chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Dizziness, SARS-CoV-2 test
Clinical narrative: Chest pain; under armpain; dizziness; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN [IBUPROFEN]; VITAMIN B 12 [CYANOCOBALAMIN]; VITAMIN D 3. Vaccination history included: BNT162b2 (Dose 2, Single, Route of administration: Intramuscular, Anatomical location: Right arm), administration date: 20Dec2021, when the patient was 56-year-old, for COVID-19 Immunization, reaction(s): "Dose Number 1 21Dec2020 / Dose Number 2 20Dec2021"; BNT162b2 (Dose 1, Single, Route of administration: Intramuscular, Anatomical location: Left arm), administration date: 21Dec2020, when the patient was 55-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 19Sep2022, outcome "not recovered"; DIZZINESS (non-serious) with onset 19Sep2022, outcome "not recovered"; AXILLARY PAIN (non-serious) with onset 19Sep2022, outcome "not recovered", described as "under armpain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, axillary pain, dizziness.  Additional information: Known allergies were none. Facility type vaccine was pharmacy or drug store. If other vaccine in four weeks was no. If covid prior vaccination was no. If covid tested post vaccination was yes.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024142 same product, patient, different AEs, different dose;
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 05Oct2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive; (Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Jan2023 to 08Jan2023. Clinical course: The patient experienced rebound COVID 2 days after testing negative. This was 5 days after completing my course of Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Vaccine brand other: Pfizer / BioNTech, Vaccine administration date: 26Apr2022/Vaccine brand other: Moderna, Vaccine administration date: 19Oct2022,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 09Feb2021 as dose 1, single (Lot number: 012M20A), in left arm, on 09Mar2021 as dose 2, single (Lot number: 002A21A), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: 039F21A), in left arm and on 19Oct2022 as dose 5 (booster), single (Lot number: 061F22A), in left arm for covid-19 immunization. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Nitrofurantoin, reaction(s): "Known Allergies: Nitrofurantoin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Apr2022, outcome "not recovered", described as "Vaccine brand other: Pfizer / BioNTech, Vaccine administration date: 26Apr2022/Vaccine brand other: Moderna, Vaccine administration date: 19Oct2022,"; 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: COVID 19 Treatment; Positive, notes: Positive Covid rapid antigen test on day 8 after finishing paxlovid 8 days earlier. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Jan2023 to 12Jan2023.
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 19Apr2021 as dose 2, single (Lot number: EW0151), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: CARVEDILOL, start date: 01Nov2021; LOSARTAN, start date: 01Dec2021; ZOLPIDEM, start date: 01Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 86-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Batch/Lot number: unknown) and on 11Jun2021 as dose 2, single (Lot number: EW0176) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Prior Vaccinations (within 4 weeks): No. Clarified that flu shot and pneumonia shot previously mentioned, were not within 4 weeks prior to Covid vaccinations and recently got pneumonia shot and flu shot. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "tested positive for COVID". Had both COVID shots. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : It was reported that, patient is very weak got their shots, didn't got the booster though.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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) (Physician). The reporter is the patient.  A 32-year-old female patient (not pregnant) 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; 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: "DM2" (unspecified if ongoing), notes: Other medical history: DM2; "hepatic adenomatosis" (unspecified if ongoing), notes: Other medical history: hepatic adenomatosis; "PCOS" (unspecified if ongoing), notes: Other medical history: PCOS; "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Jan2023) Negative; (Jan2023) Negative; (Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "Drug ineffective", "COVID-19".
