chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Nausea
Clinical narrative: very little nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Eosinophilic Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Hashimoto's Disease" (unspecified if ongoing); "controlled depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "controlled daytime sleepiness" (unspecified if ongoing). Concomitant medication(s) included: FASENRA; SYNTHROID; WELLBUTRIN; TRIAMTERENE; SYMBICORT; NUVIGIL taken for somnolence. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "very little nausea". Additional information: The initial Covid vaccines (2 spaced 3 weeks apart) were the least worst, very little nausea but still down for three days. The patient wonders if Fasenra injections are potentially making the Covid bivalent vaccine harder on his system.. The patient, prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, the patient hasn't been tested for COVID-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404908 same reporter, same vaccine, different dose (2nd) and same event;US-PFIZER INC-202300400454 same reporter and vaccine, different dose and event;
Sex: F
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) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dysautonomia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vancomycin, reaction(s): "Known allergies: Vancomycin", notes: Known allergies: Vancomycin; Reglan, reaction(s): "Known allergies: Reglan", notes: Known allergies: Reglan. Vaccination history included: Covid-19 vaccine (Dose1 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2 unknown manufacturer), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: COVID rebound. Tested negative on day 6 after taking paxlovid, and then tested positive on day 10, 4 days after negative tests. I am symptomatic again.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Drug ineffective , COVID-19 cannot be excluded
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (DOSE 1, SINGLE, Anatomical location: Left arm, At 01:00 PM), administration date: 04Mar2021, for COVID-19 immunisation; moderna covid-19 vaccine (DOSE 2, SINGLE, Anatomical location: Right arm, At 12:00 PM), administration date: 04Feb2022, for COVID-19 immunisation; moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Right arm, At 03:00 PM), administration date: 28Sep2022, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid for treatment of COVID-19 from 07Nov2023 to 11Nov2023.  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-202300385314 same reporter/patient, different drug/events.;
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Jul2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "obstructive sleep apnea" (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 Oct2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative, notes: recovered from COVID after taking the 5 day paxlovid treatment, and tested negative on a rapid antigen test on day 9, 10, and 11 since symptoms first appeared; (Nov2023) Negative, notes: recovered from COVID after taking the 5 day paxlovid treatment, and tested negative on a rapid antigen test on day 9, 10, and 11 since symptoms first appeared; (Nov2023) Negative, notes: recovered from COVID after taking the 5 day paxlovid treatment, and tested negative on a rapid antigen test on day 9, 10, and 11 since symptoms first appeared. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Oct2023 to 05Nov2023.  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-202300381397 same reporter/patient, different drug/event;
Age: 59.0
Sex: M
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 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Only lactose intolerant" (unspecified if ongoing); "Rhinitis chronic" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST taken for asthma, start date: 05Aug2022. Vaccination history included: bnt162b2 nos (Dose 2, Single, Vaccination time: 01:00 PM, Vaccination site: Left arm), administration date: 09Sep2022, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient took Paxlovid from 05Nov2023 to 10Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300372606 same patient, different drug/AE.;
Sex: U
Vaccine: COVID19
Symptoms: Freezing phenomenon, Nasopharyngitis
Clinical narrative: Previous booster just left patient freezing cold for a day; Previous booster just left patient freezing cold for a day; 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 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious), FREEZING PHENOMENON (non-serious), outcome "unknown" and all described as "Previous booster just left patient freezing cold for a day".  Additional information: Patient's last dose on October 27 attacked every joint and resulted in a Baker's Cyst behind the knee. Previous booster just left patient freezing cold for a day.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300192698 same patient, different dose/event;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have had covid once before at the end of January, and also took Paxlovid; I have had covid once before at the end of January, and also took Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 07Oct2022 at 17:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm 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 Jan2023, outcome "unknown" and all described as "I have had covid once before at the end of January, and also took Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had covid once before at the end of January, and also took Paxlovid. Patient family history of high blood pressure/high cholesterol.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300385260 same reporter/patient, different drug/AE;US-PFIZER INC-202300404991 same reporter/patient, different drug/event;
