chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dermatitis atopic, Dry skin, Eczema, Pityriasis rubra pilaris
Clinical narrative: eczema; atopic dermatitis; pityriasis rubra pilaris; dry skin patches and progressively got worse; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema), DERMATITIS ATOPIC (atopic dermatitis), PITYRIASIS RUBRA PILARIS (pityriasis rubra pilaris) and DRY SKIN (dry skin patches and progressively got worse) in a 58-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. GJ6742) for COVID-19 immunization.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) .3 milliliter. In April 2023, the patient experienced DRY SKIN (dry skin patches and progressively got worse). On 22-Apr-2023,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced ECZEMA (eczema), DERMATITIS ATOPIC (atopic dermatitis) and PITYRIASIS RUBRA PILARIS (pityriasis rubra pilaris). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at an unspecified dose and frequency; PREDNISONE for Rash all over and Swelling, at an unspecified dose and frequency; DUPILUMAB (DUPIXENT) at an unspecified dose and frequency and BIMEKIZUMAB (BIMZELX) at an unspecified dose and frequency. At the time of the report, ECZEMA (eczema), DERMATITIS ATOPIC (atopic dermatitis), PITYRIASIS RUBRA PILARIS (pityriasis rubra pilaris) and DRY SKIN (dry skin patches and progressively got worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: revealed no allergies or anomailies.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication not reported.   In Apr-2023, the patient started with dry skin patches and progressively got worse. First diagnosed as eczema, then atopic dermatitis and then to PRP (pityriasis rubra pilaris). The patient did not experience any additional symptoms/events. The topical steroidal creams for skin condition, Benadryl for allergic reactions, Prednisone for full body rash and swelling and finally Dupixent. Nothing has worked. Now was trying Bimzelx and referred to Research Center for further testing, treatment. Potential diagnosis was PRP due to clinical appearance and biopsy. Blood tests revealed no allergies or anomalies. The patient had no medical history, concomitant disease or risk factor.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient got COVID-19 symptoms started on 13-JAN-2024 and she tested positive on 14-JAN-2024; symptoms were slight fever during 24 hours on and off, light headache, slight congestion residual and fatigue; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19 symptoms started on 13-JAN-2024 and she tested positive on 14-JAN-2024; symptoms were slight fever during 24 hours on and off, light headache, slight congestion residual and fatigue) in a 56-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Blood pressure inadequately controlled, COVID-19 in June 2020 and COVID-19 in June 2022. Concurrent medical conditions included Seasonal allergy.    In 2023, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 14-Jan-2024, the patient experienced COVID-19 (Patient got COVID-19 symptoms started on 13-JAN-2024 and she tested positive on 14-JAN-2024; symptoms were slight fever during 24 hours on and off, light headache, slight congestion residual and fatigue). At the time of the report, COVID-19 (Patient got COVID-19 symptoms started on 13-JAN-2024 and she tested positive on 14-JAN-2024; symptoms were slight fever during 24 hours on and off, light headache, slight congestion residual and fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2024, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. HCP stated she already received 4 Moderna COVID-19 Vaccines, 1st one on 28DEC2020, 2nd one on 25JAN2021, 3rd one on 27OCT2021 and last one caller did not remember when she got it but it was given on 2023. Maybe 1 month after it came out. She mentioned that she already got COVID-19 3 times, but the first one it was before she received any COVID-19 Vaccine maybe on late JUN-2020, the second time she got COVID-19 on JUN-2022, and last time she got COVID-19 symptoms started on 13-JAN-2024 and she tested positive on 14-JAN-2024, symptoms were slight fever during 24 hours on and off, light headache, slight congestion residual and fatigue, by 19-JAN-2024 she was recovered at 80%, just felt a little tired and it could be easily mistaken as a cold. The treatment medication was not reported by reporter.   This case was linked to MOD-2024-758822 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: long covid; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (long covid) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: RSV on 06-Sep-2023. Past adverse reactions to the above products included No adverse event with RSV.   On 05-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 07-Dec-2023, the patient experienced POST-ACUTE COVID-19 SYNDROME (long covid). At the time of the report, POST-ACUTE COVID-19 SYNDROME (long covid) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.       No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that patient received all of the previous Moderna vaccines. Patient had the first two vaccines and 5 boosters. Patient got covid and had long covid. Patient was diagnosed with Covid on 07-Dec-2023. Patient said that the shot was fine but they have had a few months of fatigue and brain fog from the post covid thing. It was a very mild case of covid but they do wonder if they weren't protected from the most recent variant.  No treatment medication was reported.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pfizer 12+ (30mcg) given to 11 y/o female. No negative reaction noted during visit.
