chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: patient got DVT a week after the first vaccine; This spontaneous case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS (patient got DVT a week after the first vaccine) in a 74-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (patient got DVT a week after the first vaccine) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (patient got DVT a week after the first vaccine) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  Patient took the flu vaccine with no problems on an unspecified date.  No treatment information was reported.  Company comment-This spontaneous case concerns an elderly male patient aged 74 years with no medical history reported, who experienced the unexpected serious (Medically significant) event of Deep vein thrombosis (AESI) about one week after first dose of mRNA-1273 vaccination in covid -19 vaccination series. He had received first and second dose of same vaccine on unknown dates. It was reported patient got DVT a week after the first vaccine. No further information on risk factors, medical history, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. Elderly age of the patient could be a risk factor to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-674656 (Patient Link).; Sender's Comments: This spontaneous case concerns an elderly male patient aged 74 years with no medical history reported, who experienced the unexpected serious (Medically significant) event of Deep vein thrombosis (AESI) about one week after first dose of mRNA-1273 vaccination in covid -19 vaccination series. He had received first and second dose of same vaccine on unknown dates. It was reported patient got DVT a week after the first vaccine. No further information on risk factors, medical history, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. Elderly age of the patient could be a risk factor to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lichen planus, Myasthenia gravis
Clinical narrative: ocular myasthenia gravis 3 weeks after the second vaccine; lichen planus/skin rash; This spontaneous case was reported by a physician and describes the occurrence of MYASTHENIA GRAVIS (ocular myasthenia gravis 3 weeks after the second vaccine) in a 74-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included INFLUENZA VACCINE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (ocular myasthenia gravis 3 weeks after the second vaccine) (seriousness criterion medically significant) and LICHEN PLANUS (lichen planus/skin rash). At the time of the report, MYASTHENIA GRAVIS (ocular myasthenia gravis 3 weeks after the second vaccine) and LICHEN PLANUS (lichen planus/skin rash) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient took flu vaccine with no problems.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 74-years-old male patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) AESI of Myasthenia gravis that occurred about 3 weeks after receiving the second dose of mRNA-1273 vaccine in the Covid-19 vaccination series. Patient had also received first dose of Moderna vaccine . Two weeks after the second dose he had lichen planus and skin rash. He then developed ocular myasthenia gravis 3 weeks after the second dose. No further information regarding risk factors, concurrent conditions, concomitant medication, investigations and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-674655 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-years-old male patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) AESI of Myasthenia gravis that occurred about 3 weeks after receiving the second dose of mRNA-1273 vaccine in the Covid-19 vaccination series. Patient had also received first dose of Moderna vaccine . Two weeks after the second dose he had lichen planus and skin rash. He then developed ocular myasthenia gravis 3 weeks after the second dose. No further information regarding risk factors, concurrent conditions, concomitant medication, investigations and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19, Weight
Clinical narrative: Diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 85 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM980A), on 03Mar2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 11Nov2022, outcome "unknown" and all described as "Diagnosed with Covid". The patient underwent the following laboratory tests and procedures: Weight: she lost weight because of covid. Reporter called about her getting five injections of the different variants for the Covid-19 Vaccine (Confirmed all the Covid-19 Vaccines have been the Pfizer brand). The last one she received was on 05Nov2022. She was diagnosed with COVID past Saturday, later confirmed as, 12Nov2022. However, the symptoms started on the 11Nov2022. She clarified the symptoms she had that started on 11Nov2022 as she had aches, fatigue, some kind of heaviness over the eyes, stomach issues, chills, and cough. Further commented she lost weight and had lost appetite because of COVID. She also reported that aches was just about the same, commented she just got up this morning. On Saturday and Sunday pretty much slept off and on, or resting watching tv. She seemed to feel a little more alive today, she still feels cold, and still has a deep cough. However, her throat is not making her cough right now.  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-202201306632 same product, patient, different AEs, different dose;
