chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the firs dose of Shingrix in 9-20-2018 and then today 1-16-2024 received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number H379C, expiry date 30-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 20-SEP-2018).   On 16-JAN-2024, the patient received the 2nd dose of Shingrix. On 16-JAN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received the firs dose of Shingrix in 9-20-2018 and then today 1-16-2024 received the second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-JAN-2024 Pharmacist called to report that a patient received the first dose of Shingrix in 20-SEP-2018 and then today 16-JAN-2024 received the second dose. Reporter agreed for follow up but email address was declined, only option for contact was phone number. The reporter consented to follow up The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: had achy body and pain after getting both doses of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: had achy body and pain after getting both doses of Shingrix). The outcome of the general body pain was resolved (duration 24 hrs).   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR009073   Additional Information: GSK Receipt Date: 16-JAN-2024 The reporter was the husband of the patient. The patient received Shingrix years ago. The patient had achy body and pain after getting both doses of Shingrix that lasted for 12 to 24 hours. The reporter refused to provide demographics and did not provide the time of the events. The reporter did not recall enough regarding the events. The reporter did not consent to follow-up. This case was linked with US2024007067 and US2024AMR007443 reported by same reporter for different patient. For tolerance of 2nd dose refer case US2024AMR009073, reported by same reporter.; Sender's Comments:  US-GSK-US2024007067:1 Of 2 patient case/ Same reporter, male patient US-GSK-US2024AMR009073:2nd dose case for same patient US-GSK-US2024AMR007443:Same reporter, male patient
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a nurse via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JAN-2024 The reporter was the patient, and the patient was a retired registered nurse. She received her first dose of Shingrix about 3 or 4 months ago in 2023 (from the date of reporting). The patient developed shingles soon (number of days were unknown) after receiving Shingrix.  The reporter did not have the paperwork with her during the call, so date and lot number were unknown.  Nothing else was reported. The reporter did not consent to follow-up.
Sex: U
Vaccine: TDAP
Symptoms: Accidental underdose, Wrong technique in product usage process
Clinical narrative: arm not sure if the patient got all of the vaccine.; was due to needle not being attached properly to the syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number P5SR5, expiry date 26-APR-2026) for prophylaxis.   In JAN-2024, the patient received Boostrix. In JAN-2024, an unknown time after receiving Boostrix, the patient experienced accidental underdose (Verbatim: arm not sure if the patient got all of the vaccine.) and wrong technique in product usage process (Verbatim: was due to needle not being attached properly to the syringe). The outcome of the accidental underdose and wrong technique in product usage process were unknown.   Additional Information: GSK Receipt Date: 17-JAN-2024 A pharmacist reported about a nurse who went to administer Boostrix, and fluid went out of the arm not sure if the patient got all of the vaccine.  The doctor decided not to revaccinate the patient.  That was due to needle not being attached properly to the syringe, no product quality complaint confirmed, which led to accidental under dose and wrong technique in product usage process. The incident happened previous week from reporting, no date or patient details available. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Finger joint pain/joint pain in nuckles; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in joint involving hand in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included numbness in leg (numbness in legs for years). Concurrent medical conditions included crohn's disease (Crohn Disease from 30 plus years ago).   On 30-OCT-2023, the patient received the 1st dose of Shingrix. In DEC-2023, between 1 and 3 months after receiving Shingrix, the patient experienced pain in joint involving hand (Verbatim: Finger joint pain/joint pain in nuckles). The outcome of the pain in joint involving hand was not resolved.   It was unknown if the reporter considered the pain in joint involving hand to be related to Shingrix.     It was unknown if the company considered the pain in joint involving hand to be related to Shingrix.   Additional Information: GSK receipt date:18-JAN-2024 The patient self-reported this case. The patient received 1st dose of Shingrix and was never given side effects to this and started finger pain in joint a month ago from the date of reporting. According to the patient the pain was gone but little bit pain still present. The patient also experienced joint pain in knuckles for at least 3 weeks. The patient did not plan to get second shot if shingles due to this pain that was present and never had pain any pain in joints ever. The reporter consented to follow up.
