chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had all Covid vaccines, including the 5th booster/All vaccines were Pfizer/ tested positive for Covid; had all Covid vaccines, including the 5th booster/All vaccines were Pfizer/ tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US285221_OS.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years for COVID-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Kidney Disease Stage 3B" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Dec2022, outcome "not recovered" and all described as "had all Covid vaccines, including the 5th booster/All vaccines were Pfizer/ tested positive for Covid". The patient underwent the following laboratory tests and procedures: Covid-19 test: (unspecified date) Positive, notes: On Day 13 patient began to feel badly again and tested positive for Covid; (unspecified date) Negative, notes: tested negative on Day 11 and Day 12; (unspecified date) Negative, notes: tested negative on Day 11 and Day 12; (03Dec2022) Positive, notes: on 03Dec tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient is 75 years old and has had all Covid vaccines, including the 5th booster. All vaccines were Pfizer. Patient received 5th booster on 14Nov of this year, and then took monthly injection on 30Nov and was suddenly sick. The next day, patient developed a sore throat and on 03Dec tested positive for Covid. Patient's Covid was fairly bad with a high fever. On Covid Day 4, Patient received a half-dose of Paxlovid, as the patient also has Kidney Disease Stage 3B. Patient started feeling better on Covid Day 10 and tested negative on Day 11 and Day 12. On Day 13 patient began to feel badly again and tested positive for Covid.  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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Investigation, Weight
Clinical narrative: interchange of vaccine products; 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.  An 83-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "heart issues" (unspecified if ongoing), notes: I have heart issues and am taking several drugs for the heart issues." (Further not clarified.). Concomitant medication(s) included: FLU VACCINE VII. 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 "Covid-19". The patient underwent the following laboratory tests and procedures: Last blood test: Unknown Results, notes: Last blood test I think I had was in Jun; Weight: Unknown Results, notes: about 146 (pounds), 147 (pounds).  Clinical course: Other conditions was reported as yes and investigations was reported as no. He received paxlovid treatment for COVID-19. He stated, he was 83 plus years of age he had got most serious health problems (Intent History). He had all his Pfizer and Moderna vaccine and all that stuff and the booster shots and flu shot and everything but he came down with Covid19 recently which he understand you can get. So, he went to patient health in city and they diagnosed that you do have Covid-19 and they gave him one of your drug Paxlovid and he have been taking this drug and this was his second day and he do not know how to say this but it feels like miracle taking place. He had been suffering for years with a throat thing. He have got a valve in his throat that did not work right and when he eat he choked sometimes and he have been having blowing nose and cough and all these concept and that has really subsided and he was just wondering if this drug, these effects were from Covid or what because he cannot figure if it cured the other things." When clarified the concern, consumer stated, "because it do things for other than Covid-19 because he have had a problem and it seems to have cured that." He was type 2 diabetic, no medication for that and he have heart issues and he was taking several drugs for the heart issues." No lab work. Last blood test he think he had was in Jun." Consumer stated, "he was very pleased with the product. It was doing what they are supposed to do but he was thinking it had any, like some of these drugs you take all through the year and it takes forever for them to cure those problems."    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years 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 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Report about COVID treatment: Yes; If vaccine received: Yes. Other medication in 2 weeks: Unknown. COVID vaccine details: Vaccine brand: Pfizer / BioNTech, vaccine brand unknown: False, vaccine administration date Nov2022, vaccine lot unknown: True, vaccine lot unknown reason: Not available/provided to reporter at the time of report completion, vaccine dose number unknown: true, vaccine dose number unknown reason: unknown. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: Unknown. Did you/the patient previously receive a COVID-19 Vaccine?: Yes.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, 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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: el9265), on 23Feb2021 as dose 2, single (Lot number: en6198), on 22Aug2021 as dose 3 (booster), single (Lot number: fc3180) and on 16May2022 as dose 4 (booster), single (Lot number: fk9893) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "multiple myeloma" (unspecified if ongoing). Patient has no known allergies. Concomitant medication(s) included: LENALIDOMIDE, start date: 27Sep2015; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID], start date: 27Sep2015; CALCIUM CARBONATE WITH D3, start date: 01Jan2010. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Recurrent positive COVID test. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 03Sep2022 to 08Sep2022.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 19Oct2022 at 13:00 as dose number unknown, single (Lot number: FJ6739) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "hypothyroidism" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Negative; (25Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated for COVID-19 with anti-viral from 16Dec2022 to 21Dec2022. After recovering and testing negative on 22Dec2022, tested positive again on 25Dec2022.