chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two flu shots this year. one at allina on 09/17/2024, patient did not tell the facility she is living at that she received it and we gave her another one with our flu/covid clinic at the facility on 10/03/2024. Nothing noted by nursing on side effects/adverse effects
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a 2nd RSV immunization.  He previously received vaccine 11/27/23.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested to be vaccinated with RSV on 12/18/2024. When patient was asked by technician if they had it prior they said, "No" which was incorrect. They had a previous dose of same vaccine on 11/24/2023. Insurance let it bill through. The next day, 12/19/2024, Corporate sent email to store notifying of duplicate claim on vaccine and to investigate and report.  Patient was contacted and was doing fine with no side effects .  Patient was counseled on vaccine and normal schedule. Patient stated he was asthmatic and felt he needed the extra dose.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt forgot she received an Arexvy vaccine last year. So she got a second shot. She has no reactions or adverse effects.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 51 years old and received a high dose flu vaccine instead of regular dose flu.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT REQUESTED AND RECEIVED A RSV VACCINE ON 12/18/24 BUT UPON CHECKING HISTORY PATIENT HAD ALREADY RECEIVED THIS VACCINE ONCE IN 10/2023
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Vasovagal syncope 5 seconds after Fluarix administered. Patient remained on site for 30 minutes after episode.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Autoimmune disorder, Condition aggravated, Fatigue, Fibromyalgia, Full blood count normal
Clinical narrative: I developed increasing fatigue and muscle weakness that led to being unable to work or complete most activities by December 2nd. I can only walk very short distances. I am being monitored and tested by my PCP and Rheumatologist. She thinks it is a flare of my fibromyalgia or autoimmune. I hope I can go back to work within the next month.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Gait disturbance, Impaired work ability, Loss of personal independence in daily activities, Metabolic function test normal, Muscular weakness
Clinical narrative: I developed increasing fatigue and muscle weakness that led to being unable to work or complete most activities by December 2nd. I can only walk very short distances. I am being monitored and tested by my PCP and Rheumatologist. She thinks it is a flare of my fibromyalgia or autoimmune. I hope I can go back to work within the next month.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness unilateral, Laboratory test normal, Vertigo
Clinical narrative: left profound hearing loss, vertigo.  Has shown no recovery of hearing after high dose steroids so this is likely to result in a dead ear (no serviceable hearing ).
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait disturbance, Gait inability, Injection site erythema, Injection site swelling
Clinical narrative: Pt has swelling and redness at site of vaccine. Pt was unable to walk yesterday and is limping today
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Muscular weakness, Myalgia, Thrombosis
Clinical narrative: Post-vaccination bruising at injection site, some blood clotting, muscle weakness from pain
Age: 36.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: 3 days after injection arm had a 4in by 3in red rectangle that was minorly sore. Nurse recommended ibuprofen, ice, and benadryl
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Rash, Skin haemorrhage
Clinical narrative: eczema; skin was bloody; got fresh outbursts on his face on Saturday or Sunday; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA029534 (Sanofi).  An 87-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since 10Feb2022 (ongoing)) at 300 mg (300 mg every other week), subcutaneous. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISOLONE; VITAMIN D NOS; TIMOLOL MALEATE; VITAMIN C [ASCORBIC ACID]; ALENDRONATE SODIUM; CALCIUM CITRATE; FERROUS FUMARATE; FOLIC ACID; IRON POLYSACCHARIDE COMPLEX; NICOTINIC ACID; MEMANTIN; FISH OIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, for Covid-19 immunization, reaction(s): "eczema", "skin was bloody"; Bnt162b2 (DOSE 2, SINGLE), administration date: Mar2021, for Covid-19 immunization, reaction(s): "eczema", "skin was bloody"; Bnt162b2 (DOSE 3, SINGLE), administration date: 2021, for Covid-19 immunization, reaction(s): "eczema", "skin was bloody". The following information was reported: RASH (non-serious) with onset 26Oct2024, outcome "unknown", described as "got fresh outbursts on his face on Saturday or Sunday"; ECZEMA (non-serious), outcome "unknown"; SKIN HAEMORRHAGE (non-serious), outcome "unknown", described as "skin was bloody". The action taken for dupilumab was dosage not changed. Therapeutic measures were taken as a result of rash.  