chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
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 reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 54 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's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "recovering", and all described as "Treatment of COVID-19". Symptoms of COVID-19 includes fever, sore throat, congestion, and cough. Therapeutic measures were taken (Paxlovid from 28May2023 to 01Jun2023) as a result of drug ineffective, covid-19.
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL8982), in right arm, on 25Feb2021 as dose 2, single (Lot number: EN6200), in right arm, on 04Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisinopril". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2023) Negative, notes: I tested negative for COVID; (25May2023) Positive, notes: Three days later, I tested positive for COVID as symptoms returned; (04Jun2023) Negative, notes: Ten days later, I finally tested negative again. Therapeutic measures were taken as a result of covid-19, vaccination failure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
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 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Apr2023 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right 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) and in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2023) Positive; (05Jun2023) Negative; (07Jun2023) Negative; (08Jun2023) Positive. 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 has been requested and will be submitted if and when received.
Age: 67.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years 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's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Paxlovid start date 01Jun2023 to 06Jun2023. Case was reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Negative, notes: Had 2 negative rapid tests; (May2023) Negative, notes: Had 2 negative rapid tests; (May2023) Positive, notes: tested positive again; (May2023) Positive, notes: But, then tested positive again; (26May2023) Positive, notes: started Paxlovid the day after and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Very mild case of COVID. Had 2 negative rapid tests and then tested positive again. Symptoms had continually improved, energy back, felt very good. But then tested positive again. No new symptoms and energy level high, etc. Now, still testing positive and on day 17 since first testing positive for COVID. Patient is fully vaxed with the vaccine including the bivalent around Oct or Nov2022.   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.
Age: 51.0
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 (Nurse). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "LV hypertrophic cardiomyopathy" (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 "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Paxlovid day of positive home test w improving conditions waiting 24 hrs initially; Negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient has no known allergies. The patient was treated with Paxlovid from 29May2023 to 03Jun2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Infertility male
Clinical narrative: I am sterile now because of your product; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFERTILITY MALE (medically significant), outcome "unknown", described as "I am sterile now because of your product". Additional information: Consumer stated, "Well see that's the thing. I just have a couple of questions that I am very concerned about because I have taken the Pfizer Vaccine (Clarified as Pfizer COVID-19 Vaccine) and I just find out that Pfizer Vaccines have this substance called Squalene. Would Squalene make, scientifically makes men (Number of patients were not available over the call hence, spilt could not be made) sterile and I was just want know how come we were not informed about this vaccine having Squalene, sterile making a substance in it and everyone taking whose it as far as men though a sterile men because of the vaccine. So who can I talk to about this? It's very important. So, basically the COVID-19 Vaccine having this substance called Squalene in it. Squalene makes you, make men sterile. I have taken the Pfizer Vaccine. Now I am sterile because of that but yet we were not informed about this sterile making a substance inside vaccines and there is no word of it. Why is that? The Squalene is the substance that makes men sterile. Squalene is inside the Pfizer Vaccine. The Pfizer, you know Pfizer just know the government, informed everybody before people took the vaccine especially the men that have the sterile making substance called Squalene inside the Vaccine. Now I am just curious why is that nobody including especially Pfizer never said a word about this and informing everybody that before you take the vaccine be careful because you going to be sterile afterwards. That's what I was trying to figure out. When you sterile, you sterile for life. There is no one who knows expiration date on the vaccine. The vaccine has got me sterile for life because of the substance called Squalene that nobody warned us about when the vaccines came out alright which makes you sterile forever. I am forever sterile. I mean that's understood there is no expiration on that."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 6 (booster), single (Lot number: GJ2524) at the age of 60 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), 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: "Moderate asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Mar2023 at 14:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jul2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 10Aug2021 at 15:15 as dose 2, single (Batch/Lot number: unknown), in right arm and on 21Apr2022 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: yes. Concomitant medication(s) included: WARFARIN, start date: 15Mar2023; TRAMADOL, start date: 21Mar2023; LEVOTHYROXINE, start date: 14Mar2023; METHOTREXATE, start date: 05Jan2023; ALLERTEC [CETIRIZINE], start date: 01Jan2023; VITAMIN C [ASCORBIC ACID], start date: 15Mar2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course- Treatment included Paxlovid from May2023 to Jun2023.  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-202300218279 same patient, different drug, different events;
Age: 40.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 40 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's relevant medical history included: "MCAS" (unspecified if ongoing), notes: Other medical history: MCAS; "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline"; Ibuprofen, reaction(s): "known allergies: ibuprofen". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive. 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 has been requested and will be submitted if and when received.