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Interchange of vaccine products
Clinical narrative: very light headed and having to hold on to my walker; my 2 booster shots from Moderna./they gave me a Pfizer of the booster; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Dec2022 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. Vaccination history included: Moderna covid-19 vaccine (I have received my COVID, my 2 booster shots from Moderna), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Dec2022, outcome "unknown", described as "my 2 booster shots from Moderna./they gave me a Pfizer of the booster"; DIZZINESS (non-serious), outcome "unknown", described as "very light headed and having to hold on to my walker".  Additional information: Consumer stated, "I am a senior and I received, I have received my COVID, my 2 booster shots (Hence suspect captured as COVID Booster shot) from Moderna. But I went for the third booster to my local and they gave me a Pfizer of the booster (Further not clarified, hence suspect captured as Unspecified Booster Shot) And now I am hearing on that they have a record of strokes from people receiving this Pfizer booster (general statement) which was exactly what I received and since then I have received it, I received it on 20Dec2022. I have found myself very light headed and having to hold on to my walker and I am very concerned about the side effects. And I want to know I have already told my family if anything happens that they should hold Pfizer responsible but I also want to ask if there is anything that Pfizer to do to dilute the power of this booster to help to prevent stroke?" Consumer was informed about the Role of Pfizer Drug Safety and suggested to contact Pfizer Medical Information Department for the concern. Consumer stated, "Well, this was a national news channel saying they are and I don't think that they could be saying this shady because that they could be sued for (statement incomplete). And I have another concern, that they know because I asked, I called my pharmacy at and asked them to stop the injection, the booster injection the people that are 65 and older and they said they have no control over that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm and as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type1" (unspecified if ongoing), notes: Diabetes type1; "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Anxiety" (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 Jan2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 07Jan2023 to 07Jan2023, Lot number: GF1750).  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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 19:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "lowered immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received other medication in 2 weeks. Patient received covid-19 treatment with Antiviral Product Paxlovid, from 07Jan2023 till 11Jan2023. Testing positive for Covid 4 days after finishing Paxlovid and having a negative Covid test   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
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 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 41 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 14Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FJ876Z), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bi-polar" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Low Vitamin D" (unspecified if ongoing); "3 episodes of pleurisy as an adult" (unspecified if ongoing), notes: 3 episodes of pleurisy as an adult. The patient's concomitant medications were not reported. Past drug history included: Bismuth oxychloride, reaction(s): "Known allergies: Bismuth Oxychloride".  The following information was reported: VACCINATION FAILURE (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: Positive; Positive, notes: positive test result two days after testing negative; Negative, notes: positive test result two days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: weak; nauseated; dizziness; near syncope; n/v; tiredness, feeling very drained/tired; arm pain; ran low grade fever; headache; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 at 10:00 as dose 3 (booster), single (Lot number: GH9694) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic bronchitis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; DARIFENACIN; LOSARTAN; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. Past drug history included: Phenergan for known allergies: phenergan. Vaccination history included: BNT162b2 (Dose 2, lot number: ER8732, Route: Intramuscular, vaccine location Left arm), administration date: 20Apr2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "No adverse event"; BNT162b2 (Dose 1, lot number: EP6955, Route: Intramuscular, vaccine location: Right Arm), administration date: 28Mar2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: HEADACHE (non-serious) with onset 13Jan2023 at 22:00, outcome "unknown"; PYREXIA (non-serious) with onset 13Jan2023 at 22:00, outcome "unknown", described as "ran low grade fever"; PAIN IN EXTREMITY (non-serious) with onset 14Jan2023, outcome "unknown", described as "arm pain"; DIZZINESS (non-serious) with onset 15Jan2023, outcome "unknown"; VOMITING (non-serious) with onset 15Jan2023, outcome "unknown", described as "n/v"; NAUSEA (non-serious) with onset 15Jan2023, outcome "unknown", described as "nauseated"; PRESYNCOPE (non-serious) with onset 15Jan2023, outcome "unknown", described as "near syncope"; FATIGUE (non-serious) with onset 15Jan2023, outcome "unknown", described as "tiredness, feeling very drained/tired"; ASTHENIA (non-serious) with onset 16Jan2023, outcome "unknown", described as "weak". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, fatigue, headache, dizziness, presyncope, vomiting, asthenia, nausea.  Additional information: Facility type vaccine workplace clinic. Patient did not received any other vaccine in four weeks. With the 3rd dose had severe arm pain 12 hrs after administration and ran low grade fever, headache. 2 days post administration (54 hours later) tiredness, headache, n/v, dizziness, near syncope. 3rd day after administration feeling very drained tired, nauseated, weak, headache. Patient did not have COVID prior vaccination and not tested COVID post vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Presyncope, Pyrexia, Vomiting