Additional information: It was reported after Patient received two Covid shots he developed eczema. His skin was bloody. It was unknown if the patient experienced any additional symptoms/events. Patient's spouse reported patent's eczema started after four covid shots- two in Mar2021 and two in fall 2021. She advised she did not realize a connection until after all four covid vaccines. Patient's spouse also reported patient got fresh outbursts on his face on 26Oct2024 while being treated with dupilumab. She advised patient applied prescription cream for rash which was received on 30Oct2024 helped it settle down.    The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  BNT162b2 is under agreement with BIONTECH SE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400327488 same patient and event, different dose number;US-PFIZER INC-202400327487 Same patient, event, different dose number;US-PFIZER INC-202400327486 Same patient, event, different dose number ;
Age: 59.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had vaccine on 01Nov2024, confirmed Covid via 2 home test on 25Nov2024; Had vaccine on 01Nov2024, confirmed Covid via 2 home test on 25Nov2024; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Nov2024 as dose 1, 0.3 ml single (Lot number: LN0589) at the age of 59 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 01Nov2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Covid incident" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna vaccine (Primary immunization completed), for Covid-19 immunization; Moderna vaccine (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 25Nov2024 at 17:00, outcome "recovered" (28Nov2024) and all described as "Had vaccine on 01Nov2024, confirmed Covid via 2 home test on 25Nov2024". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2024) Positive, notes: confirmed Covid via 2 home test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: This was patient's 4th confirmed Covid incident. He has taken exclusively Moderna Vaccine and boosters, this was his first Pfizer experience. Treatment for the event included Paxlovid.
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Skin haemorrhage
Clinical narrative: eczema; skin was bloody; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA029534 (Sanofi).  A male patient in his 80's received BNT162b2 (BNT162B2), in Mar2021 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: ECZEMA (non-serious), outcome "unknown"; SKIN HAEMORRHAGE (non-serious), outcome "unknown", described as "skin was bloody".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400322906 Same patient, event, different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Skin haemorrhage
Clinical narrative: eczema; skin was bloody; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA029534 (Sanofi).  A male patient in his 80's received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, for COVID-19 immunization, reaction(s): "eczema", "skin was bloody". The following information was reported: ECZEMA (non-serious), outcome "unknown"; SKIN HAEMORRHAGE (non-serious), outcome "unknown", described as "skin was bloody". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400322906 Same patient, event, different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Skin haemorrhage
Clinical narrative: eczema; skin was bloody; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA029534 (Sanofi).  A male patient in his 80's received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE:1), administration date: Mar2021, for Covid-19 Immunization, reaction(s): "eczema"; Bnt162b2 (DOSE 2), administration date: Mar2021, for Covid-19 Immunization, reaction(s): "eczema", "skin was bloody"; Bnt162b2 (DOSE 1), administration date: Mar2021, for Covid-19 Immunization, reaction(s): "skin was bloody". The following information was reported: ECZEMA (non-serious), outcome "unknown"; SKIN HAEMORRHAGE (non-serious), outcome "unknown", described as "skin was bloody".  Additional information: It was reported after patient received two Covid shots he developed eczema. His skin was bloody. Patient's spouse reported patent's eczema started after four covid shots- two in Mar2021 and two in fall 2021 She advised she did not realize a connection until after all four covid vaccines.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400322906 same patient and event, different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Torticollis