Age: 66.0
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 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre-Ventricular Contractions" (unspecified if ongoing), notes: Other medical history: Pre-Ventricular Contractions. The patient's 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Note: Positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment start date: 03Jun2023 to 07Jun2023. No known allergies.   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: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (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 27Sep2022 as dose 5 (booster), single (Lot number: 027L21A) at the age of 77 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's relevant medical history included: "Known allergies: Sulpha drugs" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Aug2021, stop date: 31May2023; LISINOPRIL, start date: 01Aug2021. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 31May2023 to 05Jun2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300219453 Same reporter/patient, different product/AE.;
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years 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 included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "recovered" (2023); DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "recovered" (2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: New positive test after two negative tests 48 hours; Negative, notes: New positive test after two negative tests 48 hours; Negative, notes: New positive test after two negative tests 48 hours. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 01Jun2023 to 05Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, 'Drug Ineffective and Covid19 were assessed as related to the suspect product due to a plausible temporal association.,Linked Report(s) : US-PFIZER INC-202300219515 same patient, different drug, different event;
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Peripheral swelling
Clinical narrative: her arm is swollen; her arm is red; allergic to the components; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her arm is swollen"; ERYTHEMA (non-serious), outcome "unknown", described as "her arm is red"; ALLERGIC REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "allergic to the components". Additional information: The reporter clarified he was not the doctor who gave the prescription. The patient worked as a receptionist and her arm was red and swollen. Caller wanted to know what the adjuvant was in the vaccine? Stating patient was probably allergic to the components.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; 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 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose number unknown, single (Lot number: 056A22A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfates" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 29May2023 to 03Jun2023. Patient did not has Other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300219551 same reporter/patient, different product/AE;
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got so sick for at least a week after each; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: Bnt162b2 (DOSE 1), for COVID-19 IMMUNIZATION, reaction(s): "I got so sick for at least a week after each". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got so sick for at least a week after each".  Additional information: I have had 3 covid-19 vaccinations. I got so sick for at least a week after each. Must I have another shot?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300104327 Same patient, different dose, same event;US-PFIZER INC-202300219752 Same patient, different dose, same event;
Sex: U
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: I got so sick for at least a week after each; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 Immunization, reaction(s): "I got so sick for at least a week after each"; Bnt162b2 (Dose: 2), for Covid-19 Immunization, reaction(s): "I got so sick for at least a week after each". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got so sick for at least a week after each".  Additional information: I have had 3 covid-19 vaccinations. I got so sick for at least a week after each. Must I have another shot?  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300219751 Same patient, different dose, same event;US-PFIZER INC-PV202300104327 Same patient, different dose, same event;
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP).  An 83-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Malignant neoplasm of upper-inner quadrant of left female breast", start date: 01Oct2014 (unspecified if ongoing), notes: Date: 01Oct2014, Type: Primary, ICD-10: C50.212, Stg Date: 01Oct2014, Description: Breast Cancer (Breast Cancer) - Clinical Stage IV (AJCC v7) (TNM: cM1; ER Status: Positive: PR Status: Positive), Tx Setting: Metastatic, 1st Line, Status: Partial Response, Sts Date: 21Mar2019. Concomitant medication(s) included: PROLIA taken for breast cancer female, oestrogen therapy, start date: 21Mar2019 (ongoing); FASLODEX intramuscular taken for breast cancer female, start date: 10Apr2016 (ongoing); LETROZOLE, start date: 10Oct2014, stop date: 13Aug2015. Past drug history included: Bactrim, reaction(s): "Nausea"; Codeine, reaction(s): "Rash"; Keflex, reaction(s): "Rash"; Morphine, reaction(s): "Rash"; Oxycodone, reaction(s): "Rash". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contributory role of the suspect product to the reported event drug ineffective and COVID 19 cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. ,Linked Report(s) : US-PFIZER INC-PV202300018541 same patient/different drug/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; We both came down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-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; 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: DRUG INEFFECTIVE (medically significant) with onset 15May2023, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset 15May2023, outcome "unknown", described as "We both came down with Covid". Clinical course: Her husband had all their vaccines and boosters except the last one out now. He came down with Covid, 15May2023. It was mild-4 days and no worse the a cold or bad allergies.  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-PV202300104610 same reporter/product/event, different patient;
Age: 21.0
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) (Other HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 3 (booster), single (Lot number: gg6738) at the age of 21 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 included: "Left atrium prolapse" (unspecified if ongoing); "long COVID" (unspecified if ongoing); "Known allergies: Sulfa, amoxicillin" (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 "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product   BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300220429 same patient, different drug/AE.;
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, C-reactive protein, Magnetic resonance imaging, Myocarditis
Clinical narrative: Myocarditis; ASSESSMENT OF RISK FACTORS FOR MYOCARDITIS (US) USING ELECTRONIC HEALTH RECORDS AND CLAIMS DATA  This is a non-interventional study report received from a contactable reporter(s) (Other HCP) for protocol C4591055.  An adolescent male patient received BNT162b2 (BNT162B2), on 16Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "chronic otitis media" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization), outcome "recovering". The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: (20Jul2021) 340, notes: stated in note as elevated; Blood creatine phosphokinase MB: (20Jul2021) 11.8, notes: stated in note as elevated; C-reactive protein: (20Jul2021) 3.4, notes: stated in note as elevated; Magnetic resonance imaging: (22Jul2021) normal biventricular size and systolic function., notes: 2. Moderate myocardial edema of the basal segments of the left ventricle, particularly along the inferolateral segment; Troponin: (20Jul2021) 2624, notes: stated in note as elevated. Clinical information: The patient presented with chest pain, tachycardia and elevated troponins as well as other elevated enzymes 4 days after his second Pfizer Covid vaccination. Discharge Diagnosis: Myocarditis due to COVID vaccine-Pfizer COVID vaccine. Patient's Race: Unknown. Patient's Ethnicity: Unknown. Study Drug (Trade and Generic), Formulation, Route, Indication: Pfizer Covid-19 Vaccine 2nd dose; Dose: UNK; Units: UNK; Frequency: 1. Concomitant Drugs: Unknown. The investigator considered there was a reasonable possibility that the event was related to study drug (Pfizer Covid-19 Vaccine - 2nd dose), there was not a reasonable possibility that the event was related to concomitant drug.  The reporter considered "myocarditis" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported event myocarditis cannot be excluded based on temporal profile and known safety profile of suspect product.