Clinical narrative: weak; nauseated; dizziness; near syncope; n/v; tiredness, feeling very drained/tired; arm pain; ran low grade fever; headache; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 at 10:00 as dose 3 (booster), single (Lot number: GH9694) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic bronchitis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; DARIFENACIN; LOSARTAN; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. Past drug history included: Phenergan for known allergies: phenergan. Vaccination history included: BNT162b2 (Dose 2, lot number: ER8732, Route: Intramuscular, vaccine location Left arm), administration date: 20Apr2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "No adverse event"; BNT162b2 (Dose 1, lot number: EP6955, Route: Intramuscular, vaccine location: Right Arm), administration date: 28Mar2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: HEADACHE (non-serious) with onset 13Jan2023 at 22:00, outcome "unknown"; PYREXIA (non-serious) with onset 13Jan2023 at 22:00, outcome "unknown", described as "ran low grade fever"; PAIN IN EXTREMITY (non-serious) with onset 14Jan2023, outcome "unknown", described as "arm pain"; DIZZINESS (non-serious) with onset 15Jan2023, outcome "unknown"; VOMITING (non-serious) with onset 15Jan2023, outcome "unknown", described as "n/v"; NAUSEA (non-serious) with onset 15Jan2023, outcome "unknown", described as "nauseated"; PRESYNCOPE (non-serious) with onset 15Jan2023, outcome "unknown", described as "near syncope"; FATIGUE (non-serious) with onset 15Jan2023, outcome "unknown", described as "tiredness, feeling very drained/tired"; ASTHENIA (non-serious) with onset 16Jan2023, outcome "unknown", described as "weak". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, fatigue, headache, dizziness, presyncope, vomiting, asthenia, nausea.  Additional information: Facility type vaccine workplace clinic. Patient did not received any other vaccine in four weeks. With the 3rd dose had severe arm pain 12 hrs after administration and ran low grade fever, headache. 2 days post administration (54 hours later) tiredness, headache, n/v, dizziness, near syncope. 3rd day after administration feeling very drained tired, nauseated, weak, headache. Patient did not have COVID prior vaccination and not tested COVID post vaccination.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 11Oct2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; LEXAPRO; MUCINEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Product: COVID 19 Treatment; (13Jan2023) Negative, notes: She tested negative 2 days after her last dose of paxlovid; (Jan2023) Positive, notes: her symptoms returned and once again she tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Jan2023 to 11Jan2023.  Clinical course: The patient tested negative 2 days after her last dose of paxlovid. 3 days following her negative test her symptoms returned and once again she tested positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2022 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment with Paxlovid from 03Jan2023 to 08Jan2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Myocardial infarction
Clinical narrative: Myocardial infarction; cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 at 13:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 61 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "GI reflux" (unspecified if ongoing), notes: Other medical history: GI reflux.; "Normal cholesterol, LDL, triglycerides" (unspecified if ongoing), notes: Other medical history: Normal cholesterol, LDL, triglycerides; "Normal cholesterol, LDL, triglycerides" (unspecified if ongoing), notes: Other medical history: Normal cholesterol, LDL, triglycerides; "Normal cholesterol, LDL, triglycerides" (unspecified if ongoing), notes: Other medical history: Normal cholesterol, LDL, triglycerides. Concomitant medication(s) included: PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]. Vaccination history included: Covid-19 vaccine (Primary immunization complete; Manufacturer unknown, Dose: 1), for Covid-19 Immunization; Covid-19 vaccine (Primary immunization complete; Manufacturer unknown, Dose: 2), for Covid-19 Immunization; Covid-19 vaccine (Booster dose, Manufacturer unknown, Dose: 3), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant, life threatening) with onset 26Dec2022 at 09:30, outcome "recovering"; CARDIAC ARREST (medically significant, life threatening) with onset 26Dec2022 at 09:30, outcome "recovering". Therapeutic measures were taken as a result of myocardial infarction, cardiac arrest includes  cpr, coronary artery stent.  Clinical course: No Known allergies. covid prior vaccination Yes. covid tested post vaccination No Other vaccine in four weeks: No. Other medications in two weeks: protonix prn. Ae treatment: cpr, coronary artery stent.; Sender's Comments: Based on the available information in the case, the causal association between the events MYOCARDIAL INFARCTION, CARDIAC ARREST and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
