chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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 included: "Ventricular septal defect" (unspecified if ongoing), notes: Other medical history: VSD; "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was used for treatment of COVID-19 from 27Dec2022 to 31Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: 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 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), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "Known allergies: PCN" (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 Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 26Dec2022 to 30Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Infant irritability, Local reaction, Pain, Peripheral swelling
Clinical narrative: reaction progressed to swelling in the whole left leg; the reaction progressed; soreness; irritability; purplish, reddish not raised rash; vasculitis-like reaction; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 10-month-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE NUMBER 1, SINGLE), for Immunization, reaction(s): "local reaction with redness, red dots and tenderness in her left thigh", "local reaction with redness, red dots and tenderness in her left thigh", "local reaction with redness, red dots and tenderness in her left thigh", "local reaction with redness, red dots and tenderness in her left thigh". The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "reaction progressed to swelling in the whole left leg"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "the reaction progressed"; PAIN (non-serious), outcome "unknown", described as "soreness"; INFANT IRRITABILITY (non-serious), outcome "unknown", described as "irritability"; RASH (non-serious), outcome "unknown", described as "purplish, reddish not raised rash"; VASCULITIS (non-serious), outcome "unknown", described as "vasculitis-like reaction".  Additional information: It was reported that, call is regarding a ten-month-old female patient. Reporter referred that when the patient got their 2-month dose of Prevnar 13, had what was deemed a local reaction with redness, red dots and tenderness in her left thigh within 24 hours. When the patient got their 4-month dose of Prevnar the reaction progressed to swelling in the whole left leg, soreness, irritability and a purplish, reddish not raised rash. Reporter defined it as vasculitis-like reaction. Had been holding off the patients third dose due to the reactions and wants to know if something like what the patient experienced has been reported and if there is any recommendation. Pfizer is unable to make any medical recommendations for individual patients.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300004981 Same patient and drug, event separated in time;
Sex: F
Vaccine: PNC13
Symptoms: Rash macular, Tenderness, Vasculitis
Clinical narrative: reaction progressed to swelling in the whole left leg; the reaction progressed; soreness; irritability; purplish, reddish not raised rash; vasculitis-like reaction; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 10-month-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE NUMBER 1, SINGLE), for Immunization, reaction(s): "local reaction with redness, red dots and tenderness in her left thigh", "local reaction with redness, red dots and tenderness in her left thigh", "local reaction with redness, red dots and tenderness in her left thigh", "local reaction with redness, red dots and tenderness in her left thigh". The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "reaction progressed to swelling in the whole left leg"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "the reaction progressed"; PAIN (non-serious), outcome "unknown", described as "soreness"; INFANT IRRITABILITY (non-serious), outcome "unknown", described as "irritability"; RASH (non-serious), outcome "unknown", described as "purplish, reddish not raised rash"; VASCULITIS (non-serious), outcome "unknown", described as "vasculitis-like reaction".  Additional information: It was reported that, call is regarding a ten-month-old female patient. Reporter referred that when the patient got their 2-month dose of Prevnar 13, had what was deemed a local reaction with redness, red dots and tenderness in her left thigh within 24 hours. When the patient got their 4-month dose of Prevnar the reaction progressed to swelling in the whole left leg, soreness, irritability and a purplish, reddish not raised rash. Reporter defined it as vasculitis-like reaction. Had been holding off the patients third dose due to the reactions and wants to know if something like what the patient experienced has been reported and if there is any recommendation. Pfizer is unable to make any medical recommendations for individual patients.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300004981 Same patient and drug, event separated in time;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 14Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6203), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9729), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Known allergies: wool" (unspecified if ongoing), notes: Known allergies: wool; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: dust; "Known allergies: mold" (unspecified if ongoing), notes: Known allergies: mold. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2023 at 10:00, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Negative, notes: Tested negative on home test on 29Dec2022; (03Jan2023) Positive, notes: 03Jan2023; took a home test and it was positive for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient received the vaccine. Patient received other medications in 2 weeks. Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 20Dec2022,Treatment stop date: 24Dec2022,Indication: Treatment of COVID-19.
