chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 81-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jan2025, outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jan2025) Positive, notes: tested positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.   No follow-up attempts are possible.
Age: 8.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo - 1 vial was ordered by Physician and given by RN, but is meant for patients aged 10-55 years, and this patient was 8 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.
Age: 5.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 5 when he received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.
Age: 4.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 5 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Decreased appetite, Fatigue, Gait disturbance, Laboratory test normal
Clinical narrative: 9-10-2024 awoke to stiff neck, painful arms and hips. Cannot raise my arms above my head without extreme pain. Arms feel like they are being ripped off when I try to raise them up. Massage helps a little. Heat helps a bit.. I can't dress myself and have a hard time bathing and walking up stairs or for very far. Huge fatigue and loss of appetite. My cardiologist says not to use Ibuprofin since I have had a cardiac issue and a stent put in. Oxycodone takes away about 10% of my pain. Doctor tested for PMR but the test came back negative, Doctor started me on Prednisone 20mg tapering down to 5mg. 50 to 60% pain relief, but when tapering off, the pain comes back. When the pain started shortly after the Flu vaccine, I talked to my doctor and he assurred me that the vaccine is not the problem but, I have taken several flu shots over the the last several decades with no problems but, the Senior flu vaccine is the only thing that was different and now I have PMR and I can't get off the Predisone without the pain returning. I am still working with my doctor to see about maybe taking a bigger dose but I am gaining weight at an alarming pace for the Prednisone, but what else can I do? This is not what I want but waht now?
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: 9-10-2024 awoke to stiff neck, painful arms and hips. Cannot raise my arms above my head without extreme pain. Arms feel like they are being ripped off when I try to raise them up. Massage helps a little. Heat helps a bit.. I can't dress myself and have a hard time bathing and walking up stairs or for very far. Huge fatigue and loss of appetite. My cardiologist says not to use Ibuprofin since I have had a cardiac issue and a stent put in. Oxycodone takes away about 10% of my pain. Doctor tested for PMR but the test came back negative, Doctor started me on Prednisone 20mg tapering down to 5mg. 50 to 60% pain relief, but when tapering off, the pain comes back. When the pain started shortly after the Flu vaccine, I talked to my doctor and he assurred me that the vaccine is not the problem but, I have taken several flu shots over the the last several decades with no problems but, the Senior flu vaccine is the only thing that was different and now I have PMR and I can't get off the Predisone without the pain returning. I am still working with my doctor to see about maybe taking a bigger dose but I am gaining weight at an alarming pace for the Prednisone, but what else can I do? This is not what I want but waht now?
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: 9-10-2024 awoke to stiff neck, painful arms and hips. Cannot raise my arms above my head without extreme pain. Arms feel like they are being ripped off when I try to raise them up. Massage helps a little. Heat helps a bit.. I can't dress myself and have a hard time bathing and walking up stairs or for very far. Huge fatigue and loss of appetite. My cardiologist says not to use Ibuprofin since I have had a cardiac issue and a stent put in. Oxycodone takes away about 10% of my pain. Doctor tested for PMR but the test came back negative, Doctor started me on Prednisone 20mg tapering down to 5mg. 50 to 60% pain relief, but when tapering off, the pain comes back. When the pain started shortly after the Flu vaccine, I talked to my doctor and he assurred me that the vaccine is not the problem but, I have taken several flu shots over the the last several decades with no problems but, the Senior flu vaccine is the only thing that was different and now I have PMR and I can't get off the Predisone without the pain returning. I am still working with my doctor to see about maybe taking a bigger dose but I am gaining weight at an alarming pace for the Prednisone, but what else can I do? This is not what I want but waht now?
Age: 2.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 2 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: LARGE RED RING AROUND THE VACCINATION SITE
Age: 6.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 7 years old and was prescribed Menveo liquid form, as he was traveling. Per CDC guidelines, it must be given for ages 10+
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMRV, PNC15
Symptoms: Rash
Clinical narrative: Mom reports pt started getting rash on bilateral thighs & abdomen around 5pm, called clinic and told her to return to clinic to allow him to be assessed by provider. Rash appeared to be hives. No wheezing noted on auscultation. Pt given Benadryl prior to arriving at clinic. Benadryl & prednisolone RX sent into pharmacy.
