chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb operation, Pain
Clinical narrative: Still had stiches in arm from surgery/arm surgery; Pain; It burns; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Hypophosphatasia" (unspecified if ongoing), notes: Dexa scan; "Teeth, turned around 80 degrees/orthodontia issues" (unspecified if ongoing); "Shingles" (unspecified if ongoing), notes: last fall; "Flu" (unspecified if ongoing), notes: last fall; "Pneumonia" (unspecified if ongoing), notes: last fall. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (Did have major reaction to flu vaccine last fall), for Influenza immunisation, reaction(s): "Had baseball sized bump on arm". The following information was reported: LIMB OPERATION (medically significant), outcome "not recovered", described as "Still had stiches in arm from surgery/arm surgery"; PAIN (medically significant), outcome "unknown"; BURNING SENSATION (medically significant), outcome "unknown", described as "It burns". Therapeutic measures were taken as a result of limb operation, pain, burning sensation. Clinical course: Patient had symptoms for her whole life and teeth, turned around 80 degrees. For 9 years, has had orthodontia issues that were created, basically because, bones had been breaking since she turned 50, badly. Her Dexa scan looks like she was 90. They just kept writing it off as arthritis or osteoporosis, it was neither. HPP, was the name of the disease, Hypophosphatasia. Was very low in producing enough alpha phosphate enzymes, which produce bones and large intestines. Believes it may be formed by liver, not really sure. First Dose, Pfizer: 19Mar2021, Still had stiches in arm from surgery. When she had arm surgery, she was prescribed Oxycodone for pain. Just used ice, that was nasty medicine. Seriously, every 4 hours, it burned like hell, made her feel worse, took for 1 day. They gave her Ibuprofen, that was basically what she did. Took about 6 months to have her arm back. Felt like, she only wanted to take medicine if she needed it. Only wanted to do it because she was worried about it getting like last fall.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250485 same patient, different drug/event;US-PFIZER INC-202201212703 same patient, different drug/event;US-PFIZER INC-202201212574 Same Patient/Product, Different Dose/Event (LOE);US-PFIZER INC-202201212727 Same Patient/Product, Different Dose/Event (Dose 5);
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; 1st dose-4th dose is Moderna vaccine, 5th dose, 6th dose is Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GH9702), in right arm and on 30May2023 as dose 6 (booster), single (Lot number: GJ6796) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Lot number: 025J20-2A), in right arm, on 15Feb2021 as dose 2, single (Lot number: 032L20A), in right arm, on 05Nov2021 as dose 3 (booster), single (Lot number: 051C21A), in right arm and on 07Apr2022 as dose 4 (booster), single (Lot number: 007J21-2A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ERYTHROMYCIN, start date: Jan2023; CLIMARA [ESTRADIOL], start date: Jan2023; VITAMIN D [VITAMIN D NOS], start date: Jan2023; CALCIUM, start date: Jan2023; FERROUS SULFATE, start date: Jan2023. Past drug history included: Dicloxacillin, reaction(s): "Known allergies: Dicloxacillin"; Betadine, reaction(s): "Known allergies: Betadine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2022, outcome "unknown", described as "1st dose-4th dose is Moderna vaccine, 5th dose, 6th dose is Pfizer vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the Paxlovid treatment from 02Jul2023 to 06Jul2023.; Sender's Comments: Considering interchange of vaccine, the contributory role of company suspect drug to all the reported events Drug ineffective, Covid 19 cannot be excluded completely.,Linked Report(s) : US-PFIZER INC-202300250572 same reporter/patient, different drug/event;
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Dec2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "not recovered", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment of Paxlovid for COVID-19 from 29Jun2023 to 04Jul2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250753 same  patient/reporter, different drug/AE;
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 4th dose is Moderna vaccine, 5th dose is pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Lot number: 033K2124), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: wheat gluten" (unspecified if ongoing); "Known allergies: sulfa antibiotics" (unspecified if ongoing); "Known allergies: Opiates" (unspecified if ongoing); "Recent severe weight loss from GI" (unspecified if ongoing); "Recent severe weight loss" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2022, outcome "not recovered", described as "4th dose is Moderna vaccine, 5th dose is pfizer vaccine"; 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 using Paxlovid from 04Jul2023 to 08Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250591 same reporter/patient ,different drug/event;
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (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 "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no Known allergies. Patient received COVID 19 Treatment (Paxlovid) from 06Jul2023 to 11Jul2023.  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: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300251297 Same patient, different drug, different event;
