chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, 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 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 16:15 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Chronic sinusitis" (unspecified if ongoing); "Hyperparathyroidism" (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; Covid-19 vaccine (DOSE 6 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: below normal; SARS-CoV-2 test: Negative, notes: Tested negative approximately day 8 or 9 of illness, symptoms had resolved. Therapeutic measures (Paxlovid treatment start date: 29Dec2023, stop date: 03Jan2024) were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 81.0
Sex: M
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.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2023 at 12:00 as dose 6, single (Lot number: GJ6739) at the age of 81 years, in left arm for covid-19 immunisation; BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 12:00 as dose 1, single (Lot number: HG4677), 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: BNT162b2 (Dose Number: 1, Batch/Lot No: PAA156051, Vaccine Administration Time: 12:00 PM), administration date: 17Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: PAA165969, Location of injection: Arm Lef, Vaccine Administration Time: 12:00 PM), administration date: 10Mar2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FF250, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 08Oct2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 4, Batch/Lot No: FK9894, Location of injection: Arm Left), administration date: 20Apr2022, when the patient was 80-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2023) Positive. Therapeutic measures included Paxlovid from 30Dec2023 to 05Jan2024 were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400012192 same patient/drug, different event;
Sex: F
Vaccine: RSV
Symptoms: Asthma, Immunodeficiency, Oral disorder, Respiratory disorder
Clinical narrative: Immunocompromised; about to have oral surgeries; asthma; advanced airway disease; This is a spontaneous report received from a Consumer or other non HCP.  A 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 and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "Immunocompromised"; ORAL DISORDER (medically significant), outcome "unknown", described as "about to have oral surgeries"; ASTHMA (non-serious), outcome "unknown"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "advanced airway disease". Clinical course: The patient called in seeking assistance with the Abrysvo vaccine. During the call she stated the cost for her was just shy of (Dollar) 700 dollar's to go to the pharmacy and get those prescriptions, she has asthma, advanced airway disease and she's immunocompromised in another way and she's about to have oral surgeries.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 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. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid from 18Dec2023 to 23Dec2023. Clinical Course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; 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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (Jan2024) Never tested fully negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 02Jan2024 to 07Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 51.0
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 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HG4664) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:03, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:04, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19. Patient received Paxlovid from 31Dec2023 till 04Jan2024 for treatment of COVID-19.  No follow-up attempts are possible.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, 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 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Aug2023 at 12:00 as dose 4 (booster), single at the age of 67 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lethargy, Paranasal sinus discomfort, Rhinorrhoea, SARS-CoV-2 test, Throat irritation
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Aug2023 at 12:00 as dose 4 (booster), single at the age of 67 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure; Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure; Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure; Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Aug2023 at 12:00 as dose 4 (booster), single (Lot number: GK0928) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, on 19Aug2023. The following information was reported: PARANASAL SINUS DISCOMFORT (non-serious), LETHARGY (non-serious), THROAT IRRITATION (non-serious), RHINORRHOEA (non-serious) all with onset 22Aug2023 at 07:00, outcome "not recovered" and all described as "Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure". The event "long vax syndrome. lethargy, scratchy throat, runny nose, sinus pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paranasal sinus discomfort, lethargy, throat irritation, rhinorrhoea.  Additional information: Patient had no drug allergy.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lethargy, Paranasal sinus discomfort, Rhinorrhoea, SARS-CoV-2 test, Throat irritation