Clinical narrative: Cervical dystonia; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Legally disabled" (unspecified if ongoing); "Autism" (unspecified if ongoing); "Neurological diagnoses" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TORTICOLLIS (non-serious), outcome "unknown", described as "Cervical dystonia". Additional information: It was reported that the patient is legally disabled. He has autism and other neurological diagnoses. He is currently living in a state-funded group home. Since the home is State-funded, he was forced to get a COVID vaccination. He then suffered from cervical dystonia as a result of the vaccine on top of his other life altering maladies.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Heart rate irregular, Ligament sprain, Oral discomfort
Clinical narrative: Irregular heart beat/irregularities of the heart/ heart issues; Unspecified sensation in the mouth; back pain; new-onset arthritis; Possible sprain; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-778816 (Moderna).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: HEART RATE IRREGULAR (non-serious) with onset 2024, outcome "unknown", described as "Irregular heart beat/irregularities of the heart/ heart issues"; LIGAMENT SPRAIN (non-serious) with onset 2024, outcome "unknown", described as "Possible sprain"; ORAL DISCOMFORT (non-serious) with onset 2024, outcome "unknown", described as "Unspecified sensation in the mouth"; BACK PAIN (non-serious) with onset 2024, outcome "unknown"; ARTHRITIS (non-serious) with onset 2024, outcome "unknown", described as "new-onset arthritis".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; GARDASIL-9 expired on 11/22/2024 and was inadvertently administered on 12/18/2024; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 18-DEC-2024, the patient was inadvertently vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, lot # X019032 which was verified to be a valid lot # (expiration date reported and validated as 22-NOV-2024) administered as prophylaxis (specific dose, route, and anatomical location of administration were not provided) (expired product administered). The vaccine experienced no temperature excursions through date of administration. No additional adverse event was reported. No additional information provided.
Age: 27.0
Sex: U
Vaccine: MMR
Symptoms: Single component of a two-component product administered
Clinical narrative: 12/19/2024, patient, was made aware that medication error was made. Medical staff did not mix the agent & sterile diluent agent. Injection consisted of sterile H20.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: pain in my left shoulder where the shot was administered; The pain hindered the range of motion of my left arm; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 53XH9) for prophylaxis.   Concurrent medical conditions included barrett's esophagus and heart disorder. Concomitant products included atorvastatin, omeprazole, metoprolol succinate, clopidogrel bisulfate (Plavix) and acetylsalicylic acid (Asprin).   On 08-OCT-2024, the patient received the 1st dose of Shingrix (left arm). On 12-OCT-2024, 4 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain in my left shoulder where the shot was administered) and joint range of motion decreased (Verbatim: The pain hindered the range of motion of my left arm). The patient was treated with methylprednisolone. The outcome of the injection site pain and joint range of motion decreased were resolving.   It was unknown if the reporter considered the injection site pain and joint range of motion decreased to be related to Shingrix.     It was unknown if the company considered the injection site pain and joint range of motion decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-NOV-2024 The patient self-reported this case. After 4 days following the first Shingrix shot, the patient began to experience pain in his left shoulder where the shot was administered and the pain hindered the range of motion of his left arm The primary care physician prescribed a decreasing dose of steroids Methylprednisolone over 5 days which he completed and seemed to help and the symptoms were treated. The patient also received Atorvastatin, Omeprazole,  Metoprolol succinate, Plavix and Aspirin
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injection site abscess, Mobility decreased
Clinical narrative: pain in my left shoulder where the shot was administered; The pain hindered the range of motion of my left arm; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 53XH9) for prophylaxis.   Concurrent medical conditions included barrett's esophagus and heart disorder. Concomitant products included atorvastatin, omeprazole, metoprolol succinate, clopidogrel bisulfate (Plavix) and acetylsalicylic acid (Asprin).   On 08-OCT-2024, the patient received the 1st dose of Shingrix (left arm). On 12-OCT-2024, 4 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain in my left shoulder where the shot was administered) and joint range of motion decreased (Verbatim: The pain hindered the range of motion of my left arm). The patient was treated with methylprednisolone. The outcome of the injection site pain and joint range of motion decreased were resolving.   