chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen at site; Itchiness at the site of left arm.; Redness at site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-JUL-2024, the patient received Shingrix (intramuscular, left deltoid). On 31-JUL-2024, 2 days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Swollen at site), injection site itching (Verbatim: Itchiness at the site of left arm.) and injection site erythema (Verbatim: Redness at site). The outcome of the injection site swelling, injection site itching and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site swelling, injection site itching and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site itching and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2024 The patient self-reported this case for herself. The patient had redness, swollen and very itchy at the left arm site of the previous injection. The reporter did not wanted to give any information.  Medical disclaimer was given.  Adverse event was filed with minimal information. The reporter did not consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: REACTION WAS SEVERE RASH ALL OVER BODY, BURNING AND ITCHING; This spontaneous report received from a patient concerned an adult (59-63) year old of unspecified sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 2020 for covid-19 prophylaxis. The batch number was not reported. we are unable to perform follow up to request batch/lot numbers .No concomitant medications were reported. On an unspecified date, the patient experienced reaction was severe rash all over body, burning and itching (dose in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reaction was severe rash all over body, burning and itching was not reported. This report was non-serious.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient received vaccines, got up to leave. She was waiting in line to check out, I had time to go back to my desk and sit down. Patient then started to lean on mom, complained of being dizzy, then had syncopal episode.  Mom yelled and we came to them, I elevated patient legs. approximately 19 seconds later she woke up and hopped up. offered her water and had her sit on bed with her back against the back. Attached pulse ox, listened to by APRN, waited an additional 5 minutes or so before letting them leave.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: patient was extremely nuasea and vomiting, head ache, aches, could not get out of bed.  patient had coughing and loose phlem in lungs that would not cough out.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Sputum retention, Vomiting
Clinical narrative: patient was extremely nuasea and vomiting, head ache, aches, could not get out of bed.  patient had coughing and loose phlem in lungs that would not cough out.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT HAD SWELLING AND REDNESS AT THE SITE OF INJECTION. SHE ALSO REPORTED REDNESS AND TENDERNESS IN UPPER ARM
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Thyroid disorder
Clinical narrative: his wife has high blood pressure; thyroid problems; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERTENSION (his wife has high blood pressure) and THYROID DISORDER (thyroid problems) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (his wife has high blood pressure) and THYROID DISORDER (thyroid problems). At the time of the report, HYPERTENSION (his wife has high blood pressure) and THYROID DISORDER (thyroid problems) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient was suffered from Hypertension and Thyroid disorder  The patient did not received vaccine in the last 4 weeks.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-771602 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771602:Husband case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Graves' disease, SARS-CoV-2 test
Clinical narrative: Graves' disease; This is a spontaneous report received from a Physician.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 25Oct2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 54 years intramuscular, in arm for COVID-19 immunisation. The patient's relevant medical history included: "Long Covid", start date: Jul2022 (ongoing), notes: Developed after 1st Covid infection; "Depression", start date: 1965 (ongoing); "Anxiety", start date: 1965 (ongoing); "Hashimoto's thyroiditis" (ongoing); "Rheumatoid arthritis" (ongoing); "Psoriasis", start date: 2022 (ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); EFFEXOR oral taken for depression (ongoing); ROPINIROLE oral taken for depression (ongoing); METHIMAZOLE oral taken for graves' disease, autoimmune thyroiditis (ongoing); SIMPONI intramuscular taken for rheumatoid arthritis (ongoing). Vaccination history included: Moderna (DOSE 1, SINGLE, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Moderna 011J20A), administration date: 23Dec2020, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EW0177), administration date: 04Aug2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer Bivalent GJ6739), administration date: 11Jan2022, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: GRAVES' DISEASE (medically significant) with onset 2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: Normal High. Comments: Very dump Line as soon as liquid passed the line. Therapeutic measures were taken as a result of graves' disease. Additional information: the patient's Long Covid included cognitive defects in shifting focus, concentration, working memory, immediate memory, inability to read, and inability to do basic math problems; no longer able to work as a pediatrician. Risk factors for long covid included; autoimmune: Hashimoto's, thyroiditis, rheumatoid arthritis, with psoriasis, depression.; Sender's Comments: Based on the temporal relationship, the association between the event Grave's disease and BNT162be can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202400099201 Same reporter/patient/vaccine; different dose/event;
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: Passed out/lost consciousness; This is a spontaneous report received from a Consumer or other non HCP.  A 17-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 25Jun2024 at 08:56 as dose number unknown 0.5 ml, single (Lot number: GT6720, Expiration Date: 30Aug2025) at the age of 17 years intramuscular, in right deltoid for immunisation. The patient's relevant medical history included: "Beta thalassemia minor" (unspecified if ongoing). There were no concomitant medications. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 25Jun2024 at 09:01, outcome "unknown", described as "Passed out/lost consciousness". The event "passed out/lost consciousness" required emergency room visit. Clinical course: it was reported that the patient received TRUMENBA vaccine and then passed out about 5 minutes later.
