chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: En6198), as dose 2, single (Lot number: En6199), in left arm, on 16Mar2021 as dose 3 (booster), single (Lot number: 3014sba), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: Fj4989), 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), outcome "unknown" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney stones", start date: 2017 (unspecified if ongoing); "viral meningitis", start date: 2001 (unspecified if ongoing); "post menopausal" (unspecified if ongoing), notes: post menopausal x5 years. The patient's concomitant medications were not reported. Past drug history included: Marcaine, reaction(s): "known allergies: Marcaine"; Carbocyanine, reaction(s): "known allergies: carbocyanine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (12Feb2023) Positive, notes: positive home COVID test beginning 12Feb. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with Paxlovid, from 13Feb2023 to unknown date.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 07Apr2022 as dose 4 (booster), single (Lot number: 083J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulpa" (unspecified if ongoing); "Nonalcoholic Fatty Liver Mild" (unspecified if ongoing); "controlled high blood pressure" (unspecified if ongoing), notes: controlled high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: I tested positive; (18Dec2022) Positive; (24Dec2022) Negative; (26Dec2022) Negative; (07Jan2023) Negative; (09Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with Paxlovid, from 18Dec2022 to 22Dec2022.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with Paxlovid, from 31Jan2023 to 04Feb2023
Sex: U
Vaccine: COVID19-2
Symptoms: Visual impairment
Clinical narrative: My eyes sight getting really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for covid-19 immunization. The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "My eyes sight getting really bad". Additional information: The patient reported to having side effects to booster (Pfizer COVID-19 Vaccine) and was wondering what to do and reported eyes sight getting really bad. The patient told the physician and doctor has no idea what I should do. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 11:00 as dose 1, single (Lot number: el9269), in left arm, on 01Mar2021 at 11:00 as dose 2, single (Lot number: en6203), in left arm and on 05Nov2021 at 11:00 as dose 3 (booster), single (Lot number: fh8020) at the age of 74 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Negative, notes: Completed 5 day Paxlovid. Tested negative next three days; (07Feb2023) Negative, notes: Completed 5 day Paxlovid. Tested negative next three days; (08Feb2023) Negative, notes: Completed 5 day Paxlovid. Tested negative next three days; (09Feb2023) Positive, notes: Tested positive on day 4; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with Plaxlovid, from 01Feb2023 to 05Feb2023.
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance
Clinical narrative: dysautonomia; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), outcome "unknown", described as "dysautonomia". Additional information: approximately one month after receiving the bivalent booster, the patient went on a cruise and got COVID. After getting COVID, the patient was diagnosed with dysautonomia.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): US-PFIZER INC-PV202300030089 same patient/drug, different event.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GU5342) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Lot number: EK9321), in left arm, in Jan2021 as dose 2, single (Lot number: EL3248), in left arm, in Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and in Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Mar2018; ATORVASTATIN, start date: Mar2018, stop date: 05Feb2023. Past drug history included: Ace inhibitors, reaction(s): "Known allergies: Sensitivity to Ace Inhibitors", notes: Sensitivity to Ace Inhibitors. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment from 06Feb2023 to 10Feb2023.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Axillary adenopathy; 1st dose: 11Jan2021; 2nd dose: 04Mar2021; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Lot number: EN6201) at the age of 71 years intramuscular, in left deltoid for covid-19 immunization. The patient's relevant medical history included: "Adult onset atopic dermatitis", start date: 10Jan2012 (unspecified if ongoing), notes: Pertinent Details: Treat with narrow beam UVB. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 11Jan2021, when the patient was 71-year-old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Mar2021, outcome "unknown", described as "1st dose: 11Jan2021; 2nd dose: 04Mar2021"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Axillary adenopathy".  Amendment: This follow-up report is being submitted to amend previously reported information: added event 'Axillary adenopathy'.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300023904 same patient, different dose and event.