Age: 89.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a Prevnar 20 shot on 01/27/25, It was realized on 01/28/25 patient had received the shot in 09/2023 and a second dose was not needed. Spoke with patient on 01/28/25 and she had no adverse effects.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Additional dose of Arexvy vaccine was administered outside of clinical guideline recommendations. Patient received one dose of Arexvy on 1/11/24, and this additional dose on 1/26/25
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: Pain, in shoulder after initial vaccination
Age: 69.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Injection site erythema
Clinical narrative: Three days after vaccine given an oval area of redness developed on arm where shot was given, now spreading toward elbow. I referred patient to provider to seek care
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: PedvaxHIB given at the incorrect time. No adverse reactions noted.
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Patient reports that the shot was given very high on the arm. Red, painful rash at injection site with swelling. Patient reports openly bleeding for multiple hours after vaccine but is not on blood thinners.  Patient states there was a very large amount of pain for ~3 days after shot, that started immediately on injection.
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient reports that the shot was given very high on the arm. Red, painful rash at injection site with swelling. Patient reports openly bleeding for multiple hours after vaccine but is not on blood thinners.  Patient states there was a very large amount of pain for ~3 days after shot, that started immediately on injection.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inappropriately received a 2nd Prevnar 20 vaccine. No adverse events reported.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Rash vesicular, Varicella virus test positive
Clinical narrative: Vesicular rash from R pubic/groin down R lateral thigh to knee
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain
Clinical narrative: it is eating away my shoulder/ she will be getting a shoulder replacement/ AE:: shoulder pain; spreading into my neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a elderly female patient who received Herpes zoster (Shingrix) (batch number YZ9F7, expiry date 08-JUL-2024) for prophylaxis.   Concomitant products included cortisone.   In AUG-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shoulder pain (Verbatim: it is eating away my shoulder/ she will be getting a shoulder replacement/ AE:: shoulder pain) and neck pain (Verbatim: spreading into my neck). The outcome of the shoulder pain was not resolved and the outcome of the neck pain was unknown.   It was unknown if the reporter considered the shoulder pain and neck pain to be related to Shingrix.     It was unknown if the company considered the shoulder pain and neck pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-DEC-2024 The patient reported this case for herself. The patient reported that she had a reaction to the 2nd injection of Shingrix vaccine and it was reported to VAERS.  Patient reported that she received the vaccine sometime in August of 2023.  The patient described it as, it was eating away her shoulder. Further she stated that she would be getting a shoulder replacement, which was reported as shoulder pain as an adverse event. Patient reported that she had gotten a cortisone injection every 4 months and the cortisone was not helping, and it was spreading into her neck, which was reported as spreading into her neck as an adverse event.  Patient reported she could not take medications due to a condition called MTHFR. Patient stated the condition of MTHFR was related to the liver metabolized drugs.  No additional information was reported.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection, Herpes zoster, Pruritus
Clinical narrative: Itching; flare up of herpes/shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin lesion in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection (She states she has a history of herpes).   On 03-SEP-2024, the patient received the 1st dose of Shingrix. On 10-SEP-2024, 7 days after receiving Shingrix, the patient experienced skin lesion (Verbatim: flare up of herpes/shingles). On an unknown date, the patient experienced pruritus (Verbatim: Itching). The patient was treated with aciclovir sodium (Acyclovir) and hydrocortisone. The outcome of the skin lesion and pruritus were not resolved.   It was unknown if the reporter considered the skin lesion and pruritus to be related to Shingrix.     It was unknown if the company considered the skin lesion and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-DEC-2024 The reporter was the patient. She stated on September 3, 2024 she received Shingrix dose 1. A week later she had a flare up, with lesions on her waistline, a few near both ankles and one lesion on her right face cheek. She stated she was given 2 rounds of Acyclovir a week after the lesions appeared. She stated she had a history of herpes and was not sure if it that was herpes or shingles. She notified VAERS case and they referred her to report to GSK as well. She stated she still had some itching and uses hydrocortisone over the counter cream on her face. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Autism spectrum disorder
