chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Physician.Reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (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 3 (BOOSTER), SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Jan2024) Positive, notes: Rapid in home COVID-19 test was positive on Day 7 as well. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was treated with PAXLOVID from 29Dec2023 to 02Jan2024 for Treatment of 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: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out
Sex: M
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 39-year-old male 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (DOSE 1, SINGLE, Primary Immunization completed), for COVID-19 Immunization, reaction(s): "Covid-19".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
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 71-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 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment).  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: RSV
Symptoms: Paraesthesia
Clinical narrative: extreme pins and needles and prickly sensation in both legs, thighs, glutes, tingling in one hand; This is a spontaneous report received from a Physician from medical information team.  A 70-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "on and off parethesia", start date: 2007 (unspecified if ongoing), notes: on small areas in her body that comes and goes. . She can have years without anything (without sxs).; "covid", start date: Mar2023 (unspecified if ongoing), notes: she will have had long covid 3 years this Mar. The patient's concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine, for COVID-19 immunization, reaction(s): "10 days after receiving covid vaccine (unclear mfg ) she developed Covid", "10 days after receiving covid vaccine (unclear mfg ) she developed Covid"; Moderna vaccine, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "extreme pins and needles and prickly sensation in both legs, thighs, glutes, tingling in one hand".  Additional information: It was reported that patient received this vaccine 6 weeks ago from last Monday, unspecified date. Stated that 28 hours after receiving the vaccine, she got an 'abrupt onset of extreme pins and needles' and 'prickly sensation' in both legs, thighs, glutes, tingling in one hand. States in the past 6 weeks, it hasnt gone away and has been chronic.  States her left lower leg and other areas will act up. Stated it was as if a light switch went on and the vaccine activated her nerves in this way.  She saw her doctor and did some research. She and her doctor do not think it is guillain barre or will turn into guillain barre. Reported it has not progressed but it was so widespread in her body. Asking if there were any information and if this has been reported.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Fatigue
Clinical narrative: tired; no energy; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Lot number: ER8734, Expiration Date: Jul2021) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EN6199 or EN6/99, Expiry: Jun2021), administration date: 11Mar2021, when the patient was 69-year-old, for COVID-19 immunisation; Shingles vaccine (when he got shingles shot, told them, they gave it in left arm because he uses that arm.), for immunisation. The following information was reported: ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "no energy"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient reported feeling real tired and no energy after previous Pfizer Covid vaccine. After last Pfizer Covid shot, Oct2023, reported arm was a little sore but, not for long. The patient can't remember if he had any reaction after first initial shot. Thinks it was second shot, remembers coming home, thinks it was a Friday (as reported, possible discrepant), was just like, lying in bed, just didn't seem to have much energy. Patient clarified feeling tired with no energy, thinks that occurred after second shot, which was 01Apr2021. For "feeling real tired and no energy" patient mentioned he knows it was on a Friday, think in Oct. Thinks he had to wait after initial shot, like wait 6 months or something, before second shot. Later, it was clarified from vaccine card that he had first dose on 11Mar2021 and second dose on 01Apr2021. With the last one, he just had, back in Oct2023, noticed arm was a little sore but not for long.  When clarifying if caller had any other Covid vaccines other than these first 2 and the latest shot, in Oct2023, he states, he is not sure if there was another one. Thinks, if he got something, didn't get a card for that. If he did get something, would have been some time in 2022. If he did get a shot, does not remember. This booster he got, they call it a booster, he guesses, for this year, for 23-24. Was just trying to get some information if it was like the flu shot. They recommend everybody get flu shot every year and patient was wondering if it was going to be the same with Covid booster. Patient wanted to know if it would be like that, where you would have to go every year, or something, every winter, like a yearly booster. Patient just called to see if it was going to be a yearly shot and currently not having any issues.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 12:00 as dose 1, single (Lot number: HG4659) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ATORVASTATIN, start date: 03Apr2020, stop date: 05Jan2024. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: testing negative; Positive, notes: I then tested and was very positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses: COVID 19 Treatment included paxlovid from 28Dec2023 to 02Jan2024.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 5 (booster), single (Lot number: 024H22A) at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 at 09:00 as dose 2, single (Lot number: 030B21A), in right arm, on 26Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 037C21A), in right arm and on 17May2022 at 10:00 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient had no relevant medical history. No known drug allergies. There were no concomitant medications. 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. Treatment included Paxlovid from 02Jan2024 to 07Jan2024.   No follow-up attempts are possible.