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand Other: Jansen/Vaccine brand Other: Moderna/Vaccine brand: Pfizer / BioNTech/Vaccine brand Other: Moderna biv; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 20Aug2022 as dose 3 (booster), single (Lot number: FP7150) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 08Apr2021 as dose 1, single (Lot number: 042A21A), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Nov2021 as dose 2 (booster), single (Lot number: 021C21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 06Dec2022 as dose 4 (booster), single (Lot number: 023H22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: Other medical history: Allergies & asthma; "Asthma" (unspecified if ongoing), notes: Other medical history: Allergies & asthma. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], start date: 01Jan2022, stop date: 03Jan2023; ASTEPRO, start date: 01Jan2022, stop date: 03Jan2023; ALLEGRA [FEXOFENADINE HYDROCHLORIDE] taken for hypersensitivity, start date: 01Jan2022, stop date: 03Jan2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Aug2022, outcome "unknown", described as "Vaccine brand Other: Jansen/Vaccine brand Other: Moderna/Vaccine brand: Pfizer / BioNTech/Vaccine brand Other: Moderna biv"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received Paxlovid treatment for Covid-19 from 13Dec2022 to 17Dec2022. Reported that patient received other medication in 2 weeks. No Known allergies.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). 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), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 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: "controlled high blood pressure" (unspecified if ongoing), notes: controlled high blood pressure; "controlled hyperlipidemia" (unspecified if ongoing), notes: controlled hyperlipidemia; "known allergies: wheat, peas and Corn" (unspecified if ongoing), notes: known allergies: wheat, peas and Corn; "known allergies: Tomatoes" (unspecified if ongoing), notes: known allergies: Tomatoes; "known allergies: Eggs" (unspecified if ongoing), notes: known allergies: Eggs. The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin; Vicodin, reaction(s): "known allergies: Vicodin", notes: known allergies: Vicodin; Lyrica, reaction(s): "known allergies: Lyrica", notes: known allergies: Lyrica. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Slight Positive, notes: On 01Jan2023 I started coughing. I tested on 02Jan2023 and had a very slight positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient had other medication in 2 weeks. Treatment with Paxlovid was started on 23Dec2022 and completed on 28Dec2022.   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".
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Dec2022, outcome "unknown" and all described as "got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Dec2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: 4 COVID doses and last was bivalent and got COVID on 23Dec2022 then plus Ag 24Dec2022 after gym mild symptoms cough and congestion. COVID prior vaccination was not Unknown. Patient tested COVID post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300004020 same  patient/reporter/dose, different dose/event;
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 20Jul2021 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lumbar fusions" (unspecified if ongoing); "high liver panel results" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Normally patient had to take Oxycodone 20MG 4X a day, and experience withdrawal like symptoms when he did Not take a dose on time. He was taking Paxlovid for a case of COVID but noticed that he was sleeping a lot while taking the combination (Oxycodone does not make me sleepy regularly), but several times patient went 8-12 hours without taking my Oxycodone prescription. He had 0 withdrawal like symptoms that he normally experienced. Normally patient experienced Uncontrollable yawning, tears, jitteriness, more aches, and the anxiety feeling where he can't stay still. This was very abnormal for him to go 6 hours without seeing any of the symptoms, yet he was able to push taking half of his dose abruptly with 0 of the standard symptoms other than hurting.  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: had Pfizer vaccine and boosters / tested positive for COVID/ prescribed Paxlovid; had Pfizer vaccine and boosters / tested positive for Covid / prescribed Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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) with onset 22Dec2022, outcome "unknown", described as "had Pfizer vaccine and boosters / tested positive for COVID/ prescribed Paxlovid"; COVID-19 (medically significant) with onset 22Dec2022, outcome "unknown", described as "had Pfizer vaccine and boosters / tested positive for Covid / prescribed Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Positive; (31Dec2022) Negative; (02Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ2524) 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), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 49.0
