chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "EDS" (unspecified if ongoing); "bilateral arterial thoracic outlet syndrome" (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Chiari I malformation" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "migraines" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "meibomian gland dysfunction" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Celebrex, reaction(s): "Allergies". 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: COVID-19 (non-serious) with onset Nov2023, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Additional information: Patient took Paxlovid from 18Nov2023 to 23Nov2023.  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-202300422403 Same reporter/ patient; different drug/event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Exertion and allergy related asthma" (unspecified if ongoing); "Exertion and allergy related asthma" (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 18Nov2023 to 22Nov2023.  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-202300422421 same patient, different drug/event;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "laryngeal reflux" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Tendinitis" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 5 (BOOSTER), SINGLE at 08:30 AM, Anatomical location: Left arm), administration date: 05Jul2023, when the patient was 72-year-old, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), 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 which included Paxlovid from 15Nov2023 to 20Nov2023.  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-202300422427 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 18Nov2023 to 22Nov2023.  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-202300422501 Same patient, different product, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), 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 Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid treatment from 11Nov2023 to 16Nov2023.  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-202300419139 same patient, different drug/event;
Age: 39.0
Sex: M
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) (Other HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history and 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Nov2023, outcome "recovered" (26Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2023) Positive; (26Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Nov2023 to 22Nov2023.  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: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a  contributory role of the suspect product Vaccination failure ,COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300419201 same patient, different drug/event;
Age: 24.0
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 25-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 24 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 21Nov2023 to 26Nov2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300420814 same reporter/patient, different drug/event;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling jittery, Flushing, Hypertension
Clinical narrative: my BP was 181/90; felt jittery; felt flush; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FLUSHING (non-serious) with onset Oct2023, outcome "recovered" (2023), described as "felt flush"; FEELING JITTERY (non-serious) with onset Oct2023, outcome "recovered" (2023), described as "felt jittery"; HYPERTENSION (medically significant) with onset 19Oct2023, outcome "recovered" (2023), described as "my BP was 181/90". The events "my bp was 181/90", "felt flush" and "felt jittery" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (19Oct2023) 181/90; (Oct2023) 153/90. Therapeutic measures were not taken as a result of hypertension, flushing, feeling jittery. Clinical course: On 16Oct patient received the vaccine from Pfizer. Approximately, 4 days later, she felt flush and jittery. On Saturday her BP (blood pressure) was 181/90. When she saw her medical provider on Oct2023, well, her BP was still very elevated; 153/90, and was still jittery. She wanted to stress that this happened only one other time. There were other side effects from other COVID vaccines, but they were mild in comparison. She never had this kind of reaction or side effect from any other non-COVID vaccine. So, she was sceptical about receiving any further or would have to be followed if she does so. She contacted Doctor or other healthcare professional office/clinic visit. There were no known allergies.  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: 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) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: C7J6739), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 20May2022 as dose 3 (booster), single (Lot number: FP4554) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "known allergies: Adhesives" (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29Nov2023 to 29Nov2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300422567 Same reporter/ patient; different drug/event;
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 52 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Nov2023 to 25Nov2023. Clinical course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300423238 same reporter/patient, different product/adverse event;
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis
Clinical narrative: rashes in his lips; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID.  A male patient 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 included: "Herpes Zoster virus" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: CHEILITIS (non-serious), outcome "unknown", described as "rashes in his lips". 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal discomfort
Clinical narrative: More then 2 year, still problems with Left arm, shoulder, not getting better; More then 2 year, still problems with Left arm, shoulder, not getting better; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), on 29Sep2021 as dose 2, single (Lot number: FF8841) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: comirnaty (Dose Number: 1, Batch/Lot No: FF2587, Location of injection: Arm Left), administration date: 09Sep2022, for COVID-19 immunization. The following information was reported: LIMB DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "More then 2 year, still problems with Left arm, shoulder, not getting better". Therapeutic measures were not taken as a result of limb discomfort, musculoskeletal discomfort. Additional information: No past drug allergy. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: alopecia detected 1 week after first shot, loss of hair from January - June with full loss by early July.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 12Jan2022 as dose 2, single (Lot number: FK5618) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Alopecia 1 week after first shot), administration date: 22Dec2021, for COVID-19 immunisation, reaction(s): "Alopecia". The following information was reported: ALOPECIA (non-serious) with onset Jan2022, outcome "unknown", described as "alopecia detected 1 week after first shot, loss of hair from January - June with full loss by early July.". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300434447 Same reporter, patient, drug, event; different dose;US-PFIZER INC-202300434447 Same reporter, patient, drug, event; different dose;
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia
Clinical narrative: Fever; Chills; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2 NOS), 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: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick". 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-202300433655 same patient/drug/AEs, different dose;