Clinical narrative: Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure; Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure; Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure; Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Aug2023 at 12:00 as dose 4 (booster), single (Lot number: GK0928) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, on 19Aug2023. The following information was reported: PARANASAL SINUS DISCOMFORT (non-serious), LETHARGY (non-serious), THROAT IRRITATION (non-serious), RHINORRHOEA (non-serious) all with onset 22Aug2023 at 07:00, outcome "not recovered" and all described as "Long vax syndrome. Lethargy, scratchy throat, runny nose, sinus pressure". The event "long vax syndrome. lethargy, scratchy throat, runny nose, sinus pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paranasal sinus discomfort, lethargy, throat irritation, rhinorrhoea.  Additional information: Patient had no drug allergy.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had sore arm; This is a spontaneous report received from a Consumer or other non-HCP. The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 (between 10am and 11am) as DOSE 5 (BOOSTER), SINGLE (lot number: GJ3275, expiration date: 20Dec2022) at the age of 77 years, administered in the left deltoid for COVID-19 immunization. The patient's relevant medical history included: "Mild hypertension" (ongoing), notes: Thinks in 2006, Mild hypertension is under control and has been; "GERD" (ongoing), notes: From 2010 or 2011. Concomitant medication(s) included: CANDESARTAN oral taken for hypertension (ongoing); NEXIUM [ESOMEPRAZOLE SODIUM] oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (first dose (lot number: EN6206) via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 1, SINGLE), administration date: 03Mar2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "had sore arm"; BNT162b2 (2nd dose (lot number: ER8730; expiry date: 31Jul2021) via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 2, 0.3mL SINGLE), administration date: 01Apr2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "had sore arm"; BNT162b2 (3rd dose (lot number: FH8020), via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 3 (BOOSTER), SINGLE), administration date: 28Oct2021, when the patient was 76 years old, for COVID-19 immunization, reaction(s): "had sore arm"; BNT162b2 (4th dose (lot number: FM9992), via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 4 (BOOSTER), SINGLE), administration date: 12Jul2022, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "had sore arm." The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown" described as "had sore arm."  Additional information: Caller never really had problems with the vaccine, had sore arm, trying to be positive, had no real issues, stating some people got ill but caller did okay with vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400011049 same patient, different vaccine dose, and similar events.;
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had sore arm; This is a spontaneous report received from a Consumer or other non-HCP. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 12Jul2022 (between 10am and 11am) as DOSE 4 (BOOSTER), SINGLE (lot number: FM9992) at the age of 77 years, administered in the left deltoid for COVID-19 immunization. The patient's relevant medical history included: "Mild hypertension" (ongoing), notes: Thinks in 2006, Mild hypertension is under control and has been; "GERD" (ongoing), notes: From 2010 or 2011. Concomitant medication(s) included: CANDESARTAN oral taken for hypertension (ongoing); NEXIUM [ESOMEPRAZOLE SODIUM] oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (first dose (lot number: EN6206) via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 1, SINGLE), administration date: 03Mar2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "had sore arm"; BNT162b2 (2nd dose (lot number: ER8730; expiry date: 31Jul2021) via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 2, 0.3mL SINGLE), administration date: 01Apr2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "had sore arm"; BNT162b2 (3rd dose (lot number: FH8020), via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 3 (BOOSTER), SINGLE), administration date: 28Oct2021, when the patient was 76 years old, for COVID-19 immunization, reaction(s): "had sore arm." The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown" described as "had sore arm."  Additional information: Caller never really had problems with the vaccine, had sore arm, trying to be positive, had no real issues, stating some people got ill but caller did okay with vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400011049 same patient, different vaccine dose, and similar events.;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: had sore arm; Patient received the third dose of BNT162b2 210 days from second dose; This is a spontaneous report received from a Consumer or other non-HCP. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 (between 10am and 11am) as DOSE 3 (BOOSTER), SINGLE (lot number: FH8020) at the age of 76 years, administered in the left deltoid for COVID-19 immunization. The patient's relevant medical history included: "Mild hypertension" (ongoing), notes: Thinks in 2006, Mild hypertension is under control and has been; "GERD" (ongoing), notes: From 2010 or 2011. Concomitant medication(s) included: CANDESARTAN oral taken for hypertension (ongoing); NEXIUM [ESOMEPRAZOLE SODIUM] oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (first dose (lot number: EN6206) via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 1, SINGLE), administration date: 03Mar2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "had sore arm"; BNT162b2 (2nd dose (lot number: ER8730; expiry date: 31Jul2021) via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 2, 0.3mL SINGLE), administration date: 01Apr2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "had sore arm." The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Oct2021, outcome "unknown" described as "Patient received the third dose of BNT162b2 210 days from second dose"; PAIN IN EXTREMITY (non-serious), outcome "unknown" described as "had sore arm."  Additional information: Caller never really had problems with the vaccine, had sore arm, trying to be positive, had no real issues, stating some people got ill but caller did okay with vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400011049 same patient, different vaccine dose, and similar events.;