Age: 71.0
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 or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. Vaccination history included: 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 Dec2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 31Dec2023 to 04Jan2024. 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
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's 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 UNNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19". The event "COVID 19" required physician office visit and emergency room visit. Patient received Paxlovid as COVID 19 Treatment from 20Dec2023 to 25Dec2023. Rebound 4 days after completing series of Paxlovid. New and worse symptoms (congestion, fatigue, loss of taste and smell) which required EMT visit, cardiologist visit, requiring treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 56.0
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 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 : 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 "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 31Dec2023 to 04Jan2024. 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: Illness
Clinical narrative: Patient said she got sick; This is a spontaneous report received from a Consumer or other non HCP.  An adult 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 and concomitant medications were not reported. Vaccination history included: Pfizer (dose 1, Lot number: unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Patient said she got sick".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: all kinds of muscle pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 81-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Jan2024 at 12:23 as dose number unknown, single (Batch/Lot number: unknown) at the age of 81 years, in right arm for immunisation. The patient's relevant medical history included: "paralyzed vocal cord" (unspecified if ongoing); "lung problems" (unspecified if ongoing). There were no concomitant medications. The following information was reported: MYALGIA (non-serious) with onset Jan2024, outcome "not recovered", described as "all kinds of muscle pain". Therapeutic measures were taken as a result of myalgia.  Additional information: She developed muscle pain a few days afterwards. She had it for several days and she is still having it right now. She just took Tylenol though as treatment.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, SARS-CoV-2 test
Clinical narrative: Facial Twitching; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, lot number=EL9266, Administration time=01:00 PM, vaccine location=Left arm), administration date: 14Feb2021, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Don't know, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 07Mar2021, for Covid-19 immunization. The following information was reported: MUSCLE TWITCHING (disability) with onset 29Nov2023 at 15:00, outcome "not recovered", described as "Facial Twitching". The event "facial twitching" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2023) Positive, notes: Blood test. Therapeutic measures were taken as a result of muscle twitching (Botox to stop twitching on face but did not work).  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-202400013882 same patient, different vaccine dose/AE;US-PFIZER INC-202400013906 same patient, different vaccine dose/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Facial Twitching; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, lot number=EL9266, Administration time=01:00 PM, vaccine location=Left arm), administration date: 14Feb2021, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Don't know, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 07Mar2021, for Covid-19 immunization. The following information was reported: MUSCLE TWITCHING (disability) with onset 29Nov2023 at 15:00, outcome "not recovered", described as "Facial Twitching". The event "facial twitching" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2023) Positive, notes: Blood test. Therapeutic measures were taken as a result of muscle twitching (Botox to stop twitching on face but did not work).  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-202400013882 same patient, different vaccine dose/AE;US-PFIZER INC-202400013906 same patient, different vaccine dose/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, SARS-CoV-2 test
Clinical narrative: covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 at 13:00 as dose 3 (booster), single (Lot number: EL9266), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2023, outcome "unknown" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2023) Positive, notes: Blood test. Clinical course: No known allergies.   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-202400013529 same patient/product, different dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 at 13:00 as dose 3 (booster), single (Lot number: EL9266), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2023, outcome "unknown" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2023) Positive, notes: Blood test. Clinical course: No known allergies.   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-202400013529 same patient/product, different dose/event;
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 53-year-old 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "OCD (treated and in recovery)" (ongoing), notes: OCD (treated and in recovery). Concomitant medication(s) included: SERTRALINE, start date: 30May2022. Past drug history included: Lidocaine, reaction(s): "known allergies: Lidocaine". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (05Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2024) Negative, notes: After a negative test on Day 10 and day 12; (07Jan2024) Negative, notes: After a negative test on Day 10 and day 12. Therapeutic measures were taken as a result of vaccination failure, covid-19 Paxlovid from 26Dec2023 to 31Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: came down with Covid; came down with Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "came down with Covid". 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 with paxlovid.  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-202400013604 Same patient/product, different dose/events;US-PFIZER INC-202400013603 Same patient/product, different dose/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Illness