Age: 56.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I contracted Covid starting Friday 02Aug and tested positive on Sunday 04Aug. My symptoms are mild - runny nose, watery eyes, mild fatigue, cough. No fever.; I contracted Covid starting Friday 02Aug and tested positive on Sunday 04Aug. My symptoms are mild - runny nose, watery eyes, mild fatigue, cough. No fever.; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 30Sep2023 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Aug2024, outcome "recovering" and all described as "I contracted Covid starting Friday 02Aug and tested positive on Sunday 04Aug. My symptoms are mild - runny nose, watery eyes, mild fatigue, cough. No fever.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2024) Positive, notes: I contracted Covid starting Friday 02Aug and tested positive on Sunday 04Aug. My symptoms are mild - runny nose, watery eyes, mild fatigue, cough. No fever. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: deceased; This is a spontaneous report received from a Consumer or other non HCP from legal division.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: DEATH (death), outcome "fatal", described as "deceased". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Plaintiff, (name withheld) (deceased after taking Pfizer vaccine) were (withheld) citizens, residing in the city and county of (withheld).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: deceased
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Y'all destroyed mine and my family's lives, killed my wife; This is a spontaneous report received from a Consumer or other non HCP from legal division, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: DEATH (death), outcome "fatal", described as "Y'all destroyed mine and my family's lives, killed my wife". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The reporter stated, "This is so wrong, and you all know you have a problem with the vaccine. Too many people have died and have severe side effects. Y'all destroyed mine and my family's lives, killed my wife, killed my daughter's mother and grandchildren grandmother. How many more families did you all destroy? Trying to get the medicine out without trials and checking for side-effects and what it would do to people that are compromised with other illnesses . There will be Accountability. Lawyers are going."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: Y'all destroyed mine and my family's lives, killed my wife
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Cough, Influenza like illness, Injection site pain, Injection site rash
Clinical narrative: injection site got hot; injection site got hot and developed a little rash about 5 centimeters wide; mild vertigo; congestion; sore throat; cough; The site was sore like she got punched in the arm and is still tender to the touch; flu like symptoms; muscle and joint aches; joint aches; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 02643071 (Merck).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "injection site got hot"; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "injection site got hot and developed a little rash about 5 centimeters wide"; VERTIGO (non-serious), outcome "unknown", described as "mild vertigo"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; COUGH (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The site was sore like she got punched in the arm and is still tender to the touch"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; MYALGIA (non-serious), outcome "unknown", described as "muscle and joint aches"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint aches".  Additional information: Patient called with questions about the side effects of Prevnar 20 and mentioned AE during call. Patient said she was injected in upper arm and the injection site got hot and developed a little rash about 5 centimeters wide. The site was sore like she got punched in the arm and is still tender to the touch. She also experienced flu like symptoms (mild vertigo, congestion, sore throat and cough, muscle and joint aches). She mentioned she had been travelling a few days before she was immunized.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Myalgia, Oropharyngeal pain, Respiratory tract congestion, Vertigo
