chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: UNK, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 18 month old patient received Quadracel instead of the intended dose of Pentacel with no reported adverse event; Initial information received on 21-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 month old female patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] instead of the intended dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-May-2023, the patient received a dose 4 dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine Solution for injection lot U7564AA expiry date: 08-Nov-2024 via intramuscular route in the left thigh for immunization.  On 19-MAY-2023 18 month old patient received quadracel instead of the intended dose of pentacel with no reported adverse event (wrong product administered) on the same day following the administration of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 18 month old patient received quadracel instead of the intended dose of pentacel 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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: punctured product has been administered post excursion when the temperature has gone above 8 c total excursion lasted 20 minutes with no reported adverse event; Initial information was received on 21-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who reported that punctured product has been administered post excursion when the temperature has gone above 8 c total excursion lasted 20 minutes with no reported adverse event after receiving vaccine ipv (VERO) [IMOVAX POLIO].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect ipv (VERO) (Suspension for injection) (lot W1A191M, Expiry date : 16-Feb-2025) via unknown route in unknown administration site. On an unknown date he/she also received a unknown dose of the same vaccine (lot V1B902M, expiry date : 02-Jun-2025) (strength unknown) via unknown route in unknown administration site for Immunization and punctured product has been administered post excursion when the temperature has gone above 8 c total excursion lasted 20 minutes with no reported adverse event (poor quality product administered) (unknown latency) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event punctured product has been administered post excursion when the temperature has gone above 8 c total excursion lasted 20 minutes 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: 67.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: gave Fluzone QIV instead of the intended Fluzone HD QIV to patient with no reported adverse event; Initial information was received on 21-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 67 years old male patient who gave influenza quadrival a-b vaccine [Fluzone QIV] instead of the intended fluzone hd qiv to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Aug-2023, the patient received a dose of 0.5 ml of suspect influenza quadrival a-b vaccine (Suspension for injection) (strength was unknown) (lot V80418A, Expiry date : Jun-2024) via intramuscular route in the left arm for gave fluzone qiv instead of the intended fluzone hd qiv to patient with no reported adverse event (wrong product administered) (latency : same day) following the administration of influenza quadrival a-b vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event gave fluzone qiv instead of the intended fluzone hd qiv to patient 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: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired doses of DAPTACEL with no reported adverse event; Initial information was received on 22-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA235929 (CLUSTER), 2023SA258195 (CLUSTER), 2023SA257557 (CLUSTER), 2023SA258504 (CLUSTER) and 2023SA258195 (CLUSTER).  This case involves a 1 years old female patient who was administered expired doses of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 HIB vaccine (HIB) for Prophylactic vaccination.  On 18-Aug-2023, the patient received a 0.5 ml, total (once) dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5893AA, expiry date: 21-Jun-2023, strength; standard) via intramuscular route in left thigh for Immunisation.  On 18-Aug-2023 the patient was administered expired doses of daptacel with no reported adverse event (expired product administered) (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.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired doses of DAPTACEL with no reported adverse event; Initial information was received on 22-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA258195 (CLUSTER).  This case involves a 1 years old female patient who received an expired doses of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] 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 HIB vaccine (HIB) for Prophylactic vaccination.  On 17-Aug-2023, the patient received an expired dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (strength: standard) at dose of 0.5 ml (lot number: C5893AA, expiration date: 21-Jun-2023) via unknown route in unknown administration site for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered expired doses of daptacel 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: 1.08