Clinical narrative: gave them autism; This serious case was reported by a consumer and described the occurrence of autism in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included infliximab for product used for unknown indication.   On an unknown date, the patient received Shingrix and infliximab. On an unknown date, an unknown time after receiving Shingrix, the patient experienced autism (Verbatim: gave them autism) (serious criteria GSK medically significant). The action taken with infliximab was unknown. The outcome of the autism was resolved.   It was unknown if the reporter considered the autism to be related to Shingrix.     The company considered the autism to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that the patient got Shingrix when they started infliximab and it gave them autism. On an unknown date, an unknown time after receiving infliximab, the patient experienced autism. It was unknown if the reporter considered the autism to be related to infliximab. This case has been linked to the US2025AMR010349 case reported by the same reporter.; Sender's Comments: Autism spectrum disorder is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025AMR010349:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Maladministration of the AS01B Adjuvant of Shingrix Alone; Maladministration of the AS01B Adjuvant of Shingrix Alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-DEC-2024, the patient received the 2nd dose of Shingrix. On 30-DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-DEC-2024  The reporter reported that a patient received Shingrix diluent alone without the powder portion, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter believed this was patient's Shingrix second dose. There was no patient's information available, nor lot number or expiration date information either. The vaccine administration facility was the same as primary reporter.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug ineffective, Influenza, Influenza A virus test positive, Myalgia, Pyrexia
Clinical narrative: came down with flu type a. got a positive result on the rapid flu a test/got sick with flu; fever; severe muscle aches; lack of efficacy. got sick with flu a; Initial information received on 23-Jan-2025 regarding an unsolicited valid  non-serious case received from patient  This case involves a 56 years old female patient who got a positive result on the rapid flu a test/got sick with flu, fever, severe muscle aches and indicating lack of efficacy after receiving influenza USP trival A-B subvirion NO preservative vaccine [Fluzone].  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 06-Dec-2024, the patient received 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (Unknown strength) with lot UT8408LA and expiry date JUN-2026 via intramuscular route in unknown administration site for Flu prevention (Antiviral prophylaxis)  On 19-Jan-2025 the patient developed came down with flu type a. got a positive result on the rapid flu a test/got sick with flu (influenza a virus test positive), fever (pyrexia), muscle aches (myalgia) and lack of efficacy. got sick with flu a (vaccination failure) (Latency 1 month 13 days) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Relevant laboratory test results included: Influenza A virus test - On 19-Jan-2025: Positive  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovering / Resolving for all the events.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Only the DTaP-IPV component was administered to the patient/The Hib component was not yet administered, with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 months old male patient to whom only the dtap-ipv component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered to the patient/the hib component was not yet administered, 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 conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 21-Jan-2025, only the dtap-ipv component was administered to the patient at unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UK167AA; Expiration date: 20-Oct-2025 strength not reported) via intramuscular route in unknown administration site for Immunization, hib component was not yet administered, with no reported adverse event (single component of a two-component product administered)  (latency: on 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: No adverse event, Wrong technique in product usage process
Clinical narrative: pentacel components being administered separately with no reported adverse event; Initial information received on 22-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to US-SA-2025SA023518 (Cluster case).  This case involves a 4 months old male patient who had Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] components being administered separately 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 for Immunisation.  On 21-Jan-2025, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (lot 49281-561-01 and 49281-51105, with strength as Standard and unknown expiry) via intramuscular route in the left thigh as Immunization, but on this date only the DTaP-IPV liquid vaccine component was administered and next day on 22-Jan-2025 received an unknown dose of ActHIB vaccine component via intramuscular route in the right thigh leading to pentacel components being administered separately with no reported adverse event (wrong technique in product usage process) (Latency: same day).   Reportedly, Caregiver is unsure if the ActHIB that was administered today was the lyophilized vaccine component of PENTACEL from yesterday or if it was the actual vaccine.    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.; Sender's Comments:  US-SA-2025SA023518:02383817