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown), 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) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had received the treatment of COVID-19 as Paxlovid on 29Jun2023 to 04Jul2023.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250814 same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Erythromycin, sulfa, keflex' and code to common LLT/PT of 'Drug hypersensitivity" (unspecified if ongoing), notes: Known allergies: Erythromycin, sulfa, keflex; "svt" (unspecified if ongoing), notes: Other medical history: SVT, mgus, pre diabetic, PTSD; "mgus" (unspecified if ongoing), notes: Other medical history: SVT, mgus, pre diabetic, PTSD; "pre diabetic" (unspecified if ongoing), notes: Other medical history: SVT, mgus, pre diabetic, PTSD; "PTSD" (unspecified if ongoing), notes: Other medical history: SVT, mgus, pre diabetic, PTSD. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366756 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300249268 same reporter/patient, different product/AE;
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid treatment from 03Jul2023 to 08Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251541 Same patient, different drug/ AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "Heart failure" (unspecified if ongoing); "Raynaud syndrome" (unspecified if ongoing); "Allergy: Sulfa drugs" (unspecified if ongoing); "Allergy: shellfish/macadamia nuts" (unspecified if ongoing); "Allergies: pollens" (unspecified if ongoing); "Allergies: molds" (unspecified if ongoing); "Allergies: dust" (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 "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Positive Covid test 9 days after last Paxlovid.  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-202300251564 Same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots". Clinical course: Reporter stated, "Why are the vaccines causing blood clots in my girlfriend?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thrombotic thrombocytopenic purpura
Clinical narrative: Acute Thrombotic Thrombocytopenic Purpura; This is a literature report for the following literature source(s): "Acute Thrombotic Thrombocytopenic Purpura: Rare and Life-Threatening Side Effect of Recent BNT-162b2 COVID-19 Vaccination".  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: THROMBOTIC THROMBOCYTOPENIC PURPURA (medically significant, life threatening), outcome "unknown", described as "Acute Thrombotic Thrombocytopenic Purpura".; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for reported event ' Acute Thrombotic Thrombocytopenic Purpura' . The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: already was vaccinated 2 times plus 1 booster/ still got COVID after being vaccinated; already was vaccinated 2 times plus 1 booster/ still got COVID after being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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), COVID-19 (medically significant), outcome "unknown" and all described as "already was vaccinated 2 times plus 1 booster/ still got COVID after being vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical  course: The caller's brother was tested covid but he already was vaccinated 2 times plus 1 booster. She would want to know if her brother would still  get COVID-19 vaccine once she takes him to the doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: developed a large swollen knot in the arm where she received the Flublok vaccine; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 30 years old female patient who developed a large swollen knot in the arm where she received the influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past vaccination(s) included influenza vaccine for Flu vaccination and covid-19 vaccine for COVID-19 immunisation. The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (lot number , strength, formulation, dosage, expiry date - not reported) via intramuscular route in unknown administration site for Flu prevention (Antiviral prophylaxis). Information on the batch number was requested  On an unknown date the patient developed a large swollen knot in the arm where she received the influenza quadrivalent recombinant vaccine (vaccination site swelling) (unknown latency).  Reportedly, : Patient have had reactions in the past to both flu and Covid vaccines- Patient developed a large swollen knot in the arm where they received the FLUBLOK vaccine- it resolved with no intervention   Patient did not experience any additional symptoms/events.  There were no lab data/results available  Action taken was not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Recovered / Resolved on 11-Oct-2022 for the event.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received daptacel past the expiration date and received 2 doses of the expired vaccine caller is looking for re-vaccination information with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA214127, 2023SA213495, 2023SA213561, 2023SA214713, 2023SA213445 and 2023SA214480.  This case involves a 6 years old male patient who had received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] past the expiration date and received 2 doses of the expired vaccine caller is looking for re-vaccination information 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 polio vaccine inact 3V (vero) (IPOL) for prophylactic vaccination (Immunisation).  On 05-Jan-2023 and 04-Mar-2023, the patient received 0.5 mL dose 3 and 4 respectively of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (batch number: C5829AA; Expiry date: 03-Jan-2023) via intramuscular route in unknown administration site for Immunization, past the expiration date (2 doses of the expired vaccine) with no reported adverse event (expired product administered) (same day latency). Caller is looking for re-vaccination information.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event received daptacel past the expiration date and received 2 doses of the expired vaccine caller is looking for re-vaccination information with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 6.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received daptacel past the expiration with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA213495, 2023SA213484, 2023SA214480 and 2023SA213445.  