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally administered expired ActHIB (expiry date 11Aug2023) to patient with no reported adverse event; Initial information received on 22-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 13 months old male patient for whom accidentally expired HIB (PRP/T) vaccine [ACT-HIB] (expiry date 11-Aug-2023) was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Aug-2023, the patient received accidentally an expired dose of 0.5 ml 1x (frequency: once) suspect of standard strength HIB (PRP/T) vaccine suspension for injection (lot:  UJ787AAA, Expiry date: 11-Aug-2023) via intramuscular route in the right thigh for immunization with no reported adverse event (expired 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: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Basophil percentage, Blast cells absent, Blood albumin normal, Blood lactate dehydrogenase increased, Blood urine present
Clinical narrative: Developed  ITP for which he was admitted to the hospital on 8/22/23, received IVIG and started on steroids. Will follow-up with Heme/Onc.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: C-reactive protein, Eosinophil percentage increased, Full blood count abnormal, Granulocyte percentage, Haemoglobin normal
Clinical narrative: Developed  ITP for which he was admitted to the hospital on 8/22/23, received IVIG and started on steroids. Will follow-up with Heme/Onc.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Lymphocyte percentage, Monocyte count increased, Platelet count decreased
Clinical narrative: Developed  ITP for which he was admitted to the hospital on 8/22/23, received IVIG and started on steroids. Will follow-up with Heme/Onc.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Platelet morphology abnormal, Protein urine present, Red blood cell sedimentation rate increased, Smear test, Streptococcus test positive
Clinical narrative: Developed  ITP for which he was admitted to the hospital on 8/22/23, received IVIG and started on steroids. Will follow-up with Heme/Onc.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Thrombocytopenia, Urine analysis abnormal, White blood cell count normal, White blood cell morphology normal
Clinical narrative: Developed  ITP for which he was admitted to the hospital on 8/22/23, received IVIG and started on steroids. Will follow-up with Heme/Onc.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reactions.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy, Rib fracture, Status epilepticus
Clinical narrative: EPILEPSY, INTRACTABLE, W STATUS EPILEPTICUS 4/19/2023 RIGHT MULTIPLE RIBS FX, INIT
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reactions.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery disease, Ischaemic stroke
Clinical narrative: I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/26/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Hypertension, Neuropathy peripheral, Troponin I increased
Clinical narrative: PERIPHERAL NEUROPATHY 4/15/2023 ELEVATED TROPONIN I ACUTE NON ST ELEVATION MI 4/11/2023 ELEVATED TROPONIN I PERIPHERAL NEUROPATHY 4/15/2023 HTN (HYPERTENSION) ACUTE NON ST ELEVATION MI 4/11/2023 HTN (HYPERTENSION)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cardiac stress test normal, Chest pain, Dyspnoea
Clinical narrative: Intermittent, spontaneous shortness of breath and tachycardia without activity, chest pain that radiated to the mid-upper back, right shoulder and up the next. Extreme fatigue with any exertion, (yard work, work out activity) and decreased ability to recover. Stamina is half of what it used to be requiring many rest periods during outside work.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Electrocardiogram normal, Exercise tolerance decreased, Fatigue, Laboratory test normal
Clinical narrative: Intermittent, spontaneous shortness of breath and tachycardia without activity, chest pain that radiated to the mid-upper back, right shoulder and up the next. Extreme fatigue with any exertion, (yard work, work out activity) and decreased ability to recover. Stamina is half of what it used to be requiring many rest periods during outside work.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tachycardia
Clinical narrative: Intermittent, spontaneous shortness of breath and tachycardia without activity, chest pain that radiated to the mid-upper back, right shoulder and up the next. Extreme fatigue with any exertion, (yard work, work out activity) and decreased ability to recover. Stamina is half of what it used to be requiring many rest periods during outside work.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 52.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Pruritus