It was unknown if the reporter considered the injection site pain and joint range of motion decreased to be related to Shingrix.     It was unknown if the company considered the injection site pain and joint range of motion decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-NOV-2024 The patient self-reported this case. After 4 days following the first Shingrix shot, the patient began to experience pain in his left shoulder where the shot was administered and the pain hindered the range of motion of his left arm The primary care physician prescribed a decreasing dose of steroids Methylprednisolone over 5 days which he completed and seemed to help and the symptoms were treated. The patient also received Atorvastatin, Omeprazole,  Metoprolol succinate, Plavix and Aspirin
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received her first dose of SHINGRIX five years ago. She has not received her second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received her first dose of SHINGRIX five years ago. She has not received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-NOV-2024 The patient had not received her second dose of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site urticaria
Clinical narrative: arm has itched like absolute crazy ever since; have a red welt at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (arm has itched like absolute crazy ever since) and VACCINATION SITE URTICARIA (have a red welt at the injection site) in a 59-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included HRT (HRT for menopause) since an unknown date. Previously administered products included for Hypothyroidism: Levothyroxine. Past adverse reactions to the above products included No adverse effect with Levothyroxine. Concurrent medical conditions included Asthma (The patient had occasional asthma but only needed to carry an inhaler for a rare use), Hypothyroidism (She took Levothyroxine for mild hypothyroidism.), Menopause (HRT for menopause) and Penicillin allergy (Allergic to penicillin (as a young child) so she had avoided penicillin products all of her life since then. She sees a pulmonologist annually as she was a carrier for Alpha 1. She was not allergic to bee stings or any other injections.).    On 07-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 07-Oct-2024, the patient experienced PRURITUS (arm has itched like absolute crazy ever since) and VACCINATION SITE URTICARIA (have a red welt at the injection site). The patient was treated with Hydrocortisone valerate (Hydrocortisone) at an unspecified dose and frequency and Diphenhydramine hydrochloride (Benadryl) at an unspecified dose and frequency. At the time of the report, PRURITUS (arm has itched like absolute crazy ever since) and VACCINATION SITE URTICARIA (have a red welt at the injection site) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient arm had been persistently itchy, both day and night, since the injection, and she developed a red welt at the injection site. This continued for over two months, and she never experienced such a reaction before. She holds a deep appreciation for Moderna and entirely grateful for the protection these injections provided against illness. However, she might need to consider an alternative booster in the future due to the severity of this reaction. Unfortunately, hydrocortisone cream proven ineffective, and while Benadryl induces sleep, it does not alleviate the itching. The intensity of the itching remains unchanged since the day of the injection, and she was uncertain how much longer she will have to endure this discomfort. She would appreciate any suggestions might had, as she was not encountered any additional symptoms or events. National drug code 80777011096.
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Engerix-B late 3rd dose; Engerix-B late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number AHBVC064BB, expiry date 22-MAR-2014) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 12th February 2013).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On 23-AUG-2013, the patient received the 2nd dose of Engerix B. On 23-AUG-2013, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Engerix-B late 2nd dose). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Engerix-B late 3rd dose). The outcome of the incomplete course of vaccination and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-NOV-2024 The pharmacist reported that an adult male patient received Engerix-B first dose on 12th February 2013 and the second dose was on 23 August 2013 which led to drug dose administration interval too long. The healthcare professional stated that the hepatitis B doses recorded were Engerix-B vaccines. Till the time of reporting, patient did not receive 3rd dose which led to incomplete course of vaccination.