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) (Nurse).  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 49 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 was not reported. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT taken for immunisation, on 28Sep2022 as dose 4, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2023, outcome "not recovered" and all described as "COVID +". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Prior to vaccination, the patient was not diagnosed as COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine (as reported). List of any other medications the patient received within 2 weeks of vaccination was reported as unknown. On 02Jan2023, the patient began to have mild symptoms.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2020 as dose 1, single (Batch/Lot number: unknown) at the age of 29 years 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 Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from23Dec2022 to 27Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: symptoms 01Jan2023 ST mild cough home Ag positive 02Jan2023; symptoms 01Jan2023 ST mild cough home positive 02Jan2023; prev_dose_brand=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 3 (booster), single (Lot number: Cj6742) at the age of 41 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Apr2021 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 patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Nov2022, outcome "unknown", described as "prev_dose_brand=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2023, outcome "unknown" and all described as "symptoms 01Jan2023 ST mild cough home Ag positive 02Jan2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Positive, notes: home test, Nasal Swab. It was unknown if therapeutic measures were taken as a result of interchange drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; 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 "interchange of vaccine products", "drug ineffective", "COVID-19".
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 71-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 at 13:30 as dose 1, single (Lot number: EL9262), in left arm, on 04Mar2021 at 13:00 as dose 2, single (Lot number: EN6205), in left arm, on 24Sep2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 05Apr2022 at 10:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 13Sep2022 at 10:00 as dose 5 (booster), single (Lot number: FM0698) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic fatigue syndrome", start date: 1989 (unspecified if ongoing), notes: Chronic fatigue syndrome diag. 1989; in remission.; "Known allergies: fake crab" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 26Dec2022 mild symptom and positive test 27Dec2022; 26Dec2022 mild symptom and positive test 27Dec2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ6742) 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 was not reported. The patient took concomitant medications: Other vaccine in four weeks was reported", vaccination date on 15Sep2022, lot number: 942381.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2022, outcome "unknown" and all described as "26Dec2022 mild symptom and positive test 27Dec2022". The events "26dec2022 mild symptom and positive test 27dec2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included PAXLOVID.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5),  to the events  drug ineffective (LOE) and covid-19 cannot be ruled out.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other= Moderna/vaccine administration date=02Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 4 (booster), single (Lot number: Gn9703) at the age of 78 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Feb2021 as dose 2, single (Lot number: 013a21a), in right arm and on 02Nov2021 as dose 3 (booster), single (Lot number: 014f21a), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AVASTATIN; LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other= Moderna/vaccine administration date=02Nov2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: negative rapid test; (01Jan2023) Positive, notes: Symptoms resumed and rapid test positive about 10 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient received other medication in 2 weeks. Patient received Paxlovid for COVID 19 treatment from 18Dec2022 to 22Dec2022. No known allergies reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: persisting subcutaneous nodule on right shoulder; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: EM9809) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-ventricular contractions" (unspecified if ongoing), notes: Pre-ventricular contractions; "headaches" (unspecified if ongoing); "FSAD" (unspecified if ongoing); "degenerative disc disease" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: METOPROLOL. Vaccination history included: BNT162b2 (lot number: EL9261, dose number: 1, vaccine location: Right arm), administration date: 20Jan2021, when the patient was 30-year-old, for COVID-19 immunization. The following information was reported: SKIN MASS (non-serious) with onset 01May2021, outcome "not recovered", described as "persisting subcutaneous nodule on right shoulder". Therapeutic measures were not taken as a result of skin mass.  Additional information: The patient had covid prior vaccination. It was unknown covid tested post vaccination, patient was not aware about known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: My cousin took two doses of your Pfizer Vaccine and he now has Myocarditis; these vaccine hurting and it just does not go away; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male 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. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "My cousin took two doses of your Pfizer Vaccine and he now has Myocarditis; these vaccine hurting and it just does not go away".  Clinical course: My cousin took two doses of your Pfizer Vaccine and he now has Myocarditis and he was been battling with this for some time and I am sure you are aware of it just does 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: Death
Clinical narrative: 'pops just passed away'; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "'pops just passed away'". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: It was reported the reporter stated that their 'pops just passed away' (not clarified) with.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: 'pops just passed away'
Sex: M
Vaccine: COVID19
Symptoms: Myocardial injury
