLING (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered" and all described as "Bilateral swelling and stiffness in hands, trigger finger in right hand"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious), outcome "not recovered", described as "TMJ pain"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "right arm pain from shoulder to wrist". The events "bilateral swelling and stiffness in hands, trigger finger in right hand", "tmj pain" and "right arm pain from shoulder to wrist" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of peripheral swelling, musculoskeletal stiffness, temporomandibular joint syndrome, pain in extremity. Additional information: No COVID prior vaccination. No COVID tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300287304 same patient, different vaccine dose and different event.;US-PFIZER INC-202300287305 same patient, different vaccine dose and different event.;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sudden onset of severe pain in Left knee; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 17Aug2021 at 08:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 24Aug2021, outcome "not recovered", described as "Sudden onset of severe pain in Left knee". Therapeutic measures were not taken as a result of arthralgia.  Additional information: Patient did not have COVID prior vaccination and did not test for COVID post vaccination. Patient did not have any known allergy. It was also questioned if adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300287298 same patient, different vaccine dose and different event.;US-PFIZER INC-202300287305 same patient, different vaccine dose and different event.;US-PFIZER INC-202300287298 same patient, different vaccine dose and different event.;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sudden severe pain in Left foot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 07Sep2021 at 08:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing), notes: other medical history: Acid reflux. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: Not available/provided to reporter at the time of report completion,, Time of administration: 08:00 AM,, Anatomical location: Left arm), administration date: 17Aug2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "Severe pain in Left knee". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sudden severe pain in Left foot".  Additional information: It was reported that the patient did not take any other vaccines or medications in four weeks. The patient had sudden severe onset of severe pain in Left knee after the first vaccine. Sudden severe pain in Left foot after the second vaccine. The patient was not tested for COVID prior or post vaccination. Did not have any known allergy  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300287298 same patient, different vaccine dose and different event.;US-PFIZER INC-202300287304 same patient, different vaccine dose and different event.;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in right arm 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". 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 included Paxlovid from 17Aug2023 to 21Aug2023.  Clinical course: Covid Rebound 3 days after testing negative now positive. Different symptoms during rebound - more shortness of breath, cough and slight fever vs. prior was fever, headache, muscle aches and fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ2524) and on 05May2023 as dose 6 (booster), single (Lot number: GJ6743) at the age of 73 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: "Asthma" (unspecified if ongoing); "PVC (Premature Ventricular Contraction)" (unspecified if ongoing); "BPPV (Benign paroxysmal positional vertigo)" (unspecified if ongoing); "swollen ankles at time" (unspecified if ongoing); "Animals allergy" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy"; Sudafedrine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive. The patient received treatment of Paxlovid for COVID-19 from 16Aug2023 to 20Aug2023.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288043 Same patient/different product, different dose/event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had COVID twice/Caller also added: I've got my whole battery of COVID vaccinations with Pfizer.; had COVID twice/Caller also added: I've got my whole battery of COVID vaccinations with Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team and product quality group. The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "congenital absence of 100% IgA" (unspecified if ongoing); "IgG monoclonal gammopathy." (unspecified if ongoing); "Acute pulmonary infection" (unspecified if ongoing); "productive cough" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: had COVID twice. The patient's concomitant medications were not reported. Vaccination history included: Flu shot, for Influenza immunisation; Pneumonia vaccine, for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "had COVID twice/Caller also added: I've got my whole battery of COVID vaccinations with Pfizer." Clinical course: Patient had a history of had trained as a Craniofacial Surgeon. Patient had a congenital absence of 100% IgA and also had an IgG monoclonal gammopathy. Patient came across about a concern how the mRNA COVID vaccine had been developed and the question arose is to whether or not the mRNA that is being used is actually a modified RNA and is specifically modified M6A site and if it's in fact a modified RNA does this pose any potential risk to the patient recipients to the stability of their DNA and does it pose risk a potential neurodegenerative process in particular. Because of immune history, patient got at least a half dozen times year an acute pulmonary infection, with a productive cough, often wind up with antibiotics, patient had COVID twice, the most recent episode in Aug2022 despite being fully vaccinated and being very cautious and masking constantly, had a very nasty episode of COVID with bloody cough, you know, hemoptysis, so got an annual flu shot, and got every 5 years the pneumonia vaccine, do intend to receive an RSV vaccine (ABRYSVO) in September. HCP asked if Abrysvo had any advantage to the Respiratory Syncytial Virus Vaccine  manufactured by (other company name). HCP asked if Abrysvo an mRNA vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300288361 same reporter/patent,different doses/AE;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Epiglottitis, Haemoptysis, Myalgia, Pulmonary haemorrhage