Sex: U
Vaccine: COVID19
Symptoms: Fall, Muscle strain
Clinical narrative: Last weekend I fell and severely strained my hamstring; Last weekend I fell and severely strained my hamstring; 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), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: FALL (non-serious), MUSCLE STRAIN (non-serious) all with onset Feb2023, outcome "unknown" and all described as "Last weekend I fell and severely strained my hamstring".  Additional information: The patient had every Covid vaccine and booster that's been offered. The last booster patient had was about 6 months ago. Last weekend patient fell and severely strained hamstring. The next day patient started experiencing symptoms identical to the side effects patient had from booster shots. Is it possible.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: low-grade fever; mild to intense headache; muscles soreness; fatigue; chills; mild soreness at the injection site; on and off sweats; difficulty sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EL3247) at the age of 26 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BLISOVI 24 FE oral taken for contraception, start date: 2018 (ongoing). The following information was reported: CHILLS (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered"; INSOMNIA (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "difficulty sleeping"; FATIGUE (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered"; PYREXIA (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "low-grade fever"; INJECTION SITE PAIN (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "mild soreness at the injection site"; HEADACHE (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "mild to intense headache"; MYALGIA (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "muscles soreness"; HYPERHIDROSIS (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "on and off sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache, myalgia, fatigue, chills, injection site pain.  Additional information: the effects lasted more than 24 hours; the patient  took Acetaminophen as recommended, and recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300069389 same patient, different dose/event;US-PFIZER INC-2021336635 same patient, different dose/event;
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Myalgia, Pyrexia
Clinical narrative: low-grade fever; mild to intense headache; muscles soreness; fatigue; chills; mild soreness at the injection site; on and off sweats; difficulty sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EL3247) at the age of 26 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BLISOVI 24 FE oral taken for contraception, start date: 2018 (ongoing). The following information was reported: CHILLS (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered"; INSOMNIA (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "difficulty sleeping"; FATIGUE (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered"; PYREXIA (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "low-grade fever"; INJECTION SITE PAIN (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "mild soreness at the injection site"; HEADACHE (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "mild to intense headache"; MYALGIA (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "muscles soreness"; HYPERHIDROSIS (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "on and off sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache, myalgia, fatigue, chills, injection site pain.  Additional information: the effects lasted more than 24 hours; the patient  took Acetaminophen as recommended, and recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300069389 same patient, different dose/event;US-PFIZER INC-2021336635 same patient, different dose/event;
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety
Clinical narrative: has anxiety and is very worried; Initial information was received on 10-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 21 years old female patient who experienced has anxiety and is very worried while receiving vaccine rabies (hdc) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rabies vaccine INACT (CHICK EMBRYO) (Rabavert) for Prophylactic vaccination.  On 26-Dec-2022, the patient received a 4 dose of suspect rabies (hdc) vaccine lot PMC4928125251 via intramuscular route in unknown administration site for Immunisation.  On an unknown date the patient developed a non-serious event of has anxiety and is very worried (anxiety) (unknown latency) following the administration of rabies (hdc) vaccine.  Action taken with rabies vaccine (Imovax Rabies) was not applicable.  It was not reported if the patient received a corrective treatment for the event (has anxiety and is very worried).  At time of reporting, the outcome was Unknown for the event has anxiety and is very worried.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion was caused by the door to the refrigerator being left open with no reported adverse event; One patient was administered ACTHIB after not being suitable to use post temperature excursion with no adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and gender patient who was administered haemophilus type B (HIB) vaccine [ACT-HIB] after not being suitable to use post temperature excursion and reporter reported temperature excursion was caused by the door to the refrigerator being left open with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect haemophilus type B (HIB) vaccine, powder and solvent for solution for injection (lot number: UJ669AAA, expiry date: 07-Apr-2023) (With unknown strength, route and at unknown administration site) for immunization.  On an unknown date, caller reported that temperature excursion was caused by the door to the refrigerator being left open with no reported adverse event (product storage error) (unknown latency) and one patient was administered acthib after not being suitable to use post temperature excursion with no adverse event (poor quality product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events.   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: 48.0
Sex: M
