chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Off label use, Product use issue, Pyrexia
Clinical narrative: Fever and chills for began 9 hours after injection and lasted for 36 hours; Fever and chills for began 9 hours after injection and lasted for 36 hours; Product: COVID 19, Lot number: fh8028, Administration date: 12Apr2022/ Other vaccine same date lot number: fk9893; Product: COVID 19, Lot number: fh8028, Administration date: 12Apr2022/ Other vaccine same date lot number: fk9893; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 as dose 3 (booster), single (Lot number: fk9893) at the age of 56 years, in right arm and on 12Apr2022 at 09:00 as dose 4 (booster), single (Lot number: fh8028), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: Obese. Concomitant medication(s) included: ZYRTEK; PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; IRON. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Apr2022, outcome "unknown" and all described as "Product: COVID 19, Lot number: fh8028, Administration date: 12Apr2022/ Other vaccine same date lot number: fk9893"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 12Apr2022 at 18:00, outcome "recovered" (Apr2022) and all described as "Fever and chills for began 9 hours after injection and lasted for 36 hours". Therapeutic measures were not taken as a result of pyrexia, chills.  Additional Information:  Serious was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. If other vaccine in four weeks was reported as unknown. If COVID prior vaccination was reported as no. If COVID tested post vaccination was reported as no. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I had been infected; I had been infected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: infected by children this time. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I had been infected".  Clinical course: It was reported that in Evening, she had something to share about her family experience with Covid 19. The patient had been infected last year 1 out of the total of them. Following, the adults have been vaccinated. Her husband went through. They were again infected by their children this time and her husband again avoided it while sharing most of his time with them. She felt, he had a natural immunity and that could be helpful for all.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lichen sclerosus, Rash
Clinical narrative: uncomfortable rash; Lichen Sclerosus. An autoimmune disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colon resection", start date: 2007 (unspecified if ongoing), notes: Colon resection. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 08Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 15Feb2021, when the patient was 67-year-old, for Covid-19 immunization.  The following information was reported: LICHEN SCLEROSUS (non-serious) with onset 21Jan2022, outcome "not recovered", described as "Lichen Sclerosus. An autoimmune disease"; RASH (non-serious) with onset 21Jan2022, outcome "not recovered", described as "uncomfortable rash". The events "uncomfortable rash" and "lichen sclerosus. an autoimmune disease" required physician office visit. Therapeutic measures were taken as a result of rash, lichen sclerosus.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19? No. Clobetasol ointment after Lichen Sclerosus diagnosis.  No follow up attempts possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Nausea; aches; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) received via COVID-19 Adverse Event Self-Reporting Solution. The reporter is the patient.   A 52-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster) single (Lot number: FH8027) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Allergy to Cipro". 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; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 08Apr2022, outcome "recovered" (Apr2022); PAIN (non-serious) with onset 08Apr2022, outcome "recovered" (Apr2022), described as "aches"; PAIN IN EXTREMITY (non-serious) with onset 08Apr2022, outcome "recovered" (Apr2022), described as "sore arm". Therapeutic measures were not taken as a result of nausea, pain, pain in extremity.  Additional information: Patient did not receive other vaccine in four weeks. Patient had no COVID prior vaccination and was not COVID tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hemiplegia, Magnetic resonance imaging, Myalgia
Clinical narrative: Right side paralyzed; Muscles are being ripped apart; can hardly walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEMIPLEGIA (medically significant), outcome "unknown", described as "Right side paralyzed"; MYALGIA (non-serious), outcome "unknown", described as "Muscles are being ripped apart"; GAIT INABILITY (non-serious), outcome "unknown", described as "can hardly walk". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results. The patient reported that COVID Vaccine had affected her in a very bad way. She could hardly walk. Her right side was paralyzed. Her muscles were being ripped apart. She was waiting for her specialist to come back. She had done an MRI and they had referred her to an endocrinologist, neurologist and Psychiatrist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got Covid19; Got Covid19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid19". His wife got COVID19. Prior to getting COVID19 his wife had completed two primary COVID19 vaccine shots and the COVID19 booster shot.  Clinical information: Prior to getting COVID19 the patient had completed two primary COVID19 vaccine shots and the COVID19 booster shot  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 1, single (Lot number: FK5127) and in Jan2022 as dose 2, single (Lot number: FL0007) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: COVID test type post vaccination=Nasal Swab.  Clinical Information: No other vaccine in four weeks. No COVID prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Didn't describe exactly the adverse event but did say that he was ill for approximately 3 months. This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Didn't describe exactly the adverse event but did say that he was ill for approximately 3 months.". It was unknown if therapeutic measures were taken as a result of illness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain, Pyrexia, Sinus congestion, Sneezing