Clinical narrative: injection site got hot; injection site got hot and developed a little rash about 5 centimeters wide; mild vertigo; congestion; sore throat; cough; The site was sore like she got punched in the arm and is still tender to the touch; flu like symptoms; muscle and joint aches; joint aches; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 02643071 (Merck).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "injection site got hot"; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "injection site got hot and developed a little rash about 5 centimeters wide"; VERTIGO (non-serious), outcome "unknown", described as "mild vertigo"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; COUGH (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The site was sore like she got punched in the arm and is still tender to the touch"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; MYALGIA (non-serious), outcome "unknown", described as "muscle and joint aches"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint aches".  Additional information: Patient called with questions about the side effects of Prevnar 20 and mentioned AE during call. Patient said she was injected in upper arm and the injection site got hot and developed a little rash about 5 centimeters wide. The site was sore like she got punched in the arm and is still tender to the touch. She also experienced flu like symptoms (mild vertigo, congestion, sore throat and cough, muscle and joint aches). She mentioned she had been travelling a few days before she was immunized.  Batch/lot number is not provided, and it cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mast cell activation syndrome
Clinical narrative: mast cell/Mast cell activation syndrome; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Alpha Gal", start date: 2012 (ongoing); "Diabetes Type II", start date: 2010 (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Menopause" (unspecified if ongoing); "COVID", start date: Aug2020 (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus; LISINOPRIL taken for diabetes mellitus; TRICOR [ADENOSINE] taken for blood cholesterol abnormal; LIPITOR taken for blood cholesterol abnormal; PREMARIN taken for menopause; APAP; IBUPROFEN. Past drug history included: Celebrex, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE, Batch/Lot number: EL3302, Anatomical location: Deltoid left, Route of administration: Intramuscular), administration date: 12Jan2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, 0.3 ML SINGLE, Batch/Lot number: EL3302, Anatomical location: Deltoid right), administration date: 04Feb2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Deltoid, Route of administration: Intramuscular), administration date: 04Oct2021, when the patient was 66-year-old, for Covid-19 immunization. The following information was reported: MAST CELL ACTIVATION SYNDROME (medically significant) with onset 2024, outcome "unknown", described as "mast cell/Mast cell activation syndrome". Clinical course: Dose number 4 (Location pf injection/shot: Deltoid). Patient did not received any other vaccines on the same dates as the Pfizer vaccine. Patient did not received any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. There were no other relevant tests. Patient had covid in Aug2020 with each vaccine her reaction got worse. She did not get any more boosters after 04. Her main question was whether the vaccines had mammal products in them since she found out that she had alpha gal and mast cell. She was diagnosed with both in 2024 but she had actually alpha gal since 2012(mis-diagnosed) she don't know how long she had mast cell. Please advise about mammal products.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400068223 same patient/vaccine, different dose/event;
Age: 14.0
Sex: M
Vaccine: DTAPIPVHIB, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14 year old patient was supposed to receive boostrix, but received the pentacel instead with no reported ae; 14 year old patient was supposed to receive boostrix, but received the pentacel instead with no reported ae; Initial information received on 30-Jul-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 14 years old male patient where patient was supposed to receive boostrix (diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid), but received the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Jul-2024, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Powder and suspension for suspension for injection (strength- standard) (lot number, expiry date not reported) via unknown route in unknown administration site and received a dose of suspect Boostrix not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for Immunisation (product administered to patient of inappropriate age) and (wrong product administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  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: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently received a dose of DAPTACEL instead of the intended ADACEL with no adverse event; Initial information received on 30-Jul-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 11 years old female patient who experienced inadvertently received a dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of the intended adacel with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Prophylactic vaccination.  On 10-May-2024, the patient received a 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 05-Jul-2024 and lot 76013AA) via intramuscular route in the left thigh as Immunization inadvertently received a dose of daptacel instead of the intended adacel with no adverse event (wrong product administered) (latency: same day).   