Age: 57.0
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 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 17:00 as dose 1, single (Lot number: HD9876) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NUTRAFOL taken for supplementation therapy, start date: 01Oct2023. Vaccination history included: bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE, Vaccine administration time=05:00 PM, vaccine location=Left arm), administration date: 07Oct2022, when the patient was 56-year-old, for COVID-19 immunisation, reaction(s): "I have had covid once before at the end of January, and also took Paxlovid", "I have had covid once before at the end of January, and also took Paxlovid". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (13Nov2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2023) Positive, notes: first tested positive for covid on 08Nov2023. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 09Nov2023 to13Nov2023 as treatment of covid-19. Patient family history of high blood pressure/high cholesterol.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300385260 same patient, different drug/event;US-PFIZER INC-202300404977 same reporter/patient, different drug/event;
Age: 68.0
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 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "asthma" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: CETIRIZINE, start date: 01Jan2010; MONTELUKAST, start date: 18Feb2010; ROSUVASTATIN, start date: 01Jun2022, stop date: 31Oct2023. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Location of injection: Arm Right), administration date: 15Jan2021, when the patient was 65-year-old, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Location of injection: Arm Right), administration date: 16Feb2022, when the patient was 66-year-old, for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Location of injection: Arm Right), for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Location of injection: Arm Right), for COVID-19 immunisation; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Location of injection: Arm Right), for COVID-19 immunisation; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE, Location of injection: Arm Right), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Oct2023 at 22:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 01Nov2023 at 16:30 to 06Nov2023 as Treatment of COVID-19. First symptom at 10 pm 30Oct2023 and tested positive 01Nov2023 and symptoms gone by 04Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300372872 same patient, different drug/event;
Age: 29.0
Sex: M
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).  A 30-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "OCD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Jun2023. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received COVID-19 Treatment from 09Nov2023 to 14Nov2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300385376 same patient, different drug and events;
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Allergies Sulfa based antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "recovered" (2023); VACCINATION FAILURE (medically significant) with onset 2023, outcome "recovered" (2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 08Nov2023 to 12Nov2023.  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-202300380474 Same reporter/ patient; different drug/event;
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nasal congestion, Pain
Clinical narrative: headache; body aches; joint pain; congestion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS. The following information was reported: PAIN (non-serious) with onset 24Nov2023 at 15:45, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 24Nov2023 at 15:45, outcome "recovering", described as "congestion"; HEADACHE (non-serious) with onset 24Nov2023 at 15:45, outcome "recovering"; ARTHRALGIA (non-serious) with onset 24Nov2023 at 15:45, outcome "recovering", described as "joint pain". Therapeutic measures were not taken as a result of headache, pain, arthralgia, nasal congestion. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Eliquis within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blood test, Urticaria, Vaccination site erythema, Vaccination site mass