Age: 77.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck; Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck; Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck; Limited range of motion in my left arm; Extreme weakness in using my left arm; 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 patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "Limited range of motion in my left arm"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Extreme weakness in using my left arm". The events "severe left arm and shoulder pain/sorness in my left arm radiating into my left shoulder and neck", "limited range of motion in my left arm" and "extreme weakness in using my left arm" required physician office visit. 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: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site infection, Injection site inflammation, Mobility decreased, Muscular weakness
Clinical narrative: Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck; Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck; Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck; Limited range of motion in my left arm; Extreme weakness in using my left arm; 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 patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "Limited range of motion in my left arm"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Extreme weakness in using my left arm". The events "severe left arm and shoulder pain/sorness in my left arm radiating into my left shoulder and neck", "limited range of motion in my left arm" and "extreme weakness in using my left arm" required physician office visit. 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: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck; Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck; Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck; Limited range of motion in my left arm; Extreme weakness in using my left arm; 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 patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "Severe left arm and shoulder pain/Sorness in my left arm radiating into my left shoulder and neck"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "Limited range of motion in my left arm"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Extreme weakness in using my left arm". The events "severe left arm and shoulder pain/sorness in my left arm radiating into my left shoulder and neck", "limited range of motion in my left arm" and "extreme weakness in using my left arm" required physician office visit. 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: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: recently had a cold sore which she had not had in about 3 years; Initial information received on 28-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 66 years old female patient who recently had a cold sore which she had not had in about 3 years after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown formulation, strength, expiry date, lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient recently had a cold sore which she had not had in about 3 years (oral herpes) (unknown latency).  It was reported, patient reported she recently had a cold sore which she had not had in about 3 years. she stated this was one of the worst ones she has ever had. the cold sore is now resolved. patient also stated she received the covid and flu vaccines about 1 week before cold sore appeared. advised patient let me md know about this and if issue reoccurs to continue to follow with md  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Illness, Nasal congestion, Oropharyngeal pain
Clinical narrative: stuffy nose and congestion; sore throat; she is getting sick; Initial information was received on 27-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional (patient).  This case is linked to case 2023SA345539.  This case involves 65 years old female patient who experienced stuffy nose and congestion, sore throat and she is getting sick after receiving COVID-19 VACCINE and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site and also received a unknown dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for all prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient developed stuffy nose and congestion (nasal congestion), sore throat (oropharyngeal pain) and she is getting sick (illness) (unknown latency) following the administration of influenza vaccine and COVID-19 VACCINE.  It is unknown if there were lab data/results available.  Action taken with influenza vaccine and COVID-19 VACCINE (COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (stuffy nose and congestion, sore throat, she is getting sick).  At time of reporting, the outcome was Unknown for all the events.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Fridge got too cold but it went back to normal temperature after they adjusted it, temp reached: 32.2 F for about 15 hours max with no reported adverse eent; post-excursion Ipol was administered to patient with no reported adverse event; Initial information received on 21-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA367078.  This case involves a 2 years old male patient who was administered IPV (VERO) [IPOL] post excursion where the fridge got too cold but it went back to normal temperature after they adjusted it, temp reached: 32.2 f for about 15 hours max with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Nov-2023, the patient received 0.5 ml dose of suspect IPV (VERO) suspension for injection of lot W1A191M and expiry: 16-Feb-2025 via subcutaneous route in the left leg for immunization.  On an unknown date, it was reported that the fridge got too cold but it went back to normal temperature after they adjusted it, temp reached: 32.2 f for about 15 hours max with no reported adverse eent (product storage error) (unknown latency).  On 02-Nov-2023, post-excursion IPV (VERO) was administered to patient with no reported adverse event (poor quality product administered) (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 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: 0.5
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered quadracel to a 6 month old child instead of DTAP with no reported adverse event; Initial information was received from PRIVACY on 28-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 6 months old female patient who experienced administered quadracel to a 6 month old child instead of dtap with no reported adverse event while receiving vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/ipv (VERO) VACCINE [Quadracel (VERO)] and diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation.  On an unknown date, the patient received a unknown dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) 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  umber was requested.  On 06-Nov-2023, the patient received a dose 1 of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/ipv (VERO) VACCINE (Solution for injection in pre-filled syringe) lot U7931AB, Expiry date : 09-Nov-2025, strength was unknown via intramuscular route in the left thigh for prophylactic vaccination (Immunization).  On 06-Nov-2023 the patient was administered quadracel to a 6 month old child instead of dtap with no reported adverse event (wrong product administered) (latency: same day).  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS and ipv VACCINE (Quadracel) and DIPHTHERIA, TETANUS, AC PERTUSSIS and ipv VACCINE (Quadracel (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event administered quadracel to a 6 month old child instead of dtap with no reported adverse event.  Action taken: not applicable.   Outcome: 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.