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had sore arm; This is a spontaneous report received from a Consumer or other non-HCP. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 (between 10am and 11am) as DOSE 2, SINGLE (lot number: ER8730 and expiration date: 31Jul2021) at the age of 75 years, administered in the left deltoid for COVID-19 immunization. The patient's relevant medical history included: "Mild hypertension" (ongoing), notes: Thinks in 2006, Mild hypertension is under control and has been; "GERD" (ongoing), notes: From 2010 or 2011. Concomitant medication(s) included: CANDESARTAN oral taken for hypertension (ongoing); NEXIUM [ESOMEPRAZOLE SODIUM] oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (first dose (lot number: EN6206) via an unspecified route of administration, administered in the left deltoid, always between 10am and 11am, as DOSE 1, SINGLE), administration date: 03Mar2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "had sore arm." The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown" described as "had sore arm."  Additional information: Caller never really had problems with the vaccine, had sore arm, trying to be positive, had no real issues, stating some people got ill but caller did okay with vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400011049 same patient, different vaccine dose, and similar events.;
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had sore arm; This is a spontaneous report received from a Consumer or other non-HCP. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 (between 10am and 11am) as DOSE 1, SINGLE (lot number: EN6206) at the age of 75 years, administered in the left deltoid for COVID-19 immunization. The patient's relevant medical history included: "Mild hypertension" (ongoing), notes: Thinks in 2006, Mild hypertension is under control and has been; "GERD" (ongoing), notes: From 2010 or 2011. Concomitant medication(s) included: CANDESARTAN oral taken for hypertension (ongoing); NEXIUM [ESOMEPRAZOLE SODIUM] oral taken for gastrooesophageal reflux disease (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown" described as "had sore arm."  Additional information: Caller never really had problems with the vaccine, had sore arm, trying to be positive, had no real issues, stating some people got ill but caller did okay with vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400011049 same patient, different vaccine dose, and similar events.;
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour, Preterm premature rupture of membranes, Twin pregnancy
Clinical narrative: Protonix//Pregnancy With di/di twins; water broke and labor stated day after vaccine given; water broke and labor stated day after vaccine given; water broke and labor stated day after vaccine given; This is a spontaneous report received from an Other HCP from Regulatory Authority. Regulatory number: 2699929-1 (VAERS ID).  A 25-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 21Oct2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for immunisation; pantoprazole (PROTONIX); folic acid, iron (PRENATAL [FOLIC ACID;IRON]); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) at 81 mg; doxylamine succinate (UNISOM [DOXYLAMINE SUCCINATE]). The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver two baby(s) on 21Nov2023. The patient's concomitant medications were not reported.  The following information was reported: PREMATURE DELIVERY (hospitalization), PREMATURE LABOUR (hospitalization), PRETERM PREMATURE RUPTURE OF MEMBRANES (hospitalization) all with onset 22Oct2023, outcome "unknown" and all described as "water broke and labor stated day after vaccine given"; MATERNAL EXPOSURE DURING PREGNANCY (hospitalization), outcome "unknown", described as "Protonix//Pregnancy With di/di twins". The first baby was delivered premature, delivery date 22Oct2023. The baby weighed 2010 grams. The second baby was delivered premature, delivery date 22Oct2023. The baby weighed 2211 grams. The action taken for pantoprazole, folic acid, iron, aspirin [acetylsalicylic acid] and doxylamine succinate was unknown.  Additional information: Vaccine administered by Pharmacy. The HCP reported pre-term delivery. Pregnancy with di/di twins, no complications noted throughout pregnancy. Water broke and labor started day after vaccine given. Was set to deliver 38Week 2 day on XXNov2023. Delivered at 34week O day. Baby A birth weight 41b 70z Baby B birth weight 41b 140z. The HCP assessed the case as serious due to hospitalization with unknown days in hospital. No death, non-life threatening, no permanent disability, no, congenital anomaly/birth defect, no existing hospitalization prolonged, no emergency room visit and no office visit.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: events added - LLT: Preterm Premature Rupture Of Membranes; LLT: Premature delivery and LLT: Premature labour. The case has been upgraded to Serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400003718 baby A case;US-PFIZER INC-202400003720 baby B Case;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got covid shot but she still tested positive for Covid; got covid shot but she still tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 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 "not recovered" and all described as "got covid shot but she still tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: she got covid shot but she still tested positive for Covid.  Clinical course: Caller would like to know if it safe to take Paxlovid while taking Eliquis. Caller said even his wife got Covid shot before she still tested positive for Covid.  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: Chronic graft versus host disease