Age: 88.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received RSV Arexvy on 10/24/23 and then received RSV Abrysvo on 12/17/23. The patient had not realized they had already gotten the RSV shot and had requested it on 12/17/23. The pharmacy did not catch that he had already gotten an RSV vaccination when it administered the Abrysvo. No adverse reactions reported by patient.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Product administered at inappropriate site, Rash, Serum sickness, Shoulder injury related to vaccine administration
Clinical narrative: Chest rash followed in hours, days and weeks with significant aggravation of old injuries including hands, feet, ankles, shoulder, wrist and knees diagnosed as serum sickness. Improper needle placement at the injection site resulting in SIRVA.
Age: 15.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Eye movement disorder
Clinical narrative: Patient was nervous and crying while waiting for vaccines. We waited a few minutes for her to calm down. After receiving 2 shots, she sat in the waiting area with her mom while waiting for her sister to receive her vaccine. When coming out of the counseling room we noticed her eyes rolling to the back of her head and it seemed as she was about to pass out. We got her to come back but called an ambulance to check her out. They checked her out and she was fine to go home with her family.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Full blood count abnormal, Influenza virus test negative, Pain, Pruritus, Rash
Clinical narrative: Body itching all over the body, Body pain, rash on face and arms.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urine analysis
Clinical narrative: Body itching all over the body, Body pain, rash on face and arms.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Cheilitis, Glossodynia, Herpes simplex, Pyrexia, Scab
Clinical narrative: Child is from another country and behind on a vaccination catch up schedule.  Developed a fever the night after having received the vaccines, fever lasted about 48 hours.  48 hours later yellow crusted sores appeared on his lips, and he has sores on his tongue.  Pt presented to our clinic for an exam today, 1/31/24 and his condition is being treated as HSV.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Yellow skin
Clinical narrative: Child is from another country and behind on a vaccination catch up schedule.  Developed a fever the night after having received the vaccines, fever lasted about 48 hours.  48 hours later yellow crusted sores appeared on his lips, and he has sores on his tongue.  Pt presented to our clinic for an exam today, 1/31/24 and his condition is being treated as HSV.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated 1/6/24 but vaccine had expired 12/26/23 based on 10-week refrigerator stability. Patient will be contacted to offer re-vaccination
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated 1/23/24 but vaccine expired 12/26/23 based on 10-week refrigerator stability. Patient was still in the hospital when the error was discovered and was re-vaccinated 1/29/2024
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Estimated due date is 2/28/2024. I got the shot Sunday at 9:20 AM. On Monday, 1/29/24, I noticed my arm was itchy at the injection site. By that evening when I saw the site, it was red, raised, warm to the touch, and was hard in that area. The next day 1/30/24, the symptoms were the same. Today, 1/31/24, the spot was bigger in size than the night before. Still raised, red, and warm to touch. The hardness of area seems to be a little better. I also woke up with some drainage, needing to clear my throat a lot today as well.