This case involves a 6 years old patient of an unknown gender who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] past the expiration 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 polio vaccine inact 3V (VERO) (Ipol Polio Vaccine) for Prophylactic vaccination.  On 03-May-2023, the patient received a dose of 0.5 ml (dose 5) once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5829AA; expiry date: 01-May-2023; strength: standard) via intramuscular route in unknown administration site for Immunization.   On 03-May-2023 the patient received daptacel past the expiration with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Physician is reporting that 6 pediatric patients have received DAPTACEL past the expiration date and caller is looking for re-vaccination information. Physician reports that due to a "unscrupulous employee, who has since been fired", 6 children received DAPTACEL vaccines after expiration date. He states that 8 days ago, a box of DAPTACEL was opened and noted to be expired. That caused staff to look back at doses of DAPTACEL given after 01-May-2023 (DAPTACEL expiration date). That is when the administration of expired doses was discovered."   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 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: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received DAPTACEL past the expiration date with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA213495, 2023SA213484, 2023SA214713 and 2023SA213445.  This case involves a 5 years old patient of unknown gender diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] past the expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications polio vaccine inact 3V (VERO) (Ipol Polio Vaccine); measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine live (oka/merck) (varivax [varicella zoster vaccine live (oka/merck)]) all for Immunisation.  On 21-Mar-2023, the patient received a dose of 0.5 ml (dose 5) once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5829AA; expiry date: 01-Mar-2023; strength: standard) via intramuscular route in unknown administration site for Immunization.   On 21-Mar-2023 the patient received daptacel past the expiration with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Physician is reporting that 6 pediatric patients have received DAPTACEL past the expiration date and caller is looking for re-vaccination information. Physician reports that due to a "unscrupulous employee, who has since been fired", 6 children received DAPTACEL vaccines after expiration date. He states that 8 days ago, a box of DAPTACEL was opened and noted to be expired. That caused staff to look back at doses of DAPTACEL given after 01-Mar-2023 (DAPTACEL expiration date). That is when the administration of expired doses was discovered."  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 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: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patients have received DAPTACEL past expiration date with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from physician.  This case is linked to cases 2023SA214127, 2023SA213484, 2023SA214713, 2023SA214480 and 2023SA213445.  This case involves a 5 years old and unknown gender patient who had received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] past expiration date 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 polio vaccine inact 3V (vero) (IPOL); measles vaccine, mumps vaccine, rubella vaccine (MMR); and varicella zoster vaccine live (OKA/MERCK) (Varivax) for Prophylactic vaccination (immunization).  On 13-Mar-2023, the patient received 0.5 mL dose 5 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C5829AA; Expiry date: 01-Mar-2023) via intramuscular route in unknown administration site for immunization past expiration date with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patients have received daptacel past expiration date with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: They have given a patient ADACEL vaccine which was not suitable for use due to temperature excursion no adverse event; Initial information was received on 13-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a unknown age/gender of patient who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] vaccine which was not suitable for use due to temperature excursion no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, a patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength: standard)at dose of 0.5 ml total once (1x) (lot number: U7627AA, expiration date: 16-Dec-2024, route, administration site: Unknown) for immunization (immunisation) which was not suitable for use due to temperature excursion no adverse event (poor quality product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event they have given a patient adacel vaccine which was not suitable for use due to temperature excursion no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Brain fog, Butterfly rash, Herpes zoster, Hidradenitis
Clinical narrative: within 24 hrs of the 2nd dose, I developed  what they thought were a shingles like rash to my face. Swelling in my lower legs up to groins so extreme that my lower extemiyi malar rash to my face,  uticaria all over my body , hidradenitis suppuritiva (face, legs, Raynauds, Systemeic Lupus Eurythramatosis symptoms, brain fog, insomnia, anxiety - primary care treated with steroid and topical creams.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunology test, Insomnia, Laboratory test, Peripheral swelling, Rash
