chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 2, single (Lot number: Cw0170), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 33068D) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Sep2022) Positive, notes: I originally tested positive and started taking Paxlovid that same day. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Optic neuropathy
Clinical narrative: Presumed Autoimmune Optic Neuropathy - 3 patients/Presumed Autoimmune Optic Neuropathy After Pfizer-BioNTech (BNT162b2) COVID-19 Vaccine; This is a literature report for the following literature source.  A patient (no qualifiers provided) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), as dose number unknown, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OPTIC NEUROPATHY (medically significant), outcome "unknown", described as "Presumed Autoimmune Optic Neuropathy - 3 patients/Presumed Autoimmune Optic Neuropathy After Pfizer-BioNTech (BNT162b2) COVID-19 Vaccine".; Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report.,Linked Report(s) : US-PFIZER INC-202201206056 same article /drug /event and different patient;US-PFIZER INC-202201206165 same article /drug /event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Product use issue, Pyrexia
Clinical narrative: was fine all day but then woke up at 2 AM with a mild fever (100.2); body aches; feel worn out; received flu shot and Pfizer Bivalent vaccine against Covid on the same date; 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), on 04Oct2022 at 11:00 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Oct2022 at 11:00 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 04Oct2022 at 11:00, outcome "unknown", described as "received flu shot and Pfizer Bivalent vaccine against Covid on the same date"; FATIGUE (non-serious) with onset 05Oct2022, outcome "unknown", described as "feel worn out"; PAIN (non-serious) with onset 05Oct2022 at 02:00, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 05Oct2022 at 02:00, outcome "recovered" (05Oct2022), described as "was fine all day but then woke up at 2 AM with a mild fever (100.2)". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient received flu shot and Pfizer Bivalent vaccine against Covid. He/she was fine all day but then woke up at 2 AM with a mild fever (100.2) and body aches. Today (05Oct2022) she/he just felt worn out but his/her fever was gone.  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Eye swelling, SARS-CoV-2 test, Swelling, Swelling face
Clinical narrative: face and eyes swelled up - neck as well; face and eyes swelled up - neck as well; face and eyes swelled up - neck as well/face swelling worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 at 14:30 as dose 1, single (Lot number: EN6205) at the age of 54 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EYE SWELLING (non-serious), SWELLING (non-serious) all with onset Mar2021, outcome "unknown" and all described as "face and eyes swelled up - neck as well"; SWELLING FACE (non-serious) with onset Mar2021, outcome "not recovered", described as "face and eyes swelled up - neck as well/face swelling worse". The events "face and eyes swelled up - neck as well" and "face and eyes swelled up - neck as well/face swelling worse" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Doctors appointments after 1st vaccine. 24Mar2021: Face and eyes swelled up- neck as well. 25Mar2021: Face swelling worse.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Her hands started to immediately swell up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Past drug history included: Xeljanz 5mg. Vaccination history included: Covid-19 vaccine (Primary immunization completed (Manufactruer unknown)), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Her hands started to immediately swell up".  Additional information: Patient advised she had stopped her Xeljanz for four days w hen she got her Covid vaccine. Her hands started to immediately swell up. Patient was prescribed Xeljanz 5mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: headache; tinnitus in his hearing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus in his hearing". Therapeutic measures were taken as a result of headache, tinnitus. Additional information: Patient said that after his PFIZER vaccine he had severe headache and tinnitus in his hearing. Treatment: paracetamol  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Paralysis, Vision blurred
Clinical narrative: Semi paralyzed/immovable neck, low back; pain; blurry vision; This is a spontaneous report received from a contactable reporter (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), on 29Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HAE-type 1" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "like being crushed underneath a train car for 4 days". The following information was reported: PARALYSIS (medically significant) with onset 2022, outcome "unknown", described as "Semi paralyzed/immovable neck, low back"; VISION BLURRED (non-serious) with onset 2022, outcome "recovering", described as "blurry vision"; PAIN (non-serious) with onset 2022, outcome "recovering". Clinical course: Semi paralyzed from the most recent booster. Received on 29Sep2022. Pain 3 hours after escalating all week to immovable neck, low back and blurry vision. Today a 20% improvement, so promising! Patient had HAE-type 1 and have had all vaccines and boosters. Patient second vaccine reaction was like being crushed underneath a train car for 4 days. Patient was afraid to get another booster. Patient stated that didn't have knowledge to know if could become a fatality.  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: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Mastication disorder
Clinical narrative: Problem swallowing and mastication problem feeing therapy as of Jul2022; Problem swallowing and mastication problem feeing therapy as of Jul2022; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 8-year-old male patient received BNT162b2 (BNT162B2), on 09Dec2021 as dose 2 (orange cap), single (Lot number: FK5618) at the age of 7 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: FK5618, Anatomical Location: Left deltoid), administration date: 15Nov2021, when the patient was 7-year-old, for COVID-19 Immunization. The following information was reported: DYSPHAGIA (non-serious), MASTICATION DISORDER (non-serious) all with onset Jul2022, outcome "unknown" and all described as "Problem swallowing and mastication problem feeing therapy as of Jul2022". Additional information: Problem swallowing and mastication problem feeing therapy as of Jul2022.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Swelling, Vaccination site pain
