chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: COVID 19; COVID 19; Pfizer / BioNTech; Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15May2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypo parathyroid" (unspecified if ongoing); "THoracid aortic aneurysm" (unspecified if ongoing). Concomitant medication(s) included: SENSIPAR, start date: 01Oct2021, stop date: 20Sep2023; POTASSIUM, start date: 01Apr2020; MAGNESIUM, start date: 01Oct2020; VIT D3, start date: 01Oct2020; VIT B12, start date: 01Oct2020; VIT C, start date: 01Oct2020; LORATADINE, start date: 01Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech; Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 22Sep2023 to 26Sep2023.  Clinical course: Paxlovid rebound. Free of symptoms on 5th day after Paxlovid treatment. Tested negative for Covid on at-home test on day 7. On day 8, at 5pm fever 100.7, achey, chills/sweat, congestion, sore throat and sneezing.  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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: COVID 19; COVID 19; Pfizer / BioNTech; Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15May2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypo parathyroid" (unspecified if ongoing); "THoracid aortic aneurysm" (unspecified if ongoing). Concomitant medication(s) included: SENSIPAR, start date: 01Oct2021, stop date: 20Sep2023; POTASSIUM, start date: 01Apr2020; MAGNESIUM, start date: 01Oct2020; VIT D3, start date: 01Oct2020; VIT B12, start date: 01Oct2020; VIT C, start date: 01Oct2020; LORATADINE, start date: 01Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech; Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 22Sep2023 to 26Sep2023.  Clinical course: Paxlovid rebound. Free of symptoms on 5th day after Paxlovid treatment. Tested negative for Covid on at-home test on day 7. On day 8, at 5pm fever 100.7, achey, chills/sweat, congestion, sore throat and sneezing.  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: 43.0
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). The reporter is the patient.  A 44-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 31Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Apr2021 at 10:30 as dose 2, single (Batch/Lot number: unknown), in right arm and on 04Dec2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient was on Paxlovid treatment from 18Sep2023 to 23Sep2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314720 same patient, different drug/event (Paxlovid Case);
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jul2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "dysautonomia" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT, start date: Jan2007, stop date: 19Sep2023; FLOVENT, start date: Jun2021, stop date: 19Sep2023; NALTREXONE, start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (27Sep2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Treatment of COVID-19; (27Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 19Sep2023 to 24Sep2023 as Treatment of 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: Linked Report(s) : US-PFIZER INC-202300314834 same patient, different drug/event;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: Gj2524), in left arm and on 13May2023 as dose 6 (booster), single (Lot number: Gj3268) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 29Mar2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "calcified coronary atherosclerosis w/o angina" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 04Feb2010, stop date: 19Sep2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, 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 Paxlovid treatment from 19Sep2023 to 23Sep2023 and had no known allergies.; 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 Vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300314845 Same patient different drug/event;
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: had just flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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: INFLUENZA (non-serious), outcome "recovered", described as "had just flu". Additional information: The patient got the Covid shot (clarified as Pfizer COVID-19 Vaccine) the other day (Sep2023) at the pharmacy. The patient had just flu.  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: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Daughter has a large round oval on her arm where it was injected and it is raised; It is probably about 2 inches long by 1 inch wide; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, 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: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Daughter has a large round oval on her arm where it was injected and it is raised; It is probably about 2 inches long by 1 inch wide".  Additional Information: The reporter mentioned that they (her, her husband and her daughter) got the Covid shot (Clarified as Pfizer COVID-19 Vaccine), the other day at the Pharmacy. Reporter's daughter (patient) has a large round oval on her arm where it was injected and it was raised. It was probably about 2 inches long by 1 inch wide. She asked if it was something to worry about. None of them has ever had this before. Reporter further clarified that it was the Pfizer, it was Covid-19 Vaccine. Reporter mentioned that safety report can be filed but she was more concerned if this was something dangerous that they need to take the patient to the emergency room. That's what she wanted to know. She also said that there was nobody else that they can talk to. She called the pharmacy local and they do not know anything about this shot either. Reporter was suggested to contact nearest Health care professional and also suggested to contact Pfizer Medical Information on Monday morning for the concern.  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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 47 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 03May2021 as dose 2, single (Lot number: EWO173), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FPFD0809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "former smoker" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) Positive; (22Sep2023) Negative; (23Sep2023) Negative; (01Oct2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 18Sep2023 to 23Sep2023. Clinical course: Adverse event: covid rebound: Tested positive 18Sep2023, started Paxlovid the same day. Symptoms were gone and I tested negative within 4 days on 22Sep2023. Tested negative again on the fifth day 23Sep2023. I got symptoms and tested positive again on 01Oct2023..; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315079 Same patient, different product, different dose/event;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Wrong product administered