Clinical narrative: Fever; Body Ache; Coughing; Sneezing; Sinus congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 at 10:00 as dose 2, single (Lot number: FK9893) at the age of 15 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 01; manufacturer: Unknown), for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset Apr2022, outcome "not recovered", described as "Coughing"; SINUS CONGESTION (non-serious) with onset Apr2022, outcome "unknown"; SNEEZING (non-serious) with onset Apr2022, outcome "unknown"; PAIN (non-serious) with onset 24Apr2022, outcome "not recovered", described as "Body Ache"; PYREXIA (non-serious) with onset 24Apr2022, outcome "recovered" (2022), described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain, cough, sneezing, sinus congestion.  Additional information: Case narrative including clinical course, therapeutic measures, outcome and additional relevant information. Reporter stated, son had the second dose of the Pfizer, this last Saturday and was just called because he was having some side effects from it. He had a fever, body ache, coughing and sneezing and some sinus congestion. Date of administration: Reporter stated, Saturday, second dose was on Saturday, 23Apr. Reporter was informed about the role of Pfizer Drug Safety. When probed for date when the patient started experiencing the problem, Reporter stated, okay, so we had the second shot, Saturday morning about 10 o clock on the 23rd and then he woke up on the Sunday with a fever and the body aches. (Date clarified as 24Apr). When probed for if the patient got any treatment for the side effect, Reporter stated, well, pt mean we were just treating everything at home over the counter. Pt had not been, his fever went down immediately once he took the fever reliever that morning. So, he had not had the fever since the Sunday morning, but he still had some body ache and the cough. Pt was treating that over the counter. Pt had albuterol here, so he had taken one or two doses of that.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Fever; Body Ache; Coughing; Sneezing; Sinus congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 at 10:00 as dose 2, single (Lot number: FK9893) at the age of 15 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 01; manufacturer: Unknown), for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset Apr2022, outcome "not recovered", described as "Coughing"; SINUS CONGESTION (non-serious) with onset Apr2022, outcome "unknown"; SNEEZING (non-serious) with onset Apr2022, outcome "unknown"; PAIN (non-serious) with onset 24Apr2022, outcome "not recovered", described as "Body Ache"; PYREXIA (non-serious) with onset 24Apr2022, outcome "recovered" (2022), described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain, cough, sneezing, sinus congestion.  Additional information: Case narrative including clinical course, therapeutic measures, outcome and additional relevant information. Reporter stated, son had the second dose of the Pfizer, this last Saturday and was just called because he was having some side effects from it. He had a fever, body ache, coughing and sneezing and some sinus congestion. Date of administration: Reporter stated, Saturday, second dose was on Saturday, 23Apr. Reporter was informed about the role of Pfizer Drug Safety. When probed for date when the patient started experiencing the problem, Reporter stated, okay, so we had the second shot, Saturday morning about 10 o clock on the 23rd and then he woke up on the Sunday with a fever and the body aches. (Date clarified as 24Apr). When probed for if the patient got any treatment for the side effect, Reporter stated, well, pt mean we were just treating everything at home over the counter. Pt had not been, his fever went down immediately once he took the fever reliever that morning. So, he had not had the fever since the Sunday morning, but he still had some body ache and the cough. Pt was treating that over the counter. Pt had albuterol here, so he had taken one or two doses of that.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; positive COVID-19 test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EP6965), in Apr2021 as dose 2, single (Lot number: EP6965) and in Dec2021 as dose 3 (booster), single (Lot number: FA8027) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26Apr2022, outcome "unknown", described as "Drug ineffective "; COVID-19 (medically significant) with onset 26Apr2022, outcome "unknown", described as "positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: covid test type post vaccination-Nasal Swab.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the Covid-19 vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient was tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Tooth infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Batch/Lot# EM9810, Anatomical site of injection: L arm), administration date: 06Feb2021, for Covid-19 immunization; BNT162b2 (Dose: 02, Batch/Lot# EN6202, Anatomical site of injection: L arm), administration date: 23Feb2021, for Covid-19 immunization. The following information was reported: TOOTH INFECTION (non-serious) with onset 24Mar2022, outcome "unknown". Therapeutic measures were taken as a result of tooth infection.  Additional information: Patient had treatment for tooth infection with root canal on 18Apr2022. No specific relevant test for thromboembolic events with thrombocytopenia was performed.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vaccine_administration_date=01Oct2021, product=COVID 19 Treatment, brand=Paxlovid; vaccine_administration_date=01Oct2021, product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing); "High blood pressure and cholesterol" (unspecified if ongoing). Concomitant medication included: LOSARTAN. The following information was reported: COVID-19 (medically significant) with onset 25Apr2022, outcome "recovering", DRUG INEFFECTIVE (medically significant) with onset 25Apr2022, outcome "unknown" and all described as "vaccine_administration_date=01Oct2021, product=COVID 19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Apr2022) Negative; (22Apr2022) Negative; (25Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Illness, Pain