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient who received Adacel last week was given another dose today with no reported adverse event; Initial information received on 28-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 74-year-old male patient who received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] last week was given another dose today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s)  and family history were not provided.  Concomitant medications included RSV Vaccine (RESPIRATORY SYNCYTIAL VIRUS VACCINE) for Prophylactic vaccination.  On 28-Nov-2023, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (strength: unknown) (lot: U7837AA, expiry date: 25-Jul-2025) via intramuscular route in the right deltoid for immunization and patient who received adacel last week was given another dose today with no reported adverse event (extra dose administered) (latency: same day)  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: 53.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a fluzone quad shot for a 53 year old patient, but was given fluzone hd instead with no reported adverse event; Initial information received on 29-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 53 years old female patient who was administered Influenza Quadrival A-B High dose HV vaccine [Fluzone High-Dose Quadrivalent] instead of a fluzone quad shot for 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 Pneumococcal Vaccine CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 29-Nov-2023, the patient received 0.7 ml dose of suspect Influenza Quadrival A-B High Dose HV vaccine of lot U8162BA (formulation and expiry: not reported) via intramuscular route in the left deltoid as immunization.  On 29-Nov-2023, the patient developed a non-serious a fluzone quad shot for a 53 year old patient, but was given fluzone hd instead with no reported adverse event (wrong product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  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: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Pain, Pruritus
Clinical narrative: About 5 hours post injection I started to get body aches and fatigue.  That lasted for 11/29 and 11/30.  On 11/30, almost exactly 24-hours after the injection I began itching.  No rash, just itching on my face, arms, upper back, and head.  That lasted the duration of 11/30.  All symptoms resolved by evening of 11/30.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient (7 years of age) was injected with a dose of COVID 19 Moderna Monovalent Vaccine, for 12 years of age and older (0.5 ml=50 mcg). Patient was alert and oriented to person, place and time. Patient was monitored for 30 minutes, at which time there was no bumps, or redness noted to the left arm. Patient appeared to be in no discomfort. Patient was accompanied by his parent.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Flulaval mistakenly. Was already administered on 10/19/2023 at other organization. Patient had no adverses side effects. Provider was informed of duplicate vaccine by case manager, after visit complete.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Chills, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Pt reports side effects expected with the vaccine, but to a severity that interfered with her normal activities. Symptoms include headache, fatigue, nausea, chills, myalgias and arthralgias
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Nausea
Clinical narrative: Pt reports side effects expected with the vaccine, but to a severity that interfered with her normal activities. Symptoms include headache, fatigue, nausea, chills, myalgias and arthralgias
Age: 58.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest discomfort, Dysphagia, Dyspnoea, Erythema, Fatigue
Clinical narrative: Face turned red, hot and blood pressure went up while in waiting room after.  Asked to have blood pressure taken and it was high.  Went home.  Felt tires and achy the next day.  2 days later, I had a headache like a migraine that didn't respond to migraine medicine.  Blood pressure continued to go up and down for 2 weeks.  At points as high as 160/100 on my home cuff.  I contacted my primary care by email and told her what was going on, but then sent a follow up to say that maybe it was just a bad migraine.  When my blood pressure continued for another week or so and heart palpitations and pressure and reflux, I called the online clinic.  I had a phone visit scheduled to ask if I should go to ER, but then they left a message and told me to cancel my appointment because they were full for the day.  It was close to Thanksgiving and had to travel, so just thought perhaps it would pass.  At this point, the migraine is gone, the chest pressure is mostly gone, my blood pressure is mostly closer to normal, not all the way.  I still have heart palpitations and my breath catches and wake up as I have for weeks with swollen hands and feet and then it moves to my stomach once up.  Memory isn't perfect.  I've had acid refulx like symptoms and difficulty swallowing without pain.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Feeling hot, Gastrointestinal disorder, Gastrooesophageal reflux disease, Headache, Hypertension
Clinical narrative: Face turned red, hot and blood pressure went up while in waiting room after.  Asked to have blood pressure taken and it was high.  Went home.  Felt tires and achy the next day.  2 days later, I had a headache like a migraine that didn't respond to migraine medicine.  Blood pressure continued to go up and down for 2 weeks.  At points as high as 160/100 on my home cuff.  I contacted my primary care by email and told her what was going on, but then sent a follow up to say that maybe it was just a bad migraine.  When my blood pressure continued for another week or so and heart palpitations and pressure and reflux, I called the online clinic.  I had a phone visit scheduled to ask if I should go to ER, but then they left a message and told me to cancel my appointment because they were full for the day.  It was close to Thanksgiving and had to travel, so just thought perhaps it would pass.  At this point, the migraine is gone, the chest pressure is mostly gone, my blood pressure is mostly closer to normal, not all the way.  I still have heart palpitations and my breath catches and wake up as I have for weeks with swollen hands and feet and then it moves to my stomach once up.  Memory isn't perfect.  I've had acid refulx like symptoms and difficulty swallowing without pain.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Memory impairment, Migraine, Oropharyngeal pain, Pain, Palpitations