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Wrong vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 12:30 as dose 1, single (Lot number: GJ6665) at the age of 66 years, in left arm for covid-19 immunisation. The patient didn't receive bnt162b2 (BNT162B2). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 25Oct2022 at 12:30, outcome "unknown", described as "Wrong vaccine administered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures as Paxlovid were taken as a result of drug ineffective, covid-19 from 19Sep2023 to 23Sep2023.  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-202300315083 same patient, different drug and different AE.;
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Apr2023 as dsoe 4 (booster), single (Batch/Lot number: unknown) at the age of 62 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "slightly overweight" (unspecified if ongoing); "Tree nuts allergy" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Sep2023 to 24Sep2023 .  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-202300315563 Same patient, different drug/AE.;
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose number unknown, single (Lot number: GH9694) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDRALAZINE; OMEGA 3 FATTY ACID; ATORVASTATIN. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of pyrexia.  Additional information: Consumer stated Atorvastatin is a statin for cholesterol and the doctor said he don't have a high cholesterol but they have given that because of his age. For dose and frequency for Hydralazine, consumer stated, "Biggest dose in the morning as 320 mg then, 50 mg 5-6 hours later and again 50 mg 5-6 hours later. Consumer stated about treatment that, the only thing he took was Tylenol, he did not know what else to take.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314876 same patient, different event/ drug;
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Apr2023 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pertussis (Dose number unknown, single), for Pertussis immunisation, reaction(s): "known allergies: Pertussis immunization". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (Sep2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment taken from 20Sep2023 to 25Sep2023.  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-202300315090 same patient, different drug and different AE.;
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received the Paxlovid treatment from 21Sep2023 to 25Sep2023. Patient had no known allergies  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315554 Same patient, different drug/AE.;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Apr2022 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 01May2022 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "BP occasionally elevated" (unspecified if ongoing), notes: None. Healthy. BP occasionally elevated (128/85) but never this scary high. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: Thursday night tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Sep2023 to 26Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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.,Linked Report(s) : US-PFIZER INC-202300315587 Same patient, different drug/AE.;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Lacrimation increased, Pain, Pain in extremity
Clinical narrative: Symptoms started the night of the vaccination:  very, very sore arm; felt feverish; weak; body aches; stuffy head; runny nose; watery eyes; dehydrated; very thirsty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 13:30 as dose 4, (booster), single (Lot number: HD9835) at the age of 74 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Bipolar disorder" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing); "Penicillins allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE;  MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE;  MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE;  MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "Symptoms started the night of the vaccination:  very, very sore arm"; PAIN (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "body aches"; DEHYDRATION (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "dehydrated"; PYREXIA (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "felt feverish"; RHINORRHOEA (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "runny nose"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "stuffy head"; THIRST (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "very thirsty"; LACRIMATION INCREASED (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "watery eyes"; ASTHENIA (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "weak". Therapeutic measures were taken as a result of pain in extremity, pyrexia, asthenia, pain, upper respiratory tract congestion, rhinorrhoea, lacrimation increased, dehydration, thirst.  Additional information: Symptoms started the night of the vaccination: very, very sore arm, felt feverish & weak, body aches, stuffy head, runny nose, watery eyes, dehydrated & very thirsty. Patient had no other vaccine in four weeks, did not have covid prior to vaccination and did not test for covid post vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Thirst, Upper respiratory tract congestion