Clinical narrative: Hives all over my whole body; she had huge lump on it where the shot was given / where they gave her the shot, just went huge; Where they gave her the shot, just went huge and red and sore; Where they gave her the shot, just went huge and red and sore; allergic to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Diabetic" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: URTICARIA (non-serious) with onset Nov2023, outcome "recovered" (Nov2023), described as "Hives all over my whole body"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Nov2023, outcome "unknown" and all described as "Where they gave her the shot, just went huge and red and sore"; ALLERGY TO VACCINE (non-serious) with onset Nov2023, outcome "unknown", described as "allergic to it"; VACCINATION SITE MASS (non-serious) with onset Nov2023, outcome "unknown", described as "she had huge lump on it where the shot was given / where they gave her the shot, just went huge". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, vaccination site mass, vaccination site erythema, vaccination site pain, allergy to vaccine. Additional information: the patient got her Pfizer booster COVID shot in shoulder area and, like within just few hours, she broke out in hives all over her whole body and it had taken better than a week, about a week and half for those hives to go away and the spot where they gave her the shot was the worst, she had huge lump on it where the shot was given. Where they gave her the shot, just went huge and red and sore and then she thought she was having a little bit of a reaction to this and then all of a sudden, she started breaking out with hives everywhere. The patient did not receive any vaccination four weeks prior. She was taking a whole list of medication. Treatment included just Benadryl. She did blood work about a week before that.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Hives all over my whole body; she had huge lump on it where the shot was given / where they gave her the shot, just went huge; Where they gave her the shot, just went huge and red and sore; Where they gave her the shot, just went huge and red and sore; allergic to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Diabetic" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: URTICARIA (non-serious) with onset Nov2023, outcome "recovered" (Nov2023), described as "Hives all over my whole body"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Nov2023, outcome "unknown" and all described as "Where they gave her the shot, just went huge and red and sore"; ALLERGY TO VACCINE (non-serious) with onset Nov2023, outcome "unknown", described as "allergic to it"; VACCINATION SITE MASS (non-serious) with onset Nov2023, outcome "unknown", described as "she had huge lump on it where the shot was given / where they gave her the shot, just went huge". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, vaccination site mass, vaccination site erythema, vaccination site pain, allergy to vaccine. Additional information: the patient got her Pfizer booster COVID shot in shoulder area and, like within just few hours, she broke out in hives all over her whole body and it had taken better than a week, about a week and half for those hives to go away and the spot where they gave her the shot was the worst, she had huge lump on it where the shot was given. Where they gave her the shot, just went huge and red and sore and then she thought she was having a little bit of a reaction to this and then all of a sudden, she started breaking out with hives everywhere. The patient did not receive any vaccination four weeks prior. She was taking a whole list of medication. Treatment included just Benadryl. She did blood work about a week before that.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 59.0
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 59-year-old male patient received bnt162b2 (BNT162B2 NOS), in Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication in 2weeks. COVID 19 Treatment with Paxlovid on 07Nov2023 till 11Nov2023. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 36.0
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) (Physician). 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 24Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cephalosporins allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy"; Vancomycin, reaction(s): "Allergy"; Hydrocodone, reaction(s): "Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19". The patient was treated for COVID-19 with nirmatrelvir, ritonavir (PAXLOVID) from 06Nov2023 to 10Nov2023. 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: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: PNC20
Symptoms: Intensive care, Lung disorder
Clinical narrative: he's got a problem with his lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "he's got a problem with his lungs". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.  Additional information: Caller the patient's spouse called on behalf of the patient to see if the patient would need an additional Prevnar shot. During the call caller stated: "My husband had a Prevnar I don't know which one it was, if it was 20, 15, or 10 or whatever the heck they have. I know he had it at a hospital he's been in there several times over the past 6 years. Caller later stated on the call. Now he's got a problem with his lungs and they asked me, he's on a special medication and they asked me what Pneumonia shot he had and I don't know. He was in the hospital on several occasions for non specific problems, he was in intensive care for a long time, it was just a whole bunch of things, He's been in and out of hospitals for the last 10 years."
