chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Underdose
Clinical narrative: Patient jerked away from vaccinator after she begin injecting the vaccine, causing the vaccinator to squirt the majority of the vaccine onto the patient's arm.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer COVID vaccine administration after beyond use date.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Dry mouth, Feeling abnormal, Feeling hot, Headache, Nausea
Clinical narrative: Staff member reports feeling hot, dry mouth, nauseous, vomited twice, and does not feel like herself. Also, reported a headache.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Staff member reports feeling hot, dry mouth, nauseous, vomited twice, and does not feel like herself. Also, reported a headache.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer covid vaccine administration after the beyond use date.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Tinnitus, headache
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Magnetic resonance imaging, Nasoendoscopy, Parosmia
Clinical narrative: 6 months after I got my vaccination, I started smelling cigarette smoke.  After two months after I lost my sense of smell.
Age: 72.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Flushing, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Woke up Tuesday morning with rash running down left bicep.  Red rash is warm almost hot to touch.  Rash has continued to spread down bicep and is currently 5? long and 2.5? wide.  Taking Benadryl, Tylenol, ice, and cortisone cream.  Yesterday face was flushed but that is gone.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Pt states the morning after receiving the vaccine, there was swelling at the injection site causing a "golf ball sized knot",  accompanied by redness and warmth. According to the pt, there was no fever, no visible rash formation, and no increased difficulty breathing.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Infantile spitting up, Rash macular, Ultrasound scan
Clinical narrative: Red blotchy cheeks, specks of red blood and red streaking in stools, increased spitting up post feedings
Age: 0.25
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: none
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: The next day his leg around where the shots were given got Hot and very swollen. It was Not itchy. Couple days just went away. No coughing or breathing issues.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Impaired work ability, Memory impairment, Mental disorder, Phobia
Clinical narrative: Lost his mind and could not function at work.   He has been in and out of several hospitals ask had to stay in the facility for 3 months costing us around $14,000.   He remains in the care of Drs and a therapist due to all of his extreme phobias.  He is unable to work.  There was a point that he did not know me.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pyrexia
Clinical narrative: Was given 0.5 ml when it needed to be 0.25 ml; Patient had fever after vaccination; This spontaneous case was reported by a medical assistant and describes the occurrence of PYREXIA (Patient had fever after vaccination) and OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) in an 8-year-old male patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis.     The patient's past medical history included Dermatitis on 03-Oct-2023. Previously administered products included for Product used for unknown indication: Child vitamin (Route - Oral One chewable once a day) on 25-Jun-2019. Past adverse reactions to the above products included No adverse event with Child vitamin. Concurrent medical conditions included Egg allergy.    On 24-Oct-2023, the patient received fourth dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter. In October 2023, the patient experienced PYREXIA (Patient had fever after vaccination). On 24-Oct-2023,  after starting mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024), the patient experienced OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml). At the time of the report, PYREXIA (Patient had fever after vaccination) and OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) to be not related. No further causality assessment was provided for PYREXIA (Patient had fever after vaccination).    Concomitant medications were not reported.  Patient had fever after vaccination.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747540:Master case
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: no adverse event; HCP calling to report that patient received extra dose of VARIVAX instead of scheduled MMR II (MMR II not administered). Patient received 1st dose of VARIVAX at 12 months of age and second dose of VARIVAX was administered today at 13 months of age.; HCP calling to report that patient received extra dose of VARIVAX instead of scheduled MMR II (MMR II not administered). Patient received 1st dose of VARIVAX at 12 months of age and second dose of VARIVAX was administered today at 13 months of age.; HCP calling to report that patient received extra dose of VARIVAX instead of scheduled MMR II (MMR II not administered); This spontaneous report was received from a registered nurse, referring to a 13-month-old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were note reported.  On an unknown date November 2023 (reported as at 12 months of age), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, lot#, expiration date, dose and route of administration were not provided). On 19-DEC-2023, the patient was vaccinated with extra dose (also the second dose) of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X020149, expiration date: 01-AUG-2025 (strength, and route of administration were not provided), 0.5 milliliter, administered by health professional for prophylaxis instead of scheduled measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live [M-M-R II] not administered) (extra dose administered, inappropriate schedule of product administration, wrong product administered). No adverse effects were noted. No additional adverse event (AE) was reported (no adverse event).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: gave her a stroke; really sick for a week; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 (BNT162B2), 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, lot number unknown), administration date: 2020, for COVID-19 immunization, reaction(s): "made her sick for 6 weeks". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "gave her a stroke"; ILLNESS (non-serious), outcome "recovered", described as "really sick for a week". Clinical course: Pfizer Covid-19 Vaccine: with the second dose she got really sick for a week and it gave her a stroke.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400013602 Same patient, different drug/ event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Illness