Age: 1.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menquadfi since it was administered to a patient below 2 years old with no reported adverse event; Initial information received on 22-Jan-2025 regarding an unsolicited valid non-serious case received from a Patient.  This case involves a 1 years old female patient (below 2 years old) was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Jan-2025, a below2 years old patient was administered (dose 1) (Standard) Meningococcal A-C-Y-W135 (T Conj) Vaccine (frequency-once) (unknown strength, expiry date, batch number and route) in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency-same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Caregiver called to inquire of possible side effects with Menquadfi  and how long to look out for possible side effects.   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: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ACTHIB administered separately from Pentacel with no reported adverse event; Initial information received on 22-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  The case is linked to US-SA-2025SA023490.  This case involves a 4 months old male patient who had HIB (PRP/T) Vaccine [ACT-HIB] administered separately from pentacel 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 DTAP WITH POLIO for Immunisation.  On 22-Jan-2025, the patient received a  dose of 0.5 ml of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) strength, expiry date, lot number not reported via intramuscular route in the right thigh for Immunization and acthib administered separately from pentacel with no reported adverse event (wrong technique in product usage process) (latency : same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  Reportedly "ActHIB  that was administered today was the lyophilized vaccine component of PENTACEL from yesterday or if it was the actual vaccine. Nurse caregiver wanted to know if there are possible side effects since it was given incorrectly."  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.; Sender's Comments:  US-SA-2025SA023490:02383817
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event, Product preparation issue
Clinical narrative: patient who was due to get a shot of PENTACEL but the provider only administered the diluent part of the product with no reported adverse event; Patient was administered with 2 doses of the diluents back to back with about a 5 minute interval; Initial information received on 23-Jan-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old male patient who was administered with the diluent part of the diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and patient was administered with 2 doses of the diluents back to back with about a 5 minute interval with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Jan-2025, the patient received the diluent part of the diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection with standard strength (expiry date, lot number and dose not reported) via unknown route in unknown administration site as Immunization (single component of a two-component product administered) and was administered with 2 doses of the diluents back to back with about a 5 minute interval (extra dose administered) (same day latency).   Reportedly, caller asked on the dosing for the patient's next dose, since the patient was supposed to get it at 18 months, they wanted to know if the patient should only be given with Hib since the patient already got 2 doses of the DTAP-IPV.  Information on the batch number was requested corresponding to the one at time of event occurrence.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: pregnant patient received a second dose of ADACEL in error with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19-year-old pregnant female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] second dose in error with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported pregnant patient received a second dose of ADACEL in error with no reported adverse event occurred at unknown gestation period  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Jan-2025, the pregnant patient received a 0.5 ml dose (dose 2) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot number: U8274AA and expiry date: 31-Aug-2026 via intramuscular route in the left deltoid in error also received dose 1 on 06-Dec-2024 with no reported adverse event (extra dose administered) (latency: on same day of 2nd dose).  Reportedly, The patient is aware of the mistake and has not reported any reactions so far.  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: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of expired MENQUADFI to patient with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case linked to US-SA-2025SA024785 (cluster)  This case involves a 11 years old male patient who had inappropriate use due to administration of expired Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel); Influenza vaccine (Fluzone) and HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) for Immunisation.  On 23-Jan-2025, inappropriate use due to administration of expired dose (0.5 ml) of Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (lot U7540BD; expiry date: 31-Dec-2024) via unknown route in the left arm for Immunisation with no reported adverse event (expired 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.; Sender's Comments:  US-SA-2025SA024785:02386845
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of expired MENQUADFI to patient with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient to whom inappropriate use due to administration of expired Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine (Fluzone).  On 23-Jan-2025, the patient received a expired 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength: standard, frequency: once, expiry date: 31-Dec-2024 and lot U7540BD) via unknown route in the left arm as Immunization (expired 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.
