chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test
Clinical narrative: COVID-19; This spontaneous report received from a patient by a Business partner on 26-JAN-2024 was received on 26-JAN-2024 and concerned a 74 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) (dose series 1), start therapy date were not reported, and (dose series 2), start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and we are unable to perform follow up request for batch numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 (dose series 2). On 12-JAN-2024, it was reported that a patient started treatment on unreported dates ("when it came out") with 2 doses of Janssen COVID-19 vaccine for an unreported indication. It was reported that after vaccination, the patient got COVID-19 in MAY-2023. No additional details were provided. No further follow-up was anticipated. On MAY-2023, Laboratory data included: unspecified test: patient got COVID-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 was not reported. This report was non serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation reaction
Clinical narrative: Both people stated they had side effects; Administered dose of the prefilled syringe to patient last 30 Jan 2024 which was already beyond use date.; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (Both people stated they had side effects) and EXPIRED PRODUCT ADMINISTERED (Administered dose of the prefilled syringe to patient last 30 Jan 2024 which was already beyond use date.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030337) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 30-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose of the prefilled syringe to patient last 30 Jan 2024 which was already beyond use date.). On an unknown date, the patient experienced IMMUNISATION REACTION (Both people stated they had side effects). At the time of the report, IMMUNISATION REACTION (Both people stated they had side effects) and EXPIRED PRODUCT ADMINISTERED (Administered dose of the prefilled syringe to patient last 30 Jan 2024 which was already beyond use date.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Dosage text for suspect product was reported as unknown.  Nurse reported that they put some covid prefilled syringes in the refrigerator last 26 Dec 2023 and just realized on 07 Feb 2024 that they administered 2 doses of the prefilled syringe to 2 patients last 30 Jan 2024 which was already beyond use date. Nurse then asked if vaccines are still okay to use even after the Beyond Use Date (30 days).  It was reported that the patients who were administered an expired dose had maintained the activity necessary to elicit an immune response against the SARS-CoV-2 (COVID-19) virus at time of administration.  No treatment medication was provided.  This case contains information for the 2nd out of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-759802 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2024: Significant follow-up received: batch number added, new event immunisation reaction added, event no adverse event removed, inarrative updated and reference ids added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759802:Patient 1 case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation reaction
Clinical narrative: Both people stated they had side effects; administered dose of the prefilled syringe to patient last 30Jan2024 which was already beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (Both people stated they had side effects) and EXPIRED PRODUCT ADMINISTERED (administered dose of the prefilled syringe to patient last 30Jan2024 which was already beyond use date) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030337) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 30-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose of the prefilled syringe to patient last 30Jan2024 which was already beyond use date). On an unknown date, the patient experienced IMMUNISATION REACTION (Both people stated they had side effects). At the time of the report, IMMUNISATION REACTION (Both people stated they had side effects) and EXPIRED PRODUCT ADMINISTERED (administered dose of the prefilled syringe to patient last 30Jan2024 which was already beyond use date) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that they put some covid prefilled syringes in the refrigerator last 26-Dec-2023 and just realized on 07-Feb-2024 that they administered 2 doses of the prefilled syringe to 2 patients last 30-Jan-2024 which was already beyond use date.  It was reported that the patients who were administered an expired dose had maintained the activity necessary to elicit an immune response against the SARS-CoV-2 (COVID-19) virus at time of administration. No treatment medication was reported. This case is reported for patient 1 out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-759820 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2024: Significant follow-up received: batch number added, new event immunisation reaction added, event no adverse event removed, inarrative updated and reference ids added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759820:Patient 2
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: she still have the cold after her first dose of Moderna; covid 19; had cold before and then flu after the covid; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (had cold before and then flu after the covid), NASOPHARYNGITIS (she still have the cold after her first dose of Moderna) and COVID-19 (covid 19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 028L20A, 020F219 and 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2023, the patient experienced INFLUENZA (had cold before and then flu after the covid) and COVID-19 (covid 19). On an unknown date, the patient experienced NASOPHARYNGITIS (she still have the cold after her first dose of Moderna). At the time of the report, INFLUENZA (had cold before and then flu after the covid), NASOPHARYNGITIS (she still have the cold after her first dose of Moderna) and COVID-19 (covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient reported that after the second shot she had covid and with covid. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. On 3-September-2021 patient had Moderna Covid-19 vaccine and on mid-March -2022 patient had covid positive test. Patient felt so good with the second covid. Patient reported that she needed an infusion treatment for covid.   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2024: Live follow-up appended and reference number added. On 12-Feb-2024: Live follow-up appended and reference number added.