Age: 1.08
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menquadfi administered to infant <2 years old with no reported adverse event; Initial information received on 11-Dec-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 13 months old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant vaccination(s) and family history were not provided.   On 11-Dec-2024, the patient received 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (Unknown strength, lot and expiry date) via intramuscular route in unknown administration site for for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months through 55 years of age (Meningococcal 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.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.67
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reactions
Age: 2.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event
Clinical narrative: -N/A  Father of child said patient tolerated well, no reations.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no reactions
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reactions
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reactions
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Aphasia, Cerebral thrombosis, Cerebrovascular accident, Dysstasia, Fall
Clinical narrative: December 15 admitted to hospital for life threatening stroke/blood clot to brain,  surgery required.   Fell out of bed at 4 am on December 15 unable to speak for stand.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Laboratory test, Thrombectomy
Clinical narrative: December 15 admitted to hospital for life threatening stroke/blood clot to brain,  surgery required.   Fell out of bed at 4 am on December 15 unable to speak for stand.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient got clammy, lightheaded, nauseous, sweating and felt like she was going to pass out.  She became very pale- but did not pass out.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Angiotensin converting enzyme normal, Antinuclear antibody negative, Blood thyroid stimulating hormone normal, C-reactive protein normal, CSF oligoclonal band absent
Clinical narrative: Thoracic myelopathy, transverse myelitis I am numb on left side of body from the chest down.  I lost my job and am currently on long term disability as a result. The numbness has remains the same for the last year
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein normal, CSF red blood cell count positive, Flank pain, Full blood count, HIV test negative
Clinical narrative: Thoracic myelopathy, transverse myelitis I am numb on left side of body from the chest down.  I lost my job and am currently on long term disability as a result. The numbness has remains the same for the last year
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Intervertebral disc protrusion, Kyphosis, Loss of employment, Lymphocyte count decreased
Clinical narrative: Thoracic myelopathy, transverse myelitis I am numb on left side of body from the chest down.  I lost my job and am currently on long term disability as a result. The numbness has remains the same for the last year
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal abnormal, Metabolic function test normal, Muscular weakness, Myelitis transverse
Clinical narrative: Thoracic myelopathy, transverse myelitis I am numb on left side of body from the chest down.  I lost my job and am currently on long term disability as a result. The numbness has remains the same for the last year
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Myelopathy, Red blood cell sedimentation rate normal, Sensory loss, Spinal X-ray abnormal, Vitamin B12 normal
Clinical narrative: Thoracic myelopathy, transverse myelitis I am numb on left side of body from the chest down.  I lost my job and am currently on long term disability as a result. The numbness has remains the same for the last year
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Erythema, Influenza like illness, Rash
Clinical narrative: Moderna 1st dose on 4/16/2021 at 1130 am, around 5 pm that day patient reports that her throat felt tight, her face was puffy and red and she had a pruritic rash on her chest. Called urgent care, was told to take Benadryl, patient took 50 mg, symptoms decreased and fully resolved after 2 hours. Then for the next 4 days patient had flu like symptoms and sharp left sided chest/breast pain that lasted a few days. Patient today reports those symptoms have resolved as of 5/17/2021 when she went for her 2nd Moderna dose. She first consulted an allergist who stated that the first reaction was not consistent with IgE mediated allergy/anaphylaxis and stated it was safe to get the 2nd dose and to premedicate with Zyrtec. Patient decided to postpone 2nd dose of Moderna vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Swelling face, Throat tightness
Clinical narrative: Moderna 1st dose on 4/16/2021 at 1130 am, around 5 pm that day patient reports that her throat felt tight, her face was puffy and red and she had a pruritic rash on her chest. Called urgent care, was told to take Benadryl, patient took 50 mg, symptoms decreased and fully resolved after 2 hours. Then for the next 4 days patient had flu like symptoms and sharp left sided chest/breast pain that lasted a few days. Patient today reports those symptoms have resolved as of 5/17/2021 when she went for her 2nd Moderna dose. She first consulted an allergist who stated that the first reaction was not consistent with IgE mediated allergy/anaphylaxis and stated it was safe to get the 2nd dose and to premedicate with Zyrtec. Patient decided to postpone 2nd dose of Moderna vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Pain, Rash erythematous, Vaccination site rash