Clinical narrative: Injected arm-Upper arm pain at injection site; Extremely swollen arm pit; Pain down arm; Swollen hand; This is a spontaneous report received from a contactable consumer. 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), in arm 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injected arm-Upper arm pain at injection site"; SWELLING (non-serious), outcome "unknown", described as "Extremely swollen arm pit"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain down arm"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen hand". Additional information: the patient received COVID-19 Bivalent Vaccine, experienced injected arm-Upper arm pain at injection site, extremely swollen arm pit, pain down arm, swollen hand. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: head and face began to swell up all the time; head and face began to swell up all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious), SWELLING (non-serious) all with onset 2022, outcome "not recovered" and all described as "head and face began to swell up all the time".  Additional information: Caller got the COVID-19 vaccine before year (2021) but he didn't really want to get it. He was kind of manipulated into getting it but he had quite a few people manipulated together so he ended up getting it. After having it, between Jan and Apr the present year (2022), he started having issue where his head and face began to swell up all the time and he couldn't really think when the swelling would occur. It happened in situations that he wouldn't think it would happen like depending where he goes, buildings, home, and places that he would go in and out and then sometimes when he was using a device. So he needed to do something about that and get to stop.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Getting COVID; Getting COVID; 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 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Getting COVID". Caller would like to know when she can get her third booster shot after getting COVID.  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: Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature Excursion on my gray visor at my Pharmacy; temperature Excursion on my gray visor at my Pharmacy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  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 and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "temperature Excursion on my gray visor at my Pharmacy".  Additional information: The patient had a temperature excursion on her gray visor at her Pharmacy and she wanted to know what to do with it or if it's still good.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes, with no reported adverse event; patient received Pentacel after a temperature excursion occurred, with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an unknown age and unknown gender patient who had received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (VERO)] after a temperature excursion occurred and temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received 0.5ml total dose (0.5 ml 4X) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation, route: unknown) (lot number: UJ666AAA and expiry date: 04-May-2023) in unknown administration site for Immunization.  On 23-Sep-2022, non-serious events reported, temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event (product storage error) and patient received pentacel after a temperature excursion occurred, with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, a temperature excursion that occurred on 23SEP2022 and was reported on 26SEP2022. The cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case. Doctor states that she was told that the vaccines are no longer viable and has discarded all of them. Doctor asked for specific guidance on whether these patients needed to be re-vaccinated before they contacted the patients? Individual patient information was not available at this time. This situation is reported as a medication error due to vaccines being administered post-excursion.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was 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.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: broke out in hives; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a female patient of unknown age who broke out in hives while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Prophylactic vaccination. Batch number requested.  On an unknown date the patient broke out in hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (broke out in hives).  At time of reporting, the outcome was Unknown for the event broke out in hives.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: took the regular flu shot"and broke out in hives; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care profesisonal.  This case involves a female patient of unknown age who broke out in hives,after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Prophylactic vaccination.  On an unknown date, the patient broke out in hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (broke out in hives).  At time of reporting, the outcome was Unknown for the event broke out in hives.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Atrial fibrillation, Heart rate increased
Clinical narrative: heart rate increased to 150 and continued to remian this high rate throughout the night; was in afib; Initial information received on 05-Oct-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 66 years old male patient who was in afib (atrial fibrillation), after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past  medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On 28-Sep-2022 at 02:00 pm, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , suspension for injection in prefilled syringe, (lot: UT7714AA ; expiry date: not reported) via intramuscular route for flu vaccination (influenza vaccination).  On the same day at 3:30pm following the administration, heartrate increased to 150 and continued to remain at this high rate throughout the night (heart rate increased) and went into afib (atrial fibrillation). These events were assessed as medically significant. The patient went to my local emergent care in the morning, where they gave me last dose aspirin and intravenous (iv) diltiazim. Heart rate decreased, but was still in afib. The higher heart rate and afib resolved on evening of 30-Sep-2022. Patient did not experience any additional symptoms/events.  There were no lab data/results available  Relevant laboratory test results included: Heart rate - On 28-Sep-2022:  [heartrate increased to 150]  Action taken: not applicable.  Corrective treatment: ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) and DILTIAZEM (DILTIAZEM) for atrial fibrillation and its symptom.  Outcome:  Recovered / Resolved on 30-Sep-2022 for the event of atrial fibrillation and its symptom.; Sender's Comments: Sanofi company comment date 10-Oct-2022:  This case involves a 66 years old male patient who experienced atrial fibrillation after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The time to onset (same day) is suggestive of a relationship with the vaccine. However, a detailed clinical course was not provided. Limited information was also provided regarding circumstances leading to and patient's health status directly preceding the reported events. Further information is needed to fully assess the case.