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 and Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: inappropriate use due to administration of ACT-HIB diluted with a sterile diluent instead of the diluent that came with ACT-HIB with no reported adverse event; Initial information received on 30-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient, inappropriate use due to administration of HIB (PRP/T) VACCINE [ACT-HIB]. diluted with a sterile diluent instead of the diluent that came with act-hib with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (VAQTA) for Immunisation.  On 30-Jul-2024, the patient received 0.5 ml, 1X (total) suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK005AA) (strength and expiry:unknnown) (product preparation error, latency same day) via intramuscular route in the left thigh for prophylactic vaccination.   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: 21.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administered the Yf-Vax yellow vaccine intramuscularly, with no reported adverse event; Initial information received on 02-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 21 years old female patient who got administered the yellow fever vaccine - [YF-Vax] intramuscularly, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Aug-2024, the patient received 0.5 ml dose of suspect yellow fever vaccine - Solution for injection (lot- UK032AB and expiration date- 31-MAR-2025) via intramuscular route in Left Deltoid (strength: not provided) for Immunisation (incorrect route of product administration) (latency- same day).  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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Single component of a two-component product administered
Clinical narrative: only the liquid dtap-ipv portion of pentacel was administered to a patient. the acthib powder portion was not reconstituted with no reported adverse event; Initial information received on 05-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 months old male patient where only the liquid dtap-ipv portion of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] was administered to a patient, the acthib powder portion was not reconstituted 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 pneumococcal vaccine and rotavirus vaccine for Prophylactic vaccination.  On 05-Aug-2024, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Powder and suspension for suspension for injection (lot- UJ994AA and expiration date- 14-MAR-2025) via intramuscular route in unknown administration site (strength: not provided) for Immunisation (single component of a two-component product administered) (latency- same day).  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: FLUX
Symptoms: COVID-19, Condition aggravated, Thrombocytopenia
Clinical narrative: Covid; Thrombocytopenia; Covid; This spontaneous case, initially received on 22-Jul-2024, was reported by a non health professional and concerns an patient of unknown age/gender.  Past medical history included Thrombocytopenia on 14-Jan-2021.  On 26-Feb-202114:00, patient received Covid-19 vaccine, Anatomical site of injection: Left arm, Route of administration: intramuscular; Lot number: EN6203. On 19-Mar-202115:00, patient received Covid-19 vaccine, Anatomical site of injection: Left arm, Route of administration: intramuscular; Lot number: EN6208. On 05-Oct-202214:00, patient received Covid-19 vaccine, Anatomical site of injection: Left arm, Route of administration: intramuscular; Lot number: GJ3277. On 09-Oct-202314:00, patient received Covid-19 vaccine, Anatomical site of injection: Left arm, Route of administration: intramuscular; Lot number: HG2282. On 19-Oct-202115:00, patient received Covid-19 vaccine, Anatomical site of injection: Left arm, Route of administration: intramuscular; Lot number: FD0809. The patient also received booster dose in Oct-2023.   Administration of company suspect drug(s): On 09-Oct-2023, the patient received Influenza virus vaccine for Indication not reported, route of administration: Not reported, Anatomical Location: left arm, Lot number: 371435.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 27-Dec-2023, the patient experienced Covid (outcome: Recovered / Resolved, stop date: 05-Jan-2024). On 27-Dec-2023 09:00, the patient experienced Thrombocytopenia (Medically Significant, outcome: Recovered / Resolved with sequelae). On 14-Jan-2024, the patient experienced Covid (outcome: Recovered / Resolved, stop date: 25-Jul-2024). Influenza virus vaccine action taken: Not Applicable Treatment medication: Paxlovid for Thrombocytopenia and Covid.  Reporter's assessment: Seriousness or causality assessment was not provided by the reporter.; Reporter's Comments: Causality: Not related for the event of COVID-19 due to biological implausibility. The recent global COVID-19 pandemic with high prevalence of respiratory transmission in the community provides a more plausible explanation. The event of thrombocytopenia is more plausibly attributable to COVID-19 infection and hence not related. The events resolved following treatment with Nirmatrelvir/ritonavir. Of note, the patient had a history of thrombocytopenia which occurred during the COVID-19 season in 2021.