Clinical narrative: Patient's arm at vaccination site turned red, looked like a rash that measured about 10 cm and induration. Pt was under pain.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pt got Rsv vaccination on 12/19/24 and 1 on 12/1/23
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: CHILD INADVERTENTLY RECEIVED A 3RD DOSE OF VARICELLA ON 12/19/2024.  THUS FAR THERE HAVE BEEN NO ADVERSE REACTIONS RELATED TO THE DOSE RECEIVED. MOTHER CONTACTED AND ADVISED TO MONITOR THE CHILD AND REPORT ANY ADVERSE REATIONS IMMEDIATELY TO THE COUNTY HEALTH DEPARTMENT.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site reaction, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: When I received the injection in the left arm, the administrator told me that he noticed the muscle pulse when he injected the needle into my arm. He said that he believed he struck a nerve based on the muscular reaction. I did not think anything of it at the time. However, after having the usual aches in my arms on the following days after the injection, the pain began to increase substantially. Within a week, my left and right shoulder areas became sore to the point that the pain would keep me up at night and affected my day to day activities. I began to do some basic stretches and took pain reliever medication for a week in hopes that would help. I was able to get the pain in my right arm reduced, but I could not get the left arm to improve. I struggled incredibly to reach behind my back, straight out, over my head, and across my body. Since I was not able to get this pain to improve on my own, I went to my primary physician on November 8th. He recommended that I try physical therapy. This has helped substantially in increasing my range of motion and decreasing the pain threshold. At this point, that treatment has seemed to work. I have been able to resume most of my day to day activities without substantial pain.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Ear pain, Productive cough, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Severe congestion, blowing nose constantly and bringing up phlegm. The chills and ear aches
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Patient had called on 12/19/24 to the pharmacy indicating that she had a reaction of cellulitis following her flu vaccination and wanted to report it. Followed up with her on 12/20/24 to ensure everything was okay. Pt stated that she had noticed it and went to urgent care on 12/13 to be seen and received antibiotics. Pt states that she is completing her antibiotics and feeling better now.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain, Pruritus, Tenderness
Clinical narrative: 1.5" diameter raised red area on arm, pain to touch and upon movement, mild itching
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Covid vaccine was expired. Expiration date of vaccine was 11/27 /2024
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC21, RV1
Symptoms: Decreased appetite, Irritability, Lethargy, Pyrexia
Clinical narrative: High fever, lethargy, decreased appetite, fussiness
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose of Covid
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Two days following the vaccination the patient experienced bruising which looks like bleeding underneath his skin. The purple bruising had spread down to his elbow. Patient says his only symptom outside of the appearance was soreness, but it did not itch and there was no heat coming from the affected area.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no previous adverse eventnot applicable
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Covid vaccine was given to patient.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Magnetic resonance imaging head normal, Migraine
Clinical narrative: migraine - every day, non-stop. responds slightly to NSAIDs but returns.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Area is swollen with a lump, redness and itchy at injection site.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong formulation administered; was given the 6M-11YR dose instead of the 12+ spikevax in error
Age: 20.0
Sex: M
Vaccine: TBE
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event but patient requested Japanese Encephalitis vaccine for travel and was given Ticovac in error
Age: 52.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Limb mass, Skin reaction
Clinical narrative: Patient received vaccines on 12/17/2024 stated that the following day (L) arm was red, had a lump, no other reactions to vaccines. Pt was seen by physician on 12/20/2024 was given steroids, and advised to take aleve.  Pt will return to clinic for evaluation following treatment.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain, Pain
Clinical narrative: The patient was complaining of shooting pain from shoulder to neck. I called about 2-3 times and left a voicemail to call me back the day after to see how the patient is feeling. Did not get back until pharmacist called on 12/20/2024. Tried asking if they took any pain medication but would not mention.
Age: 46.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Varicella was given too soon
Age: 46.0
Sex: M
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Varicella given too soon
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Induced labour, Pyrexia
Clinical narrative: Estimated due date 12 19, 2024. Was induced due to advanced maternal age and fetal size on 12-xx-2024. Received Miso, pitocin, epidural. Experienced fevers during labor and was given IV antibiotics.