Age: 44.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: ST on 04Jan2023 and positive AG test; ST on 04Jan2023 and positive AG test; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 44-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: CJ6742) at the age of 44 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2023, outcome "not recovered" and all described as "ST on 04Jan2023 and positive AG test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received any other vaccines within 4 weeks of COVID-19 vaccine. ST on 04Jan2023 and positive AG test after large football event on 01Jan2023.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; 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 BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "she is allergic to Aspirin". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "not recovered", described as "pain in her arm". The event "pain in her arm" required physician office visit.  Additional information: The patient received the vaccine 2 months ago. Since she got the vaccine, she had pain in her arm and it doesn't go away. She wanted to know recommendations for arm pain that has not gone away since she got the Pfizer Biontech COVID-19 bivalent vaccine two months ago. She went to an orthopedist, and he prescribed naproxen but the patient referred she was afraid to take it since she was allergic to Aspirin.   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: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 16:00 as dose number 5 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number 1, single (Batch/Lot number: unknown), as dose number 2, single (Batch/Lot number: unknown), as dose number 3 (booster), single (Batch/Lot number: unknown) and as dose number 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Penicillin" (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 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid treatment for COVID-19 from 27Dec2022 to 31Dec2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in left arm and as dose 3 (booster), single (Lot number: FF2589) for 1 day, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm and on 12Sep2022 as dose 5 (booster), single (Lot number: A57144B), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Mar2022, outcome "unknown", described as "dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Moderna / dose #5 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: two days after negative; Negative, notes: two days after negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: no known allergies and other medical history. The patient was given PAXLOVID from 27Dec2022 to 31Dec2022 for treatment for COVID 19.
Age: 52.0
Sex: F
Vaccine: 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Nov2022 at 17:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram abnormal, Odynophagia
Clinical narrative: pain in his chests; pain in his chests and swallowing; abnormal ekg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old male patient 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: CHEST PAIN (non-serious), outcome "unknown", described as "pain in his chests"; ODYNOPHAGIA (non-serious), outcome "unknown", described as "pain in his chests and swallowing"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "unknown", described as "abnormal ekg". The events "pain in his chests", "pain in his chests and swallowing" and "abnormal ekg" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was required to get the vaccine for him to continue with school and go to school settings and the only vaccine offered to minors was Pfizer. Since the shot he has been experiencing issues with pain in his chests and swallowing and had seen numerous specialists from GI to cardiology that only says he shows an abnormal ekg but can't find any reason and the parent just want some sort of reason their way to help him.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN6205), in left arm, on 29Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 08Jul2022 as dose 4 (booster), single (Lot number: FF2908) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 12Nov2022 as dose 5 (booster), single (Lot number: 010H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure (controlled with medication; "high cholesterol" (unspecified if ongoing), notes: Other medical history: high cholesterol (controlled with medication and exercise). The patient took concomitant medications. Other medical history: diabetes, narcolepsy, high blood pressure (controlled with medication, high cholesterol (controlled with medication and exercise). Past drug history included: Prozac, reaction(s): "Known allergies: Prozac", notes: Known allergies: Prozac; Trazadone, reaction(s): "Known allergies: Trazadone", notes: Known allergies: Trazadone.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2022, outcome "unknown", described as "dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported that the patient received treatment of Paxlovid from 21Dec2022 to 26Dec2022, for treatment of COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: en6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: en6206), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: ff2587), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: fj6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "crohns disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE; LIOTHYRONINE; LEVOTHYROXINE. Past drug history included: Barium sulfate, reaction(s): "Known Allergies: Barium sulfate".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005868 Same patient, different product and event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia
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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: en6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: en6206), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: ff2587), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: fj6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "crohns disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE; LIOTHYRONINE; LEVOTHYROXINE. Past drug history included: Barium sulfate, reaction(s): "Known Allergies: Barium sulfate".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005868 Same patient, different product and event;
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: lung disease; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 76-year-old female patient 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. The patient's relevant medical history and concomitant medications were not reported. 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. The following information was reported: LUNG DISORDER (medically significant), outcome "unknown", described as "lung disease". Therapeutic measures were taken as a result of lung disorder. Clinical information: the reporter considered the case as non-serious. She is concerned as she has a lung disease, has to wear oxygen all day, and other health issues. She mentioned that she had her 4th booster of the covid vaccine months ago but added that, it does not cover this particular variant.  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: 63.0
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 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6203), in left arm, on 09Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: EJ4939), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "allergy induced asthma" (unspecified if ongoing); "post menopausal vaginal atrophy" (unspecified if ongoing), notes: post menopausal vaginal atrophy; "visual migraines" (unspecified if ongoing); "migraine headaches" (unspecified if ongoing); "high eye pressures" (unspecified if ongoing), notes: high eye pressures. Concomitant medication(s) included: LUMIGAN, start date: May2013; ALLERGAN, start date: May2013; ESTRADIOL, start date: May2013. Past drug history included: Ampicillin, reaction(s): "known allergies: ampicillin", notes: known allergies: ampicillin; Ceclor, reaction(s): "known allergies:ceclor", notes: known allergies:ceclor; Keflex, reaction(s): "known allergies:keflex", notes: known allergies:keflex; Tetracycline, reaction(s): "known allergies:tetracycline", notes: known allergies:tetracycline; Erythromycin, reaction(s): "known allergies:erythromycin", notes: known allergies:erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient started anti-viral treatment with Paxlovid on26Dec2022 to 30Dec2022 for the treatment of COVID-19. Other medication in 2weeks product: Estrace tabs.