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported. No additional AE; PNEUMOVAX 23 was inadvertently administered after its labeled expiry date.; This spontaneous report was received from Pharmacist and refers to a 73-year-old patient of unspecified gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 26-JUL-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) lot #U023827, expiration date: 17-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered by mistake instead of a chicken pox vaccine; Inappropriate age at vaccine administration; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 44-year-old female patient who received Herpes zoster (Shingrix) (batch number 4935H) for prophylaxis.   On 23-JUL-2024, the patient received Shingrix. On 23-JUL-2024, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: administered by mistake instead of a chicken pox vaccine) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered was unknown and the outcome of the inappropriate age at vaccine administration was not reported.   Additional Information: GSK receipt date: 30-JUL-2024 The physician called to report that a 44 year old female patient was administered by mistake a shingles vaccine instead of a chicken-pox vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter Did not consent to follow-up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Upon leaving the exam room, father stopped to use restroom.  While in the bathroom reported by father that the child fainted and hit head on sink going all the way to the ground.  RN cleaning exam room, child was carried back to room crying by father .  Child alert, crying laying flat on exam table.  Vital signs obtained.  Cool cloth to forehead, feet elevated. Alert and oriented, although appears scared and pale.  NP called to room.  No apparent goose egg noted at this time.  Responds to questions appropriately.  After 5-10 minutes, child stands at side of bed with assist.  Denies feelings of dizziness.  Child able to ambulate to check out with father.  Advised to monitor closely and call back/return to clinic with concerns. Father verbalizes understanding.
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: gave wrong vaccine patient should have received dtab
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Erythema, soreness, itchy, no treatment will continue to monitor.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching over an area of nearly 5 inches. Small blister, hot to touch, and hardness at center. Diagnosed with cellulitis at injection site.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: Redness, swelling, itching over an area of nearly 5 inches. Small blister, hot to touch, and hardness at center. Diagnosed with cellulitis at injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cyanosis, Fear, Loss of consciousness, Syncope, Tearfulness
Clinical narrative: Patient fainted and was caught by mom. Mom yelled out for help. Patient immediately came too and was teary eyed as she was scared. Mom stated her lips looked like they turned blue. Had patient lie down on the bed and raised her legs above her head. Gave her water and piece of candy. She stated she had not eaten anything  all day and it was already after 12PM. COlor was back to normal. Told her I would give her 10 minutes to rest and would come back to check on her. After 5min, mom came out of the room and stated she felt better and patient was wanting to  go. Checked on patient and breathing normally, color was appropriate with normal HR. Watched her as she got up and walked out on her own without any help.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV, PNC20
Symptoms: Wrong product administered
Clinical narrative: Ordered Dtap-IPV  combo . But, patient was only given the DTaP.  Patient/guardian notified to schedule visit for IPV/polio vaccine portion.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Hep A was given instead of Hep B
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: I've never had shingles in my life and had 2 small outbreaks.  One on my back about 3 inches long and 1/2 inch wide.  And one on my left arm inside my elbow which was about 2" long and 1" or more wide.  my back I never had any inching, but my arm did itch.  I never would have known about my back if my husband hadn't pointed it out.  So I'm not sure exactly when either started, but it was within 1 week of the vaccine and both book at least 4-6 weeks to clear.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Blood glucose normal, Blood pressure increased, Confusional state, Dizziness