Vaccine: MNQ, TD, TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involving  unopened adacel, tenivac and menquadfi and the condition was 48.9f for 7 days due to a refrigerator malfunction with no reported adverse event; ADACEL being administered post excursion with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA052418(CLUSTER).  This case involves a 48 years old male patient to whom Diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] being administered post excursion with no reported adverse event and temperature excursion involving  unopened Meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi], diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] and the condition was 48.9f for 7 days due to a refrigerator malfunction with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult and meningococcal a-c-y-w135 (t conj) vaccine (formulation, strength, lot number and expiry date were not reported) temperature excursion occured and the condition was 48.9f for 7 days due to a refrigerator malfunction with no reported adverse event  (product storage error)    On 07-Feb-2023, the patient received a suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at dose of 0.5 ml (strength not reported) ( lot U7648AA and expiry date- 15-Feb-2025) via intramuscular route in the left deltoid for immunization post excursion with no reported adverse event (poor quality product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: quadracel administered to 2 years age child with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 2-year-old male patient of whom  was reported administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] to 2 years age child with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for Immunisation.  On 12-Apr-2022, the patient received 0.5ml total dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, strength: standard (Lot Number: C5970AA, Expiration Date: 02-Feb-2024) via intramuscular route in the left thigh for Immunization and it was administered to 2 years age child with no reported adverse event (product administered to patient of inappropriate age; latency: same day).  It was reported, Nurse asking for guidance moving forward. This situation is reported as a medication error due to administering dose outside of approved age indication.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: U
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate administration of FLUBLOK to a patient under 18 years of age with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old and unknown gender patient who had inappropriate administration of influenza quadrivalent recombinant vaccine [Flublok Qiv] to a patient under 18 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrivalent recombinant vaccine(strength, formulation was unknown, lot QFAA2234 and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Influenza.  On an unknown date the patient developed a non-serious event of inappropriate administration of flublok to a patient under 18 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  Action taken :not applicable.  Outcome: Unknown  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: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: accidentally injected with MENQUADFI instead of a Meningococcal B vaccine, with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an 18-year-old female patient to whom accidentally injected with MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] instead of a meningococcal b vaccine, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Feb-2023, the patient received dose 3 at 0.5ml (frequency: once) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation: unknown) (strength: standard, 0.5ml) (lot number: U7596AB and expiry date: 14-Mar-2025) via intramuscular route in the left deltoid for Immunization and on the same day patient was accidentally injected with menquadfi instead of a meningococcal b vaccine, with no reported adverse event (wrong product administered).  It was reported, the medical assistant (MA) asks if there is an issue with taking MENQUADFI so close together, what to expect, and how long they should wait until they give the Meningococcal B vaccine.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown.  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: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired ACTHIB given to a patient with no reported adverse event; Initial information received 14-Feb-2023 regarding an unsolicited valid  non-serious case received from  other health professional.  This case involves a 1 year old female patient to whom expired haemophilus type B (HIB) vaccine (HIB (PRP/T) vaccine) (ACT HIB) given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination (immunization).  On 14-Feb-2023, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection, (lot number: UJ740AAA: expiry date: 11-Feb-2023) via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAP, MMRV, PNC, DTAP, MMRV, PNC
Symptoms: Guillain-Barre syndrome
Clinical narrative: hospitalized and diagnosed with guillain barre syndrome; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a non-healthcare professional.  This case involves a 15-month-old female patient who was hospitalized and diagnosed with guillain barre syndrome after receiving vaccines PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and 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.  On 20-Jan-2023, the patient received suspects DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, PREVNAR not produced by Sanofi Pasteur and PROQUAD not produced by Sanofi Pasteur (strength, formulation, route, dose, lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination (Immunisation).  On 20-Jan-2023, the patient developed a serious event of hospitalized and diagnosed with guillain barre syndrome (guillain-barre syndrome) same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, PROQUAD and PREVNAR. This event was assessed as medically significant, and patient was hospitalized due to this event.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) was not applicable.  It was not reported if the patient received a corrective treatment for the event (hospitalized and diagnosed with guillain barre syndrome).  At time of reporting, the outcome was Unknown for the event hospitalized and diagnosed with guillain barre syndrome.; Sender's Comments: Sanofi company comment dated 16-Feb-2023: This case involves a 15-month-old female patient who was hospitalized and diagnosed with guillain barre syndrome after receiving vaccines PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Based upon the reported information, the role of vaccine cannot be assessed. Additional information regarding additional risk factor, medical treatment, underlying conditions and family history, concomitant medications excluding other predisposing etiologies would be needed for complete assessment of the case.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of IPOL with no reported adverse events; Initial information received on 14-Feb-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 5 years old female patient who was diagnosed with patient received an expired dose of ipol with no reported adverse events while receiving vaccine ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]).  On 14-Feb-2023, the patient received suspect ipv (vero) lot R1F80 (dose, strength, frequency, formulation: unknown) via subcutaneous route in unknown administration site for prophylactic vaccination.  On 14-FEB-2023 the patient had a non-serious patient received an expired dose of ipol with no reported adverse events (expired product administered) following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  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: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient got a Shingrix immunization on 12/09/2022.  She said that she had developed a rash a week later on her arm that went up to her back and into her hair.  The patient still has this rash.  She attributed it to the shingles shot.  She said she had been to her regular doctor and he referred her to a dermatologist and her dermatologist wanted her to bring a record of what she got so that he could check her for an allergy to any components.