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenopia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 85 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM980A), on 03Mar2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 11Nov2022, outcome "unknown" and all described as "Diagnosed with Covid". The patient underwent the following laboratory tests and procedures: Weight: she lost weight because of covid. Reporter called about her getting five injections of the different variants for the Covid-19 Vaccine (Confirmed all the Covid-19 Vaccines have been the Pfizer brand). The last one she received was on 05Nov2022. She was diagnosed with COVID past Saturday, later confirmed as, 12Nov2022. However, the symptoms started on the 11Nov2022. She clarified the symptoms she had that started on 11Nov2022 as she had aches, fatigue, some kind of heaviness over the eyes, stomach issues, chills, and cough. Further commented she lost weight and had lost appetite because of COVID. She also reported that aches was just about the same, commented she just got up this morning. On Saturday and Sunday pretty much slept off and on, or resting watching tv. She seemed to feel a little more alive today, she still feels cold, and still has a deep cough. However, her throat is not making her cough right now.  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-202201306632 same product, patient, different AEs, different dose;
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling cold, Gastric disorder, Malaise, Musculoskeletal chest pain, Pain
Clinical narrative: Diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 85 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM980A), on 03Mar2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 11Nov2022, outcome "unknown" and all described as "Diagnosed with Covid". The patient underwent the following laboratory tests and procedures: Weight: she lost weight because of covid. Reporter called about her getting five injections of the different variants for the Covid-19 Vaccine (Confirmed all the Covid-19 Vaccines have been the Pfizer brand). The last one she received was on 05Nov2022. She was diagnosed with COVID past Saturday, later confirmed as, 12Nov2022. However, the symptoms started on the 11Nov2022. She clarified the symptoms she had that started on 11Nov2022 as she had aches, fatigue, some kind of heaviness over the eyes, stomach issues, chills, and cough. Further commented she lost weight and had lost appetite because of COVID. She also reported that aches was just about the same, commented she just got up this morning. On Saturday and Sunday pretty much slept off and on, or resting watching tv. She seemed to feel a little more alive today, she still feels cold, and still has a deep cough. However, her throat is not making her cough right now.  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-202201306632 same product, patient, different AEs, different dose;
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Visual impairment, Weight decreased
Clinical narrative: Diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 85 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM980A), on 03Mar2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 11Nov2022, outcome "unknown" and all described as "Diagnosed with Covid". The patient underwent the following laboratory tests and procedures: Weight: she lost weight because of covid. Reporter called about her getting five injections of the different variants for the Covid-19 Vaccine (Confirmed all the Covid-19 Vaccines have been the Pfizer brand). The last one she received was on 05Nov2022. She was diagnosed with COVID past Saturday, later confirmed as, 12Nov2022. However, the symptoms started on the 11Nov2022. She clarified the symptoms she had that started on 11Nov2022 as she had aches, fatigue, some kind of heaviness over the eyes, stomach issues, chills, and cough. Further commented she lost weight and had lost appetite because of COVID. She also reported that aches was just about the same, commented she just got up this morning. On Saturday and Sunday pretty much slept off and on, or resting watching tv. She seemed to feel a little more alive today, she still feels cold, and still has a deep cough. However, her throat is not making her cough right now.  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-202201306632 same product, patient, different AEs, different dose;
Age: 72.0
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) (Physician) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 15:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 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), 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: "hyperlipidemia" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). There were no concomitant medications. No known allergies. 