Age: 90.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 2nd dose FLUZONE HD was admisntered instead of Prevnar 20 with no reported adverse event; 2nd dose FLUZONE HD was admisntered instead of Prevnar 20 with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 90 years old male patient who received 2nd dose INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] was admisntered instead of PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2024, the patient received  0.5 ml of 1 and dose 2 (on 22-Jan-2025) of suspect, INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot UT8470CA and expiry 30-JUN-2025)  via intramuscular route in the left deltoid for Influenza instead of prevnar 20 with no reported adverse event (wrong product administered) (extra dose administered) (latency same day).  Reportedly: Once they realized their mistake, they went ahead and gave the patient Prevnar 20. Medical assistant is asking if there would be safety concerns with regards to the situation.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MEN
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnant patient received Menquadfi with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age female patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient received Menquadfi with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unkown previous pregnancy/ies.   On an unknown date, the patient received unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization with no adverse event (exposure during pregnancy) (Latency same day).  There was no information related to Relevant prenatal testing after exposure.  Reportedly, Nurse called on behalf of a physician. They said that the physician administered Menactra to a pregnant patient.informed the nurse that Menactra has been discontinued.The nurse clarified that they meant MENQUADFI instead of Menactra.  Information on the batch number could not be requested corresponding to the one at time of event occurrence   Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 2.17
Sex: M
Vaccine: FLU3
Symptoms: Blood culture negative, CSF culture negative, CSF glucose normal, CSF protein normal, CSF red blood cell count
Clinical narrative: Parent reported fever night after vac.Patient was seen in UCC 3 days after vaccination for complaint of fever and ear pain, dx with otitis media and prescribed antibiotics.  On the way home, pt developed right sided tonic clonic seizure activity and taken to ED.  Admitted and treated with antiseizure medication and antibiotics.  Patient continued seizure and fever on anti-seizure meds and antibiotics.  LP with 50 WBCs, <1 RBCs,  protein 19, glucose 60.  Transfered to  Hospital for persistent seizure activity.  symptoms improved after IVIG.  No infectious etiology identified - some labs still pending.  Autoimmune encephalitis panel pending.  Planning discharge.  Will need Neurology follow-up
Age: 2.17
Sex: M
Vaccine: FLU3
Symptoms: CSF test normal, CSF white blood cell count increased, Ear pain, Generalised tonic-clonic seizure, Immunoglobulin therapy
Clinical narrative: Parent reported fever night after vac.Patient was seen in UCC 3 days after vaccination for complaint of fever and ear pain, dx with otitis media and prescribed antibiotics.  On the way home, pt developed right sided tonic clonic seizure activity and taken to ED.  Admitted and treated with antiseizure medication and antibiotics.  Patient continued seizure and fever on anti-seizure meds and antibiotics.  LP with 50 WBCs, <1 RBCs,  protein 19, glucose 60.  Transfered to  Hospital for persistent seizure activity.  symptoms improved after IVIG.  No infectious etiology identified - some labs still pending.  Autoimmune encephalitis panel pending.  Planning discharge.  Will need Neurology follow-up
Age: 2.17
Sex: M
Vaccine: FLU3
Symptoms: Magnetic resonance imaging head normal, Nucleic acid test, Otitis media, Polymerase chain reaction negative, Pyrexia
Clinical narrative: Parent reported fever night after vac.Patient was seen in UCC 3 days after vaccination for complaint of fever and ear pain, dx with otitis media and prescribed antibiotics.  On the way home, pt developed right sided tonic clonic seizure activity and taken to ED.  Admitted and treated with antiseizure medication and antibiotics.  Patient continued seizure and fever on anti-seizure meds and antibiotics.  LP with 50 WBCs, <1 RBCs,  protein 19, glucose 60.  Transfered to  Hospital for persistent seizure activity.  symptoms improved after IVIG.  No infectious etiology identified - some labs still pending.  Autoimmune encephalitis panel pending.  Planning discharge.  Will need Neurology follow-up
Age: 2.17
Sex: M
Vaccine: FLU3
Symptoms: Respiratory pathogen panel, SARS-CoV-2 test negative
Clinical narrative: Parent reported fever night after vac.Patient was seen in UCC 3 days after vaccination for complaint of fever and ear pain, dx with otitis media and prescribed antibiotics.  On the way home, pt developed right sided tonic clonic seizure activity and taken to ED.  Admitted and treated with antiseizure medication and antibiotics.  Patient continued seizure and fever on anti-seizure meds and antibiotics.  LP with 50 WBCs, <1 RBCs,  protein 19, glucose 60.  Transfered to  Hospital for persistent seizure activity.  symptoms improved after IVIG.  No infectious etiology identified - some labs still pending.  Autoimmune encephalitis panel pending.  Planning discharge.  Will need Neurology follow-up