Age: 31.0
Sex: M
Vaccine: 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 31-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies Sesame" (unspecified if ongoing), notes: known allergies: Sesame; "known allergies seafood" (unspecified if ongoing), notes: known allergies: seafood. 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, notes: Rebound testing positive COVID symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was reported as Yes. Anti-viral details was reported as Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 24Dec2022, Treatment stop date: 28Dec2022, Indication: Treatment of COVID-19.  Other medication in 2weeks product: Advil, Other medication in 2weeks product: Daquil, Other medication in 2weeks brand: Lexapro  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: Arthralgia, Gout, Inappropriate schedule of product administration
Clinical narrative: 1st dose Apr2022/ Second dose Oct2022; have gout/About 2.5 wks after Oct 2022 Pfizer shot, I had a major attack in my left hand/wrist; I feel my joints everywhere in my body all the time now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Apr2022, for COVID-19 Immunization, reaction(s): "gout". The following information was reported: ARTHRALGIA (non-serious) with onset 2022, outcome "not recovered", described as "I feel my joints everywhere in my body all the time now"; GOUT (non-serious) with onset 2022, outcome "unknown", described as "have gout/About 2.5 wks after Oct 2022 Pfizer shot, I had a major attack in my left hand/wrist"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Oct2022, outcome "unknown", described as "1st dose Apr2022/ Second dose Oct2022".  Additional information: The patient having an adverse reaction to the past 2 Pfizer Covid-19 vaccinations and submitted my issues in the CDC VAERS reporting. Until after Apr2022 shot, gout attacks were at best mild and rare, maybe 1 attack in about a year. After Apr2022's shot, about 2mos/2wks. The patient had the worst attack lasted over 4wks in my foot/ankle. About 2.5 wks after Oct22 Pfizer shot, had a major attack in left hand/wrist. The patient felt like joints everywhere in body all the time now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling jittery, Heart rate, Heart rate increased
Clinical narrative: entire body was racing/felt jittery; pulse shot up to 208 bpm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 at 12:30 as dose 3 (booster), single (Lot number: EWD168) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma". The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "known allergies Ceftin"; Cipro, reaction(s): "known allergies Cipro"; Levoquin, reaction(s): "known allergies Levoquin". Vaccination history included: BNT162b2 (Dose 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 06Feb2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "Covid Positive", "Covid Positive"; BNT162b2 (Dose 1, Batch/Lot No: EL3249, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 16Jan2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "Covid Positive", "Covid Positive". The following information was reported: HEART RATE INCREASED (medically significant) with onset 04Nov2022 at 20:00, outcome "not recovered", described as "pulse shot up to 208 bpm"; FEELING JITTERY (non-serious), outcome "recovering", described as "entire body was racing/felt jittery". The event "pulse shot up to 208 bpm" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: (04Nov2022) 208, notes: bpm. Therapeutic measures were taken as a result of heart rate increased and included treatment with diltiazem hydrochloride (CARTIA XT) 240 in the morning and 120 in the evening, apixaban (ELIQUIS) 5 mg, twice a day, digoxin 0.125mg at night. She cannot take a beta blocker due to her asthma. The patient personally believe this all had to do with her booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300007504 same patient, different dose and event;
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: entire body was racing/felt jittery; pulse shot up to 208 bpm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 at 12:30 as dose 3 (booster), single (Lot number: EWD168) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma". The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "known allergies Ceftin"; Cipro, reaction(s): "known allergies Cipro"; Levoquin, reaction(s): "known allergies Levoquin". Vaccination history included: BNT162b2 (Dose 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 06Feb2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "Covid Positive", "Covid Positive"; BNT162b2 (Dose 1, Batch/Lot No: EL3249, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 16Jan2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "Covid Positive", "Covid Positive". The following information was reported: HEART RATE INCREASED (medically significant) with onset 04Nov2022 at 20:00, outcome "not recovered", described as "pulse shot up to 208 bpm"; FEELING JITTERY (non-serious), outcome "recovering", described as "entire body was racing/felt jittery". The event "pulse shot up to 208 bpm" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: (04Nov2022) 208, notes: bpm. Therapeutic measures were taken as a result of heart rate increased and included treatment with diltiazem hydrochloride (CARTIA XT) 240 in the morning and 120 in the evening, apixaban (ELIQUIS) 5 mg, twice a day, digoxin 0.125mg at night. She cannot take a beta blocker due to her asthma. The patient personally believe this all had to do with her booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300007504 same patient, different dose and event;
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling jittery, Heart rate, Heart rate increased