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Myocarditis; ASSESSMENT OF RISK FACTORS FOR MYOCARDITIS (US) USING ELECTRONIC HEALTH RECORDS AND CLAIMS DATA  This is a non-interventional study report received from a contactable reporter(s) (Other HCP) for protocol C4591055.  An adolescent male patient received BNT162b2 (BNT162B2), on 16Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "chronic otitis media" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization), outcome "recovering". The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: (20Jul2021) 340, notes: stated in note as elevated; Blood creatine phosphokinase MB: (20Jul2021) 11.8, notes: stated in note as elevated; C-reactive protein: (20Jul2021) 3.4, notes: stated in note as elevated; Magnetic resonance imaging: (22Jul2021) normal biventricular size and systolic function., notes: 2. Moderate myocardial edema of the basal segments of the left ventricle, particularly along the inferolateral segment; Troponin: (20Jul2021) 2624, notes: stated in note as elevated. Clinical information: The patient presented with chest pain, tachycardia and elevated troponins as well as other elevated enzymes 4 days after his second Pfizer Covid vaccination. Discharge Diagnosis: Myocarditis due to COVID vaccine-Pfizer COVID vaccine. Patient's Race: Unknown. Patient's Ethnicity: Unknown. Study Drug (Trade and Generic), Formulation, Route, Indication: Pfizer Covid-19 Vaccine 2nd dose; Dose: UNK; Units: UNK; Frequency: 1. Concomitant Drugs: Unknown. The investigator considered there was a reasonable possibility that the event was related to study drug (Pfizer Covid-19 Vaccine - 2nd dose), there was not a reasonable possibility that the event was related to concomitant drug.  The reporter considered "myocarditis" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported event myocarditis cannot be excluded based on temporal profile and known safety profile of suspect product.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Drug ineffective, Pneumonia pneumococcal
Clinical narrative: had pneumonia after having two Pneumonia shots; had pneumonia after having two Pneumonia shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), 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: DRUG INEFFECTIVE (medically significant), PNEUMONIA PNEUMOCOCCAL (medically significant), outcome "unknown" and all described as "had pneumonia after having two Pneumonia shots". The patient reported she had already had pneumonia after having two Pneumonia shots. One of the vaccines the respondent reported receiving was Prevnar 13.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Completed suicide
Clinical narrative: had a series of adverse events after COVID vaccination which had led to suicide; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: COMPLETED SUICIDE (death), outcome "fatal", described as "had a series of adverse events after COVID vaccination which had led to suicide". The patient date of death was unknown. Reported cause of death: "had a series of adverse events after COVID vaccination which had led to suicide". Clinical course: On a routine first interaction, web based, with an HCP this morning, 09Jun2023 at 8:15 AM, they had mentioned, essentially in passing and off-topic of the conversation, that a "friend of theirs" had a series of adverse events after COVID vaccination which had led to suicide. The HCP stated that the friend had refused treatments of these adverse events. The HCP did not indicate that they wanted to formally report this event, nor did they ask for nor imply the need for any further interaction on this mention which they shared. Additionally, they did not specifically state which manufacturers vaccine had been used nor did they share any details of other medical or behavioral health issues that were occurring at that time.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited available information, the causality between the reported fatal event (Completed suicide) resulting in patients death and the suspect product BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN) cannot be excluded as the reported event may have been related to patient's subjective purpose and not associated with the vaccines medicinal effect. However, on conservative basis the case is considered Related. Case will be reassessed upon receiving additional information. 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.; Reported Cause(s) of Death: had a series of adverse events after COVID vaccination which had led to suicide