Clinical narrative: After about 10 minutes after administering the Boostrix vaccine the patient said was dizzy, felt weak , some confusion and back of tongue was dumb. He had no difficulty breathing , no hives , no itching , no nausea or vomiting , no headache. He said he received the same vaccine 10 years ago no problems then . He has had the flu and Covid vaccines and had no problems but remarked that he tends to be anxious and has anxiety before getting vaccines.  I called 911 and the paramedics came and evaluated him . His BP was elevated at 140/100 blood sugar normal and everything else was normal . I gave him a bottle of water and the paramedics left and he was told if he didn't feel better to call them. He felt better when he left the pharmacy about 4:30pm
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia oral
Clinical narrative: After about 10 minutes after administering the Boostrix vaccine the patient said was dizzy, felt weak , some confusion and back of tongue was dumb. He had no difficulty breathing , no hives , no itching , no nausea or vomiting , no headache. He said he received the same vaccine 10 years ago no problems then . He has had the flu and Covid vaccines and had no problems but remarked that he tends to be anxious and has anxiety before getting vaccines.  I called 911 and the paramedics came and evaluated him . His BP was elevated at 140/100 blood sugar normal and everything else was normal . I gave him a bottle of water and the paramedics left and he was told if he didn't feel better to call them. He felt better when he left the pharmacy about 4:30pm
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abnormal menstrual clots, Asthenia, Dysmenorrhoea, Fatigue, Heavy menstrual bleeding
Clinical narrative: Tiredness, weak and mainly my period started after months of not having a menstrual period. Also my period produced bad cramps (severe) with heavy bleeding for a long period of time.  Hopefully someone will act and really check into the side effects from the Pfizer COVID-19 vaccination and booster shots. I was a 48-old perimenopausal woman who had not had a menstrual period in months until I took the first dose of the Pfizer vaccination days upon being vaccination along with side effects of being severely weak and tired and in having a sore arm my menstrual period returned with a heavy blood clotted flow. The second doses of the vaccination and the booster also had the same effects the heaviest menstrual periods that I have ever had in my adult female life, and almost 2 years after the booster my body is still not back on track has, I have now advanced into menopause. I wanted and felt that I really needed to take the COVID-19 vaccination in order to keep myself and those around me safe from COVID infection, however I greatly regret ever taking the vaccination at that time in my life when I was so healthy (e.g., eating right, taking multi-vitamins, exercising and mainly praying) so please make sure that a label is placed on the Pfizer COVID-19 vaccination immediately in letting female patients now that your menstrual period may very well return if you no longer have one, and let the patient(s) then decide for themselves if they even want to take a risk in taking the vaccination.   In my opinion there were not enough clinical trials performed on women (people) of all ages and stages of life by Pfizer before the COVID-19 vaccination was rolled out to the public for use.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Menopause, Menstrual disorder, Menstruation irregular, Pain, Pain in extremity
Clinical narrative: Tiredness, weak and mainly my period started after months of not having a menstrual period. Also my period produced bad cramps (severe) with heavy bleeding for a long period of time.  Hopefully someone will act and really check into the side effects from the Pfizer COVID-19 vaccination and booster shots. I was a 48-old perimenopausal woman who had not had a menstrual period in months until I took the first dose of the Pfizer vaccination days upon being vaccination along with side effects of being severely weak and tired and in having a sore arm my menstrual period returned with a heavy blood clotted flow. The second doses of the vaccination and the booster also had the same effects the heaviest menstrual periods that I have ever had in my adult female life, and almost 2 years after the booster my body is still not back on track has, I have now advanced into menopause. I wanted and felt that I really needed to take the COVID-19 vaccination in order to keep myself and those around me safe from COVID infection, however I greatly regret ever taking the vaccination at that time in my life when I was so healthy (e.g., eating right, taking multi-vitamins, exercising and mainly praying) so please make sure that a label is placed on the Pfizer COVID-19 vaccination immediately in letting female patients now that your menstrual period may very well return if you no longer have one, and let the patient(s) then decide for themselves if they even want to take a risk in taking the vaccination.   In my opinion there were not enough clinical trials performed on women (people) of all ages and stages of life by Pfizer before the COVID-19 vaccination was rolled out to the public for use.