Age: 31.0
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: HCP gave an adult a pediatric strength of Engerix B; HCP gave an adult a pediatric strength of Engerix B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 31-year-old patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 12-DEC-2023, the patient received Engerix B pediatric (left arm) .5 ml. On 12-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: HCP gave an adult a pediatric strength of Engerix B) and adult use of a child product (Verbatim: HCP gave an adult a pediatric strength of Engerix B). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JAN-2024 The healthcare professional (HCP) gave an adult a pediatric strength of Engerix B, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administration of Flulaval to patient post excursion 22C x 74 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 77-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 2XT9D, expiry date 30-JUN-2024) for prophylaxis.   On 15-JAN-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: administration of Flulaval to patient post excursion 22C x 74 hours). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Jan-2024 The patient received Flulaval vaccine post excursion to 22 degree C for 74 hours, which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024009516:Different patient US-GSK-US2024009517:Different patient US-GSK-US2024009518:Different patient US-GSK-US2024009520:Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he received his first dose of Shingrix prior to the Covid pandemic but did not receive the 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose prior to the Covid pandemic).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: he received his first dose of Shingrix prior to the Covid pandemic but did not receive the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2024 The patient self-reported this case. The reporter stated that he received his first dose of Shingrix prior to the Covid pandemic (late dose.)  No further information was known. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to an incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity ; Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement) ; Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity ), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement) ), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MALAISE (Moderate malaise/feeling sick present with some interference with activity ), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement) ), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain and no interference with activity). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity ), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement) ), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Database Subject ID was reported as 5469791.  Regulatory Authority Subject ID was reported as 89780-13749.  Concomitant medications were not reported.   Patient had experienced malaise, vaccination site pain, fatigue, muscle pain and arthralgia anytime during the 2 days after the COVID-19 vaccination, which occurred on Saturday, 13-Jan-2024 and Sunday, 14-Jan -2024.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-757662, US-MODERNATX, INC.-MOD-2024-757663 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757663:Patient 3 US-MODERNATX, INC.-MOD-2024-757662:Patient 2
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Pyrexia
Clinical narrative: Severe malaise/feeling sick present with significant interference with activity; Moderate fever (101.3 to 102 °F) ; Severe fatigue with significant interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Severe malaise/feeling sick present with significant interference with activity), PYREXIA (Moderate fever (101.3 to 102 °F) ) and FATIGUE (Severe fatigue with significant interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MALAISE (Severe malaise/feeling sick present with significant interference with activity), PYREXIA (Moderate fever (101.3 to 102 °F) ) and FATIGUE (Severe fatigue with significant interference with activity). At the time of the report, MALAISE (Severe malaise/feeling sick present with significant interference with activity), PYREXIA (Moderate fever (101.3 to 102 °F) ) and FATIGUE (Severe fatigue with significant interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2024, Body temperature: Moderate fever (101.3 to 102 °F).         Company ID was reported.  Company Subject ID was reported.  Concomitant medications were not reported.   Patient had experienced fever, fatigue, Malaise/feeling sick anytime during the 2 days after the COVID-19 vaccination, which occurred on Saturday, 13-Jan-2024 and Sunday, 14-Jan -2024.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-757659 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757659:Master case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Upper respiratory tract infection
Clinical narrative: How do you explain why I get URTI almost monthly ever since I got COVID infection and CoVId jab; COVID infection; This spontaneous case was reported by a patient and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (How do you explain why I get URTI almost monthly ever since I got COVID infection and Covid jab) and COVID-19 (COVID infection) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (How do you explain why I get URTI almost monthly ever since I got COVID infection and Covid jab) and COVID-19 (COVID infection). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (How do you explain why I get URTI almost monthly ever since I got COVID infection and Covid jab) and COVID-19 (COVID infection) outcome was unknown.      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was reported that patient got URTI almost monthly ever since patient got COVID infection and Covid jab. Treatment medication was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7008121001, 7006320006 and 7006320003) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to antibiotic (Bactrim), Drug allergy (Codeine), Hypertension (Since age 35, no recent change in condition status), Type 2 diabetes mellitus (10 years, no recent change in condition status) and Hypothyroidism (10 years, no recent change in condition status).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 05-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: Positive.         Patient weight was reported as 180.  Patient received all 3 doses in deltoid.  No concomitant medication was reported.  No treatment information was provided.   This case was linked to MOD-2024-757206 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I have not been able to stop vomiting.; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (I have not been able to stop vomiting.) in a 26-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 23-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VOMITING (I have not been able to stop vomiting.). At the time of the report, VOMITING (I have not been able to stop vomiting.) had not resolved.            No concomitant medication was reported.  Patient have not been able to stop vomiting and can't keep anything down water or solids It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.