Clinical narrative: Symptoms started the night of the vaccination:  very, very sore arm; felt feverish; weak; body aches; stuffy head; runny nose; watery eyes; dehydrated; very thirsty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 13:30 as dose 4, (booster), single (Lot number: HD9835) at the age of 74 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Bipolar disorder" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing); "Penicillins allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE;  MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE;  MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE;  MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "Symptoms started the night of the vaccination:  very, very sore arm"; PAIN (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "body aches"; DEHYDRATION (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "dehydrated"; PYREXIA (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "felt feverish"; RHINORRHOEA (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "runny nose"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "stuffy head"; THIRST (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "very thirsty"; LACRIMATION INCREASED (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "watery eyes"; ASTHENIA (non-serious) with onset 01Oct2023 at 12:00, outcome "recovering", described as "weak". Therapeutic measures were taken as a result of pain in extremity, pyrexia, asthenia, pain, upper respiratory tract congestion, rhinorrhoea, lacrimation increased, dehydration, thirst.  Additional information: Symptoms started the night of the vaccination: very, very sore arm, felt feverish & weak, body aches, stuffy head, runny nose, watery eyes, dehydrated & very thirsty. Patient had no other vaccine in four weeks, did not have covid prior to vaccination and did not test for covid post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Chest pain; Racing heart beats; He had difficulty breathing; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult 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: CHEST PAIN (non-serious), outcome "recovered"; HEART RATE INCREASED (non-serious), outcome "recovered", described as "Racing heart beats"; DYSPNOEA (non-serious), outcome "recovered", described as "He had difficulty breathing". The events "chest pain", "racing heart beats" and "he had difficulty breathing" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest pain, heart rate increased, dyspnoea.  Additional Information: Individual was advised by medical professional to not receive any more mRNA vaccines including the new COVID vaccine. About a week after receiving the second dose of the initial COVID vaccine, individual experienced chest pain and racing heart beats. As an athlete, the individual was unable to participate in a marathon because his chest would burn and he had difficulty breathing. When he returned to his racing, he would only run for a brief time until his heart rate got too fast. It took almost a full year for all the symptoms to resolve. The patient did not test positive after or before vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Tremor
Clinical narrative: shakes; headache; feel real bad for about 8 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: TREMOR (non-serious), outcome "unknown", described as "shakes"; HEADACHE (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel real bad for about 8 hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: it is red and hot; it is red and hot; her right arm became sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bitten by red ants" (unspecified if ongoing); "Highly allergic to red ants" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advil. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "her right arm became sore"; ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 02Oct2023, outcome "unknown" and all described as "it is red and hot".  Additional Information: It was reported that patient experienced right arm became sore on an unspecified date in 2023. On 02Oct2023, it was now red and hot. Patient was inquiring if this was okay and if she needs to see a healthcare professional.  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: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Pain
Clinical narrative: could hardly walk; joint pain worsened; joint pain worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "left knee arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "could hardly walk"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "joint pain worsened". Additional information: the patient got the vaccine on a Saturday, a couple of weeks ago and said that suffered from arthritis in the left knee but the pain never bothered before. Joint pain worsened on Monday night. The patient could hardly walk or move and was in so much pain.  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: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Gait disturbance
Clinical narrative: could hardly walk; joint pain worsened; joint pain worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "left knee arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "could hardly walk"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "joint pain worsened". Additional information: the patient got the vaccine on a Saturday, a couple of weeks ago and said that suffered from arthritis in the left knee but the pain never bothered before. Joint pain worsened on Monday night. The patient could hardly walk or move and was in so much pain.  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: M
Vaccine: COVID19
Symptoms: Motor dysfunction, Pain, Poisoning