Clinical narrative: came down with Covid; came down with Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 at 10:00 as dose 1, single (Lot number: EL3249), in left arm, on 06Feb2021 at 10:00 as dose 2, single (Lot number: EL9269), in left arm and on 13Oct2021 at 12:30 as dose 3 (booster), single (Lot number: EWD168) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "blood thinner" (unspecified if ongoing), notes: Doctor couldn't put the patient on the typical medications for Covid because of the blood thinner. The patient had no other vaccine in four weeks. The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Cipro, reaction(s): "Known allergies: Cipro"; Levaquin, reaction(s): "Known allergies: Levaquin". The patient had no covid prior vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2023, outcome "unknown" and all described as "came down with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Doctor had the patient on Cartia xt 240 in the morning and Cartia Xt 120 in the evening, eliquis 5 mg twice a day and digoxin .125mg at night. The patient cannot take a beta blocker due to asthma. And on top of all this, the patient came down with Covid 05Jan2023. Doctor couldn't put the patient on the typical medications for Covid because of the blood thinner. So, she called in a steroid pack. The patient personally believed this all had to do with the booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300006118 same patient, different dose and event;
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: came down with Covid; came down with Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 at 10:00 as dose 1, single (Lot number: EL3249), in left arm, on 06Feb2021 at 10:00 as dose 2, single (Lot number: EL9269), in left arm and on 13Oct2021 at 12:30 as dose 3 (booster), single (Lot number: EWD168) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "blood thinner" (unspecified if ongoing), notes: Doctor couldn't put the patient on the typical medications for Covid because of the blood thinner. The patient had no other vaccine in four weeks. The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Cipro, reaction(s): "Known allergies: Cipro"; Levaquin, reaction(s): "Known allergies: Levaquin". The patient had no covid prior vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2023, outcome "unknown" and all described as "came down with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Doctor had the patient on Cartia xt 240 in the morning and Cartia Xt 120 in the evening, eliquis 5 mg twice a day and digoxin .125mg at night. The patient cannot take a beta blocker due to asthma. And on top of all this, the patient came down with Covid 05Jan2023. Doctor couldn't put the patient on the typical medications for Covid because of the blood thinner. So, she called in a steroid pack. The patient personally believed this all had to do with the booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300006118 same patient, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Muscle spasms, Muscle tightness
Clinical narrative: knee arthritis; Cramping in his legs; Tension in the back of his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-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. The patient's relevant medical history included: "Knee arthritis" (ongoing), notes: Knee arthritis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 04Jan2023, outcome "not recovered", described as "Cramping in his legs"; MUSCLE TIGHTNESS (non-serious) with onset 04Jan2023, outcome "not recovered", described as "Tension in the back of his neck"; ARTHRITIS (non-serious), outcome "not recovered", described as "knee arthritis". Additional information: Caller reports he is having a side effect at the time of report, and he is not sure if he had it with his previous vaccines. Caller states as he was going to bed last night and it has persisted and is here still, it is not dangerous or life threatening but having cramping in his legs and tension in the back of his neck. Caller states the leg cramping is worse. He reports he has knee arthritis, and he is not sure if that anything to do with it. Caller states he was wanting to find out the reason for the leg cramping. He states if it gets bad enough, it can continue to his toes.  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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 at 15:45 as dose 1, single (Lot number: EL9264), in left arm, on 15Mar2021 at 09:30 as dose 2, single (Lot number: EN6203), in left arm, on 29Sep2021 at 15:00 as dose 3 (booster), single (Lot number: PC3184), in right arm and on 31Mar2022 at 13:30 as dose 4 (booster), single (Lot number: FK9395), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney disease" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM], start date: 01Jan2022; AMLODIPINE, start date: 01Jan2022, also reported as other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  Clinical information: Patient had known allergies included NKDA. Patient received COVID-19 Treatment with Paxlovid from 28Dec2022 to 03Jan2023. Patient began to experience symptoms on 04Jan2023 at 09:00 included headache, sore throat, sinus congestion. No treatment received for symptoms and not recovered from symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech,; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23May2022, outcome "unknown", described as "Vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Proprietary medicinal product name: Pfizer.Indication for use in the case: Treatment of COVID-19. Date of start of drug on 25Nov2022. Date of last administration on 25Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication in 2 weeks. No known allergies. Anti viral details: product=COVID 19 Treatment, brand=Paxlovid , treatment start date=12Nov2022, treatment stop date=16Nov2022, indication=Treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.