Sex: U
Vaccine: RSV
Symptoms: Device leakage, No adverse event
Clinical narrative: the luer lock broke off and the Abrysvo vaccine leaked all over counter; the luer lock broke off and the Abrysvo vaccine leaked all over counter; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 17Jan2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9849) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "the luer lock broke off and the Abrysvo vaccine leaked all over counter".  Causality for "the luer lock broke off and the abrysvo vaccine leaked all over counter" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: when the diluent syringe was threaded onto vial, the luer lock broke off and the Abrysvo vaccine leaked all over counter. Confirmed no patients involved with the Abrysvo vaccine with the issue, caller stated one of the patients needs to come back because caller doesn't have an extra vial.
Age: 76.0
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 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart issues" (unspecified if ongoing); "reflux" (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 Jan2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid from 09Jan2024 to 14Jan2024. The patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; Shivers; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: I had COVID before 2 years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID"; CHILLS (non-serious), outcome "unknown", described as "Shivers".  Clinical course: Consumer stated, "Look, I just have a question, okay. I am not going to give you all my information, all my first and last name. I just have a question. I have COVID right now I have COVID it's very mild symptoms. I had shivers to begin with I have shivers and I had COVID before 2 years ago. It was really bad. I had shivers, I had sore throat for 2 week that was so bad. It was unbearable. It was like if I take a glass of water, it was like drinking glass of 'phenyl' that's how bad it hurts. It was real bad anyways that was 2 years ago when I got COVID when things were different. No, this is my question, I got vaccinated with whatever the in 23Oct2023, 3 months ago. I got vaccinated now it was Pfizer I got it at (Name withheld) and I don't know what the days is that it had in there to fight or whatever I don't know if it was up to current to what's available now but that's not my question. Here is my question how or why do I have COVID now if I got vaccinated always just always really it was 3 months ago. I got COVID. I got. Let's don't go with the details what kind it was but at the time they are selling was the most current vaccine that they had, Pfizer. I don't if it's the same one that's they giving it now, but my point is and my big question is, I mean it's nothing you can't do anything about it or anything. I am just very curious of how I could catch COVID this soon after getting the shot. They probably say something like 3 months. I thought it was firstly protects me for at least 6 months.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 84.0
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.  An 84-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 at 02:45 as dose 1, single at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fib" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Pancreatic insufficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Composine, reaction(s): "Allergy: Composine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid as treatment from 06Jan2024 to 11Jan2024.
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 38-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), 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". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment from 10Jan2024 to 15Jan2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Deafness, Feeding disorder, Malaise
Clinical narrative: Lost her hearing; Sick; Have not eaten yet for two days; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Feb2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Lost her hearing"; MALAISE (non-serious), outcome "unknown", described as "Sick"; FEEDING DISORDER (non-serious), outcome "unknown", described as "Have not eaten yet for two days".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment from 06Jan2024 to 10Jan2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 at 08:30 as dose 5 (booster), single (Lot number: GJ3274) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Nov2023 at 15:30 as dose 6 (booster), single (Lot number: AU3919B), in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Drug allergy"; Naproxen, reaction(s): "Drug allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Nov2023, outcome "unknown", described as "vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jan2024, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2024) Positive; (15Jan2024) Negative; (19Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 08Jan2024 to 13Jan2024).