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Paranasal sinus hypersecretion, Throat clearing
Clinical narrative: Estimated due date is 2/28/2024. I got the shot Sunday at 9:20 AM. On Monday, 1/29/24, I noticed my arm was itchy at the injection site. By that evening when I saw the site, it was red, raised, warm to the touch, and was hard in that area. The next day 1/30/24, the symptoms were the same. Today, 1/31/24, the spot was bigger in size than the night before. Still raised, red, and warm to touch. The hardness of area seems to be a little better. I also woke up with some drainage, needing to clear my throat a lot today as well.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Blood test, Cholecystectomy, Cholelithiasis, Computerised tomogram heart abnormal
Clinical narrative: MODERNA FIRST INJECTION 3/17/2021, SECOND INJECTION 04/13/2021, THIRD INJECTION 12/21/2021, IN JANUARY 1 2022 AND BEYOND DEVELOPED COVID-19 VACCINE PERICARDITIS, SMALL FIBER NEUROPATHY, WEIGHT LOSS, HAIR LOSS, POST-EXERTIONAL MALAISE.  VACCINE INDUCED WEIGHT LOSS PRECIPATED GALLSTONES AND 2023 HAD CHOLECYSTECTOMY.  TREATED WITH SLOW IMPROVEMENT
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram abnormal, Impaired work ability, Malaise, Pericardial effusion, Pericarditis
Clinical narrative: MODERNA FIRST INJECTION 3/17/2021, SECOND INJECTION 04/13/2021, THIRD INJECTION 12/21/2021, IN JANUARY 1 2022 AND BEYOND DEVELOPED COVID-19 VACCINE PERICARDITIS, SMALL FIBER NEUROPATHY, WEIGHT LOSS, HAIR LOSS, POST-EXERTIONAL MALAISE.  VACCINE INDUCED WEIGHT LOSS PRECIPATED GALLSTONES AND 2023 HAD CHOLECYSTECTOMY.  TREATED WITH SLOW IMPROVEMENT
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Small fibre neuropathy, Sucrose intolerance, Weight decreased
Clinical narrative: MODERNA FIRST INJECTION 3/17/2021, SECOND INJECTION 04/13/2021, THIRD INJECTION 12/21/2021, IN JANUARY 1 2022 AND BEYOND DEVELOPED COVID-19 VACCINE PERICARDITIS, SMALL FIBER NEUROPATHY, WEIGHT LOSS, HAIR LOSS, POST-EXERTIONAL MALAISE.  VACCINE INDUCED WEIGHT LOSS PRECIPATED GALLSTONES AND 2023 HAD CHOLECYSTECTOMY.  TREATED WITH SLOW IMPROVEMENT
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Syringe issue
Clinical narrative: The hub broke off after he tried to reconstitute it; he can't put the needle on it; This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: J743F, Expiration Date: 11Dec2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "The hub broke off after he tried to reconstitute it; he can't put the needle on it".  Additional information: The reporter stated potential product quality on Abrysvo. The hub broke off after he tried to reconstitute it. So, he cannot put the needle on. Reporter stated, "Expiration date is 01Jun2027 and the LOT# is J743F. Expiration date is 11Dec2025. The other expiration date given was on the vial adaptor. On the actual product is 11Dec2025. The LOT# is J743F, expiration date is 11Dec2025 (LOT# and expiration date captured as provided) on the product. The vial adaptor has LOT# F664 and the expiration date is 01Jun2027."  Causality for "the hub broke off after he tried to reconstitute it; he can't put the needle on it" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Colonoscopy, Drug ineffective, Thyroid disorder, Weight
Clinical narrative: Second time getting COVID; Second time getting COVID; Lost a lot of weight; now he has thyroid problems; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: 2022 (unspecified if ongoing), notes: Colonoscopy, found out had cancer 2 years ago.; "Stomach Problems" (ongoing); "COVID-19", start date: 2023, stop date: 2023, notes: First time getting COVID was last year.; "Bipolar" (ongoing). Concomitant medication(s) included: LITHIUM oral taken for bipolar disorder (ongoing). Vaccination history included: Bnt162b2 NOS (Dose 1), for COVID-19 immunisation. The following information was reported: WEIGHT DECREASED (non-serious) with onset Jan2024, outcome "unknown", described as "Lost a lot of weight"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "Second time getting COVID"; THYROID DISORDER (non-serious) with onset Jan2024, outcome "unknown", described as "now he has thyroid problems". The event "second time getting covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Colonoscopy: (2022) cancer, notes: Colonoscopy, found out had cancer 2 years ago; Thought had prostate cancer. Was having a lot of testing done and has seen different doctors, but told does not have it. Weight: (Jan2024) Lost a lot of weight.  Therapeutic measures were taken as a result of drug ineffective, covid-19, thyroid disorder.Clinical course: Reporter on the line enrolled to get covid medication, Paxlovid, at lower cost. He stated that it was his second time getting covid and was reported as worsened. He also lost a lot of weight. He  was diagnosed with COVID again this week and this is why he is prescribed Paxlovid. The first time he had covid he went to the doctor last year.  While providing details mentioned now he has thyroid problems. Now he takes Levothyroxine 50mg tablet every day in the morning by mouth.  Confirmed was not taking at time had Covid Vaccine. He stated he received the first dose and then the booster. However, referred to product as the Pfizer Covid Vaccine throughout report.   