Clinical narrative: had COVID twice/Caller also added: I've got my whole battery of COVID vaccinations with Pfizer.; had COVID twice/Caller also added: I've got my whole battery of COVID vaccinations with Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team and product quality group. The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "congenital absence of 100% IgA" (unspecified if ongoing); "IgG monoclonal gammopathy." (unspecified if ongoing); "Acute pulmonary infection" (unspecified if ongoing); "productive cough" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: had COVID twice. The patient's concomitant medications were not reported. Vaccination history included: Flu shot, for Influenza immunisation; Pneumonia vaccine, for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "had COVID twice/Caller also added: I've got my whole battery of COVID vaccinations with Pfizer." Clinical course: Patient had a history of had trained as a Craniofacial Surgeon. Patient had a congenital absence of 100% IgA and also had an IgG monoclonal gammopathy. Patient came across about a concern how the mRNA COVID vaccine had been developed and the question arose is to whether or not the mRNA that is being used is actually a modified RNA and is specifically modified M6A site and if it's in fact a modified RNA does this pose any potential risk to the patient recipients to the stability of their DNA and does it pose risk a potential neurodegenerative process in particular. Because of immune history, patient got at least a half dozen times year an acute pulmonary infection, with a productive cough, often wind up with antibiotics, patient had COVID twice, the most recent episode in Aug2022 despite being fully vaccinated and being very cautious and masking constantly, had a very nasty episode of COVID with bloody cough, you know, hemoptysis, so got an annual flu shot, and got every 5 years the pneumonia vaccine, do intend to receive an RSV vaccine (ABRYSVO) in September. HCP asked if Abrysvo had any advantage to the Respiratory Syncytial Virus Vaccine  manufactured by (other company name). HCP asked if Abrysvo an mRNA vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300288361 same reporter/patent,different doses/AE;
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 13Dec2021 as dose 3 (booster), single (Lot number: F5870T), in left arm and on 17May2022 as dose 4 (booster), single (Lot number: FH9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". 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 vaccination failure, covid-19. Patient was on treatment with Paxlovid from 21Aug2023 to 24Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288070 same patient, different drug, different event (Paxlovid case);
Age: 55.0
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: 4 / Pfizer BioNTech Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 04Apr2021 as dose 2, single (Lot number: ER863S), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm and on 02Oct2022 as dose 5 (booster), single (Lot number: AS7165B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022, outcome "unknown", described as "Moderna Dose Number: 4 / Pfizer BioNTech Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 19Aug2023 to 24Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288007 same patient, different drug, different event;US-PFIZER INC-202300288090 same patient/ product, different dose/ event;
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Moderna/ Dose #4: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 at 09:00 as dose 1, single (Lot number: EN5318), in left arm, on 21Mar2021 at 09:00 as dose 2, single (Lot number: EN6208), in left arm and on 27Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Dec2021 at 09:00 as dose 3 (booster), single (Lot number: 012H21B), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021 at 09:00, outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Moderna/ Dose #4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 20Aug2023 to 24Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288024 same reporter/ patient, different drug/ event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have COVID. I have done all the shots and boosters. I am coughing, runny nose. I am on paxlovid. Is this normal; I have COVID. I have done all the shots and boosters. I am coughing, runny nose. I am on paxlovid. Is this normal; 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 patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID. I have done all the shots and boosters. I am coughing, runny nose. I am on paxlovid. Is this normal". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid. Clinical course: Reporter had COVID. Reporter had done all the shots and boosters.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288281 Same patient, different drug/AE;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Sep2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 18Aug2023 to 23Aug2023 for COVID-19.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288121 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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) from product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jun2023 at 15:00 as dose number unknown, single (Lot number: GL0087), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "MGUS" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid treatment from 21Aug2023 to 26Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288164 same patient, different drug/event;
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 on at home test.; Tested positive for COVID-19 on at home test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 3-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jun2022 as dose 1 (maroon cap), single (Batch/Lot number: unknown), on 12Jul2022 as dose 2 (maroon cap), single (Batch/Lot number: unknown) and on 08Sep2022 as dose 3 (maroon cap), single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Aug2023, outcome "recovering" and all described as "Tested positive for COVID-19 on at home test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Course: The patient did not receive other vaccine in four weeks. Patient had no known allergies. Patient had no other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: pneumonia; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: high blood pressure From: 10 or 12 years ago; "COPD" (ongoing), notes: When turned 55 years old; "Asthma" (ongoing), notes: Ever since caller was in day school; "has never smoked" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "kidneys weren't functioning really great" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Date: 04Mar2021, NDC, lot, expiry: EN6206, Dose amount, route, anatomical location: In right shoulder, dose amount unknown, All 5 doses were administered at (name-withheld).), administration date: 04Mar2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Date: 25Mar2021, NDC, lot, expiry: ER8733, Dose amount, route, anatomical location: In right shoulder, dose amount unknown, All 5 doses were administered at (name-withheld).), administration date: 25Mar2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3, (BOOSTER) SINGLE, Date: 11Oct2021, NDC, lot, expiry: Hard to read the handwriting on vaccination card, looks like all numbers, 30155 or 301SS, or 3018A, not sure, Dose amount, route, anatomical location: In right shoulder, dose amount unknown, All 5 doses were administered at (name-withheld).), administration date: 11Oct2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4, (BOOSTER) SINGLE, Date: 31Mar2022, NDC, lot, expiry: FL809, then after the 9 it is either S or 5, Dose amount, route, anatomical location: In right shoulder, dose amount unknown, All 5 doses were administered at (name-withheld).), administration date: 31Mar2022, when the patient was 72-year-old, for Covid-19 immunization. The following information was reported: PNEUMONIA (medically significant) with onset 2022, outcome "unknown".  The patient reported he had pneumonia last year (2022). He also reported that he takes medicine for blood pressure that, no product name provided, takes a steroid inhaler, no specific product name provided, takes once a day every morning.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288412 same reporter/patinet/drug,different doses/AE;