Age: 50.0
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.  A 50-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 10:00 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: "Diabetes" (unspecified if ongoing); "known allergies: Ni" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Single), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: mother got sick after the last vaccine; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Nov2023 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "mother got sick after the last vaccine". Additional information: The reporter's mother is lives in a assistant living facility, and she acquired COVID in November. The reporter was asking, for elderly people, because she got sick after the last vaccine. The reporter inquired on the recommended timeframe after contracting COVID before she can get the vaccine safely. Reportedly the reporter tried to look all over Pfizer's website and she was not having much success. The reporter mentioned that her mother got sick after the last vaccine. Batch/lot number is not provided, and it cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other: Moderna: dose 4, dose 5/ vaccine brand other: Pfizer / BioNTech: dose 1, dose 2, dose 3/ vaccine brand other: Novavax dose 6; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 54 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jun2022 as dose 4 (booster), single (Lot number: 014B22A), in left arm and on 09Oct2022 at 14:30 as dose 5 (booster), single (Lot number: 061F22A), in left arm for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 31Oct2023 at 13:00 as dose 6 (booster), single (Lot number: 80631-0105-02), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Jun1997. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jun2022, outcome "unknown", described as "vaccine brand other: Moderna: dose 4, dose 5/ vaccine brand other: Pfizer / BioNTech: dose 1, dose 2, dose 3/ vaccine brand other: Novavax dose 6"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid administered from 08Jan2024 to 12Jan2024 for the treatment of COVID 19. No known allergies.
Age: 71.0
Sex: U
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 71-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 14:00 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 included: "Heart failure" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 3 (booster); administration time: 02:00 PM; location: Left arm), administration date: 07Dec2022, when the patient was 70-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2; administration time: 02:00 PM; location: Right arm [also reported as 06Nov2023]), administration date: 06Nov2022, when the patient was 70-year-old, for covid-19 immunization; Covid-19 vaccine (dose 1; manufacturer and lot number 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 11Jan2024 to 15Jan2024. Additional information: patient has no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, HLA marker study, Lipids abnormal, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Physician.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "elevated lipids" (unspecified if ongoing); "HLAB27+" (unspecified if ongoing); "axial spondyloarthritis" (unspecified if ongoing); "microscopic hematuria" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Allergy: Demerol". Vaccination history included: Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2 SINGLE, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: HLA marker study: Positive; Lipids abnormal: Elevated. Therapeutic measures were taken which was Paxlovid as a result of vaccination failure, 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: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand: Pfizer / BioNTech/Vaccine brand other: Moderna; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 7 (booster), single (Lot number: GH9703) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Oct2023 at 14:30 as dose 8 (booster), single (Lot number: 8058492), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single), as dose 5 (booster), single) and as dose 6 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Raynaud's Disease" (unspecified if ongoing); "known allergies: Shellfish dye" (unspecified if ongoing). Concomitant medication(s) included: ACTEMRA, start date: 11Feb2023, stop date: 31Dec2023; VENTOLIN HFA, start date: 01Jan1970. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2023 at 14:30, outcome "unknown", described as "Vaccine brand: Pfizer / BioNTech/Vaccine brand other: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid (Lot# 1969071A) administered from 08Jan2024 to 13Jan2024 for the treatment of covid-19. Patient has Asthma, Rheumatoid Arthritis. She stopped taking Actemra (biological) when she started to feel unwell.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna  Dose 5; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Apr2023 as dose 6 (booster), single (Lot number: 693268) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 16Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9844), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Sep2022 as dose 5 (booster), single (Lot number: AS71443), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "cardiovascular disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Sep2022, outcome "unknown", described as "Moderna  Dose 5"; DRUG INEFFECTIVE (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 drug ineffective, covid-19.  Clinical course: Patient developed a cough and runny nose on 07Jan2024, his doctor prescribed Paxlovid on 08Jan2024, he completed the course on 12Jan2024. No known allergies.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: NSAID" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". 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; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 10Jan2024 to 14Jan2024. 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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a consumer (patient herself).  A 54-year-old female patient (not pregnant) received BNT162B2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: 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) all with onset Jan2024, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19 test: (20Jan2024) positive, notes: 5 days after last dose of PAXLOVID (given from 10Jan2024 to 15Jan2024 for 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: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Dec2023 as dose 4 (booster), single) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Dec2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2024) Negative, notes: Tested negative 8 days prior to today. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.