Clinical narrative: Patient came in to get M-M-R II Live vaccine and Varivax  at our pharmacy  on 8/22/23.  She called today and complained about her left arm being super itchy.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Pyrexia, Skin warm, Swelling
Clinical narrative: The next day after the patient received her flu shot the patient experienced the following symptoms: redness to whole upper arm, swelling, hard, fever, and hot to the touch. Patient went to the doctor and was prescribed an antibiotic and medrol dosepack.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Headache, fatigue, and diarrhea.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood creatinine normal, Blood potassium normal, Blood testosterone, Blood thyroid stimulating hormone normal
Clinical narrative: Intense and continuing hair loss for 14+ months (at the time of reporting). Reported to Family Doctor and Dermatologist. Rogaine, Ketoconazole 2% and Fluocinonide 0.05% prescribed. None of the prescribed medication helped or improved this condition.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydroepiandrosterone test, Glomerular filtration rate, Serum ferritin normal, Vitamin D
Clinical narrative: Intense and continuing hair loss for 14+ months (at the time of reporting). Reported to Family Doctor and Dermatologist. Rogaine, Ketoconazole 2% and Fluocinonide 0.05% prescribed. None of the prescribed medication helped or improved this condition.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Biopsy spinal cord abnormal, Computerised tomogram abnormal, Diffuse large B-cell lymphoma, Hepatic mass
Clinical narrative: Three weeks after having gotten the Pfizer Covid-19 booster I started experience severe back pain - which wound-up being three lesions pressing against my spinal cord; biopsy showed DLBCL (Diffuse Large B-Cell Lymphoma).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Positron emission tomogram abnormal, Spinal cord injury, Spinal operation, Splenic neoplasm malignancy unspecified
Clinical narrative: Three weeks after having gotten the Pfizer Covid-19 booster I started experience severe back pain - which wound-up being three lesions pressing against my spinal cord; biopsy showed DLBCL (Diffuse Large B-Cell Lymphoma).
Age: 22.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Upon administering MMR and TST, pt became dizzy and vomited. Pt states did not have anything to eat yet, and advised pt to drink water, eat something solid and sit for 15 minutes before administering the TDAP. After administering TDAP, pt left ambulatory and in stable condition.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Pallor
Clinical narrative: Pt states having a headache and feeling dizzy since receiving the vaccination on Tuesday 08/22/23. Pt denies nausea, no vomiting, no syncope, no fevers and no problems with swallowing. Denies any throat swelling only continues to state, "I have a headache and feel dizzy". Pt also states that her mother noticed she looked pale yesterday (08/23/23).  Pt has been able to keep foods down and states drinking fluids throughout the day.  Discussed with patient common side effects from the Tdap vaccine can include headache, body aches, and possible mild fevers. Encouraged pt to drink water to help with hydration and headache. Discussed with pt she can also take OTC Tylenol or ibuprofen as directed from packaging for mild symptoms' relief. Pt states taking ibuprofen on Tuesday 08/22/23 with no relief of headache. Discussed to also take a COVID test to check status. ED precautions given and encouraged since pt is continuing to have her symptoms. Pt verbalized understanding and agreed to follow up with ED for further evaluation.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling cold, Injection site erythema
Clinical narrative: Swollen injection site, red and hot  Severe joint pain Chills Fatigue  Severe weakness
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swollen injection site, red and hot  Severe joint pain Chills Fatigue  Severe weakness
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No symptoms
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No symptoms
Age: 3.0
Sex: F
Vaccine: COVID19-2, MMRV
Symptoms: Wrong product administered
Clinical narrative: Pt received Proquad(MMRV) and Pediatric Pfizer Bivalent. Pt was due to receive DTAP, PCV, and Infant Pfizer Bivalent.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac ablation, Heart rate increased
Clinical narrative: 9/10/2021 - Dr. observes very high heartrate 9/10/2021 - Dr. confers with primary care physician; they mutually send me to ER. 9/17/2021 - Dr. performs heart ablation. [5/19/2021 - Annual physical by primary care physician, showed no heart abnormalities.]