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fall, Malaise
Clinical narrative: I Did and almost died. I fell out at work and mis five days of work; but had to be help to my car. wife's car who came to get me from work. Worth feeling ever.; 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 male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization; Bnt162b2 (dose 2, single), for COVID-19 immunization; Bnt162b2 (dose 3 (booster), single), for COVID-19 immunization; Bnt162b2 (dose 4 (booster), single), for COVID-19 immunization. The following information was reported: FALL (medically significant), outcome "unknown", described as "I Did and almost died. I fell out at work and mis five days of work"; MALAISE (non-serious), outcome "unknown", described as "but had to be help to my car. wife's car who came to get me from work. Worth feeling ever.".  Clinical course details: Pfizer has a commercial encouraging people to "get both the Flu and the Pfizer shot at the same time.". Patient did and almost died. He stated that "I fell out at work and miss five days of work". Patient had 4 Pfizer shots with no affects. Patient had to be help to his car wife's car who came to get him from work. Worst feeling ever.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Synovial cyst
Clinical narrative: attacked every joint and resulted in a Baker's Cyst behind my knee; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 immunization; Bnt162b2 nos (dose # unknown (booster), manufacturer unknown), for COVID-19 immunization, reaction(s): "Previous booster just left me freezing cold for a day", "Previous booster just left me freezing cold for a day". The following information was reported: SYNOVIAL CYST (non-serious) with onset 2023, outcome "unknown", described as "attacked every joint and resulted in a Baker's Cyst behind my knee".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404973 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Memory impairment, Renal disorder, Respiratory disorder
Clinical narrative: cardiac, kidney, memory, and respiratory issues; cardiac, kidney, memory, and respiratory issues; cardiac, kidney, memory, and respiratory issues; cardiac, kidney, memory, and respiratory issues; 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 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long Haul COVID", start date: 18Nov2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), RENAL DISORDER (non-serious), MEMORY IMPAIRMENT (non-serious), RESPIRATORY DISORDER (non-serious), outcome "unknown" and all described as "cardiac, kidney, memory, and respiratory issues".  Additional information: the patient has already had COVID-19 vaccination. The patient had it within 3-5 days after it was available. As the patient was still dealing with the after effects of Long Haul COVID from 18Nov2020, wanted to make sure if he/she got any form of COVID again, it was never going to take the patient down that dark road again. The patient had cardiac, kidney, memory, and respiratory issues.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300409625 same patient, different events after different doses of the vaccine;
Age: 17.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Body temperature increased, Malaise
Clinical narrative: feeling unwell; temperature of 102 degrees; Initial information received on 20-Nov-2023 regarding an unsolicited valid non-serious Courtesy case received from other health professional.  This case involves a 17-year-old female patient who was feeling unwell and had temperature of 102 degrees after receiving HPV vaccine and meningococcal vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect HPV VACCINE not produced by Sanofi Pasteur and meningococcal vaccine produced by unknown manufacturer (strength, formulation, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient was feeling unwell (malaise) and had temperature of 102 degrees (body temperature) (unknown latency) following the administration of meningococcal vaccine and (HPV vaccine.  Relevant laboratory test results included: Body temperature - On an unknown date: 102 deg  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (feeling unwell, temperature of 102 degrees).  At time of reporting, the outcome was Unknown for both the events.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: patient was administered with the ACTHIB using sterile water as the diluent instead of the specific ACTHIB diluent with no reported adverse event; Initial information received on 15-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who was administered with the HIB (PRP/T) VACCINE [ACT-HIB] using sterile water as the diluent instead of the specific ACTHIB diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A vaccine (Hepatitis A), Measles vaccine, Mumps vaccine, Rubella vaccine (MMR VACCIN), and Pneumococcal vaccine CONJ 20V (CRM197) (Pneumococcal Vaccine CONJ 20V (CRM197)) all for Immunisation.  On 15-Nov-2023, the patient received 0.5 ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UK007AB via intramuscular route in the left vastus lateralis as prophylactic vaccination(immunization).  On 15-Nov-2023, the patient was administered with the HIB (PRP/T) vaccine using sterile water as the diluent instead of the specific ACTHIB diluent with no reported adverse event (product preparation error) (latency: same day).  No lab data was reported.   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 and Regulatory Authority 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.