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: (16Nov2022) Positive, notes: Positive rapid test 6 days after trearment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment of COVID-19 with Paxlovid from 06Nov2022 to 10Nov2022.; Sender's Comments: Based on the information given in narrative, the causal relationship between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: very itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EN6207) at the age of 48 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma, Asthma is severe, that is why she got the shot; "Anxiety" (unspecified if ongoing); "Known allergies: Soy" (unspecified if ongoing); "Antihistamines" (unspecified if ongoing); "Birth control" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Reflux med" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR taken for asthma (ongoing); SYMBICORT taken for asthma (ongoing); ACIPHEX taken for gastrooesophageal reflux disease, asthma (ongoing); XYZAL taken for antiallergic therapy (ongoing); XOLAIR taken for food allergy (ongoing); ATROVENT taken for asthma; VENTOLIN [SALBUTAMOL] taken for asthma; LIPITOR taken for blood cholesterol (ongoing); NORETHISTERONE taken for contraception; EPIPEN; VENLAFAXINE taken for anxiety (ongoing). The following information was reported: PRURITUS (medically significant) with onset 21Mar2021, outcome "unknown", described as "very itchy". The event "very itchy" required emergency room visit. Therapeutic measures were taken as a result of pruritus.  Clinical course: Had the first shot 21Mar2021 and had the reaction within 25 minutes of the injection. Started getting very itchy and they kept her there for an hour and a half. Took Benadryl and they just monitored her.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; She has COVID-19; She has COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vocal cord's problems" (unspecified if ongoing); "pouch in her esophagus" (unspecified if ongoing); "she cannot swallow big pills" (unspecified if ongoing); "Polio" (unspecified if ongoing); "bulbar polio" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 "She has COVID-19". Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5:Pfizer / Dose Number: 4:Moderna / Dose Number: 3:Moderna / Dose Number 2:Moderna / Dose Number 1: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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 10:15 as dose 5 (booster), single (Lot number: GH9702) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Lot number: 027A21A), in left arm, on 03Apr2021 at 15:00 as dose 2, single (Lot number: 046A21A), in left arm, on 01Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 939404), in left arm and as dose 4 (booster), single (Lot number: 046A21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022 at 10:15, outcome "unknown", described as "Dose Number: 5:Pfizer / Dose Number: 4:Moderna / Dose Number: 3:Moderna / Dose Number 2:Moderna / Dose Number 1:Moderna"; 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: (unspecified date) Positive; (Nov2022) Negative, notes: tested positive (after two negative at home tests-following 10 day isolation); (Nov2022) Negative, notes: tested positive (after two negative at home tests-following 10 day isolation); (Nov2022) Positive, notes: tested positive (after two negative at home tests following 10 day isolation). Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Recurrence of Covid symptoms and positive RAT test after multiple days testing negative and feeling well.; Recurrence of Covid symptoms and positive RAT test after multiple days testing negative and feeling well.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 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: "orthostatic hypotension" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Amoxicilin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Recurrence of Covid symptoms and positive RAT test after multiple days testing negative and feeling well.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: multiple days testing negative; Positive, notes: positive RAT test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Other medication in 2 weeks. Patient received paxlovid for COVID 19 treatment started on 06Nov2022 and stopped on 10Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: 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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. 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 Treatment". 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 drug ineffective, covid-19.  Clinical information: The patient did not receive any other medication in 2weeks. She received paxlovid treatment 09Nov2022 to 12Nov2022 for Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: COVID-19, Feeling abnormal, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: he got Covid; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 05Nov2022 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (Dose 2, single), for COVID-19 immunization, reaction(s): "covid-19"; Bnt162b2 (Dose 3 (booster), single), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (Dose 4 (booster), single), administration date: Jul2022, for COVID-19 immunization, reaction(s): "COVID-19".  The following information was reported: COVID-19 (non-serious) with onset Nov2022, outcome "unknown", described as "he got Covid". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had four of Pfizer COVID-19 vaccine, with the most recent dose being in Jul2022. Patient started feeling poorly soon after, probably 07Nov2022 or 08Nov2022, didn't do a Covid test at first but was pretty sure patient had Covid the entire time, but did the test 13Nov2022 and tested positive but patient had Covid starting the beginning of that week. Just thought patient was having a reaction to the Prevnar 20, like an immune response, at the beginning and started feeling like reaction was going on way too long, had a pretty bad sore throat, so tested and tested positive for Covid.