Clinical narrative: poisoned from the vaccine/ poisoned his muscles, his bones, poisoned his blood, everything, damage was done to his body; suffering with pain/ It hurts when he is doing anything/painful for him to walk around; immobile/can barely move; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), in 2021 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: MOTOR DYSFUNCTION (non-serious) with onset 2021, outcome "not recovered", described as "immobile/can barely move"; POISONING (medically significant) with onset 2021, outcome "not recovered", described as "poisoned from the vaccine/ poisoned his muscles, his bones, poisoned his blood, everything, damage was done to his body"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "suffering with pain/ It hurts when he is doing anything/painful for him to walk around".  Clinical course: The patient reported that he is poisoned from the vaccine and is seeking 10 million in damages (settlement). He said that the company are (withheld) criminals and they don't know it. He said that he has been suffering with pain since receiving the vaccine, but he is not going to go into it. He reported he is immobile, can barely move, it hurts when he is doing anything. He stated that the vaccine has poisoned his muscles, his bones, poisoned his blood, everything, damage was done to his body. He mentioned that he wants money for suffering. It is painful for him to walk around and has been going on for years since 2021 since that date he received the vaccine. He is suffering for many years now, at least 2 years.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9604) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 3 (booster), single), second regimen (Batch/Lot number: unknown) at single (dose 2, single) and third regimen (Batch/Lot number: unknown) at single (dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "cardiac sarcoidosis" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing); "allergic to sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Had tested  negative two times in a row with 48 hours  between; Negative, notes: Had tested  negative two times in a row with 48 hours  between; positive, notes: Then 2 days after the last  negative test I got cold-like symptoms and  tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 22Sep2023 to 27Sep2023.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001190 (Novavax). A female patient received bnt162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "recovered" (2023), described as "POTS". Additional information: On 16Sep2023, it was reported that a patient started treatment on unreported dates with 4 doses of Pfizer BioNTech COVID-19 vaccine for COVID-19 immunisation. It was reported the patient had POTS for a year and a half. The patient never knew when the episodes would turn up, and so she only had 4 of the shots. At the time of reporting, the patient did not have a POTS episode for 6 months.  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: Fatigue, Rhinorrhoea
Clinical narrative: feeling tired; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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. The following information was reported: FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "feeling tired"; RHINORRHOEA (non-serious) with onset Sep2023, outcome "unknown", described as "runny nose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Six month UTI; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "Six month UTI".  Additional information: Caller said that she had 2 Pfizer vaccines and 2 boosters way back and is calling because she said that many others had a severe reaction to the second booster. She said that it was a six month UTI and said that a lot of her friends had GYN reactions as well. Caller wanted to know if the current vaccine, a vaccine or if it is a booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle and joint pain; Muscle and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08May2023 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 immunisation. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset May2023, outcome "not recovered" and all described as "Muscle and joint pain".  Additional information: Received a Pfizer covid booster shot on 08May at primary doc. Muscle and joint pain started about 10 days later, and continues today, 30Sep2023. Patient wanted to know if there could be a connection.  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: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: definitely not a sheep and a lab rat i have a flu shot allergy; Initial information received on 25-Sep-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient (unknown age and gender) who reported definitely not a sheep and a lab rat he/she had a flu shot allergy after receiving  INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  concomitant medication included holistic vitamins.  On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, administration site, batch number and expiry date: unknown) for prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient reported definitely not a sheep and a lab rat i have a flu shot allergy (allergy to vaccine) (unknown latency).  It was reported "Definitely not a sheep and a lab rat! I have a flu shot allergy.. Still on my hollistic vitamins intakes.. None of any your business. If we are in right mind does not want to take any drugs to ruin our system.. We all have a right to refuse any man made medical drugs ."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Age: 69.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 69 year old patient was supposed to receive fluzone hd qiv but received fluzone qiv instead with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 69 years old female patient who was supposed to receive Influenza quadrival A-B high dose hv vaccine [fluzone high-dose quadrivalent] but received fluzone qiv (influenza quadrival A-B multidose vaccine preserved) instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2023, the patient received a 0.5 ml dose of suspect influenza quadrival A-B multidose vaccine preserved Suspension for injection (lot U8049BA, Expiry: 30-Jun-2024) via intramuscular route in the deltoid nos (not otherwise specified) as immunization instead of Influenza quadrival A-B high dose hv vaccine with no reported adverse event (wrong product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.