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Myasthenia gravis
Clinical narrative: Diagnosed with myasthenia gravis in September 2022
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4, PNC20, RSV
Symptoms: Feeling abnormal, Memory impairment
Clinical narrative: Patient felt "spaced out" the next day and can't recall details. Forgot to set alarm saturday night after vaccination because she plays an instrument at church on sundays and was late and didn't call anyone. Similar events happened two more times since date of vaccination. Patient claims husband and her were going to dinner and she just sat there and didn't do anything. Patient says she has had a stroke previously, unrelated to these vaccines.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient received injection on 2/12/24 to upper left thigh.  Pts mom reported on 2/14/24 that her left thigh area where she received the Infanrix (DTAP) vaccine was red and warm to the touch and she felt a knot under it.  The pt was diagnosed with an ear infection on 2/12/24 at the visit and prescribed amoxicillin.  Pts mom spoke w/ provider on 2/14/24 about the pt having the same reaction as her twin sister to her left upper thigh, the provider prescribed prednisolone to help with the adverse reaction and instructed to continue on the antibiotics.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Night sweats, Product administered to patient of inappropriate age
Clinical narrative: one night of night sweats; Inappropriate age at vaccine administration; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 28Dec2023 as dose 7 (booster), single (Lot number: HH7007) for covid-19 immunisation. The patient's relevant medical history included: "Kidney disorder", start date: 2009 (unspecified if ongoing); "Type 2 diabetes mellitus", start date: 1986 (unspecified if ongoing); "Lyme's disease" (unspecified if ongoing); "Obesity", start date: 1980 (unspecified if ongoing); "Blood pressure abnormal" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Sensation of pressure in eye" (unspecified if ongoing); "Cancer surgery" (unspecified if ongoing); "Clostridium difficile colitis" (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing); "Respiratory infection" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE; AMLODIPINE oral taken for blood pressure measurement; LEVOTHYROXINE oral taken for hypothyroidism; LATANOPROST. Vaccination history included: moderna (Dose 1, My first two shots were Moderna , Moderna 043220A 18Feb2021 withheld), administration date: 18Feb2021, for COVID-19 immunisation, reaction(s): "diarrhea", "Chills", "Pyrexia", "Pain in extremity"; moderna (Dose 2, My first two shots were Moderna , Moderna 001321A 18Mar2021), administration date: 18Mar2021; BNT162b2 (Dose: 3, Date: 04Nov2021, Time: Morning, Anatomical location: Shoulder, Route of administration: Intramuscular, Batch/lot number: FF2593), administration date: 04Nov2021, for COVID-19 immunisation, reaction(s): "Angina pectoris", "Neurological symptom", "Spinal pain", "Bacterial infection", "Arthralgia", "Neuralgia"; BNT162b2 (Dose: 4, Date: 15Jul2022, Anatomical location: Shoulder, Batch/lot number: FJ4991), administration date: 15Jul2022, for COVID-19 immunisation, reaction(s): "Angina pectoris", "Neurological symptom", "Spinal pain"; BNT162b2;BNT162b2 omi ba.4-5 (Dose: 5, Date: 11Oct2022, Anatomical location: Right Shoulder, Batch/lot number: GJ2524 BV (Bivalent)), administration date: 11Oct2022, for COVID-19 immunisation, reaction(s): "Angina pectoris", "Neurological symptom", "Spinal pain"; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE), administration date: 11Aug2023, for COVID-19 immunisation, reaction(s): "cardiac pain", "Interchange of vaccine products". The following information was reported: NIGHT SWEATS (non-serious), outcome "unknown", described as "one night of night sweats"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Inappropriate age at vaccine administration"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400000955 same patient, different event/vaccine dose;US-PFIZER INC-202400001841 same patient, different dose, different events;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Allergic cough, Drug hypersensitivity, Vaccination site erythema
Clinical narrative: Allergic reaction/Occurred with the 1st shot/coughing attack; Allergic reaction/Occurred with the 1st shot/coughing attack; injection in arm, did get red all over; This is a spontaneous report received from a Nurse.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8733) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sensitive" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), ALLERGIC COUGH (non-serious) all with onset 29Mar2021, outcome "recovered" (29Mar2021) and all described as "Allergic reaction/Occurred with the 1st shot/coughing attack"; VACCINATION SITE ERYTHEMA (non-serious) with onset 29Mar2021, outcome "unknown", described as "injection in arm, did get red all over". Therapeutic measures were taken as a result of drug hypersensitivity, allergic cough. Additional information: The first dose was administered on 29Mar2021, at probably about 1PM or 2PM, on the patient's left upper arm. The first dose was injected in the patient's arm, did get red all over, which the patient stated happens; she was very sensitive, so she was not surprised. The patient reported that the allergic reaction occurred with the 1st shot, like 15 minutes after, as she was just getting into her car. The patient had a coughing attack, coughed 5 minutes, took Benadryl and water then was good. It was reported as non-serious by the patient. The patient took Benadryl and the throat never closed. The patient thinks the allergic reaction was related to the vaccine stating, "Yes, thinks so, but can't prove it, feels that way". The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine, and the patient stated that she doesn't take flu, or shots, or any of that.