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-202400025157 Same reporter/drug, different patient;US-PFIZER INC-202400025159 Same reporter/drug, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Second time getting COVID; Second time getting COVID; Lost a lot of weight; now he has thyroid problems; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: 2022 (unspecified if ongoing), notes: Colonoscopy, found out had cancer 2 years ago.; "Stomach Problems" (ongoing); "COVID-19", start date: 2023, stop date: 2023, notes: First time getting COVID was last year.; "Bipolar" (ongoing). Concomitant medication(s) included: LITHIUM oral taken for bipolar disorder (ongoing). Vaccination history included: Bnt162b2 NOS (Dose 1), for COVID-19 immunisation. The following information was reported: WEIGHT DECREASED (non-serious) with onset Jan2024, outcome "unknown", described as "Lost a lot of weight"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "Second time getting COVID"; THYROID DISORDER (non-serious) with onset Jan2024, outcome "unknown", described as "now he has thyroid problems". The event "second time getting covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Colonoscopy: (2022) cancer, notes: Colonoscopy, found out had cancer 2 years ago; Thought had prostate cancer. Was having a lot of testing done and has seen different doctors, but told does not have it. Weight: (Jan2024) Lost a lot of weight.  Therapeutic measures were taken as a result of drug ineffective, covid-19, thyroid disorder.Clinical course: Reporter on the line enrolled to get covid medication, Paxlovid, at lower cost. He stated that it was his second time getting covid and was reported as worsened. He also lost a lot of weight. He  was diagnosed with COVID again this week and this is why he is prescribed Paxlovid. The first time he had covid he went to the doctor last year.  While providing details mentioned now he has thyroid problems. Now he takes Levothyroxine 50mg tablet every day in the morning by mouth.  Confirmed was not taking at time had Covid Vaccine. He stated he received the first dose and then the booster. However, referred to product as the Pfizer Covid Vaccine throughout report.   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-202400025157 Same reporter/drug, different patient;US-PFIZER INC-202400025159 Same reporter/drug, different patient;
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: tested positive with Covid; tested positive with Covid; This is a spontaneous report received from a Consumer or other non HCP.  An 88-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 87 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown, single, caller had taken all Pfizer shots), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (Dose number unknown (Booster), single, caller had taken all Pfizer shots), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jan2024, outcome "not recovered" and all described as "tested positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2024) negative; (24Jan2024) negative; (26Jan2024) positive; Weight: (unspecified date) About 107. Additional information: patient was speaking on how she had shots with Pfizer, had been taking shots before, never had Covid. She testes negative for 2 days (Tuesday and Wednesday), third day, tested positive on 26Jan2024, now prescribed Paxlovid. This is her first time with Covid. Paxlovid was just prescribed to her, does not have the medication yet. As of right now, is not very sick, really was surprised test was positive. Was not getting better, just thought it was a cold. Never had any bad reaction to any vaccinations or anything else. Tends to be in pretty good health.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 07:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, 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. Patient had no known allergies. 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 12Jan2024 to 18Jan2024.  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: Based on the known the information available the Causal relation between the events Vaccination failure, Covid 19 and suspect drug cannot be excluded completely
Age: 40.0
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 Physician.  A 41-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment from 16Jan2024 to 21Jan2024).; 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid rebound; Covid rebound; This is a spontaneous report received from a Physician.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing); "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) all with onset Jan2024, outcome "not recovered" and all described as "Covid rebound". Therapeutic measures were taken as a result of covid-19 included Paxlovid treatment from 15Jan2024 to 19Jan2024.  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: Based on the known the information available the Causal relation between the events Vaccination failure, Covid 19 and suspect drug cannot be excluded completely
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis acute
Clinical narrative: acute pancreatitis; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 50-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATITIS ACUTE (medically significant), outcome "unknown", described as "acute pancreatitis". Clinical course: The patient asked, "Have you received reports connecting the Pfizer vaccine and pancreatitis?". The patient then stated, "I was 50 the first time I was diagnosed with acute pancreatitis, and it happened to come a feed days after my first vaccination. Since then, I have had several instances of this, and it has correlated with either boosters I received (all were Pfizer) or me getting the actual COVID virus. I am just curious if other Patients have experienced this, it has been painful and very expensive to try and figure out the cause."  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-202400028184 same vaccine/patient, different doses/events;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis
Clinical narrative: acute pancreatitis; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 50-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATITIS ACUTE (medically significant), outcome "unknown", described as "acute pancreatitis". Clinical course: The patient asked, "Have you received reports connecting the Pfizer vaccine and pancreatitis?". The patient then stated, "I was 50 the first time I was diagnosed with acute pancreatitis, and it happened to come a feed days after my first vaccination. Since then, I have had several instances of this, and it has correlated with either boosters I received (all were Pfizer) or me getting the actual COVID virus. I am just curious if other Patients have experienced this, it has been painful and very expensive to try and figure out the cause."  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-202400028184 same vaccine/patient, different doses/events;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis acute