Clinical narrative: gave her a stroke; really sick for a week; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 (BNT162B2), 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, lot number unknown), administration date: 2020, for COVID-19 immunization, reaction(s): "made her sick for 6 weeks". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "gave her a stroke"; ILLNESS (non-serious), outcome "recovered", described as "really sick for a week". Clinical course: Pfizer Covid-19 Vaccine: with the second dose she got really sick for a week and it gave her a stroke.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400013602 Same patient, different drug/ event;
Age: 76.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called to report a 76-year-old patient who received a first dose of GARDASIL 9 in 2020.; No additional AE/PQC; This spontaneous report was received from a nurse and referred to a 76-year-old male patient.  The patient's medical history, concurrent conditions, drugs reactions and allergies, and concomitant therapies were not reported.  On an unknown date in 2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, once, administered as prophylaxis (strength, lot #, expiry date, anatomical location and route of administration were not provided) (product administered to patient to inappropriate age). No additional adverse event (AE) was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery disease, Dyspnoea, Pulmonary mass
Clinical narrative: Shortness or breath; mass in my left lung; Accelerated coronary artery disease; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY MASS (mass in my left lung), CORONARY ARTERY DISEASE (Accelerated coronary artery disease) and DYSPNOEA (Shortness or breath) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 001C21A) for COVID-19 prophylaxis.     The patient's past medical history included Cataract, Arterial stent insertion in 2021 and Surgery (Cataract).   On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 21-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced PULMONARY MASS (mass in my left lung) and CORONARY ARTERY DISEASE (Accelerated coronary artery disease). On an unknown date, the patient experienced DYSPNOEA (Shortness or breath). At the time of the report, PULMONARY MASS (mass in my left lung) and CORONARY ARTERY DISEASE (Accelerated coronary artery disease) had not resolved and DYSPNOEA (Shortness or breath) outcome was unknown.            The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.  Patient experienced shortness of breath, mass in his left lung, arterial stent placement and cataract surgery. He had a second arterial stent placement within 2 years of stent placement in 2021 and had accelerated coronary artery disease Company comment: This spontaneous case concerns a 51-year-old male patient, with medical history of arterial stent insertion, who experienced the unexpected and non-serious AESI of CORONARY ARTERY DISEASE (reported as accelerated coronary artery disease), among other non-serious events, approximately 2 months after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine. Previously he received another unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine), but no dose number was reported. Patient´s age, gender and his medical history of arterial stent insertion suggestive of underlying cardiovascular disease could be a risk factor for the event. Very limited information regarding this events has been provided, further information has been requested. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Blood pressure abnormal, Chest pain, Fatigue
Clinical narrative: uncontrollable blood pressure; stomach problems; extreme fatigue; anxiety; chest pains; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (anxiety), CHEST PAIN (chest pains), BLOOD PRESSURE ABNORMAL (uncontrollable blood pressure), ABDOMINAL DISCOMFORT (stomach problems) and FATIGUE (extreme fatigue) in a 43-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030371) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VIRUS VACCINE on 18-Sep-2023. Past adverse reactions to the above products included No adverse event with INFLUENZA VIRUS VACCINE.    On 18-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 20-Sep-2023, the patient experienced ANXIETY (anxiety), CHEST PAIN (chest pains) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (uncontrollable blood pressure) and ABDOMINAL DISCOMFORT (stomach problems). At the time of the report, ANXIETY (anxiety), CHEST PAIN (chest pains) and FATIGUE (extreme fatigue) had not resolved and BLOOD PRESSURE ABNORMAL (uncontrollable blood pressure) and ABDOMINAL DISCOMFORT (stomach problems) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Alopecia, Anosmia, COVID-19, Drug ineffective
Clinical narrative: Has Covid 19 at this time and has been in bed for 4 days and this is her second time with Covid-19; Has Covid 19 at this time and has been in bed for 4 days and this is her second time with Covid-19; She was very sick; have been so sick these last few days; I lost my taste and smell; I lost my taste and smell; Lost huge patch of hair that's never grown back; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Dec2020 (unspecified if ongoing), notes: I got the Covid in Dec2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Has Covid 19 at this time and has been in bed for 4 days and this is her second time with Covid-19"; ILLNESS (non-serious), outcome "unknown", described as "She was very sick; have been so sick these last few days"; ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "unknown" and all described as "I lost my taste and smell"; ALOPECIA (non-serious), outcome "unknown", described as "Lost huge patch of hair that's never grown back". Clinical information: Transferring agent stated, "And the caller, I have on the other end of the line during our conversation stated that she is about three months behind on her Premarin medication due to shipping issue. The patient also stated that she has Covid 19 at this time and has been in bed for 4 days and this is her second time with Covid-19. The first time she was very sick and lost hair and she states that she will not have the another vaccine and that's it for that regarding that part of the conversation." When paraphrased the concern: Consumer stated, "No, I had two vaccines already after Covid and one booster. I am not getting anymore. Because of the Covid vaccine, I lost huge patch of hair that's never grown back. I lost my taste of smell. My taste and smell are lost permanently and yes, no more vaccines." When confirm if administered two Pfizer Covid 19 Vaccine and one Pfizer Covid-19 booster vaccine: Consumer stated, "Right the booster I got in 2021. I got the Covid in Dec2020, vaccines in 2021 and the booster in 2022." Consumer was unwilling to further answer the questions. Hence, Limited information was available over the call.