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a consumer via  interactive digital media. The patient had received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description,  completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, X-ray
Clinical narrative: Patient felt so sick, a little bit fever/it's still looks like she had a cold/weak/very sick/COVID.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient felt so sick, a little bit fever/it's still looks like she had a cold/weak/very sick/COVID.) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Lung disorder NOS (problems with lungs).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 30-Dec-2024, the patient experienced COVID-19 (Patient felt so sick, a little bit fever/it's still looks like she had a cold/weak/very sick/COVID.). At the time of the report, COVID-19 (Patient felt so sick, a little bit fever/it's still looks like she had a cold/weak/very sick/COVID.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: COVID. On an unknown date, X-ray: X-ray was fine.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant product use was not provided by the reporter.  Patient never ever thought that she was gonna get the COVID because she was very careful. She was using the mask because she had a problem with lungs before. About 3 weeks ago, she felt so sick, a little bit fever, she think she got the COVID. When she got to the emergency room front door they came and they had that kind of the test for the COVID and inside of her nose and everything they did and they said go and sit in the waiting room. Now it was from the 30-Dec-2024, she went to the emergency room and they said, she got the COVID, but they took the X-ray from her lungs to be sure everything was fine with her lungs and they said, yes, the X-ray was fine, but she had the COVID and she had to go home and did not go with anybody around her because she was gonna spread the COVID to other people. She called her physician for lungs because she had a problem with her lungs before. Patient asked to quarantine for 4 weeks. From the 30-Dec-2024 she take the lots of the vitamin C and had lots of rest, and she was going to get better. She was a little bit better, but it still was going on with her.  She was very, very weak, and she had a cold. When she was in a hospital in the emergency room, she heard that there was a medication that  was gonna give it to the patient and stop the COVID. it was about 6-7 days ago. They said, usually we're gonna give that kind of the medication to the patient for the 3rd day of this COVID and it was too late for her and she could not be prescribe that kind of the medication for you. At the time of reporting patient was suffering so much and she was very, very sick.  It was unknown if the patient experienced any additional symptoms or events.  Reporter causality was not reported.   Reporter did not allow further contact
Age: 93.0
Sex: F
Vaccine: RSV
Symptoms: Blood glucose normal, Breath sounds abnormal, Chest X-ray, Dysarthria, Dyspnoea
Clinical narrative: Resident recieved vaccine 12/5/24. Came sick and tested positive for RSV on 12/27/24 Resident was on the mend feeling better, came off of isolation. Resident had sudden decline, sudden death. Was unable to got her to ER to be evaluated by ER before she declined. I was leaving the dining room from passing lunch meds I was passing by residents room when I heard resident yell help. Went into residents room resident had c/o SOB. Resident did not have O2 on. I reapplied O2. Resident also said that she had to go to thebathroom. CNA was walking by the room. I yelled out for CNA to take resident to the bathroom. I parked med cart in med room grabbed plus ox and glucometer. Another CNA grabbed v/s cart. Resident kept saying I don't feel good. I can't breath. BS was not low. SPO2 was not low. Resident was slurring her words. I did stroke assessment, it was WNL. I called supervisor RN and stated what was going on and that I was going to send to ER. CNAs and other nurse put resident on gurney as I printed off paperwork. I took resident down to ER. Resident passed in the elevator as we exited into ER. TOD was 1257. Notified Dr @ 1310. @1315 pronounced. @ 1415 Funeral home picked up. Resident coughing productively thick brown sputum. lung sounds rhonchi. o2 sat 85% room air. I have placed on o2@2lpm.nc. Chest x-ray results pending. Dr notified of resident condition and of chest x-ray results. new orders for levaquin 500 mg one daily x 5 days and decadron 8 mg IM daily x 1 dose. Family notified. Resident continues to have cough/congestion/sinus drainage. Lung sounds diminished. she is coughing productively yellow sputum. T 97.9 P 103 R 28 b/p 121/70 o2 sat 92% room air. I spoke with RN. new order received for chest x-ray today. Family notified. Resident coughing productively light yellow sputum, lung sounds diminished bases and rhonchi upper airway. T 97.9 P 96 R 32 b/p 103/59 o2 96% I have administered prn cough syrup and tylenol. results pcr fo follow. allergies: promethazine. Dr. notified new orders received for cefdinir 300 mg one bid x 5 days, decadron 8 mg IM x 1 injection, mupirocin ointment to bilateral nares bid x 5 days. Family notified.