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: Pentacel was found out to be used on a patient post excursion with no adverse event; Initial information was received on 29-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 15 months old female patient to whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was found out to be used post excursion with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 23-Sep-2022, the patient received 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ736AAA expiry-30-09-23) (strength and formulation; unknown) via intramuscular route in the left upper thigh for Immunization.   On 23-SEP-2022 the patient developed a non-serious pentacel was found out to be used on a patient post excursion with no adverse event (poor quality product administered) (latency same day).   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event pentacel was found out to be used on a patient post excursion 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 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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Adult and unknown gender patient to whom expired vaccine administered with no reported adverse event for vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received an expired dose of suspect influenza quadrival A-B vaccine, suspension for injection, (strength: not reported) (lot UT7325MA; Expiry date: 30-Jun-2022) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: on same day).  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: 14.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: IPOL being administered post excursion, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via nurse on 04-Oct-2022. Agency number: 01306733  This case is linked to cases 2022SA409671, 2022SA412043, 2022SA412040 and 2022SA411401 (CLUSTER).  This case involves a 14 years old female patient to whom IPV (VERO) [IPOL] being administered post excursion, with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 27-Sep-2022, the patient received 6th dose of suspect IPOL vaccine being administered post excursion at dose 0.5 ml once via intramuscular route in the left deltoid (lot: U1C571M, expiry: 17-Jun-2023) for prophylactic vaccination with no adverse event (poor quality product administered) (latency same day).  Action taken: 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: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: new employee accidentally only gave the DTAP/IPV portion of the PENTACEL vaccine with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 year old male patient who accidentally received only the dtap/ipv portion of the pentacel vaccine 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.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 27-Sep-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection (Strength, dose, frquency unknown) (lot UJ641AAA, expiry date: 28-Feb-2023) via intramuscular route in the right thigh for Immunization who accidentally only recieved the dtap/ipv portion of the pentacel vaccine with no reported adverse event (incorrect dose administered) (unknown latency).  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: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: physician have administered QUADRACEL instead of PENTACEL to a 2-year-old patient with no reported AE; vaccine administered to a 2 year old with no reported AE; Initial information received  on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient whose physician have administered quadracel instead of pentacel to a 2-year-old patient with no reported ae (adverse event) and vaccine administered to a 2 year old with no reported ae while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot number not reported in unknown administration site as Immunization.The patient used the product previously. Lot number requested.  On an unknown date the physician have administered quadracel instead of pentacel to a 2-year-old patient with no reported ae (wrong product administered) and the vaccine administered to a 2 year old with no reported ae (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (physician have administered QUADRACEL instead of PENTACEL to a 2-year-old patient with no reported AE, vaccine administered to a 2 year old with no reported AE).  At time of reporting, the outcome was Unknown for all.  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: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ADACEL accidentally being given to the wrong patient who is under 10 years of age with no reported AE; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a Non Healthcare professional.  This case involves a suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [ADACEL] accidentally being given to the wrong patient who is under 10 years of age with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV Vaccine VLP RL1 9V (YEAST) (GARDASIL 9) and Meningococcal Vaccine A/C/Y/W CONJ (CRM197) (MENVEO) both for prophylactic vaccination.  On 05-Oct-2022, the patient who is under 10 years of age accidentally received a 2nd 0.5 ml  dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine with no reported AE (product administered to patient of inappropriate age), Suspension for injection (lot U7306BA, Expiry date- 11-Mar-2024, Strength- standard)) via intramuscular route in left deltoid for prophylactic vaccination (Latency- same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, Ocular hyperaemia, Wrong product administered