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Hyperhidrosis, Lip swelling, Pain
Clinical narrative: PATIENT REPORTED ACHINESS AND SWEATS THE EVENING OF THE VACCINE AND LOWER LIP SWELLING THE FOLLOWING MORNING.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion, Computerised tomogram, Coronary arterial stent insertion, Heart rate decreased
Clinical narrative: Heart rate dropped to 30 beats per minute. Heart stint & pacemaker surgeries
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Fatigue, Headache
Clinical narrative: Lower back pain headache Feeling tired
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events / side effects. Given HD to patient under 65 yrs old
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Immediate post-injection reaction, Pain
Clinical narrative: Severely bruised left arm from flu shot. Experienced severe pain right after injection
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Death, Dyspnoea, Respiratory failure
Clinical narrative: Covid-19 Breakthrough Infection.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Weaning failure
Clinical narrative: Covid-19 Breakthrough Infection.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint dislocation, Pain in extremity, SARS-CoV-2 test
Clinical narrative: positive on 16Jan2023; positive on 16Jan2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 16 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jul2021 as dose 1, single (Lot number: EW0198), in left arm, on 06Aug2021 as dose 2, single (Lot number: EW0198), in left arm and on 03Mar2022 as dose 3 (booster), single (Lot number: FL3198), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Migraines", start date: Dec2021 (ongoing); "Crohn's", start date: Jan2021 (ongoing); "Pain relief", start date: Mar2022 (ongoing). Concomitant medication(s) included: GABAPENTIN oral taken for migraine, start date: Mar2022 (ongoing); INFLUENZA VACCINE intramuscular taken for influenza immunisation, on 21Oct2022 as dose number unknown, single; NAPROXEN oral taken for analgesic therapy, start date: Mar2022 (ongoing); PENTASA oral taken for crohn's disease, start date: Jul2021 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jan2023, outcome "unknown" and all described as "positive on 16Jan2023". The patient underwent the following laboratory tests and procedures: Colonoscopy: (29Mar2021) Crohn's; Electromyogram: (27Mar2023) Unknown results; Endoscopy: (Oct2021) Crohn's; Magnetic resonance imaging: (12Apr2021) Crohn's; (02Apr2022) Migranes; (13Feb2023) slight loosnes of humeral head; SARS-CoV-2 test: (16Jan2023) Positive; (23Dec2021) Positive; Ultrasound joint: (17Mar2023) Unknown results; X-ray: (04Jan2023) Unknown results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272460 same patient different dose.;
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Colonoscopy, Drug ineffective, Electromyogram, Endoscopy
Clinical narrative: positive on 16Jan2023; positive on 16Jan2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 16 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jul2021 as dose 1, single (Lot number: EW0198), in left arm, on 06Aug2021 as dose 2, single (Lot number: EW0198), in left arm and on 03Mar2022 as dose 3 (booster), single (Lot number: FL3198), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Migraines", start date: Dec2021 (ongoing); "Crohn's", start date: Jan2021 (ongoing); "Pain relief", start date: Mar2022 (ongoing). Concomitant medication(s) included: GABAPENTIN oral taken for migraine, start date: Mar2022 (ongoing); INFLUENZA VACCINE intramuscular taken for influenza immunisation, on 21Oct2022 as dose number unknown, single; NAPROXEN oral taken for analgesic therapy, start date: Mar2022 (ongoing); PENTASA oral taken for crohn's disease, start date: Jul2021 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jan2023, outcome "unknown" and all described as "positive on 16Jan2023". The patient underwent the following laboratory tests and procedures: Colonoscopy: (29Mar2021) Crohn's; Electromyogram: (27Mar2023) Unknown results; Endoscopy: (Oct2021) Crohn's; Magnetic resonance imaging: (12Apr2021) Crohn's; (02Apr2022) Migranes; (13Feb2023) slight loosnes of humeral head; SARS-CoV-2 test: (16Jan2023) Positive; (23Dec2021) Positive; Ultrasound joint: (17Mar2023) Unknown results; X-ray: (04Jan2023) Unknown results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272460 same patient different dose.;
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Ultrasound joint, X-ray