Clinical narrative: Very sick with reaction to all three Covid vaccines; fever; body aches; fatigue; loss of appetite; HA; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FE3594), in right arm and on 30Apr2021 at 14:00 as dose 2, single (Lot number: EW0172), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing), notes: Had Covid Nov2020 no other illness since; "Hypothyroidism" (ongoing). Concomitant medication(s) included: ASPIRIN 81 oral, start date: 2019 (ongoing); SYNTHROID taken for hypothyroidism, start date: 2017 (ongoing). The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Very sick with reaction to all three Covid vaccines"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; HEADACHE (non-serious), outcome "unknown", described as "HA".  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Very sick with reaction to all three Covid vaccines; fever; body aches; fatigue; loss of appetite; HA; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FE3594), in right arm and on 30Apr2021 at 14:00 as dose 2, single (Lot number: EW0172), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing), notes: Had Covid Nov2020 no other illness since; "Hypothyroidism" (ongoing). Concomitant medication(s) included: ASPIRIN 81 oral, start date: 2019 (ongoing); SYNTHROID taken for hypothyroidism, start date: 2017 (ongoing). The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Very sick with reaction to all three Covid vaccines"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; HEADACHE (non-serious), outcome "unknown", described as "HA".  No follow up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough covid-19 infection; Breakthrough covid-19 infection; 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), on 14Jan2021 at 13:00 as dose 1, single (Lot number: EL3247), in right arm, on 04Feb2021 at 13:15 as dose 2, single (Lot number: EL3247), in right arm and on 06Oct2021 at 13:00 as dose 3 (booster), single (Lot number: EW0217) at the age of 43 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Apr2022, outcome "recovered" and all described as "Breakthrough covid-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive, notes. Therapeutic measures were not taken as a result of the event. The patient experienced the following symptoms: mild headache, significant cough, fever, chills and general fatigue. Most symptoms lasted about 3 days. Fatigue and cough have persisted for approximately 1 week with some lingering coughing.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: 6 month old was given PENTACEL that expired 22JUN2021 with no reported adverse event; Initial information received on 15-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient was given pentacel that expired 22jun2021 with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious 6 month old was given pentacel that expired 22jun2021 with no reported adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event 6 month old was given pentacel that expired 22jun2021 with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion due to a refrigerator malfunction, dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 38 years old female patient who experienced temperature excursion due to a refrigerator malfunction, dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for immunization; and influenza vaccine (Flu)for Immunisation.  On 23-Mar-2022, the patient received a  0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (batch lot :C5873AA,Expiry date :30-Jun-2023) (unknown dosage, route, formulation )via intramuscular route in the right deltoid for immunization.  On 23-MAR-2022 (latency :same day)the patient developed a non-serious event of temperature excursion due to a refrigerator malfunction, dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event (product storage error) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of DAPTACEL with no adverse event; Initial information received on 21-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced received an expired dose of daptacel with no adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and HEPATITIS A VACCINE (HEPATITIS A).  On 21-Apr-2022, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5706AA via intramuscular route in unknown administration site for Immunization.  On 21-APR-2022 the patient developed a non-serious received an expired dose of daptacel with no adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received an expired dose of DAPTACEL with no adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose of daptacel with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: expired dose of ADACEL it was administered with no adverse event; 31 week pregnant patient who had adacel expired dose with no adverse event; Initial information received on 25-Apr-2022 regarding an unsolicited valid non-serious case received from a Nurse via call center.  This case involves a 28 years old female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of expired dose of adacel it was administered in 31 week pregnant patient with no adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The gestation period at onset was 31 week. The date of last menstrual period was reported as 06-Feb-2021. The estimated due date is 16-Jun-2022. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.    On 22-Apr-2022, the patient received a Dose: 1, 0.5 ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5669AA (formulation, expiry date: unknown) via intramuscular route in the left deltoid for immunization.  On 22-APR-2022 the patient had expired dose of adacel it was administered with no adverse event (expired product administered) and 31 week pregnant patient who had adacel expired dose with no adverse event (exposure during pregnancy) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Relevant prenatal testing after exposure was not reported.  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for both events.  Additionally, at time of reporting, the pregnancy is still ongoing.     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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: an expired dose of MENACTRA was inadvertently administered to a patient. The dose expired on 17APR2022, with no reported AE; Initial information received on 26-Apr-2022 regarding an unsolicited valid non-serious case received from an other health professional via nurse.  This case involves a 17 years old male patient who took an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was inadvertently administered to a patient, the dose expired on 17-Apr-2022, with no reported AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Apr-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection once (total) (lot U6921AB, expiry date: 17-Apr-2022; strength: unknown) via intramuscular route in the right upper arm as Immunization.  On 26-Apr-2022, an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine which was inadvertently administered to the patient and the dose expired on 17-Apr-2022, with no reported AE (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event (expired product administered).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: dose of menactra given after the expiration date with no reported adverse event; Initial information was received on 26-APR-2022 regarding an unsolicited valid non-serious case received from other health care professional via call center.  This case involves a 17 years old female patient who experienced dose of menactra given after the expiration date with no reported adverse event while receiving vaccine meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 26-Apr-2022, the patient received 0.5 ml of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (lot-U6921AB, expiry-17-Apr-2022) via intramuscular route in the left deltoid for immunization.  On 26-APR-2022 the patient developed a non-serious dose of menactra given after the expiration date with no reported adverse event (expired product administered) (latency: same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event dose of menactra given after the expiration date with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthroscopic surgery, Debridement, Mobility decreased, Musculoskeletal stiffness, Vaccination site erythema
Clinical narrative: She could barelypick her arm up and only 90 degrees; Huge red circle around the vaccine site; Arm was stiff; This spontaneous case was received on 20-Apr-2022 from a other non-health professional (consumerr) via Agency (reference number: SEQW22-01266) and concerned a 74-year-old female patient.  The patient's concurrent conditions included scoliosis. The patient's past medical history included a rotator cuff tear after a car accident in 2012, and no surgery was done. The patient's concomitant medication included an unspecified statin, supplements and Norco (fentanyl citrate), all used for an unreported indication.  On 18-Jan-2018, the patient was vaccinated with Fluad TIV (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: arm; dose and route of administration: not reported) for influenza prophylaxis. The batch number reported was 179603 and expiration date was reported as 30-Jun-2018.  On 19-Jan-2018, one day after receiving Fluad TIV, the patient experienced a huge red circle around the vaccine site and her arm was stiff.  On 20-Jan-2018, two days after receiving Fluad TIV, the patient could barely pick her arm up and only 90 degrees.  On an unspecified date, the patient saw an orthopedic physician. The patient tried physical therapy for six months but it did not help.  On an unspecified date, the patient underwent debridement and arthroscopy procedures.  On an unspeciified date, reported as after abot four years, the patient recovered from the events.  The reporter did not provide a causality assessment.  The events of 'stiffness' and 'mobility decreased' were considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 74-year-old patient developed a huge red circle around the vaccine site, arm stiffness, and decreased mobility (reportedly, the patient could barelypick arm up and only 90 degrees) within two days after receiving the suspect product Fluad TIV. Underlying medical history of rotator cuff tear contributed to the development of the events arm stiffness and decreased mobility. Nevertheless, causal role of the suspect vaccine is assessed as possibly related for all events, due to chronological plausibility.; Sender's Comments: A 74-year-old patient developed a huge red circle around the vaccine site, arm stiffness, and decreased mobility (reportedly, the patient could barelypick arm up and only 90 degrees) within two days after receiving the suspect product Fluad TIV. Underlying medical history of rotator cuff tear contributed to the development of the events arm stiffness and decreased mobility. Nevertheless, causal role of the suspect vaccine is assessed as possibly related for all events, due to chronological plausibility.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Eye swelling, Skin discolouration
