chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Mental disorder, Pain, Tinnitus
Clinical narrative: 1st Dose Covid-19 on 05Aug2021;2nd Dose Covid-19 on 21Aug2023; bi-polar and mood disorder; suffers headaches/non-stop headaches; constant ears are ringing; it hurts/ pain on walking; my monthly Menstruation stopped; suffers from mental health; depression; 5'9" is fading away by weight loss; suffer hair loss; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49-year-old female patient received bnt162b2 (BNT162B2), on 21Aug2021 as dose 2, single (Lot number: FA7485) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No.: FA7484), administration date: 05Aug2021, when the patient was 48-year-old, for COVID-19 immunisation. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "5'9" is fading away by weight loss"; BIPOLAR DISORDER (medically significant) with onset 2021, outcome "unknown", described as "bi-polar and mood disorder"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "constant ears are ringing"; DEPRESSION (non-serious) with onset 2021, outcome "unknown"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "it hurts/ pain on walking"; AMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "my monthly Menstruation stopped"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "suffer hair loss"; MENTAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "suffers from mental health"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "suffers headaches/non-stop headaches"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Aug2021, outcome "unknown", described as "1st Dose Covid-19 on 05Aug2021;2nd Dose Covid-19 on 21Aug2023". The patient underwent the following laboratory tests and procedures: Weight: Loss, notes: 5'9" is fading away by weight loss; 130. Clinical course: She got sick for a whole month after she was forced to take the Pfizer vaccination on Aug2021. She was disabled.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300305019 same reporter/product, diff event/patient;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: 1st Dose Covid-19 on 05Aug2021;2nd Dose Covid-19 on 21Aug2023; bi-polar and mood disorder; suffers headaches/non-stop headaches; constant ears are ringing; it hurts/ pain on walking; my monthly Menstruation stopped; suffers from mental health; depression; 5'9" is fading away by weight loss; suffer hair loss; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49-year-old female patient received bnt162b2 (BNT162B2), on 21Aug2021 as dose 2, single (Lot number: FA7485) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No.: FA7484), administration date: 05Aug2021, when the patient was 48-year-old, for COVID-19 immunisation. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "5'9" is fading away by weight loss"; BIPOLAR DISORDER (medically significant) with onset 2021, outcome "unknown", described as "bi-polar and mood disorder"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "constant ears are ringing"; DEPRESSION (non-serious) with onset 2021, outcome "unknown"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "it hurts/ pain on walking"; AMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "my monthly Menstruation stopped"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "suffer hair loss"; MENTAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "suffers from mental health"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "suffers headaches/non-stop headaches"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Aug2021, outcome "unknown", described as "1st Dose Covid-19 on 05Aug2021;2nd Dose Covid-19 on 21Aug2023". The patient underwent the following laboratory tests and procedures: Weight: Loss, notes: 5'9" is fading away by weight loss; 130. Clinical course: She got sick for a whole month after she was forced to take the Pfizer vaccination on Aug2021. She was disabled.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300305019 same reporter/product, diff event/patient;
Sex: F
Vaccine: UNK
Symptoms: Drug interaction, International normalised ratio increased
Clinical narrative: interactions with coumadin; INR increased; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received pf-06928316 (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; warfarin sodium (COUMADIN), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "interactions with coumadin"; INTERNATIONAL NORMALISED RATIO INCREASED (non-serious), outcome "unknown", described as "INR increased". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for warfarin sodium was unknown. Additional information: Patient was on coumadin and her INR was increased the week after receiving the vaccine. The reporter was asking if there any interactions with coumadin. Her dose has always been the same historically but he doesn't know the dose.  The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Ear discomfort, Swollen tongue
Clinical narrative: anaphylaxis; my tongue blew up; had trouble breathing; pain in my chest; ears were blocked; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "sulfites, artificial color, and preservatives." (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine, for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "recovered", described as "anaphylaxis"; SWOLLEN TONGUE (non-serious), outcome "unknown", described as "my tongue blew up"; DYSPNOEA (non-serious), outcome "unknown", described as "had trouble breathing"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in my chest"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "ears were blocked". The patient had anaphylaxis the night after she took Prevnar 20. That subsided. And at night, her tongue blew up and she had trouble breathing in with some pain in her chest and her ears were blocked. She've taken the Pfizer COVID vaccine with no problem with that. She was allergic to sulfites and some artificial color and preservatives. She was asking what is in Prevnar 20, if there was aluminum in Prevnar 20 and what was the aluminum used for.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxious about vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE. Vaccination history included: Covid-19 vaccine ( unknown manufacturer), for COVID-19 immunization. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "anxious about vaccination". The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 18Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Patient suffered cardiac arrest 30Mar2021 died 04Apr2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 46-year-old male patient received bnt162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: CARDIAC ARREST (death, hospitalization) with onset 30Mar2021, outcome "fatal", described as "Patient suffered cardiac arrest 30Mar2021 died 04Apr2021". The patient was hospitalized for cardiac arrest (hospitalization duration: 5 day(s)). The patient date of death was 04Apr2021. Reported cause of death: "Patient suffered cardiac arrest 30Mar2021 died 04Apr2021". It was not reported if an autopsy was performed.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Patient suffered cardiac arrest 30Mar2021 died 04Apr2021