Clinical narrative: within 24 hrs of the 2nd dose, I developed  what they thought were a shingles like rash to my face. Swelling in my lower legs up to groins so extreme that my lower extemiyi malar rash to my face,  uticaria all over my body , hidradenitis suppuritiva (face, legs, Raynauds, Systemeic Lupus Eurythramatosis symptoms, brain fog, insomnia, anxiety - primary care treated with steroid and topical creams.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Raynaud's phenomenon, Swelling, Systemic lupus erythematosus, Urticaria
Clinical narrative: within 24 hrs of the 2nd dose, I developed  what they thought were a shingles like rash to my face. Swelling in my lower legs up to groins so extreme that my lower extemiyi malar rash to my face,  uticaria all over my body , hidradenitis suppuritiva (face, legs, Raynauds, Systemeic Lupus Eurythramatosis symptoms, brain fog, insomnia, anxiety - primary care treated with steroid and topical creams.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity, Skin abrasion
Clinical narrative: allergic reactions (flayed skin); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of excoriation in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE (TRADE NAME UNKNOWN)) for prophylaxis.   On an unknown date, the patient received Influenza vaccine and PNEUMONIA VACCINE (TRADE NAME UNKNOWN). On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced excoriation (Verbatim: allergic reactions (flayed skin)). The outcome of the excoriation was unknown.   It was unknown if the reporter considered the excoriation to be related to Influenza vaccine.     It was unknown if the company considered the excoriation to be related to Influenza vaccine.   Additional Information: GSK receipt date: 11-JUL-2023 The pharmacist had a female patient who experienced allergic reactions (flayed skin) after a pneumonia and flu vaccine (no brand name available) and they were figuring out whether administer Shingrix vaccine or not. The reporter did not consent to follow up. The reporter called back Healthcare professional in order to clarify influenza brand but Pharmacy was closed. It was unknown if the reporter considered the excoriation to be related to PNEUMONIA VACCINE .
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 2 year old was given a Kinrix (DTaP-IPV) which is only for ages 4 years - 6 years.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose normal, Confusional state, Depressed level of consciousness, Full blood count, Glycosylated haemoglobin
Clinical narrative: Saturday around 1PM after child received both meningitis immunizations, her sugar dropped to 54 and she was difficult to arouse, dilated pupils, severe confusion, and paleness. After giving her 10oz of milk and 4 Reese cups, her sugar came up to 84 and she was able to answer basic questions and respond to basic commands. I did have her eat a meal afterwards and continued to monitor her sugar throughout the rest of the day, and had her eat every 4-6 hours, which her sugar stayed above 85.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: HIV test, Lipids, Mydriasis, Pallor, Vitamin D
Clinical narrative: Saturday around 1PM after child received both meningitis immunizations, her sugar dropped to 54 and she was difficult to arouse, dilated pupils, severe confusion, and paleness. After giving her 10oz of milk and 4 Reese cups, her sugar came up to 84 and she was able to answer basic questions and respond to basic commands. I did have her eat a meal afterwards and continued to monitor her sugar throughout the rest of the day, and had her eat every 4-6 hours, which her sugar stayed above 85.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina unstable, Symptom recurrence
Clinical narrative: UNSTABLE ANGINA 1/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia, Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY HYPOXIA
Age: 97.0
Sex: F
Vaccine: COVID19-2
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Coagulopathy
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Symptom recurrence
Clinical narrative: CHRONIC RESPIRATORY FAILURE 1/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/8/2022  &  1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, UNSPECIFIED
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Epilepsy, Partial seizures
Clinical narrative: FOCAL MOTOR SEIZURE EPILEPSY, UNSPECIFIED
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Limb injury, Migraine, Sleep disorder
Clinical narrative: Same day of vaccine, seemed sore around injection site, 6-7 hours later was hit in the arm at work, hurt worse afterwards. The night of 7-14-2023 red area around injection site and felt worse. On 7-17-2023 woke up with a migraine and prism type vision, changes in OD, vomiting.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Visual impairment, Vomiting
Clinical narrative: Same day of vaccine, seemed sore around injection site, 6-7 hours later was hit in the arm at work, hurt worse afterwards. The night of 7-14-2023 red area around injection site and felt worse. On 7-17-2023 woke up with a migraine and prism type vision, changes in OD, vomiting.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE 3/7/2023  &  2/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Pneumonia aspiration
Clinical narrative: R09.02 HYPOXIA 3/23/2023 ASPIRATION PNEUMONIA
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given a nonviable vaccine. The vaccine was exposed to cold holding temperatures. Patient had no adverse symptoms from the nonviable vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Angina unstable
Clinical narrative: I20.0 UNSTABLE ANGINA 4/19/2023 UNSTABLE ANGINA
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Vaccination site induration, Vaccination site nodule, Vaccination site pain
Clinical narrative: Patient c/o pain and described a knot sensation on L deltoid area where vaccine was given. Painful to the touch. Induration was formed on site. Ice pack was applied and instructions were given to take OTC Ibuprofen or Tylenol. Advised patient to move arm. She was able to move arm and finger.