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 non-contactable reporter(s) (Other HCP).  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Losartan, reaction(s): "Known allergies: Losartan". 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 04Jan2023 to 08Jan2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 05May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 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 had no relevant medical history. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 16Dec2022 to 21Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 15Nov2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) positive, notes: Tested positive first time on 31Dec2022; (09Jan2023) positive, notes: tested positive again on 09Jan2023. 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.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 07Jan2023 to 12Jan2023).  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, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 16Jan2023 to an unspecified date in Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE (LOT NUMBER: 3246)), administration date: 10Jan2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "Blood Clots"; BNT162b2 (DOSE 1, SINGLE (Lot Number: 1141)), administration date: 21Dec2020, when the patient was 69-year-old, for Covid-19 Immunization.  The following information was reported: THROMBOSIS (hospitalization, life threatening), outcome "unknown", described as "Blood Clots". The patient was hospitalized for thrombosis (hospitalization duration: 3 day(s)). The event "blood clots" required physician office visit and emergency room visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101244668 Same patient and drug, event separated in time;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Iscemic stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 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), administration date: Jul2021, for COVID-19 immunization. The following information was reported: ISCHAEMIC STROKE (medically significant), outcome "unknown", described as "Iscemic stroke". Therapeutic measures were taken as a result of ischaemic stroke.  Clinical course: Patient was fit and healthy. Patients employer required patient to take the COVID vaccine in Jul2021. Patient was given two doses of the Pfizer vaccine. Patient suffered an iscemic stroke just after the holidays. Patient did not know if it was related. Now patient had to take medication and rehab. Eliquis was one of them. The cost was extreme for supposedly lifesaving Rx. Patient mentioned patient would have preferred getting COVID again than a stroke. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I just caught Omicron recently; I just caught Omicron recently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I just caught Omicron recently". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. Clinical information: Reportedly, "I am just an average person who happens to be Type 2 Diabetic. These past years have been horrible with COVID-19. I wanted to simply contact you to say thank you for all of your work with the vaccines, as well as Paxlovid - as I just caught Omicron recently. I Truly believe your work protected me from severe disease, and for that I am eternally grateful! Thank you to all of you for all you have done, everything you do, and everything you   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Therapeutic response unexpected
Clinical narrative: My cough was better and I could belch and burp that I could not do before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 88-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cough" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunisation Completed, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "My cough was better and I could belch and burp that I could not do before".  Additional information: I am 88-year-old and got my fourth booster shot at the # 02Dec2022 and in one week noticed my cough was better and I could belch and burp that I could not do before. Thank you so much for keeping on working to perfect vaccine. I feel so much better now.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Hepatitis C, Hepatitis C virus test positive
Clinical narrative: positive for Hepatitis C; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series complete), for COVID-19 immunization; Bnt162b2 (Booster dose (DOSE NUMBER UNKNOWN)), for COVID-19 immunization. The following information was reported: HEPATITIS C VIRUS TEST POSITIVE (non-serious), outcome "unknown", described as "positive for Hepatitis C". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event Outcome: Reporter had been vaccinated with the Pfizer COVID-19 vaccine and boosters. Recently reporter was tested and found to be positive for Hepatitis C (which to the best of reporter knowledge, reporter never had). Reporter wife's sister also had the same thing happen to her. Reporter thought this was rather strange and asked if there was any relationship between COVID-19 vaccine and Hepatitis C.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): PFIZER INC-202300022264 same reporter/drug/event, different patient;
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 13 years intramuscular 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 13Jan2023, outcome "recovering" and all described as "Covid". The event "covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: vaccine [Pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event.; Initial information received on 12-Jan-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 6-month-old male patient (76 cm and 16 kg) who experienced vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (strength, expiry date: unknown) (lot: UJ678AAA) via unknown route in unknown administration site for Childhood vaccination.  On an unknown date the patient had a non-serious event vaccine [pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event (product preparation issue) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken with diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine (pentacel) was not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.;
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: product preparation error with no adverse event; Initial information received on 12-Jan-2023 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 16 months old male patient who experienced product preparation error, with no adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ678AAA, Expiry date: 09-Sep-2023) via unknown route in unknown administration site (form, Strength: unknown) for Childhood vaccination.  On an unknown date the patient had a product preparation error with no adverse event (product preparation error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.