Age: 49.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pain, Vaccination site pain
Clinical narrative: generalized body aches the following morning; Injection site pain within a few hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2023 at 16:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm. The patient had no relevant medical history. Concomitant medication(s) included: MAGNESIUM CITRATE; CO-Q10-CHLORELLA; MULTIVITAMIN [VITAMINS NOS]; FISH OIL. Vaccination history included: Covid-19 vaccine (Dose: 1-4, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Sep2023 at 20:00, outcome "recovering", described as "Injection site pain within a few hours"; PAIN (non-serious) with onset 19Sep2023, outcome "recovering", described as "generalized body aches the following morning". Therapeutic measures were not taken as a result of vaccination site pain, pain.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious), outcome "recovered". It was unknown if therapeutic measures were taken as a result of migraine. Additional information: Pharmacy Technician reported migraine following administration of second dose of original Comirnaty formulation (ca. early-2021). Serious was No. Seriousness criteria-Results in death was No. Seriousness criteria-Life threatening was No. Seriousness criteria-Caused/prolonged hospitalization was No. Seriousness criteria-Disabling/Incapacitating was No. Seriousness criteria-Congenital anomaly/birth defect was No. If COVID prior vaccination was Unknown. if COVID tested post vaccination was Unknown.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Nausea, Wrong product administered
Clinical narrative: Shaking chills; nausea; tired; couldn't sleep; Wrong vaccine administered; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 18Sep2023 as dose 5 (booster), single (Lot number: HP9275) at the age of 48 years, in left arm for covid-19 immunisation. The patient didn't receive bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, Manufacturer Unknown), for COVID-19 immunization.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 18Sep2023, outcome "unknown", described as "Wrong vaccine administered"; CHILLS (non-serious) with onset 18Sep2023 at 22:30, outcome "recovering", described as "Shaking chills"; INSOMNIA (non-serious) with onset 18Sep2023 at 22:30, outcome "recovering", described as "couldn't sleep"; NAUSEA (non-serious) with onset 18Sep2023 at 22:30, outcome "recovering"; FATIGUE (non-serious) with onset 18Sep2023 at 22:30, outcome "recovering", described as "tired". Therapeutic measures were taken as a result of chills, nausea, fatigue, insomnia.  Additional information: AE treatment: Extra strength Tylenol  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: generalized body aches the next morning; Pain at injection site within a few hours; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2023 at 16:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Sep2023 at 20:00, outcome "recovering", described as "Pain at injection site within a few hours"; PAIN (non-serious) with onset 19Sep2023, outcome "recovering", described as "generalized body aches the next morning". Therapeutic measures were not taken as a result of vaccination site pain, pain.   Additional information: Patient has no known allergies. Patient did not receive other vaccine in four weeks. Other medications in two weeks included statin.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 70 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Primary Lateral Sclerosis" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Gadolinium agents allergy" (unspecified if ongoing). Concomitant medication(s) included: BACLOFEN, start date: 01Dec2019, stop date: 19Sep2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Anti-viral details: Paxlovid (full 5 days) was received in Sep2023 for COVID 19 Treatment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GJ3277) for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EWG201), on 12Mar2021 as dose 2, single (Lot number: 6203), on 28Sep2021 as dose 3 (booster), single (Lot number: FF8841) and as dose 4 (booster), single (Lot number: FM9992) 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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 from 09Sep2023 till 13Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300304837 same patient, different drug/events;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "seizures" (unspecified if ongoing). Concomitant medication(s) included: CARBAMAZEPINE; TEGRETOL taken for seizure. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 18Sep2023. Clinical course: he developed a covid infection and his doctor put him on comirnaty (as reported).   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1: Pfizer/Dose 2: Pfizer/Dose 3: Pfizer/Dose 4: Moderna/Dose 5: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 31Jul2021 as dose 2, single (Lot number: EW0161), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25May2022 as dose 4 (booster), single (Lot number: 059M21A), in left arm and on 21Sep2022 as dose 5 (booster), single (Lot number: AS7163B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "borderline hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2018; METOPROLOL, start date: Jan2018; ACETYLSALICYLIC ACID, start date: Jan2018. No known allergy.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25May2022, outcome "unknown", described as "Dose 1: Pfizer/Dose 2: Pfizer/Dose 3: Pfizer/Dose 4: Moderna/Dose 5: Moderna"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Sep2023, outcome "unknown" and all described as "COVID 19 Treatment" including Paxlovid from 04Sep2023 to 09Sep2023. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Sep2023) Positive.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood cortisol, Blood glucose, COVID-19, Drug ineffective, Oxygen saturation