Clinical narrative: new onset oral and skin cGVHD; This is a literature report.  A 74-year-old male with primary myelofibrosis underwent allogeneic hematopoietic stem cell transplant (HCT) from matched unrelated donor in March of 2020 (post-HCT 10 months). He did well without acute or Graft-versus-host disease (cGVHD). He received first dose of Pfizer vaccine in January 2021. He had no side effect after the first vaccine shot (as reported). Two weeks following the first dose of vaccine he developed mouth soreness with moderate to severe buccal and palatal mucosal erythema. Oral changes were accompanied by macular erythematous rash. He was on gradual taper of dose of tacrolimus at that time. For new onset oral and skin cGVHD, he was started on prednisone and ruxolitinib. He was able to come off prednisone and now on tacrolimus and ruxolitinib. Although not an FDA indication, ruxolitinib is often started in first-line de novo cGVHD in severe cases or in patients with perceived poor tolerability of corticosteroids.  The author reported the case of oral manifestations that may have been stimulated by COVID-19 or vaccination with Pfizer. Author believed it was the first to report oral changes driven by an inflammatory/immune mechanism leading to oral symptomatic cGVHD. The clinical impact of this case was early recognition and appropriate management of oral symptomatic cGVHD following COVID-19 disease or SARS-CoV-2 vaccination. In this case, patient had oral, skin changes, suggesting relation to vaccination. Withholding immunosuppression taper during and immediately after COVID-19 vaccination will probably be helpful to prevent new or worsening GVHD. The case suggested that host response to SARS-CoV-2 vaccination can lead to de novo presentation of oral immune conditions not previously identified (or activation of prior oral GVHD).   No follow-up attempts are possible.; Sender's Comments: The event chronic graft versus host disease is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202400008833 Same article/drug and different patient /event;US-PFIZER INC-202400008845 Same article/drug and different patient /event;US-PFIZER INC-202400008824 Same article/patient/drug and different event;
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone, Physical examination, Scan thyroid gland, Thyroid stimulating immunoglobulin
Clinical narrative: Subacute Thyroiditis due to SARS-CoV-2 Vaccine; This is a literature report.  A 39-year-old male healthcare worker presented with four weeks history of symptoms: fullness of the anterior neck, odynophagia, enlarged cervical lymph nodes, palpitations, anxiety and weight loss. Onset of symptoms was two days the second dose of Pfizer-BioNTech vaccine. There was no recent history of upper respiratory system infection or COVID-19 infection. Vital signs and physical exam findings were unavailable, as it was a telephone encounter. Initial workup was significant for a TSH of 0. 020 uIU/mL (n 0.45-5.330 uIU/mL), free T4 of 2.42 ng/mL (n 0.45-1.80 ng/mL) and total T3 225.4 pg/mL (n 87-179 pg/mL). There was no evidence of leukocytosis. Ultrasound of the thyroid gland was unremarkable for nodules or hyperemia. Autoimmune thyroid disease was ruled out with negative levels of thyroid stimulating immunoglobulin, thyroid receptor antibody and anti-microsomal antibody. Thyroid scintigraphy was significant for abnormally low uptake, consistent with SAT. Clinical and biochemical improvements (TSH 4.193 uIU/mL; free T4 0.98 ng/dL) were seen after 5 months. Conclusion: Subacute thyroiditis (SAT) is an acute inflammatory disorder of the thyroid usually related to a viral infection. It was described in total of 27 patients of COVID-19 infection. There are only a handful of cases related to COVID-19 vaccine and most of them are due to the inactivated vaccine. To the authors' knowledge, there are only three documented cases of subacute thyroiditis after receiving the Pfizer mRNA vaccine. The pathophysiology in generating an autoimmune response is believed to be due to molecular mimicry and cross recognition between the coronavirus spike protein targeted with the mRNA vaccine and healthy thyroid cell antigens. Clinicians should be alert and consider the possibility of SARS-CoV-2 vaccine as an etiology when evaluating patients for subacute thyroiditis.; Sender's Comments: The event Thyroiditis subacute is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Thyroiditis subacute, Thyroxine free, Tri-iodothyronine, Ultrasound thyroid, Vital signs measurement
Clinical narrative: Subacute Thyroiditis due to SARS-CoV-2 Vaccine; This is a literature report.  A 39-year-old male healthcare worker presented with four weeks history of symptoms: fullness of the anterior neck, odynophagia, enlarged cervical lymph nodes, palpitations, anxiety and weight loss. Onset of symptoms was two days the second dose of Pfizer-BioNTech vaccine. There was no recent history of upper respiratory system infection or COVID-19 infection. Vital signs and physical exam findings were unavailable, as it was a telephone encounter. Initial workup was significant for a TSH of 0. 020 uIU/mL (n 0.45-5.330 uIU/mL), free T4 of 2.42 ng/mL (n 0.45-1.80 ng/mL) and total T3 225.4 pg/mL (n 87-179 pg/mL). There was no evidence of leukocytosis. Ultrasound of the thyroid gland was unremarkable for nodules or hyperemia. Autoimmune thyroid disease was ruled out with negative levels of thyroid stimulating immunoglobulin, thyroid receptor antibody and anti-microsomal antibody. Thyroid scintigraphy was significant for abnormally low uptake, consistent with SAT. Clinical and biochemical improvements (TSH 4.193 uIU/mL; free T4 0.98 ng/dL) were seen after 5 months. Conclusion: Subacute thyroiditis (SAT) is an acute inflammatory disorder of the thyroid usually related to a viral infection. It was described in total of 27 patients of COVID-19 infection. There are only a handful of cases related to COVID-19 vaccine and most of them are due to the inactivated vaccine. To the authors' knowledge, there are only three documented cases of subacute thyroiditis after receiving the Pfizer mRNA vaccine. The pathophysiology in generating an autoimmune response is believed to be due to molecular mimicry and cross recognition between the coronavirus spike protein targeted with the mRNA vaccine and healthy thyroid cell antigens. Clinicians should be alert and consider the possibility of SARS-CoV-2 vaccine as an etiology when evaluating patients for subacute thyroiditis.; Sender's Comments: The event Thyroiditis subacute is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Subacute Thyroiditis due to SARS-CoV-2 Vaccine; This is a literature report.  