Clinical narrative: patient's eyes are red; Patient received fluzone high dose QIV on 25-Sep-2022, then he accidentally received a second dose of fluzone high dose QIVon 28-Sep-2022 instead of Covid-19 vaccine with NO AE; Patient received fluzone high dose QIV on 25-Sep-2022, then he accidentally received a second dose of fluzone high dose QIVon 28-Sep-2022 instead of Covid-19 vaccine with NO AE; Initial information was received on 5-Oct-22 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male (older) patient's eyes are red and fluzone high dose qiv on 25-sep-2022, then he accidentally received a second dose of fluzone high dose given 28-sep-2022 instead of covid-19 vaccine with no ae.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 25-SEP-2022 the patient received fluzone high dose qiv (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) (dose, formulation, strength, lot and expiry date: unknown), then he accidentally received a second dose of fluzone high dose given on 28-Sep-2022 instead of covid-19 vaccine with no ae (extra dose administered and wrong product administered) (latency same day) via unknown route in an unknown administration site for immunization.  On an unknown date the patient developed a non-serious patient patient's eyes are red (ocular hyperaemia) (unknown latency).  It was reported that- wife also states that the patient is feeling under the weather. The patient is going to see a doctor today, 05Oct2022, for his red eyes and feeling under the weather  Action taken: not applicable for both suspects.  Corrective- Unknown   outcome was Unknown for all 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.
Sex: F
Vaccine: FLUX, UNK
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: fast heartbeat; weakness; difficulty breathing; dizziness; Initial information received on 05-Oct-2022 and live follow-up received on same day (processed together) regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had fast heartbeat, weakness, difficulty breathing and dizziness after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 12-Sep-2021, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation was unknown, lot 312832 and expiry date: 11-May-2022) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a serious event of fast heartbeat (heart rate increased), weakness (asthenia), difficulty breathing (dyspnoea) and dizziness (latency: unknown) following the administration of INFLUENZA VACCINE. Patient had a bad experience after receiving the Seqirus flu shot last year (2021), and still have not recovered. Patient ended up on a rehabilitation unit for 43 days, and was still weak from it. Patient denied facial swelling. patient went to hospital and was admitted for ten days. Patient used it for the first time.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: Not Recovered for all events.  Seriousness criteria: Hospitalized for all events.; Sender's Comments: Sanofi company comment dated 10-Oct-2022: This case involves an unknown age female patient who had fast heartbeat, weakness, difficulty breathing and dizziness after receiving vaccine INFLUENZA VACCINE.  The time to onset was not reported with the vaccine. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the few reported information, the role of the suspect vaccine cannot be assessed.
Age: 26.0
Sex: F
Vaccine: FLUR3
Symptoms: Exposure during pregnancy
Clinical narrative: a pregnant employee that was given FLUBLOK. with no reported adverse event; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 26 years old female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] in context of a pregnant employee that was given flublok. with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported a pregnant employee that was given FLUBLOK. with no reported adverse event occurred at 21 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at 21 weeks of pregnancy, during second pregnancy trimester for INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  The date of last menstrual period was reported as 13-May-2022. The estimated due date is 17-Feb-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications: none.  On 30-Sep-2022, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength: unknown) lot USAA225 via intramuscular route in the left deltoid as Immunization.  On 30-SEP-2022 the pregnant employee was given flublok with no reported adverse event (exposure during pregnancy) same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (a pregnant employee that was given FLUBLOK. with no reported adverse event).  At time of reporting, the outcome was Unknown for the event
Sex: M
Vaccine: UNK
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction; This spontaneous case was received on 29-Sep-2022 from pharmacist via Communications and concerned an elderly, male patient. At the time of this report, the patient was 69-year-old.  The patient's medical history and concomitant medications were not reported  On unspecified date, last flu season as reported, the patient was vaccinated with Fluad Quadrivalent (2021-2022 formulation) (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed an injection site reaction.  On unspecified date, the patient recovered from the event of 'vaccination site reaction'.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 69-year-old male patient developed an injection site reaction after vaccination as reported. Elapsed time between vaccination and the onset of the event is unknown. Due to lack of information concerning chronology and diagnostic findings, causality for the reported event is unassessable.; Sender's Comments: A 69-year-old male patient developed an injection site reaction after vaccination as reported. Elapsed time between vaccination and the onset of the event is unknown. Due to lack of information concerning chronology and diagnostic findings, causality for the reported event is unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pericarditis