Sex: M
Vaccine: COVID19-2
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: Severe rash 2 hours after getting the Pfizer-BioNTech booster around my waist line and inner groin areas. I have now been diagnosed with Urticaria. I have the rashes almost daily now. The rash is now migrating across my body. I now have the rash at my arm pit, buttocks, testicles, and penis in addition to my waist line and other areas. I take 2 benadryl and apply calamine lotion to the affected areas as required. The rash subsides after 1 hr after taking benadryl an applying calamine lotion. In January, my right lower lip blew up as well.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Welts from Shingrix Vaccine took 9 months to finally go away. No other adverse effects.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  Moderna dose 1 5/18/21  022B21A Moderna dose 2 6/15/21  018B2A
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 8/27/21, 3/15/22. Positive on 2/16/23 (offsite)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient began to experience itching on her palms the next morning. Itching lessened and became more of a tingling sensation over the next day or so. As of 2/17/2023, patient states problem has "mostly" resolved.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bronchiolitis, Cough, Pyrexia, Sinusitis
Clinical narrative: I had a fever that went away in a couple of days. I developed a cough that just would not go away. Normally when I take over the counter medication a cough will go away, this time it did not. I made an appointment with my doctor and discovered I had a sinus infection and bronchiolitis. I was prescribed an albuterol inhaler and doxycycline. I haven't totally recovered but I am starting to feel better,
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Cellulitis, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of pain at the injection site immediately after vaccine. Arm was "super sore over the weekend. Starting on 2/9/23, patient was describing pain as sharp and felt like something sharp was moving around in her arm. Left deltoid area became red, painful, and slightly swollen. Area was warm to touch on day of exam, redness spreading. Treated for cellulitis.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Patient complained of pain at the injection site immediately after vaccine. Arm was "super sore over the weekend. Starting on 2/9/23, patient was describing pain as sharp and felt like something sharp was moving around in her arm. Left deltoid area became red, painful, and slightly swollen. Area was warm to touch on day of exam, redness spreading. Treated for cellulitis.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bursitis, Injection site pain, Product administered at inappropriate site
Clinical narrative: Administration was given proximal to intended location of deltoid muscle. Believed to have punctured bursa causing bursitis. Patient reported immediate pain upon injection reporting pain scale 10/10. Patient reported continual pain in upper arm and shoulder near acromion. Patient has been taking acetaminophen 500 mg twice daily to mitigate pain. At time of this report, patient still reports pain 5/10.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram, Cough, Diarrhoea, Dry mouth
Clinical narrative: I experienced soreness all over my body, headaches, nausea, coughing, dry mouth, migraines, diarrhea, sharp stabbing pain in my left arm, back pain and I also passed out.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Migraine, Nausea, Pain
Clinical narrative: I experienced soreness all over my body, headaches, nausea, coughing, dry mouth, migraines, diarrhea, sharp stabbing pain in my left arm, back pain and I also passed out.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I experienced soreness all over my body, headaches, nausea, coughing, dry mouth, migraines, diarrhea, sharp stabbing pain in my left arm, back pain and I also passed out.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, FLU4, HEPA, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Covid 19 Vaccine incorrectly given subcutaneously instead of intramuscularly; no adverse effect.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac procedure complication, Coronary artery bypass, Myocardial infarction
Clinical narrative: Heart attacks... Unknown cause Quadruple bypass
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Influenza virus test negative, Oropharyngeal pain, Pharyngitis streptococcal, SARS-CoV-2 test positive
Clinical narrative: 26JAN2023 my son was vaccinated 29JAN2023 my son became symptomatic and tested positive for COVID-19 on 31JAN2023. 06FEB2023 my son returned to school. 08FEB2023 my son came home complaining of sore throat and tested positive for Strep throat 13FEB2023 returned to school.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Streptococcus test positive
Clinical narrative: 26JAN2023 my son was vaccinated 29JAN2023 my son became symptomatic and tested positive for COVID-19 on 31JAN2023. 06FEB2023 my son returned to school. 08FEB2023 my son came home complaining of sore throat and tested positive for Strep throat 13FEB2023 returned to school.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: Hospitalized 6/22/22-6/25/22 Fall, dizziness, UTI, hip fx, weakness, cough, fever, chills, SOB,
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture, Pyrexia, Urinary tract infection
Clinical narrative: Hospitalized 6/22/22-6/25/22 Fall, dizziness, UTI, hip fx, weakness, cough, fever, chills, SOB,
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received a second Bivalent booster for COVID-19. CDC only recommends one bivalent booster. MD on site evaluated the patient, no current harm. Will continue to follow and monitor. Dose 0.5 ml. Moderna manufacturer.