Clinical narrative: he still got Covid; he still got Covid; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "high stress" (unspecified if ongoing); "cortisol being high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he still got Covid". The patient underwent the following laboratory tests and procedures: Blood cortisol: High; Blood glucose: High; Oxygen saturation: 94 %; SARS-CoV-2 antibody test: greater than 250; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 17Sep2023.  Clinical course: He developed general muscle ache, weakness and sore throat. When he took a test it was so black line which means that he has a high viral load. He has a CGM (continuous glucose monitor) and insulin pump, and even though he's not really eating anything, due to the high stress and cortisol being high, his blood sugar is high.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccines BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: he still got Covid; he still got Covid; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "high stress" (unspecified if ongoing); "cortisol being high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he still got Covid". The patient underwent the following laboratory tests and procedures: Blood cortisol: High; Blood glucose: High; Oxygen saturation: 94 %; SARS-CoV-2 antibody test: greater than 250; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 17Sep2023.  Clinical course: He developed general muscle ache, weakness and sore throat. When he took a test it was so black line which means that he has a high viral load. He has a CGM (continuous glucose monitor) and insulin pump, and even though he's not really eating anything, due to the high stress and cortisol being high, his blood sugar is high.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccines BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller had all the covid-19 vaccine shot, He mentioned that this is his 2nd Covid/has sinus and chest symtoms; Caller had all the covid-19 vaccine shot, He mentioned that this is his 2nd Covid/has sinus and chest symtoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: loss of taste, fatigue and intense chill. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller had all the covid-19 vaccine shot, He mentioned that this is his 2nd Covid/has sinus and chest symtoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment included Paxlovid.  Clinical course: Caller had all the covid-19 vaccine shot and just started Paxlovid yesterday because he still tested positive. He would like to know whats going on. The patient started Paxlovid yesterday because he tested positive for Covid. He currently has metallic taste as a side effect. He mentioned that this is his 2nd Covid and it's not like his 1st Covid when he experienced loss of taste, fatigue and intense chill. He says he only has sinus and chest symtoms, no loss of taste and smell with the 2nd Covid. He said he is like a guinea pig for this medication and so he wants to know why is he still positive with Covid and need information about the metallic taste too. He is also asking if Comirnaty or the Pfizer Covid vaccine is going to be an annual thing like flu shots. Advised him that Paxlovid is indicated for the treatment of mild-to-moderate (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. The goal of the medication is not to result in a negative test necessarily but to prevent hospitalization from Covid in high-risk patients.  Also told him that altered sense of taste or that metallic taste he is experiencing is one of the most common side effects reported for Paxlovid.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 3 (booster), single (Lot number: GJ6789) at the age of 65 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19 as Paxlovid from 09Sep2023 to 14Sep2023.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) and in Jun2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), in Oct2021 as dose 1, single (Batch/Lot number: unknown) and in Feb2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Allergy: Sulfa antibiotics" (unspecified if ongoing); "Allergy: mussels" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) negative, notes: Positive COVID-19 rapid antigen test result on 19Sep2023. Test result was negative on morning of 18Sep2023; (19Sep2023) Positive, notes: Positive COVID-19 rapid antigen test result on 19Sep2023. Test result was negative on morning of 18Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300305354 same reporter/patient, different dose/AE;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL0140), on 18Jan2021 as dose 2, single (Lot number: EL3246) and on 14Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Sep2022 as dose 4 (booster), single (Lot number: A57145B) for covid-19 immunisation. The patient's relevant medical history included: "Congenital pulmonic stenosis" (unspecified if ongoing); "arrhythmia (PVCs with occasional NSVT)" (unspecified if ongoing); "mild URI induced asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction: "Drug Allergy: Erythromycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19".  Therapeutic measures were taken as a result of vaccination failure, covid-19 included PAXLOVID from 06Sep2023 to 10Sep2023.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Brain fog, Immune system disorder, Lethargy