Clinical narrative: heart damage; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INJURY (medically significant), outcome "unknown", described as "heart damage".  Clinical Course: Reporter stated that I also have a nephew and a niece that have heart damages because of these shots, so no comments needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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: "Stage three kidney disease" (unspecified if ongoing); "Known allergies: Sulfa based 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 Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The event was treated with Paxlovid from 25Dec2022 to 30Dec2022.  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, FLUX
Symptoms: Death, Off label use, Product use issue
Clinical narrative: patient get a flu shot and they gave her Pfizer injection she passed away; get a flu shot and they gave her Pfizer injection; get a flu shot and they gave her Pfizer injection; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 03Jan2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2021 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Second dose; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Third dose; manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Fourth dose; manufacturer unknown), for COVID-19 Immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "patient get a flu shot and they gave her Pfizer injection she passed away"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "get a flu shot and they gave her Pfizer injection". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  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.; Reported Cause(s) of Death: patient get a flu shot and they gave her Pfizer injection she passed away
Sex: F
Vaccine: COVID19
Symptoms: Depression, Discouragement, Herpes zoster, Pain
Clinical narrative: received the Pfizer covid vaccine, and developed shingles; depression; being discourage; in pain; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non-HCP), Program ID:   A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: XELJANZ XR oral taken for rheumatoid arthritis, start date: 27Nov2022 (ongoing).  The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "received the pfizer covid vaccine, and developed shingles"; DEPRESSION (non-serious), outcome "unknown"; DISCOURAGEMENT (non-serious), outcome "unknown", described as "being discourage"; PAIN (non-serious), outcome "unknown", described as "in pain".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: my best friend who died a week after getting Pfizer's death shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "my best friend who died a week after getting Pfizer's death shot". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course (Additional information): the reporter lost his best friend who died a week after getting Pfizer's death shot.   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-PV202300001872 same reporter and suspect drug/different patient and AE;; Reported Cause(s) of Death: my best friend who died a week after getting Pfizer's death shot
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got my flu shot and here I am day 5 of the flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid Social media non-serious case from a consumer/non-health care professional.  This case involves an unknown age and gender patient who got his flu shot and here his day 5 of the flu after receiving Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for influenza immunisation.  On an unknown date the patient had got my flu shot and here i am day 5 of the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for event.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Influenza
Clinical narrative: still coughing; flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown age and gender who experienced still coughing and flu after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Oct-2022, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient was still coughing (cough) (latency: unknown) following the administration of influenza vaccine.  On 19-Oct-2022, the patient developed flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event still coughing and was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient developed flu (influenza) after receiving an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site with unknown form, strength, frequency, expiry date for influenza.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 02-Jan-2023 regarding an unsolicited valid non-serious social media case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced got the flu after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  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 influenza vaccine produced by unknown manufacturer (lot, strength, formulation, dose, expiry date: Unknown) via unknown route in unknown administration site as prophylactic vaccination .  On an unknown date the patient developed got the flu (influenza) (unknown latency)  It is unknown if the patient experienced any additional symptoms/events Medication Details  It is unknown if there were lab data/results available  Action taken was unknown.  It was not reported if the patient received a corrective treatment for the event (got the flu).  At time of reporting, the outcome was Unknown for the event got the flu.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired ACTHIB to a patient with no reported adverse event; Initial information received  on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 year old female patient who experienced administered an expired acthib to a patient with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Dec-2022, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE for Powder and solvent for solution for injection (frequency: 1 day) (lot: UJ600AA, expiry date: 30-Nov-2022, strength: unknown) via intramuscular route in the left thigh for immunization.  On 28-DEC-2022 (latency: 1 day) the patient developed a non-serious administered an expired acthib to a patient with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  No lab test available. Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.