Clinical narrative: positive on 16Jan2023; positive on 16Jan2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 16 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jul2021 as dose 1, single (Lot number: EW0198), in left arm, on 06Aug2021 as dose 2, single (Lot number: EW0198), in left arm and on 03Mar2022 as dose 3 (booster), single (Lot number: FL3198), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Migraines", start date: Dec2021 (ongoing); "Crohn's", start date: Jan2021 (ongoing); "Pain relief", start date: Mar2022 (ongoing). Concomitant medication(s) included: GABAPENTIN oral taken for migraine, start date: Mar2022 (ongoing); INFLUENZA VACCINE intramuscular taken for influenza immunisation, on 21Oct2022 as dose number unknown, single; NAPROXEN oral taken for analgesic therapy, start date: Mar2022 (ongoing); PENTASA oral taken for crohn's disease, start date: Jul2021 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jan2023, outcome "unknown" and all described as "positive on 16Jan2023". The patient underwent the following laboratory tests and procedures: Colonoscopy: (29Mar2021) Crohn's; Electromyogram: (27Mar2023) Unknown results; Endoscopy: (Oct2021) Crohn's; Magnetic resonance imaging: (12Apr2021) Crohn's; (02Apr2022) Migranes; (13Feb2023) slight loosnes of humeral head; SARS-CoV-2 test: (16Jan2023) Positive; (23Dec2021) Positive; Ultrasound joint: (17Mar2023) Unknown results; X-ray: (04Jan2023) Unknown results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272460 same patient different dose.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: wheezing; he gets mucous; asthma like symptoms; sleepless nights; sweating while sitting by himself; cough; inflammation of the airway; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 09Apr2021, for COVID-19 immunisation. The following information was reported: WHEEZING (non-serious), outcome "unknown"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "he gets mucous"; ASTHMA (non-serious), outcome "unknown", described as "asthma like symptoms"; INSOMNIA (non-serious), outcome "unknown", described as "sleepless nights"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating while sitting by himself"; COUGH (non-serious), outcome "unknown"; RESPIRATORY TRACT INFLAMMATION (non-serious), outcome "unknown", described as "inflammation of the airway". Therapeutic measures were taken as a result of wheezing, secretion discharge, asthma, cough, respiratory tract inflammation.  Additional information: Patient said he did get Covid. He reported ever since received the vaccines he had been having respiratory symptoms of wheezing, drainage, and asthma like symptoms. Never had then prior to the vaccinations. He had these problems severely since 2022. He had sleepless nights and sweating while sitting by himself. He wheezes when he got mucous. He had to cough so much to clear the drainage and reduced the wheezing. Had to use to use a nebulizer to reduce the inflammation and felt better.  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-202300283474 same patient, same product, different event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthma, Cough, Hyperhidrosis, Insomnia, Respiratory tract inflammation
Clinical narrative: wheezing; he gets mucous; asthma like symptoms; sleepless nights; sweating while sitting by himself; cough; inflammation of the airway; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 09Apr2021, for COVID-19 immunisation. The following information was reported: WHEEZING (non-serious), outcome "unknown"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "he gets mucous"; ASTHMA (non-serious), outcome "unknown", described as "asthma like symptoms"; INSOMNIA (non-serious), outcome "unknown", described as "sleepless nights"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating while sitting by himself"; COUGH (non-serious), outcome "unknown"; RESPIRATORY TRACT INFLAMMATION (non-serious), outcome "unknown", described as "inflammation of the airway". Therapeutic measures were taken as a result of wheezing, secretion discharge, asthma, cough, respiratory tract inflammation.  Additional information: Patient said he did get Covid. He reported ever since received the vaccines he had been having respiratory symptoms of wheezing, drainage, and asthma like symptoms. Never had then prior to the vaccinations. He had these problems severely since 2022. He had sleepless nights and sweating while sitting by himself. He wheezes when he got mucous. He had to cough so much to clear the drainage and reduced the wheezing. Had to use to use a nebulizer to reduce the inflammation and felt better.  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-202300283474 same patient, same product, different event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Secretion discharge, Wheezing