Clinical narrative: brain fog; complete lethargy; couldn't think or organize; can't pick up feet to move; can't say words; can't remember words; Blood pressure is up; very sensitive to heat or humid in summer and could not go outside; very sensitive to heat or humid in summer and could not go outside; immune system was all screwed up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose number unknown, 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: BRAIN FOG (non-serious), outcome "unknown"; LETHARGY (non-serious), outcome "unknown", described as "complete lethargy"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "couldn't think or organize"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "can't pick up feet to move"; SPEECH DISORDER (non-serious), outcome "unknown", described as "can't say words"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "can't remember words"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure is up"; TEMPERATURE INTOLERANCE (non-serious), SENSITIVE SKIN (non-serious), outcome "unknown" and all described as "very sensitive to heat or humid in summer and could not go outside"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system was all screwed up". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: reporter said she has 2 friends who are experiencing the same reactions, this patient is a long hauler for 3 years now.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Memory impairment, Movement disorder, Sensitive skin, Speech disorder, Temperature intolerance
Clinical narrative: brain fog; complete lethargy; couldn't think or organize; can't pick up feet to move; can't say words; can't remember words; Blood pressure is up; very sensitive to heat or humid in summer and could not go outside; very sensitive to heat or humid in summer and could not go outside; immune system was all screwed up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose number unknown, 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: BRAIN FOG (non-serious), outcome "unknown"; LETHARGY (non-serious), outcome "unknown", described as "complete lethargy"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "couldn't think or organize"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "can't pick up feet to move"; SPEECH DISORDER (non-serious), outcome "unknown", described as "can't say words"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "can't remember words"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure is up"; TEMPERATURE INTOLERANCE (non-serious), SENSITIVE SKIN (non-serious), outcome "unknown" and all described as "very sensitive to heat or humid in summer and could not go outside"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system was all screwed up". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: reporter said she has 2 friends who are experiencing the same reactions, this patient is a long hauler for 3 years now.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: brain fog; complete lethargy; couldn't think or organize; can't pick up feet to move; can't say words; can't remember words; Blood pressure is up; very sensitive to heat or humid in summer and could not go outside; very sensitive to heat or humid in summer and could not go outside; immune system was all screwed up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose number unknown, 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: BRAIN FOG (non-serious), outcome "unknown"; LETHARGY (non-serious), outcome "unknown", described as "complete lethargy"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "couldn't think or organize"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "can't pick up feet to move"; SPEECH DISORDER (non-serious), outcome "unknown", described as "can't say words"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "can't remember words"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure is up"; TEMPERATURE INTOLERANCE (non-serious), SENSITIVE SKIN (non-serious), outcome "unknown" and all described as "very sensitive to heat or humid in summer and could not go outside"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system was all screwed up". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: reporter said she has 2 friends who are experiencing the same reactions, this patient is a long hauler for 3 years now.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (COMIRNATY), on 19Sep2023 at 12:15 as dose 1, single (Lot number: HF9275EXP) at the age of 52 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 19Sep2023 at 21:00, outcome "recovering"; HEADACHE (non-serious) with onset 19Sep2023 at 21:00, outcome "recovering". Therapeutic measures were not taken as a result of fatigue, headache.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 68-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 27Apr2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 68 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single, as dose 3 (booster), single and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia"; "osteoarthritis"; "known allergies: sulfa". The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "allergy". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective: Paxlovid from 08Sep2023 to 12Sep2023.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Uterine cancer
Clinical narrative: Had uterine cancer; Maternal exposure during pregnancy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: UTERINE CANCER (medically significant), outcome "unknown", described as "Had uterine cancer"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown". Clinical course: Caller had 4 first 4 Covid shots from Pfizer. While making appointment for new Pfizer Covid shot, reading brochure with all the side effects, wanting to know if there are more side effects with new Covid shot. With the Covid shot, have they heard of any increase of women coming down with Uterine cancer from Covid shot? Had uterine cancer, niece is pregnant, said something to her OBGYN about it, was telling her, there have been increase with women who have all ready gone through change of life with Covid shot. Told caller, she better not get any more shots.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Inh, reaction(s): "Known allergies: INH". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Tested positive for Covid 19 four days after completion of 5 day paxlovid treatment; (Sep2023) negative, notes: negative Covid test. Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.