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400037259 same patient/drug, different dose/event;US-PFIZER INC-202400037260 same patient/drug, different dose/event;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from a Nurse, Program ID.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: ER8729) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single Lot No.: ER8733, Time: Probably about 1PM or 2PM, Anatomical Site of injection: Left upper arm), administration date: 29Mar2021, when the patient was 69-year-old, for COVID-19 Immunisation, reaction(s): "Allergic reaction", "Coughing", "Did get red all over". The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "Hair loss". Therapeutic measures were not taken as a result of alopecia. Additional information: The patient noticed hair loss after 2nd injection, initially caller stated caller doesn't have vaccination card with caller to provide details, occurred so many weeks later, started on top of head, thought what could be going on. The patient has no prior vaccinations (within 4 weeks). The event did not require the initiation of new medication/other treatment/ procedure. Caller stated caller took care of herself.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400037249 same patient/drug, different dose/event;US-PFIZER INC-202400037260 same patient/drug, different dose, similar event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Condition aggravated
Clinical narrative: Hair loss; made worse; This is a spontaneous report received from a Nurse.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: 33130A8) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Anatomical Site of injection: Left upper arm, lot: ER8733), administration date: 29Mar2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Coughing", "Coughing", "did get red all over"; BNT162b2 (Dose 2, single, Anatomical Site of injection: Right upper arm, lot: ER8729), administration date: 19Apr2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Hair loss". The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Hair loss"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "made worse". Additional information: Patient then had 3rd injection, which caller stated was stupid, shouldn't have done it, made worse. Comes and goes, now is really bad, has never been the same.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400037249 same patient/drug, different dose/event;US-PFIZER INC-202400037259 same patient/drug, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: cold sores have decreased in frequency; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "cold sores" (unspecified if ongoing); "latex allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "cold sores have decreased in frequency". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Nov2022, outcome "recovered", described as "cold sores have decreased in frequency".  Additional information: Positive event is more accurate. Ever since, patient have started receiving the Covid Vaccine from Pfizer, her cold sores have decreased in frequency. There was a 1-1.5 year gap between her 3rd and 4th doses, where her cold sores returned. After her 4th dose, she has not had another.  Prior to vaccination, she was not diagnosed with COVID-19.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400041188 Same patient, same drug, different event, different dose;US-PFIZER INC-202400037387 Same patient, same drug, different event, different dose;US-PFIZER INC-202400037377 Same patient, same drug, different event, different dose;
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Oral herpes
Clinical narrative: cold sores returned; cold sores returned; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in 2022 as dose 3 (booster), single (Lot number: Unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; XULANE. The following information was reported: ORAL HERPES (non-serious), DISEASE RECURRENCE (non-serious) all with onset Nov2022, outcome "recovered" and all described as "cold sores returned". Therapeutic measures were not taken as a result of oral herpes, disease recurrence. Additional information: Positive event is more accurate. Ever since I have started receiving the Covid Vaccine from Pfizer, my cold sores have decreased in frequency. There was a 1-1.5 year gap between my 3rd and 4th doses, where my cold sores returned. After my 4th dose, I have not had another. Not diagnosed with COVID prior to vaccination.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Positive event / cold sores have decreased in frequency / After her 4th dose, she has not had another; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Lot number: Unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "Latex Allergy" (unspecified if ongoing); "cold sores" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; XULANE. Vaccination history included: Pfizer covid-19 vaccine (Dose 1, single), for COVID-19 Immunisation, reaction(s): "Positive event / cold sores have decreased in frequency"; Pfizer covid-19 vaccine (Dose 2, single), for COVID-19 Immunisation, reaction(s): "Positive event / cold sores have decreased in frequency"; Pfizer covid-19 vaccine (Dose 3 (booster), single), for COVID-19 Immunisation, reaction(s): "Positive event / cold sores have decreased in frequency". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Positive event / cold sores have decreased in frequency / After her 4th dose, she has not had another". Therapeutic measures were not taken as a result of therapeutic response unexpected. Additional information: Positive event was more accurate. Ever since patient have started receiving the Covid Vaccine from Pfizer, her cold sores have decreased in frequency. There was a 1-1.5 year gap between her 3rd and 4th doses, where her cold sores returned. After her 4th dose, she has not had another. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400037264 Same patient, same drug, different event, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: cold sores have decreased in frequency; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "cold sores" (unspecified if ongoing); "latex allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "cold sores have decreased in frequency".  Additional information: Positive event is more accurate. Ever since, patient have started receiving the Covid Vaccine from Pfizer, her cold sores have decreased in frequency. There was a 1-1.5 year gap between her 3rd and 4th doses, where her cold sores returned. After her 4th dose, she has not had another.  Prior to vaccination, she was not diagnosed with COVID-19.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400037264 Same patient, same drug, different event, different dose;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted Covid; contracted Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HH7595) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "keep cholesterol in check" (unspecified if ongoing), notes: keep cholesterol in check; "Type 2 diabetic without complications" (unspecified if ongoing), notes: w/o complications Not being treated w/ medication, is controlled w/ exercise and diet. Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal (ongoing); ROSUVASTATIN taken for blood cholesterol (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: EL92109, left arm), administration date: 06Feb2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, LOT: First provides as CN6207 then, states, it looks more like EN6207 or EN6202 Can't read it, writing is terrible., NDC, EXP: Unknown), administration date: 01Mar2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT:  301458A, left arm), administration date: 28Sep2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 11Apr2022, when the patient was 71-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, LOT: G35342, left arm), administration date: 16Sep2022, when the patient was 71-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2024, outcome "unknown" and all described as "contracted Covid". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes: Paxlovid from 08Feb2024 and ongoing (Expiry Date: Jan2025).   Additional information: the patient reported that usually has shots done in left arm, does not remember getting in right, any time. The patient has been taking Lisinopril about a year, he guesses. For Rosuvastatin it was about a year, has been taking. Is preventative, to keep cholesterol in check and aspirin taking over 20 years. It was reported that the patient has contracted Covid, has all Pfizer booster and shots, now taking Paxlovid.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "microscopic lymphocytic colitis" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Morphine, reaction(s): "known allergies: morphine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 31Jan2024 to 04Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
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 Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical location: Arm left), administration date: 12Feb2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical location: Arm left), administration date: 05Mar2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Arm left), administration date: 18Aug2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Arm left), administration date: 03Apr2022, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jan2024, outcome "recovering" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jan2024) Positive, notes: mild symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 26Jan2024 to 31Jan2024. Clinical course: The first day patient tested positive with ''mild'' symptoms she started Paxlovid. This was the first time she had COVID. She was a type 1 diabetic and knew the risks so her Dr and she decided it best to go on Paxlovid. 5 days after her original symptoms she felt much better.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Sep2023 as dose 1, 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. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 5 (booster), single; manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Negative, notes: 2 consecutive negative tests. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Additional information: The patient took Paxlovid from 30Jan2024 to 04Feb2024. After completing Paxlovid, the patient had 2 consecutive negative tests.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