Clinical narrative: Face turned red, hot and blood pressure went up while in waiting room after.  Asked to have blood pressure taken and it was high.  Went home.  Felt tires and achy the next day.  2 days later, I had a headache like a migraine that didn't respond to migraine medicine.  Blood pressure continued to go up and down for 2 weeks.  At points as high as 160/100 on my home cuff.  I contacted my primary care by email and told her what was going on, but then sent a follow up to say that maybe it was just a bad migraine.  When my blood pressure continued for another week or so and heart palpitations and pressure and reflux, I called the online clinic.  I had a phone visit scheduled to ask if I should go to ER, but then they left a message and told me to cancel my appointment because they were full for the day.  It was close to Thanksgiving and had to travel, so just thought perhaps it would pass.  At this point, the migraine is gone, the chest pressure is mostly gone, my blood pressure is mostly closer to normal, not all the way.  I still have heart palpitations and my breath catches and wake up as I have for weeks with swollen hands and feet and then it moves to my stomach once up.  Memory isn't perfect.  I've had acid refulx like symptoms and difficulty swallowing without pain.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Peripheral swelling, Sleep disorder
Clinical narrative: Face turned red, hot and blood pressure went up while in waiting room after.  Asked to have blood pressure taken and it was high.  Went home.  Felt tires and achy the next day.  2 days later, I had a headache like a migraine that didn't respond to migraine medicine.  Blood pressure continued to go up and down for 2 weeks.  At points as high as 160/100 on my home cuff.  I contacted my primary care by email and told her what was going on, but then sent a follow up to say that maybe it was just a bad migraine.  When my blood pressure continued for another week or so and heart palpitations and pressure and reflux, I called the online clinic.  I had a phone visit scheduled to ask if I should go to ER, but then they left a message and told me to cancel my appointment because they were full for the day.  It was close to Thanksgiving and had to travel, so just thought perhaps it would pass.  At this point, the migraine is gone, the chest pressure is mostly gone, my blood pressure is mostly closer to normal, not all the way.  I still have heart palpitations and my breath catches and wake up as I have for weeks with swollen hands and feet and then it moves to my stomach once up.  Memory isn't perfect.  I've had acid refulx like symptoms and difficulty swallowing without pain.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Chills, Cyanosis, Haematochezia, Infant irritability, Mucous stools
Clinical narrative: 5 hours after vaccines given, he was fussy and irritable. Lips turned blue for about an hour, he was chattering his gums, hands and feet were cold. He never stopped breathing. Specs of blood in poop with a large mucus, loose stool. He was taken to ED
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Peripheral coldness
Clinical narrative: 5 hours after vaccines given, he was fussy and irritable. Lips turned blue for about an hour, he was chattering his gums, hands and feet were cold. He never stopped breathing. Specs of blood in poop with a large mucus, loose stool. He was taken to ED
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Headache  Myalgia Arthralgia Injection site pain and swelling
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Pyrexia
Clinical narrative: Chills. Leading to fever 100,1  up to 101.1 back down to 100.1
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Pt. received extra dose of MenQuadfi, pt. notified and provider notified and incident report filed through place of work.
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: patient states 3 days post immunization that he noticed redness, like a rash, at injection site. site also sore. feels tired.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The injection site is swollen, red, hot, painful and hard.  Patient has been using cold compresses, I advised today to take Tylenol for the pain.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Malaise, Resuscitation
Clinical narrative: Patient's wife came into the pharmacy on 12/5/23 to get her flu shot.  During the vaccination she mentioned that her husband had passed away after getting his vaccines at pharmacy. She stated that he got both his covid and flu shot on  09/28/2023 and the next day at 3 am he woke up feeling sick. She called 911 but they were not able to resuscitate him. Autopsy was not performed to ascertain the cause.
Age: 70.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Headache, Impaired work ability, Influenza like illness
Clinical narrative: Patient complained severe headache and flulike illness that caused her to miss multiple days at work
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Assumed patient was 65 instead of 63. Grabbed high dose flu shot and administered. Patient and family notified.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Drug hypersensitivity, Eye discharge, Nasopharyngitis, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: I?m not sure it?s related to my vaccines, but on 11/27 I had bacterial conjunctivitis in my right eye. It was painful with thick yellow discharge out of my eye that was very red also. This week I have a cold: sneezing, runny nose and sore throat.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: I?m not sure it?s related to my vaccines, but on 11/27 I had bacterial conjunctivitis in my right eye. It was painful with thick yellow discharge out of my eye that was very red also. This week I have a cold: sneezing, runny nose and sore throat.