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Have lost a lot of hair/noticed hair in my sink; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Mar2021 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: ALOPECIA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Have lost a lot of hair/noticed hair in my sink". Therapeutic measures were taken as a result of alopecia.  Additional information: It was reported that the patient has lost a lot of hair due to getting the COVID-19 vaccine and booster. The patient's hair was great until the patient got the vaccine on 13Mar2021 and noticed hair on the sink and then also lots of hair loss after 16Apr2022 shot and 20Sep2022 booster. The patient had bangs all life and now has no bangs. The patient's hair on top is so thin and it was devastating. The patient has before and after photos to see the loss of hair. The patient spent close to $3000 on platelet-rich plasma (PRP) blood platelet treatments in Feb2023 and got a topper costing $811.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300219428 same patient/reporter, different drug; US-PFIZER INC-202300219429 same patient/reporter, different drug;
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got so sick for at least a week after each; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got so sick for at least a week after each".  Additional information: I have had 3 covid-19 vaccinations. I got so sick for at least a week after each. Must I have another shot?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300219751 Same patient, different dose, same event;US-PFIZER INC-202300219752 Same patient, different dose, same event;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Nephrolithiasis
Clinical narrative: Kidney stone/Nephrolithiasis recurrent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 at 14:10 as dose 3 (booster), single (Lot number: FD8448) at the age of 68 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Percutaneous nephrolithotomy", start date: 24Aug2020 (not ongoing), notes: to remove 12mm stone; "cardiac disorder/cardiac health" (ongoing); "Blood pressure abnormal" (ongoing); "Cholesterol control" (ongoing); "Chest pain", start date: 10Oct2016 (unspecified if ongoing); "Atrial stents implanted" (not ongoing); "herniatic disk L4-L5", start date: 2014, stop date: 2019; "Micro discectomy", start date: 14Oct2019 (not ongoing); "Kidney stone", start date: 2014, stop date: 2020; "Prostate health" (ongoing); "very high blood pressure", start date: 10Oct2016 (unspecified if ongoing); "arterial sclerosis" (unspecified if ongoing); "hydrocodone allergy" (unspecified if ongoing). The patient's medical history, reported also as family history included: "Father died of heart problems at age 68/Mother died of heart attack at age 47" (unspecified if ongoing); "mother had childhood scarlet fever" (unspecified if ongoing), notes: approx. 1919-2020. Concomitant medication(s) included: LISINOPRIL oral taken for blood pressure abnormal (ongoing); METOPROLOL oral taken for cardiac disorder (ongoing); FLOMAX [MORNIFLUMATE] oral taken for prostate infection (ongoing); ATORVASTATIN oral taken for blood cholesterol abnormal (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] oral taken for cardiac disorder (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, at 14:40 , Anatomical location: right arm, Route of administration: Intramuscular , Batch/Lot number: EN5318), administration date: 28Jan2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, at 13:00, Anatomical location: right arm, Route of administration: Intramuscular , Batch/Lot number: EN6200), administration date: 23Feb2021, for COVID-19 immunisation. The following information was reported: NEPHROLITHIASIS (medically significant) with onset 02Feb2022, outcome "unknown", described as "Kidney stone/Nephrolithiasis recurrent". The patient underwent the following laboratory tests and procedures: Too many test: Unknown results. Therapeutic measures were taken as a result of nephrolithiasis. Clinical course: Patient also received BNT162B2 (BNT162B2) on 20May2022 at 14:15 as DOSE 4 (BOOSTER), SINGLE  (lot number: FM7553) intramuscular, in right arm and BNT162B2 (comirnaty bivalent BA4/5) on 16Sep2022 at 12:45 as DOSE 5 (BOOSTER), SINGLE  (lot number: GH9694) intramuscular, in right arm  for COVID-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175662 same patient/reporter, different drug/AE;US-PFIZER INC-202300176199 Same patient, same product, different dose (Dose 3), Different events;
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Taste disorder
Clinical narrative: lost her sense of smell; sense of taste is limited and makes eating quite unpleasant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 21Jul2022 as dose number unknown, single (Lot number: FP7135) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious) with onset 2022, outcome "unknown", described as "lost her sense of smell"; TASTE DISORDER (non-serious) with onset 2022, outcome "unknown", described as "sense of taste is limited and makes eating quite unpleasant". Additional information: Received the Pfizer vaccine on 21Jul2022. A few days after this vaccine patient lost her sense of smell. Her sense of taste is limited and makes eating quite unpleasant. It has been almost a year since this vaccine and her senses have not returned. She have never had COVID, only COVID vaccines. Her life is diminished due to this issue.