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: high blood pressure From: 10 or 12 years ago; "COPD" (ongoing), notes: When turned 55 years old; "Asthma" (ongoing), notes: Ever since caller was in day school; "has never smoked" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "kidneys weren't functioning really great" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Date: 04Mar2021, NDC, lot, expiry: EN6206, Dose amount, route, anatomical location: In right shoulder, dose amount unknown, All 5 doses were administered at (name-withheld).), administration date: 04Mar2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Date: 25Mar2021, NDC, lot, expiry: ER8733, Dose amount, route, anatomical location: In right shoulder, dose amount unknown, All 5 doses were administered at (name-withheld).), administration date: 25Mar2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3, (BOOSTER) SINGLE, Date: 11Oct2021, NDC, lot, expiry: Hard to read the handwriting on vaccination card, looks like all numbers, 30155 or 301SS, or 3018A, not sure, Dose amount, route, anatomical location: In right shoulder, dose amount unknown, All 5 doses were administered at (name-withheld).), administration date: 11Oct2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4, (BOOSTER) SINGLE, Date: 31Mar2022, NDC, lot, expiry: FL809, then after the 9 it is either S or 5, Dose amount, route, anatomical location: In right shoulder, dose amount unknown, All 5 doses were administered at (name-withheld).), administration date: 31Mar2022, when the patient was 72-year-old, for Covid-19 immunization. The following information was reported: PNEUMONIA (medically significant) with onset 2022, outcome "unknown".  The patient reported he had pneumonia last year (2022). He also reported that he takes medicine for blood pressure that, no product name provided, takes a steroid inhaler, no specific product name provided, takes once a day every morning.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288412 same reporter/patinet/drug,different doses/AE;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jan2023 as dose 4 (booster), single (Lot number: GL0446) at the age of 40 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: EW0217), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "rosacea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Aug2023, outcome "not recovered" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2023) Positive; (24Aug2023) Negative; (27Aug2023) Positive; (29Aug2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient has no known allergies. The patient was tested positive for COVID on 16Aug2023, was given Paxlovid on 17Aug2023, finished course on 21Aug2023, tested negative on 24Aug2023 with no symptoms, 26Aug2023 started with symptoms again, tested positive on 27Aug2023 with continued symptoms still positive with symptoms as of today 29Aug2023.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1: Pfizer BioNTech, Dose 2: Pfizer BioNTech, Dose 3: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 28May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Connective tissues disorder" (unspecified if ongoing); "mast cell disorder" (unspecified if ongoing); "history of spontaneous cerebrospinal fluid leak" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Pots" (unspecified if ongoing); "tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fibrin glue, reaction(s): "Known allergies: Fibrin glue"; Paxlovid for COVID-19, reaction(s): "Paxlovid rebound". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022, outcome "not recovered", described as "Dose 1: Pfizer BioNTech, Dose 2: Pfizer BioNTech, Dose 3: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1: Pfizer BioNTech, Dose 2: Pfizer BioNTech, Dose 3: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 28May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Connective tissues disorder" (unspecified if ongoing); "mast cell disorder" (unspecified if ongoing); "history of spontaneous cerebrospinal fluid leak" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Pots" (unspecified if ongoing); "tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fibrin glue, reaction(s): "Known allergies: Fibrin glue"; Paxlovid for COVID-19, reaction(s): "Paxlovid rebound". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022, outcome "not recovered", described as "Dose 1: Pfizer BioNTech, Dose 2: Pfizer BioNTech, Dose 3: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 83-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 at 04:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Jan2021 at 04:15 as dose 2, single (Batch/Lot number: unknown), in left arm and on 21Sep2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm, on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 06Dec2022 at 09:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; 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: COVID-19 Rapid Antigen Test is Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received COVID-19 treatment with Paxlovid from 16Aug2023 to 21Aug2023 (lot number GF7316).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure, Covid -19, interchange of vaccine products  cannot be ruled out.
Age: 75.0
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) (Pharmacist).  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: 6H9694) at the age of 75 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: "osteoporosis" (unspecified if ongoing); "osteoarthritis" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Took COVID test which gave positive results; (19Aug2023) Positive, notes: COVID self-test positive on 19Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had COVID; had COVID; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), COVID-19 (hospitalization), outcome "not recovered" and all described as "had COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid). The patient had COVID and had all of her shots (Pfizer COVID-19 Vaccine), so it did not work for her at least may the final strand.  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 available information and temporal association the causal role of suspect product cannot be excluded for reported event Bacterial enteritis.Case will be reviewed on receipt of FU information.