Clinical narrative: Since then I have had several instances of this and it has correlated with either boosters I received (all were Pfizer) or me getting the actual COVID virus; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) 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 / biontech (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Pancreatitis acute".  The following information was reported: PANCREATITIS (medically significant), outcome "unknown", described as "Since then I have had several instances of this and it has correlated with either boosters I received (all were Pfizer) or me getting the actual COVID virus".  Clinical course: it has been asked whether there were reports connecting the Pfizer vaccine and pancreatitis. It was mentioned that patient was 50 the first time patient was diagnosed with acute pancreatitis and it happened to come a few days after patient's first vaccination. Since then, patient had several instances of this and it has correlated with either boosters the patient received (all were Pfizer) or patient getting the actual COVID virus. Patient was just curious if other patients have experienced this, it has been painful and very expensive to try and figure out the cause.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400027564 same vaccine/patient, diff doses/events;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis
Clinical narrative: Since then I have had several instances of this and it has correlated with either boosters I received (all were Pfizer) or me getting the actual COVID virus; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) 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 / biontech (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Pancreatitis acute".  The following information was reported: PANCREATITIS (medically significant), outcome "unknown", described as "Since then I have had several instances of this and it has correlated with either boosters I received (all were Pfizer) or me getting the actual COVID virus".  Clinical course: it has been asked whether there were reports connecting the Pfizer vaccine and pancreatitis. It was mentioned that patient was 50 the first time patient was diagnosed with acute pancreatitis and it happened to come a few days after patient's first vaccination. Since then, patient had several instances of this and it has correlated with either boosters the patient received (all were Pfizer) or patient getting the actual COVID virus. Patient was just curious if other patients have experienced this, it has been painful and very expensive to try and figure out the cause.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400027564 same vaccine/patient, diff doses/events;
Age: 57.0
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 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 17:45 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Calamine, reaction(s): "Allergy", notes: Only known allergies are to some topical medications (calamine lotion and mederma); Mederma, reaction(s): "Allergy", notes: Only known allergies are to some topical medications (calamine lotion and mederma). Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 17Jan2024 to 22Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 26.0
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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EWU161), on 07May2021 as dose 2, single (Lot number: EW0179) and on 18Dec2021 as dose 3 (booster), single (Lot number: 331308a) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history included: "Inflammatory arthritis" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: Apr2021; SULFASALAZINE, start date: Dec2021; LEFLUNOMIDE, start date: Jul2023. 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 15Jan2024 to 19Jan2024.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Peripheral swelling
Clinical narrative: Legs swollen; Abdominal swollen; 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)), 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Legs swollen"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "Abdominal swollen". Additional information: Patient stated, "I have been having an effects and I do not know if the effects are from the Pfizer vaccine or not, my legs swollen, my abdominal swollen and stuff like that, is that any of the side effects of it?"  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose: 1, 2 and 3: Pfizer/Dose: 4, 5 and 6: Moderna; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 at 12:00 as dose 4 (booster), single), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 09Sep2022 at 12:00 as dose 5 (booster), single), in left arm and on 29Sep2023 at 08:00 as dose 6 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ruptured intestine" (unspecified if ongoing); "sepsis" (unspecified if ongoing); "microvascular heart damage from sepsis" (unspecified if ongoing); "Known allergies: most antibiotics-penicillin, tetracyline, myacins" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 01Apr2021, stop date: 17Jan2024; ISOSORBIDE, start date: 01Apr2021, stop date: 29Jan2024; NORVASC, start date: 01Apr2021, stop date: 29Jan2024; BYSTOLIC, start date: 01Apr2021, stop date: 29Jan2024. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022 at 12:00, outcome "unknown", described as "Dose: 1, 2 and 3: Pfizer/Dose: 4, 5 and 6: Moderna"; 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 from 17Jan2024 to 22Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 48.0