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: Headache; Nausea; Tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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; Lot number: Unknown), for Covid-19 Immunization, reaction(s): "Headache", "Nausea"; Covid-19 vaccine (DOSE 2, SINGLE; Lot number: Unknown), for Covid-19 Immunization, reaction(s): "Headache", "Nausea"; Covid-19 vaccine (DOSE 3, SINGLE; Lot number: Unknown), for Covid-19 Immunization, reaction(s): "Headache", "Nausea"; Covid-19 vaccine (DOSE 4, SINGLE; Lot number: Unknown), for Covid-19 Immunization, reaction(s): "Headache", "Nausea". The following information was reported: HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Caller was inquiring about the Pfizer Covid-19 vaccine bivalent booster. They just received it with her husband and they are elderly. She wants to know long the bivalent booster will last and they will get another one. It was reported that the patient had the first, second, third and fourth doses of the COVID 19 vaccine. Now we received this new Omicron BA4/BA5 dose. When the information was shared, caller mentioned she  had a little bit of a headache and nausea, but we the previous vaccinations the patient  had similar effects that last 1 day or 2, so patient was not worried about it. She also mentioned that they got COVID in Jul, but that it was very mild. She mentioned she still had some tiredness, but that she was old. Caller declined to be transferred and mentioned that she will call and report it in a couple of days in case these do not go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: Omicron BA.1/BA.2 coinfection; Omicron BA.1/BA.2 coinfection; This is a literature report.  A 59-year-old male patient received BNT162b2 (BNT162B2), 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: "Asthma" (unspecified if ongoing); "Stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Omicron BA.1/BA.2 coinfection". The patient underwent the following laboratory tests and procedures: Multiple fragment analysis: COVID-19 cases caused by coinfection with, notes: different SARS-CoV-2 variants (Delta/Omicron BA.1 and Omicron BA.1/BA.2); SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. The patients had a mild course and overcame their symptoms within 2 weeks.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events "Drug ineffective" and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201307874 Same article, drug, event and different patient;
Age: 37.0
Sex: M
Vaccine: 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 37-year-old male patient received BNT162b2 (BNT162B2), on 20Jul2021 as dose 2 (booster), single (Batch/Lot number: unknown) and on 05Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: multiple at-home tests; (Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as no. Patient received Paxlovid treatment from Nov2022 to Nov2022 for Covid-19. The patient reported that two days after the conclusion of my Paxlovid treatment, he tested negative for COVID-19 on multiple at-home tests. 3 days after that, he found himself feeling mild cold symptoms and testing positive again.   The lot number for [BNT162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vascular stenosis
Clinical narrative: They though it was the heart at first, but they think it's a thinning vessel.  It can create all kinds of stuff and cause issues and problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient 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, SINGLE), for COVID-19 immunization, reaction(s): "They though it was the heart at first, but they think it's a thinning vessel.  It can create all kinds of stuff and cause issues and problems". The following information was reported: VASCULAR STENOSIS (non-serious), outcome "not recovered", described as "They though it was the heart at first, but they think it's a thinning vessel.  It can create all kinds of stuff and cause issues and problems". The events "they though it was the heart at first, but they think it's a thinning vessel.  it can create all kinds of stuff and cause issues and problems" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was a very health person. Used to do yearly checkups and blood work. The patient had concerns that have gotten worse after she got the first vaccine. The doctor sent her to all kinds of places to be checked out. They got issues after getting the vaccine that they never had before. They have found something that was totally similar to everyone else issue when they took the vaccine, which was very scary. They though it was the heart at first, but they think it was a thinning vessel. It would create all kinds of stuff and cause issues and problems. She has had symptoms for about 2 years already. What can I do, If I can say it came from the vaccine, I want to know what Pfizer can do about it if I get sick or end up in the hospital. If it came from the vaccine, they may have to take care of my bill. The patient said she will never take the second booster.  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-202201307619 same patient/drug/AE,differnt doses;