Clinical narrative: Client presented at the vaccination site on 01/27/22. The client reported he received a first dose of Pfizer COVID vaccine on 01/06/22 (lot #: FL3029). Client reported after 48 hours receiving his first dose of Pfizer COVID vaccine, he reported he had weakness and lightheadedness for two days without taking any medications and developed swelling and purple color of his left eye for four days with no medication applied to his eye. He reported he didn?t follow-up with his PCP. Client denied any chronic illnesses or taking any medications. He stated he had no known allergy. Today, client has a slight bump on his left eye with an unknown cause. PHN texted a picture of his left eye bump with his permission along with his request for a second dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the second dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the second dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. Client received second dose of Pfizer COVID vaccine, LOT #: FK9896 on 01/27/22 at 1414 by LVN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1444 unassisted and with a steady gait.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: sore arms that radiates to neck, shoulder, and down the arm. Slight pain when raising arm, may follow up with her orthopedic. Today 4/25/22 she states its slightly better but will see if she follows up with md and will continue monitoring pain and limitations
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Fever-Severe
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypotension, Palpitations, Pyrexia, Syncope
Clinical narrative: Severe joint pain Heart palpation Low blood pressure  Fainting Fever
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Joint injury, Limb injury, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium, Additional Details: She said the side effect happened 24 hours after receiving her vaccine. Discussed to follow up with the pharmacist on Thursday, April 28 to update us on the condition of her lymph nodes under her armpit.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: she developed rash on the left side of her body about 2 weeks after the vaccine. mmr vaccine was given sc in left arm. started with small rash and got larger. got rx from dr today 4/25/22 for triamcinolone crm and an antifungal crm. is going on beach vacation soon and wants rash resolved.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Neuralgia
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: patient complained of arm pain in the site of injection and it has been over a month now. Patient states he went to physician and physician state it may be nerve pain from the shot.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Site: Redness at Injection Site-Medium, Additional Details: patient states she developed a red rash the evening after her vaccine. it is located about 3 inches below the site of injection. it is a red rash about 2x2ins that is red and painful. patient will put cortisone cream on rash.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Medium, Additional Details: patient given shingrix 2nd dose...immediately felt extremely lightheaded/dizzy/weak. Complained of severe arm pain. Injection site was appropriate. Blood pressure checked and was normal 111/82. patient given water and sat for 20-30 minutes post injection to assess severity. no complaint of difficulty breathing/anaphylaxis. also given sugar in case bs was low. follow up in er and er advised to treat with ibuprofen or tylenol. no other treatment given. 2 days post vaccine patient feeling better.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Medium, Additional Details: patient given shingrix 2nd dose...immediately felt extremely lightheaded/dizzy/weak. Complained of severe arm pain. Injection site was appropriate. Blood pressure checked and was normal 111/82. patient given water and sat for 20-30 minutes post injection to assess severity. no complaint of difficulty breathing/anaphylaxis. also given sugar in case bs was low. follow up in er and er advised to treat with ibuprofen or tylenol. no other treatment given. 2 days post vaccine patient feeling better.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiomegaly, Chest X-ray abnormal, Cough, Productive cough, Respiratory tract congestion
Clinical narrative: Congestion, continued to increase. Appointment with NP.  Possibly sinusitis, treated with antibiotics.  Increase cough with thick phlegm. Unable to contact NP regarding increase of symptoms.  Went to urgent care facility and chest x ray was done which showed Cardiomegaly.  Follow up with NP who scheduled a visit with a Cardiologist.  Comparison of last chest x ray was done.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Contusion, Cough, Fatigue
Clinical narrative: Burning headaches, haven?t had a period in 15 years and have been bleeding up to 20 days at times every month, brain fog, night sweats, very tired, no energy, a lot of bruising, cough that won?t go away, rapid heart rate
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Night sweats, Vaginal haemorrhage
Clinical narrative: Burning headaches, haven?t had a period in 15 years and have been bleeding up to 20 days at times every month, brain fog, night sweats, very tired, no energy, a lot of bruising, cough that won?t go away, rapid heart rate
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Vaccinated pt admitted and tested positive for covid infection. No information available on vaccination details.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Fall, Headache, Joint instability
Clinical narrative: Covid19 breakthrough. 1st vaccine-03/16/2021.  2nd vaccine-04/06/2021.  3rd vaccine-11/10/2021. 84 y/o with PMHx of HTN, HLD, AFIB presents to ED with 2 day history of sore throat, headache and multiple falls.  Pt states that her knees keep giving out, denies injuries.  Afebrile, room air sat 95% and CXR with mildly increased Right basal interstitial opacities.  No covid treatment at this time, monitoring pt.