Age: 4.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: administered a wrong vaccine to an outpatient. They have given a dose of ADACEL instead of DAPTACEL with no reported adverse event; Initial information was received on 22-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old male patient who reported that administered a wrong vaccine to an outpatient. they have given a dose of diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of vaccines diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Immunisation; and hepatitis a vaccine (HEPATITIS A) for Immunisation.  On 06-Nov-2023, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot U7905AA, Expiry date:30-Oct-2025, strength was unknown) via intramuscular route in the right deltoid for prophylactic vaccination(Immunization). On an unknown date, the patient received a dose 5 of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (Suspension for injection) (strength, expiry date lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was requested.  On 06-Nov-2023 the patient had administered a wrong vaccine to an outpatient. they have given a dose of adacel instead of daptacel with no reported adverse event (wrong product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered a wrong vaccine to an outpatient. they have given a dose of adacel instead of daptacel with no reported adverse 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.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: reconstituting ACT-HIB with a sterile water and administering the reconstituted dose to a patient with no adverse event; Initial information received on 22-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 15 months old male patient who was administered the reconstituted dose after reconstituting HIB (PRP/T) VACCINE [ACT-HIB] with a sterile water with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation; and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Immunisation.  On 17-Nov-2023, the patient received 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UJ856AB; Expiration Date : 25-MAR-2024) via intramuscular route in the right thigh for Immunization after reconstituting with a sterile water with no adverse event (product preparation error) (Latency: on same day).  Site manager calling from a medical center stated that one of their nurses gave the ACT-HIB to a patient but she didn't use the supplied vial of sodium chloride to reconstitute the lyophilized powder.    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 and Regulatory Authority 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.
Age: 30.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: Bleeding at site after injection; Bruising at site; Pain at site; This spontaneous case was received on 16-Nov-2023 from other non-healthcare professional (consumer) (reference number: SEQW23-04314) and concerned a 30-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 09-Nov-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose; 0.5 ml; route of administration: intramuscular (IM); anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 372395 and the expiry date 13-Jun-2024.  On the same date, after receiving Flucelvax Quadrivalent, the patient experienced bleeding at the site after injection, pain at the site, and bruising. There were no treatment measures associated with the events.  On an unspecified date in Nov-2023, the patient recovered from the events of 'vaccination site bleeding' and 'vaccination site pain'. As reported, the bleeding and pain had resolved.  At the time of the initial reporting, the patient had not recovered from the event of 'vaccination site bruising'. As reported, the patient still had bruising at the site.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A patient was vaccinated with Flucelvax Quadrivalent. On the same day after vaccination, the patient experienced bleeding, pain, and bruising at the injection site. Causal role of the suspect vaccine is assessed as possibly related for the events vaccination site haemorrhage, vaccination site pain and vaccination site bruising, due to anatomical and chronological plausibility.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent. On the same day after vaccination, the patient experienced bleeding, pain, and bruising at the injection site. Causal role of the suspect vaccine is assessed as possibly related for the events vaccination site haemorrhage, vaccination site pain and vaccination site bruising, due to anatomical and chronological plausibility.
Sex: U
Vaccine: FLUC3
Symptoms: Urticaria
Clinical narrative: Patient with alpha-gal allergy who had urticaria one hour after receiving Flucelvax; This spontaneous case was received on 20-Nov-2023 from other healthcare professional via Communications (reference number: SEQW23-04404) and concerned a patient of unreported age and gender.  The patient's concurrent condition included alpha-gal allergy. The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, and anatomical location: not reported) for active immunization against influenza disease. The batch number was not reported.  On the same date, one hour after receiving Flucelvax Quadrivalent, the patient experienced urticaria.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: The event of urticaria is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.; Sender's Comments: The event of urticaria is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.
Sex: F
Vaccine: RVX
Symptoms: Injection site pain
Clinical narrative: I have never experienced pain for this long after a vaccine; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concomitant products included levothyroxine sodium (Synthroid).   On 09-NOV-2023, the patient received RSV vaccine. On 09-NOV-2023, less than a day after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: I have never experienced pain for this long after a vaccine). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to RSV vaccine.     It was unknown if the company considered the injection site pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date - 20-NOV-2023  The patient received RSV vaccine and stated that she had never experienced pain for this long after a vaccine. The patient received Synthroid as concomitant medication for indication thyroid. The patient asked that what was the problem or what she should do. The symptom was not treated. The reporter consented to follow-up.