Age: 56.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: Extreme fatigue and soreness during the day.  Woke up with markedly increased soreness, nausea, chills. Very fatigue and sore today. In the night, I brought my epi-pen to the bathtub with me because i feared an increasing reaction. I had the 2nd shingles shot yesterday, also.  First time for pneumonia.  1st shingles made me a little sore and tired, but nothing like this.
Age: 76.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Extra dose administered
Clinical narrative: Second dose given of RSV.  First dose was given on 06/17/2024.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Patient reported to pharmacy today stating that she has had trouble moving her arm, since the night of the injection. She will make an appointment with PCP to follow up.
Age: 26.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Cyanosis, Dizziness, Loss of consciousness, Syncope
Clinical narrative: PATIENT WAS GIVEN TWINRIX FOLLOWED BY TYPHIM.  HE FAINTED AFTER THE TWINRIX INJECTION, BUT SAID HE BEGAN FEELING WOOZY AFTER THE TWINRIX.  HE REMAINED IN THE CHAIR, BUT TURNED BLUE AND LOST CONSCIOUSNESS FOR MAYBE 10 SECONDS.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, MMRV, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: An adult dose of Havrix was inadvertently given instead of a pediatric dose. The error was found in an audit of records.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: severe pain in biceps
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Pentacel was ordered by Dr.. The MA only administered the DTAP/IPV portion of the vaccine and did not prepare with the powder of ACT HIB. IR helpdesk notified as well.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently given a third Shingrix vaccine which was realized as I documented this vaccine on 12/20/24.    Patient was called and counseled to monitor for injection site pain, fatigue, and myalgia per GSK medical information.    Patient proceeded to tell me he was aware he received a third vaccine and felt it was necessary due to receiving first Shingrix vaccine in 11/2023 and not following up within 2-6 month time period to receive second vaccine.    Made patient aware it is not recommended to repeat the Shingrix vaccine series and the second dose in 10/2024 would have completed the series. Patient had no concerns on receiving the third Shingrix dose today. Provider made aware.    When prescription was sent in for patient to receive Shingrix vaccine, it was sent in with 1 refill also making the error easier to occur with an assumption that a repeat vaccine was to be given.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vasculitis
Clinical narrative: Vasculitis on feet and legs
Age: 17.0
Sex: M
Vaccine: COVID19, MENB
Symptoms: Pain in extremity
Clinical narrative: sore arm
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Biopsy lung abnormal, Chills, Computerised tomogram thorax abnormal, Extranodal marginal zone B-cell lymphoma (MALT type)
Clinical narrative: developed: (1) rigors at about 12 hours, lasting several hours; (2) prolonged muscle aches over months-year from summer 2021 to at least late 2022; and (3) lung nodule, identified in Feb 2022, progressed (doubled in size) by Jul 2024, biopsied as marginal zone lymphoma of the lung (pulmonary MALT lymphoma) in Aug 2024, treated with radiation therapy Oct/Nov 2024, awaiting follow up in Feb 2025 to determine further treatment
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Myalgia, Positron emission tomogram, Pulmonary mass, Radiotherapy
Clinical narrative: developed: (1) rigors at about 12 hours, lasting several hours; (2) prolonged muscle aches over months-year from summer 2021 to at least late 2022; and (3) lung nodule, identified in Feb 2022, progressed (doubled in size) by Jul 2024, biopsied as marginal zone lymphoma of the lung (pulmonary MALT lymphoma) in Aug 2024, treated with radiation therapy Oct/Nov 2024, awaiting follow up in Feb 2025 to determine further treatment
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Eczema, Mechanical urticaria, Pruritus, Rash, Sensitive skin