Clinical narrative: came down with Covid; came down with Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "came down with Covid". 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 with paxlovid.  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-202400013604 Same patient/product, different dose/events;US-PFIZER INC-202400013603 Same patient/product, different dose/events;
Sex: M
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 43-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Dec2023 to 04Jan2024. Clinical course: Patient denied for any known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 37.0
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 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "known allergies: Celiac - gluten allergy" (unspecified if ongoing), notes: known allergies: Celiac - gluten allergy. Concomitant medication(s) included: SYNTHROID, start date: 16Oct2017, stop date: 13Jan2024. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 05Jan2024 to 09Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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 or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 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; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. 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 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 02Jan2024 to 06Jan2024. Clinical course: Patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; 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)), as dose 1, single (Lot number: Unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient recently took the COVID 19 vaccine a few days ago and she has had a fever since. The patient had no vaccinations four weeks prior.  Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Dec2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 53 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 (PRIMARY IMMUNIZATION SERIES COMPLETE; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: MYOCARDITIS (prolonged hospitalization, disability, life threatening) with onset 01Jan2024, outcome "unknown". The event "myocarditis" required emergency room visit.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "insulin resistence" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL, start date: Jan2019; METFORMIN, start date: May2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: Rebound of Covid-19 positive - within 7 days of completing Paxlovid; had 6 days of negative tests before re-testing positive; (Jan2024) Negative, notes: Rebound of Covid-19 positive - within 7 days of completing Paxlovid; had 6 days of negative tests before re-testing positive; (Jan2024) Negative, notes: Rebound of Covid-19 positive - within 7 days of completing Paxlovid; had 6 days of negative tests before re-testing positive; (Jan2024) Negative, notes: Rebound of Covid-19 positive - within 7 days of completing Paxlovid; had 6 days of negative tests before re-testing positive; (Jan2024) Negative, notes: Rebound of Covid-19 positive - within 7 days of completing Paxlovid; had 6 days of negative tests before re-testing positive; (Jan2024) Negative, notes: Rebound of Covid-19 positive - within 7 days of completing Paxlovid; had 6 days of negative tests before re-testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 31Dec2023 to 05Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 36.0
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 36-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Dec2023 to 31Dec2023. Clinical course: Patient had no known allergies  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Mar2023 as dose 3 (booster), single (Lot number: GL0447) at the age of 47 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: 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 with Paxlovid from 05Jan2024 to 09Jan2024. Clinical course: Patient had no known allergies.  No follow-up attempts are possible.
Age: 52.0
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 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Not really, some arthritis" (unspecified if ongoing); "gout" (unspecified if ongoing); "eczema" (unspecified if ongoing); "known allergies: Sulfar antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Jan2024 to 06Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Pfizer / BioNTech, Dose Number: 4; Name of Drug as Reported: Moderna, Dose Number: 5; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 20Apr2021 as dose 2, single (Lot number: ER8735), in right arm and on 23Nov2021 as dose 3 (booster), single (Lot number: 30125BA), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Oct2023 as dose 5 (booster), single (Lot number: Av3914b), in right arm 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. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2023, outcome "unknown", described as "Name of Drug as Reported: Pfizer / BioNTech, Dose Number: 4; Name of Drug as Reported: Moderna, Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 04Jan2024 to 08Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 77.0
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 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 27Dec2023 to 01Jan2024.  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: Treatment of COVID-19; Treatment of 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)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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 06Jan2024 to 11Jan2024. Clinical course: Patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Positive; (Jan2024) Negative, notes: it had been negative for several days before that. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 29Dec2023 to 02Jan2024.  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: The efficacy of a vaccine varies individually and can be affected by different factors. However, a contributory role of BNT162b2 omi xbb.1.5 to the events Vaccination failure and Covid-19 cannot be ruled out.
Age: 52.0
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 from product quality group.  A 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Lot number: HD9876) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Drug allergy; erythromycin". Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 BOOSTER, SINGLE; lot GM9703,), administration date: 09Oct2022, when the patient was 51-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 4 BOOSTER, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 BOOSTER, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2024) Negative, notes: tested negative on 08Jan2024,; (11Jan2024) Positive, notes: started experiencing symptoms on 11Jan2024 and tested positive that day. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 02Jan2024 to 07Jan2024.