Age: 12.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pain in extremity
Clinical narrative: Sore arm
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Cor pulmonale acute, Pulmonary embolism, Respiratory failure
Clinical narrative: ACUTE COR PULMONALE ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Hypersensitivity
Clinical narrative: CHRONIC RESPIRATORY FAILURE ALLERGIC REACTION, INIT
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccine dose given past espire date of 3/1/2023
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Tdap expired on 7/15/23 and was given on 7/18/23, 3 days past expiration date. No adverse effects. Patient will be called to repeat this vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pyrexia, Urticaria
Clinical narrative: Pt reported hives, extreme tiredness, nausea, and fever
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Cardiogenic shock, Symptom recurrence
Clinical narrative: ACUTE RESPIRATORY FAILURE CARDIOGENIC SHOCK 2/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypotension
Clinical narrative: HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered Infarix (DTaP). Medical Assistant administered Kinrix (DTaP-IPV). No adverse reactions noted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Diarrhoea, Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient with reported (per mother) large amount of redness/swelling starting with spot on top of thigh where IM injection was given (Kinrix). Started about 2 hours after administration of vaccine and redness/swelling/heat spread to the remainder of the leg beyond the normal swelling/redness. Patient also developed limping and impaired walking due to swelling and pain. Patient also developed very loose stools for a couple of days after vaccination as well.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expired the date of 7/3/2023
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Gait disturbance, Hypersensitivity, Laboratory test normal, Pyrexia
Clinical narrative: Patient developed a rash, fever, and difficulty walking about 2 weeks after vaccination. Went to the ER. Per patient's wife,  labs were normal. Patient physician  believes that the patient had an allergic reaction to a component in the vaccine.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash, fever, and difficulty walking about 2 weeks after vaccination. Went to the ER. Per patient's wife,  labs were normal. Patient physician  believes that the patient had an allergic reaction to a component in the vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Symptom recurrence, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA 11/28/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Coronary artery disease, Respiratory failure
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/26/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/26/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA I21.4 ACUTE NON ST ELEVATION MI 4/26/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/26/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Diabetic nephropathy
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 3/27/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 3/27/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 3/27/2023 DM 2 W RENAL MANIFESTATION
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  No complications reported by patient.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest X-ray, Computerised tomogram, Confusional state, Connective tissue disorder
Clinical narrative: My heart went racing and had irregular palpitations with complete confusion. I could not drive
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Magnetic resonance imaging, Magnetic resonance imaging heart, Myocarditis, Palpitations
Clinical narrative: My heart went racing and had irregular palpitations with complete confusion. I could not drive
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Nausea, Pallor, Syncope, Vision blurred
Clinical narrative: Patient 11 y/o, 113.6 lbs was vaccinated at 9:15.  He received his first dose of HPV9 and MCV4. Both vaccines were administered and during the 15-minute monitoring time he experienced a vasovagal syncope while sitting. The syncope episode lasted about 30 seconds and then gained consciousness. His skin appeared pale, moist and clammy but was fanned while nurse took vitals. Temp 98.5F, blood pressure 117/69, pulse 70, oxygen 97%. No oxygen was needed. He stated that he felt nauseous and vision was blurry. He was advised to remain seated for an additional 10 minutes. Nurse asked if he would like a cold juice to soothe his stomach and he agreed. He was given a juice and skin color returned to normal color and vision slowly returned. Education was given to mother to monitor for any additional adverse symptoms and advised to go to the emergency room if needed. Patient's mother verbalized understanding and had no further questions.