Clinical narrative: SHORTNESS OF BREATH; PERICARDITIS; This 60-year-old, female subject was participating in study and experienced shortness of breath and pericarditis.  The subject's medical history, as provided by the investigator, included anxiety, restless leg syndrome, seasonal allergies, and post-menopausal. Concomitant medications reported included fluoxetine, ropinirole, and cetirizine hydrochloride.  The subject previously experienced the SAE shortness of breath while participating in this study.  Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3, booster) for SARS-CoV-2 vaccination on 27 Oct 2021, approximately 10 months before onset of the event.   On 26 Aug 2022, the subject experienced shortness of breath and pericarditis and was admitted to the hospital. She had a pericardial window procedure and was treated, however, treatment information was not provided.  On 30 Aug 2022, the subject was discharged from the hospital for the event of shortness of breath.  On 05 Sep 2022, the subject was discharged from the hospital for the event of pericarditis.   The subject received all scheduled doses of study drug prior to the event of shortness of breath; therefore, action taken with study drug in response to the event was not applicable.   No action was taken with the study drug in response to pericarditis.  The events, shortness of breath and pericarditis, were reported as resolved on 05 Sep 2022.  The investigator assessed the event, shortness of breath, as not related to study drug and not applicable to study procedure.  The investigator assessed the event, pericarditis, as not applicable to study drug and not applicable to study procedure.  Follow-up received on 29 Sep 2022 included updated event outcome, end date, and hospitalization discharge date.   Follow-up received on 03 Oct 2022 and 05 Oct 2022 included additional event of pericarditis, updated causality of the study drug, and event end date of the event shortness of breath.   Company Comment: This case concerns a 60-year-old female subject with a medical history of anxiety, restless legs syndrome, seasonal allergies, and post-menopause, who experienced the unlisted event of shortness of breath, and the listed event of pericarditis. The events occurred approximately 2 years 18 days after the first dose of mRNA-1273 and 10 months after third (booster) dose. The events, shortness of breath and pericarditis, were reported as resolved. The event shortness of breath was considered not related to agreement with the investigator. The event might be explained by concurrent event of pericarditis. The investigator assessed the event pericarditis, as not applicable to study drug and not applicable to study procedure. The sponsor considers the event as not related due to long latency. Additional information was requested.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Paraesthesia, Syncope
Clinical narrative: Fainted 9/29 but not sure if that?s related. Currently continue to have paresthesia, most  notably in legs and hands.
Age: 54.0
Sex: F
Vaccine: FLUA4
Symptoms: Unevaluable event
Clinical narrative: PATIENT RECEIVED FLUAD 2021-2022; NO REACTION REPORTED
Age: 91.0
Sex: F
Vaccine: FLUA4
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT RECEIVED FLUAD 2021-2022; NO REACTION REPORTED
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT RECEIVED FLUAD 2021-2022; NO REACTION REPORTED
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever of 102F Chills Nausea  Headache All for about 36 hours
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT RECEIVED FLUAD 2021-2022; NO REACTION REPORTED
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Intensive care, Nasopharyngitis
Clinical narrative: Narrative: 60 year old male admitted on July 17 2022 and was transferred with cold-like symptoms and found to have COVID-19. He was admitted to ICU for isolation. He had received Moderna vaccine x 3 on March 24, 2021, April 21, 2021, July 28, 2022. He was treated with he received remdesivir x 5 days and dexamethasone 6 mg IV daily x 5 days. He clinically improved and treatment discontinued after 5 days.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cerebrospinal fluid leakage, Craniotomy, Intensive care, Iron deficiency anaemia, Lumbar puncture
Clinical narrative: H. Flu meningitis - PICU hospitalization -Spinal tap - IV antibiotics - ceftriaxone Seizures - Keppra Subdural fluid collection -MRI Burr Hole drilled - Hospital Iron Deficiency anemia - Packed RBC transfusion
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Magnetic resonance imaging head abnormal, Meningitis haemophilus, Red blood cell transfusion, Seizure
Clinical narrative: H. Flu meningitis - PICU hospitalization -Spinal tap - IV antibiotics - ceftriaxone Seizures - Keppra Subdural fluid collection -MRI Burr Hole drilled - Hospital Iron Deficiency anemia - Packed RBC transfusion