Age: 15.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Dizziness, Nausea, Presyncope, Syncope, Vomiting
Clinical narrative: Vasovagal reaction: dizziness, syncope, nausea/vomiting
Age: 37.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Cough, Headache, Oropharyngeal pain, Rhinorrhoea, Vaccine positive rechallenge
Clinical narrative: Deep cough, Runny nose, Headache and sore throat. All has subsided except for deep cough. She states that the same thing happened after she had the 1st dose from her PCP.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Febrile convulsion, Rash vesicular
Clinical narrative: Complex febrile seizures, Mild chicken pox rash
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Cough, Dysstasia, Feeling abnormal, Muscle rigidity
Clinical narrative: Tdap was administered at 08:10 to the left deltoid. MenQuafi was administered at 08:11 to the right deltoid. At approximately08:11-08:12 pt slumped to the left et became unresponsive. Within approximately 10 seconds pt appeared to cough, went rigid et experienced tremors to his legs. Within 15 seconds rigidity ceased et pt began to speak loudly different phrases et names et stood up. Pt then regained his awareness of his surroundings et sat back down. Pt appeared to be drowsy at approximately 08:13-08:14. Mother et RN at chairside with pt. Pt states that his head "feels funny" et is slightly clammy. Mother states pt did not eat breakfast et has not slept. RN provided alert pt with a granola bar et box of apple juice x 2. Pt able to correctly state his full name, DOB, recognized his mother et aware of what he was in the office for today. BP at 08:15 was 110/70, pulse 88, lungs CTAB, RRR apical heart sounds, appropriate tracking with eyes, speech clear, hand grasps strong et equal bilat, no visual changes, no auditory changes noted, slight swaying when standing unassisted x 1. Pt sat back down with RN et mother at chairside where he drank another apple juice. Stood up again with no visible swaying but does admit to muscle soreness/weakness. Hepatitis A vaccine delayed for another day. Education was provided to pt et mother that they should report any changes to pt health or behaviors immediately to PCP. Mother states that they are going on for an orthodontic appointment et will go to the ER if needed. Pt et mother exited building unassisted at approx. 08:18 at their request.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Muscular weakness, Myalgia, Posture abnormal, Somnolence, Tremor
Clinical narrative: Tdap was administered at 08:10 to the left deltoid. MenQuafi was administered at 08:11 to the right deltoid. At approximately08:11-08:12 pt slumped to the left et became unresponsive. Within approximately 10 seconds pt appeared to cough, went rigid et experienced tremors to his legs. Within 15 seconds rigidity ceased et pt began to speak loudly different phrases et names et stood up. Pt then regained his awareness of his surroundings et sat back down. Pt appeared to be drowsy at approximately 08:13-08:14. Mother et RN at chairside with pt. Pt states that his head "feels funny" et is slightly clammy. Mother states pt did not eat breakfast et has not slept. RN provided alert pt with a granola bar et box of apple juice x 2. Pt able to correctly state his full name, DOB, recognized his mother et aware of what he was in the office for today. BP at 08:15 was 110/70, pulse 88, lungs CTAB, RRR apical heart sounds, appropriate tracking with eyes, speech clear, hand grasps strong et equal bilat, no visual changes, no auditory changes noted, slight swaying when standing unassisted x 1. Pt sat back down with RN et mother at chairside where he drank another apple juice. Stood up again with no visible swaying but does admit to muscle soreness/weakness. Hepatitis A vaccine delayed for another day. Education was provided to pt et mother that they should report any changes to pt health or behaviors immediately to PCP. Mother states that they are going on for an orthodontic appointment et will go to the ER if needed. Pt et mother exited building unassisted at approx. 08:18 at their request.