A 39-year-old male healthcare worker presented with four weeks history of symptoms: fullness of the anterior neck, odynophagia, enlarged cervical lymph nodes, palpitations, anxiety and weight loss. Onset of symptoms was two days the second dose of Pfizer-BioNTech vaccine. There was no recent history of upper respiratory system infection or COVID-19 infection. Vital signs and physical exam findings were unavailable, as it was a telephone encounter. Initial workup was significant for a TSH of 0. 020 uIU/mL (n 0.45-5.330 uIU/mL), free T4 of 2.42 ng/mL (n 0.45-1.80 ng/mL) and total T3 225.4 pg/mL (n 87-179 pg/mL). There was no evidence of leukocytosis. Ultrasound of the thyroid gland was unremarkable for nodules or hyperemia. Autoimmune thyroid disease was ruled out with negative levels of thyroid stimulating immunoglobulin, thyroid receptor antibody and anti-microsomal antibody. Thyroid scintigraphy was significant for abnormally low uptake, consistent with SAT. Clinical and biochemical improvements (TSH 4.193 uIU/mL; free T4 0.98 ng/dL) were seen after 5 months. Conclusion: Subacute thyroiditis (SAT) is an acute inflammatory disorder of the thyroid usually related to a viral infection. It was described in total of 27 patients of COVID-19 infection. There are only a handful of cases related to COVID-19 vaccine and most of them are due to the inactivated vaccine. To the authors' knowledge, there are only three documented cases of subacute thyroiditis after receiving the Pfizer mRNA vaccine. The pathophysiology in generating an autoimmune response is believed to be due to molecular mimicry and cross recognition between the coronavirus spike protein targeted with the mRNA vaccine and healthy thyroid cell antigens. Clinicians should be alert and consider the possibility of SARS-CoV-2 vaccine as an etiology when evaluating patients for subacute thyroiditis.; Sender's Comments: The event Thyroiditis subacute is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: Mild injection site pain/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue; Mild malaise/feeling sick; Mild muscle pain; Joint pain; Mild nausea/vomiting or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting or 1-2 episodes of nausea/vomiting; Headache; 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild injection site pain/ Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; PYREXIA (non-serious), outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "Mild nausea/vomiting or 1-2 episodes of nausea/vomiting"; HEADACHE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: All events had no interference with activity.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild injection site pain/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue; Mild malaise/feeling sick; Mild muscle pain; Joint pain; Mild nausea/vomiting or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting or 1-2 episodes of nausea/vomiting; Headache; 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild injection site pain/ Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; PYREXIA (non-serious), outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "Mild nausea/vomiting or 1-2 episodes of nausea/vomiting"; HEADACHE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: All events had no interference with activity.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Mild injection site pain/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue; Mild malaise/feeling sick; Mild muscle pain; Joint pain; Mild nausea/vomiting or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting or 1-2 episodes of nausea/vomiting; Headache; 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild injection site pain/ Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; PYREXIA (non-serious), outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "Mild nausea/vomiting or 1-2 episodes of nausea/vomiting"; HEADACHE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: All events had no interference with activity.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Vaccination site movement impairment
Clinical narrative: 2-Moderate injection site pain interfering with activity/2-Moderate injection site tenderness (tenderness with movement); 2-Moderate injection site pain interfering with activity/2-Moderate injection site tenderness (tenderness with movement); 1-Mild injection site swelling; 2-Moderate fatigue with some interference with activity; 1-Mild malaise/feeling sick and no interference with activity; 1-Mild muscle pain and no interference with activity; 2-Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; 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)), in Dec2023 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 SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild muscle pain and no interference with activity"; HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "2-Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) all with onset Dec2023, outcome "unknown" and all described as "2-Moderate injection site pain interfering with activity/2-Moderate injection site tenderness (tenderness with movement)". Therapeutic measures were taken as a result of headache.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.