Clinical narrative: wheezing; he gets mucous; asthma like symptoms; sleepless nights; sweating while sitting by himself; cough; inflammation of the airway; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 09Apr2021, for COVID-19 immunisation. The following information was reported: WHEEZING (non-serious), outcome "unknown"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "he gets mucous"; ASTHMA (non-serious), outcome "unknown", described as "asthma like symptoms"; INSOMNIA (non-serious), outcome "unknown", described as "sleepless nights"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating while sitting by himself"; COUGH (non-serious), outcome "unknown"; RESPIRATORY TRACT INFLAMMATION (non-serious), outcome "unknown", described as "inflammation of the airway". Therapeutic measures were taken as a result of wheezing, secretion discharge, asthma, cough, respiratory tract inflammation.  Additional information: Patient said he did get Covid. He reported ever since received the vaccines he had been having respiratory symptoms of wheezing, drainage, and asthma like symptoms. Never had then prior to the vaccinations. He had these problems severely since 2022. He had sleepless nights and sweating while sitting by himself. He wheezes when he got mucous. He had to cough so much to clear the drainage and reduced the wheezing. Had to use to use a nebulizer to reduce the inflammation and felt better.  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-202300283474 same patient, same product, different event;
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram ambulatory, Palpitations, Ventricular extrasystoles
Clinical narrative: Frequent PVC, palpitations
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Alcoholic seizure, COVID-19, Dysphagia, Dyspnoea, Endotracheal intubation
Clinical narrative: admitted for seizures. intubated in ER. per mom, SOB and difficulty swallowing x 2 weeks; ETOH withdrawal seizures. keppra, no covid treatments-not symptomatic.  extubated 12/31 placed on cpap. wean as tolerated until dc'd home.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Positive airway pressure therapy, Seizure
Clinical narrative: admitted for seizures. intubated in ER. per mom, SOB and difficulty swallowing x 2 weeks; ETOH withdrawal seizures. keppra, no covid treatments-not symptomatic.  extubated 12/31 placed on cpap. wean as tolerated until dc'd home.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cough, Dyspnoea
Clinical narrative: SOB, cough, Sats at 70% on RA. Acute resp failure w/hypoxia, COVID Pneumonia, Treatment - O2 @ 2L, abx, vit C&D, zinc, Remdisivir, decadron. O2 titrated down toRA at dc.. home with abx, dexamethasone and zinc
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Cough, Hypoxia, Oropharyngeal pain
Clinical narrative: Presented w/ cough, fever, sore throat, confusion, hypoxia. Tested covid+, pneumonia. Tx w/ Redesivir, O2, Dexamthasone
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Presented w/ cough, fever, sore throat, confusion, hypoxia. Tested covid+, pneumonia. Tx w/ Redesivir, O2, Dexamthasone
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, SARS-CoV-2 test positive, Syncope
Clinical narrative: Presented after sycnope in personal car, c/o weakness. Reported testing Covid +. Tx w/ Decadron, Remdesivir
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure congestive, Cough, Dyspnoea, Fluid imbalance
Clinical narrative: Presented w/ cough, tested Covid + prior to visit. Worsening edema legs/abdomen, SOB. R/o acute kidney injury, likely due to fluid imbalance d/t congestive heart failure
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Localised oedema, Oedema peripheral, SARS-CoV-2 test positive
Clinical narrative: Presented w/ cough, tested Covid + prior to visit. Worsening edema legs/abdomen, SOB. R/o acute kidney injury, likely due to fluid imbalance d/t congestive heart failure
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Presented w/ SOB, fever, cough, wheezing. Recent outside Covid+ test. Tx / dexamethasone, Redesivir, zinc
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Presented w/ SOB, fever, cough, wheezing. Recent outside Covid+ test. Tx / dexamethasone, Redesivir, zinc
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Decreased appetite, Diarrhoea, Pneumonia
Clinical narrative: Presented w/ weakness, lack of appetite, diarrhea. Covid+, pneumonia. Tx w/ O2.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Presented w/ weakness, lack of appetite, diarrhea. Covid+, pneumonia. Tx w/ O2.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Hypertension, Nausea, SARS-CoV-2 test positive
Clinical narrative: Presented w/ HTN, n/v, abdominal pain.Covid +. Tx w/ Vit C/D
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Presented w/ HTN, n/v, abdominal pain.Covid +. Tx w/ Vit C/D
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Presented w/ SOB, tested Covid +. Tx w/ O2, Remdesivir, steroids, abx
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Lung infiltration, Orthostatic hypotension, Pleural effusion
Clinical narrative: Presented w/ sycope secondary to orthostatic hypotension and SOB. Dx w/ bilat. Pleural effusions and pulm infiltrates. Tested covid +, tx w/ O2, abx
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Syncope
Clinical narrative: Presented w/ sycope secondary to orthostatic hypotension and SOB. Dx w/ bilat. Pleural effusions and pulm infiltrates. Tested covid +, tx w/ O2, abx
Sex: F
Vaccine: PNC13
Symptoms: Antibody test abnormal