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 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (batch/lot number: unknown) at the age of 48 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medications included: BONIVA, start date: 15Oct2022. Past drug history included: Compazine, reactions: "allergies". Vaccination history included: BNT162b2 (dose 1, location of injection arm right), administration date: 27Mar2021, when the patient was 45-year-old, for COVID-19 immunization; BNT162b2 (dose 2, location of injection arm right), administration date: 17Apr2021, when the patient was 45-year-old, for COVID-19 immunization; BNT162b2 (dose 3, location of injection arm left), administration date: 09Nov2021, when the patient was 46-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (dose 4, location of injection arm left), administration date: 07Oct2022, when the patient was 47-year-old, for COVID-19 immunization. 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 which included 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
Symptoms: Discomfort, Pain
Clinical narrative: felt pain; discomfort; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 81-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 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: PAIN (non-serious), outcome "unknown", described as "felt pain"; DISCOMFORT (non-serious), outcome "unknown".  Additional information: The caller and his wife got the Pfizer COVID-19 vaccine on 22Dec (as reported, also reported as "Dec2022"). They both felt pain and discomfort when they had it administered. The wife (patient) just pain and discomfort. Mentioned that they both felt pain and discomfort right after getting shot.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer.  A 49-year-old male patient received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had 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 Jan2024, outcome "recovered with sequelae" and all described as "COVID-19". Therapeutic measures were taken as a result of the events which included nirmatrelvir/ritonavir (PAXLOVID) from 11Jan2024 to 15Jan2024 as anti-viral treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Also states he received a pfizer covid shot Sep but got covid last monday anyway; Also states he received a pfizer covid shot Sep but got covid last monday anyway; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient 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 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 "Also states he received a pfizer covid shot Sep but got covid last monday anyway". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from last week and took his last dose on saturday  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: M
Vaccine: COVID19, COVID19-2
Symptoms: Autoimmune disorder, Interchange of vaccine products, Laboratory test
Clinical narrative: Autoimmune disease; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2023 as dose 5 (booster), single (Lot number: GL0087) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, Batch/Lot number: 025L20A), administration date: 19Jan2021, when the patient was 57-year-old, for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 2, SINGLE, Batch/Lot number: 030M20A), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 002F21A), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: 06K21A), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2023, outcome "unknown"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune disease". The patient underwent the following laboratory tests and procedures: Lab work: Unknown results, notes: Yes, I have had probably about 50. Therapeutic measures were taken as a result of autoimmune disorder. Clinical course: Patient took 4 Moderna shots. Patient now on steroids (Cortisone) as a treatment for autoimmune disease.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Arthralgia, Eye swelling, Mouth swelling, Multisystem inflammatory syndrome in adults, Swelling
Clinical narrative: Autoimmune disease; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2023 as dose 5 (booster), single (Lot number: GL0087) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, Batch/Lot number: 025L20A), administration date: 19Jan2021, when the patient was 57-year-old, for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 2, SINGLE, Batch/Lot number: 030M20A), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 002F21A), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: 06K21A), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2023, outcome "unknown"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune disease". The patient underwent the following laboratory tests and procedures: Lab work: Unknown results, notes: Yes, I have had probably about 50. Therapeutic measures were taken as a result of autoimmune disorder. Clinical course: Patient took 4 Moderna shots. Patient now on steroids (Cortisone) as a treatment for autoimmune disease.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Autoimmune disease; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2023 as dose 5 (booster), single (Lot number: GL0087) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, Batch/Lot number: 025L20A), administration date: 19Jan2021, when the patient was 57-year-old, for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 2, SINGLE, Batch/Lot number: 030M20A), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 002F21A), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: 06K21A), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2023, outcome "unknown"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune disease". The patient underwent the following laboratory tests and procedures: Lab work: Unknown results, notes: Yes, I have had probably about 50. Therapeutic measures were taken as a result of autoimmune disorder. Clinical course: Patient took 4 Moderna shots. Patient now on steroids (Cortisone) as a treatment for autoimmune disease.