Age: 63.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm 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: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: GLATIRAMER ACETATE, start date: Mar2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (15Nov2022) Positive, notes: positive covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received other medication in weeks. Patient had no known allergies. Adverse event: coughing, headache, diarrhea, congestion, mild chest pain, positive covid test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 17:30 as dose 4 (booster), single (Lot number: GJ3274) at the age of 49 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing), notes: 25 plus year history of migraine; "hypothyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LEVOTHYROXINE; RIZATRIPTAN; NURTEC ODT; IBUPROFEN; BOTOX. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 16Nov2022 at 02:30, outcome "recovering"; MIGRAINE (non-serious) with onset 16Nov2022 at 02:30, outcome "recovering"; MYALGIA (non-serious) with onset 16Nov2022 at 02:30, outcome "recovering", described as "muscular pain at injection site". Therapeutic measures were taken as a result of migraine. Therapeutic measures were not taken as a result of myalgia, fatigue.  Additional information: Patient had not received any vaccines within four weeks. Patient received the treatment with rizatriptan and neurotic for migraine nothing for fatigue or muscle pain. Patient had COVID-19 prior to vaccination. Patient had not been tested for COVID-19 post vaccination. The patient had no known allergies.  Did does not result in physician office visit or emergency room visit.;
Age: 38.0
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) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 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: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (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 "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of covid symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details for Covid-19 Treatment included; Brand: Paxlovid, treatment start date was 06Nov2022 and treatment stop date was 10Nov2022.  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: Based on limited information in the case a possible causal association between the reported event COVID-19 , Drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19, FLUX, PPV
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: White blood cell count was up a little/ higher white blood cell count; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose nubmer 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: WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "White blood cell count was up a little/ higher white blood cell count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Doctor said his white blood cell count was up a little and thinks it was because he got the booster for Omicron and Flu and Pneumonia vaccine. Just having all of those at once probably led to the higher white blood cell count. Unknown manufacturer, lot and expiration for all of those vaccines.  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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 15Mar2021 as dose 2, single (Batch/Lot number: unknown), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic biliary cholangitis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: URSODIOL; MYRBETRIQ; LEVOTHYROXINE; RISEDRONATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 03Nov2022 to 07Nov2022.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: Nasal Swab: positive; Nasal Swab: positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "Nasal Swab: positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 168/104, notes: now have continual readings of 168/104; (20Jan2022) normal 124/78, notes: have always had normal Blood Pressure  124/78; SARS-CoV-2 test: (20Jan2022) Positive, notes: Nasal Swab; Weight: (20Jan2022) Normal, notes: I am normal weight and activity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he got Covid; he got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "he got Covid".   Clinical course: I got the Prevnar 20 shot a week and a half ago on Saturday and two days later I found out I got Covid. I've had four of the Pfizer COVID-19 immunizations, the last being in Jul2022. How can the Covid infection affect the efficacy of Prevnar 20?" Got Prevnar 20 on 05Nov2022, started feeling poorly soon after, probably 07Nov2022 or 08Nov2022, didn't do a Covid test at first but is pretty sure caller had Covid the entire time, but did the test 13Nov2022 and tested positive but thinks caller had Covid starting the beginning of that week. Just thought caller was having a reaction to the Prevnar 20, like an immune response, at the beginning and started feeling like reaction was going on way too long, had a pretty bad sore throat, so tested and tested positive for Covid. Indication: Turned 65 in July and then coming and flu season and still Covid being around caller thought was a good idea to be vaccinated for pneumonia, standard thing. Confirmed all 4 doses were the Pfizer BioNTech COVID-19 vaccine. Lack of efficacy for the Pfizer BioNTech COVID-19 vaccine, got Prevnar 20 vaccine 05Nov2022 and 2 days later came down with Covid-19. Had 4 doses of the Pfizer BioNTech COVID-19 vaccine, with the most recent dose being in Jul2022. Calling more in regards to Prevnar 20 about efficacy of Prevnar 20 vaccine since contracted Covid after getting Prevnar 20. Had Covid also in Jan2022. Had Covid also in Jan2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.