Clinical narrative: the PCV titers were very low; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 3-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose  4, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevenar 13 (first dose), for immunization; Prevenar 13 (second dose), for immunization; Prevenar 13 (third dose), for immunization. The following information was reported: ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "the PCV titers were very low".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product packaging confusion, Wrong product administered
Clinical narrative: patient did not experience any issues, side effects, or adverse events that he was aware of; he accidentally administered a dose of GARDASIL 9 to instead of the intended vaccine VAXNUEVANCE /; he accidentally administered a dose of GARDASIL 9 to instead of the intended vaccine VAXNUEVANCE / package inserts had a similar color and he accidentally grabbed the GARDASIL 9; The spontaneous report was received from a physician regarding a 4-month-old female patient. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 28-JUL-2023, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5mL via injection in the left thigh (lot number X004375 and expiration date 02-JAN-2025 have verified to be valid) (no more vaccination details were provided) as prophylaxis instead of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (wrong product administered). The reporter wanted to know how to "deal with and proceed" and "what to tell the parents of a 4-month-old" that he accidentally administered that dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) instead of the intended vaccine pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE). The reporter was the person who administered the vaccine as an experienced user stating that the package inserts had a similar color, and he accidentally grabbed the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) mistaking it for the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (product packaging confusion). The patient did not experience any issues, side effects, or adverse events that he was aware of (no adverse event), and he did not realize the error until after the patient left his office.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Product preparation error; no adverse event; Office manager calling to report adverse event regarding administration of expired VAQTA vaccine.  Office manager originally called to inquire about expiration date of an administered VAQTA syringe.  Called stated the vaccine was administered on 4/10; This spontaneous report was received from a physician and refers to a 5-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-APR-2022, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml/once, (lot #T033304, has been verified to be a valid lot number, expiration date: 02-APR-2022) (Expired product administered), administered in left arm for prophylaxis (strength reported as 25/0.5, route of administration were not provided).  It was reported that the medication error (Expired product administered) was occurred at the point of preparation for administration (Product preparation error). Office manager stated that patient involved did not report any adverse reaction to this adverse event and the patient's physician was aware of the event and consented to correspondence regarding this adverse event. No additional AE/PQC reported (no adverse event). All the outcome was not reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE; a 4 year old patient received the PROQUAD and VARIVAX concomitantly; This spontaneous report was received from a nurse referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 15-AUG-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (strength, dose, route of administration, lot#, and expiration date were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot#: W003818, expiration date: 02-FEB-2024, product circular#: uspi-v210-i-fro-2303r722; strength, dose, and route of administration were not reported) concomitantly for prophylaxis (overdose). No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE  TE Case02454494; This spontaneous report was received from a pharmacy technician (also reported as medical tech) and refers to a patient of unknown demographics.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-AUG-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, albumin status: recombinant human albumin (rHA), lot #w038812, expiration date reported and confirmed as 04-JUN-2024 (dose, route and site of administration not provided) administered one time for prophylaxis.  It was reported that the administered dose was given during a temperature excursion that it had underwent for unreported amount of time on unreported temperature (product storage error). No further adverse event (AE) (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No further AE; vaccine given during an excursion; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.    On 17-AUG-2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # W038815, expiration date was not reported, but upon internal validation established as 04-JUN-2024; strength, dose and route were not reported; one time) was given during an excursion to the patient for prophylaxis (product storage error).