Clinical narrative: Wednesday - 11/27/24, 2 days after the vaccine was administered, I became very itchy.  Upon checking my body later in the day, I had severe scratch marks left behind that were red and purple in nature.   I looked like I had been attacked.   Dermatologist, Dr, diagnosed it a dermographia but it wasn't fading in the typical 30 min time frame on 12/4/24. This took 5-6 days to fade but were still detectable over 2 weeks later.  I also had a rash on my torso that also began that day, 11/27/24.  After 2 days the rash was detected on my legs in 2 small spots.  I did not have a fever.  My scalp was very itchy and my eczema on my neck looked like an open wound.  My skin seemed to be particularly delicate and sensitive to any cuts or abrasions.  I was prescribed a 10-day course of prednisone on 11/29/24 by an urgent care provider.  They also suggested I continue taking Benadryl which I started on 11/28/2024. They suggested I follow up with dermatology and allergy.  After seeing my dermatologist on 12/4/24, she suggested I continue the Benadryl for another week.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Wednesday - 11/27/24, 2 days after the vaccine was administered, I became very itchy.  Upon checking my body later in the day, I had severe scratch marks left behind that were red and purple in nature.   I looked like I had been attacked.   Dermatologist, Dr, diagnosed it a dermographia but it wasn't fading in the typical 30 min time frame on 12/4/24. This took 5-6 days to fade but were still detectable over 2 weeks later.  I also had a rash on my torso that also began that day, 11/27/24.  After 2 days the rash was detected on my legs in 2 small spots.  I did not have a fever.  My scalp was very itchy and my eczema on my neck looked like an open wound.  My skin seemed to be particularly delicate and sensitive to any cuts or abrasions.  I was prescribed a 10-day course of prednisone on 11/29/24 by an urgent care provider.  They also suggested I continue taking Benadryl which I started on 11/28/2024. They suggested I follow up with dermatology and allergy.  After seeing my dermatologist on 12/4/24, she suggested I continue the Benadryl for another week.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse gave the 12 year and older vaccine
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: An adult dose was given to a pediatric patient.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Nausea
Clinical narrative: Patient received Prevnar 20 vaccine on 12/18/2024. corporate sent out an email on 12/19/24 indicating patient received a Prevnar 20 vaccine previously on 7/20/2022. Patient was notified of error and counseled on potential adverse events. She said she experience only nausea and no other side effects. She stated she had nausea that day (12/18/24) and the next day but she was not feeling nausea today on 12/20/2024.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: An adult dose was given to a pediatric patient.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Product preparation issue, Wrong product administered
Clinical narrative: Patient was supposed to receive a hep a vaccine.  He was given a DTaP by mistake.  He was also supposed to receive a MMR but was only given the sterile diluent and not the vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Tachycardia
Clinical narrative: Afib, tachycardia, had to go to Clinic for treatment.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at vaccine site with slight headache. Managing with antihistamine, cold compresses, and Tylenol
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was given to 64 year old and 3 months patient. Consent was singed by patient. Name, DOB and vaccines names were verbally repeated and confirmed with patient. Provider did not verify the age and electronic chart alerted when vaccine information was charted.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given two doses of the high dose flu vaccine, fluzone, in her left deltoid.  Duty doctor, was made aware.  Patient was then observed for approximately 20 minutes with no adverse reaction observed.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a COVID vaccine intended for a 12+ aged child; she is 7 years old.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Angiogram, Arthralgia, Back pain, Blood iron decreased
Clinical narrative: Lower back severe pain, hip joint severe pain, knee pain, ankle pain, headaches which are now migraines, low iron and vitamin D, peripheral vision is extremely blurry while straight on sight is 20/20, episodes of tunnel vision, episodes of spacing out which is now being tested for absent seizures, POTS, dizzy spells, extreme muscle fatigue, random rash outbreaks, unexplained random fevers, extreme fatigue, premature atrial contractions, stomach pain and nausea with eating anything, tachycardia, Trivial mitral valve regurgitation. Mild tricuspid valve regurgitation, pulmonary valve insufficiency