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 a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "UC (Ulcerative colitis)" (unspecified if ongoing); "Recent squamous skin cancer on nose and neck" (unspecified if ongoing), notes: squamous skin cancer on nose and neck; "Pericarditis" (unspecified if ongoing); "aortic valve replacement" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Paprika" (unspecified if ongoing); "Known allergy: Adhesive tape" (unspecified if ongoing); "cardiac loop monitor" (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL, start date: 10Dec2021; ASPIRIN EC, start date: 10Dec2021; ACETOPHEN [ACETYLSALICYLIC ACID], start date: 13Nov2023; CORICIDIN [ACETYLSALICYLIC ACID;CAFFEINE;CHLORPHENAMINE MALEATE], start date: 01Feb2024, stop date: 02Feb2024; ATORVASTATIN, stop date: 02Feb2024. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin"; Inapsine, reaction(s): "Known allergies: Inapsine", notes: Enapsine. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Feb2024, outcome "unknown", COVID-19 (medically significant) with onset Feb2024, 4 months 1 day 12 hrs after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Feb2024 to 06Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP; "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Celebrex, reaction(s): "Known allergies: Celebrex". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included taking PAXLOVID from 03Feb2024 to 08Feb2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 treatment; COVID 19 treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Jun2023 at 09:00 as dose 5 (booster, initial Pfizer dose), single (Lot number: GH9694) at the age of 69 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jan2021 at 13:00 as dose 1, single (Lot number: 042L20A), in left arm, on 25Feb2021 at 13:00 as dose 2, single (Lot number: 001A21A), in left arm, on 07Apr2022 at 09:00 as dose 3 (booster), single (Lot number: 065K21A), in left arm and on 30Sep2022 at 09:00 as dose 4 (booster), single), in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ANASTROZOLE, start date: 01Jan2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Jun2023 at 09:00, outcome "unknown"; 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. Additional information: The patient took Paxlovid from 31Jan2024 to 05Feb2024. The patient has no known allergies.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a consumer. A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (lot number unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "IBS-D" (unspecified if ongoing). Concomitant medications included: ADVAIR, start date: Jan2019, stop date: 01Feb2024; CETIRIZINE, start date: Jan2018, stop date: 31Jan2024; ASTEPRO, start date: Jan2018, stop date: 05Feb2024; FAMOTIDINE, start date: Jan2019, stop date: Feb2024. Past drug history included: Biaxin, reaction: "allergy"; Fluconozole, reaction: "allergy". Vaccination history included: Moderna (dose 4 (booster), lot number unknown), administration date: Sep2022, when the patient was 52 years old, for Covid-19 immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, 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 taken from 02Feb2024 to 06Feb2024.  Additional Information: Suspect dose was also reported as "dose 5".   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (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 2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 02Feb2024 to 07Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, manufacturer: unknown), for Covid-19 Immunization; Covid-19 vaccine (dose 2, single, manufacturer: unknown), for Covid-19 Immunization; Covid-19 vaccine (dose 3 (booster), single, manufacturer: unknown), for Covid-19 Immunization. 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.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Lot number: HG4665) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Advil, reaction(s): "Drug Allergy: Advil". Vaccination history included: Covid-19 vaccine (Dose: 5 (Booster), Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 4 (Booster), Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 3 (Booster), Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 1, Unknown manufacturer), for Covid-19 immunization. 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. Clinical course information: Patient took Paxlovid from 29Jan2024 to 02Feb2024 as treatment for Covid-19.  No follow-up attempts are possible.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a consumer or other non HCP.  A 57-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 13:00 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 was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid for treatment of COVID-19 from 30Jan2024 to 03Feb2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: Hd9835) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa based antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (Booster), SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (Booster), SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (started on 31Jan2024 and stopped on 05Feb2024).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HH7595) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "pacemaker for vasovagal syncope" (unspecified if ongoing); "pacemaker for vasovagal syncope" (unspecified if ongoing); "palpitations" (unspecified if ongoing); "mild hypertension (controlled)" (unspecified if ongoing); "iodine contrast allergy" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; LISINOPRIL; PRAVASTATIN; GABAPENTIN; POTASSIUM CHLORIDE; FAMOTIDINE; VITAMIN D3; MIRTAZAPINE; LORAZEPAM. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: en6198), administration date: 25Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: ep7534), administration date: 18Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: fe3590), administration date: 06Oct2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: fp7135), administration date: 16Jun2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE; Lot number: gj5342), administration date: 02Dec2022, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid treatment from 02Feb2024 to 07Feb2024.   No follow-up attempts are possible.