Age: 39.0
Sex: M
Vaccine: COVID19-2, IPV, TDAP
Symptoms: Headache, Pruritus, Rash, Varicella zoster virus infection
Clinical narrative: I had a rash on the left side of my torso that kept growing. I went into the doctor; they called in a dermatologist who immediately identified it as the zoster virus. I had very mild itching, slight headache. I was given a prescription that helped to clear it up and feel that I am doing much better.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphasia, Chest discomfort, Dizziness, Feeling abnormal, Headache
Clinical narrative: Severe heart palpitations, rapid heart rate, chest pressure, dizzy, immediate urge to urinate, tingling hands and feet, headache, tinnitus, brain fog, inability to finish sentences.  diagnosed with IST - no treatment given.  Sent home and told to follow up in 6 months
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Micturition urgency, Palpitations, Paraesthesia, Sinus tachycardia
Clinical narrative: Severe heart palpitations, rapid heart rate, chest pressure, dizzy, immediate urge to urinate, tingling hands and feet, headache, tinnitus, brain fog, inability to finish sentences.  diagnosed with IST - no treatment given.  Sent home and told to follow up in 6 months
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Severe heart palpitations, rapid heart rate, chest pressure, dizzy, immediate urge to urinate, tingling hands and feet, headache, tinnitus, brain fog, inability to finish sentences.  diagnosed with IST - no treatment given.  Sent home and told to follow up in 6 months
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Dyspnoea, Epistaxis
Clinical narrative: On 11/17/2022 I received my Covid 19 vaccine. On 01/27/2023 I woke up with a severe sore throat with coughing and sneezing throughout the day. The next morning, I began to have nosebleed severe headache body aches and fevers. The symptoms began to progress. I took a home Covid test and was tested positive for Covid-19. I contacted my doctor and was prescribed molnupiravir for 5 days. The following Wednesday I was still coughing with tightness and trouble breathing so I contacted my doctor again and was prescribed albuterol and TESSALON PEARLS. Symptoms are still on going.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 11/17/2022 I received my Covid 19 vaccine. On 01/27/2023 I woke up with a severe sore throat with coughing and sneezing throughout the day. The next morning, I began to have nosebleed severe headache body aches and fevers. The symptoms began to progress. I took a home Covid test and was tested positive for Covid-19. I contacted my doctor and was prescribed molnupiravir for 5 days. The following Wednesday I was still coughing with tightness and trouble breathing so I contacted my doctor again and was prescribed albuterol and TESSALON PEARLS. Symptoms are still on going.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: On 11/17/2022 I received my Covid 19 vaccine. On 01/27/2023 I woke up with a severe sore throat with coughing and sneezing throughout the day. The next morning, I began to have nosebleed severe headache body aches and fevers. The symptoms began to progress. I took a home Covid test and was tested positive for Covid-19. I contacted my doctor and was prescribed molnupiravir for 5 days. The following Wednesday I was still coughing with tightness and trouble breathing so I contacted my doctor again and was prescribed albuterol and TESSALON PEARLS. Symptoms are still on going.