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Has Covid 19 at this time and has been in bed for 4 days and this is her second time with Covid-19; Has Covid 19 at this time and has been in bed for 4 days and this is her second time with Covid-19; She was very sick; have been so sick these last few days; I lost my taste and smell; I lost my taste and smell; Lost huge patch of hair that's never grown back; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Dec2020 (unspecified if ongoing), notes: I got the Covid in Dec2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Has Covid 19 at this time and has been in bed for 4 days and this is her second time with Covid-19"; ILLNESS (non-serious), outcome "unknown", described as "She was very sick; have been so sick these last few days"; ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "unknown" and all described as "I lost my taste and smell"; ALOPECIA (non-serious), outcome "unknown", described as "Lost huge patch of hair that's never grown back". Clinical information: Transferring agent stated, "And the caller, I have on the other end of the line during our conversation stated that she is about three months behind on her Premarin medication due to shipping issue. The patient also stated that she has Covid 19 at this time and has been in bed for 4 days and this is her second time with Covid-19. The first time she was very sick and lost hair and she states that she will not have the another vaccine and that's it for that regarding that part of the conversation." When paraphrased the concern: Consumer stated, "No, I had two vaccines already after Covid and one booster. I am not getting anymore. Because of the Covid vaccine, I lost huge patch of hair that's never grown back. I lost my taste of smell. My taste and smell are lost permanently and yes, no more vaccines." When confirm if administered two Pfizer Covid 19 Vaccine and one Pfizer Covid-19 booster vaccine: Consumer stated, "Right the booster I got in 2021. I got the Covid in Dec2020, vaccines in 2021 and the booster in 2022." Consumer was unwilling to further answer the questions. Hence, Limited information was available over the call.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 53.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administered with YF-VAX intramuscularly instead of the recommended subcutaneous route with no reported adverse event; Initial information received on 09-Jan-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 53-year-old female patient who was administered with yellow fever vaccine - US [YF-VAX] intramuscularly instead of the recommended subcutaneous route with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant Medication/ Additional Medications: No other vaccines.  On 03-Jan-2024, the patient received 0.5 mL dose of suspect yellow fever vaccine, Solution for injection (Frequency = Once; Strength = standard) (lot number: UJ966AA; expiry date: Jan-2025) via intramuscular route in the right deltoid for immunization instead of the recommended subcutaneous route with no reported adverse event (incorrect route of product administration) (same day latency).  Treatment: No treatment required.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: HIBV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertent administration of ADACEL instead of DAPTACEL to a 15-month-old patient with no reported adverse event; Initial information received on 10-Jan-2024 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 15 months old male patient who experienced inadvertent administration of Diphtheria-2/Tetanus/5 AC Pertussis vaccine [Adacel] instead of Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] to a 15-month-old 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 Pneumococcal Vaccine CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization).  On 17-Nov-2023, the patient received an unknown dose (dose 1) of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection of lot 2CA61C1 and expiry: 06-Jun-2025 via intramuscular route in the right thigh for immunization, instead of suspect Diphtheria-15/Tetanus/5 AC Pertussis vaccine with no reported adverse event (wrong product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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: 56.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Angiogram, Arrhythmia, Blood pressure fluctuation, Blood test, Cardiac failure
Clinical narrative: Acute Myocarditis, Heart failure, Irregular heart beat, PVC's, Severe chest pain, Shortness of breath, Fuctuating blood pressure, High blood pressure, Cardiac pause
Age: 56.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Heart rate irregular, Hypertension
Clinical narrative: Acute Myocarditis, Heart failure, Irregular heart beat, PVC's, Severe chest pain, Shortness of breath, Fuctuating blood pressure, High blood pressure, Cardiac pause
Age: 56.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Magnetic resonance imaging, Myocarditis, Ventricular extrasystoles
Clinical narrative: Acute Myocarditis, Heart failure, Irregular heart beat, PVC's, Severe chest pain, Shortness of breath, Fuctuating blood pressure, High blood pressure, Cardiac pause
Sex: F
Vaccine: RSV
Symptoms: Autoimmune disorder
Clinical narrative: when patient was in hospital for Autoimmune disorder; This serious case was reported by a physician via sales rep and described the occurrence of autoimmune disorder in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced autoimmune disorder (Verbatim: when patient was in hospital for Autoimmune disorder) (serious criteria hospitalization and GSK medically significant). The outcome of the autoimmune disorder was not resolved.   It was unknown if the reporter considered the autoimmune disorder to be related to Arexvy.     It was unknown if the company considered the autoimmune disorder to be related to Arexvy.   Additional Information: GSK receipt date: 12-JAN-2024 The physician reported that the patient received 1st dose of Arexvy and had autoimmune disorder. The reporter did not consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Cough, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; COPD; RSV; COUGH IS JUST TERRIBLE; covid; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), chronic obstructive pulmonary disease (Verbatim: COPD), respiratory syncytial virus infection (Verbatim: RSV), cough (Verbatim: COUGH IS JUST TERRIBLE) and covid-19 (Verbatim: covid). The patient was treated with antibiotics and Cough Pills. The outcome of the vaccination failure was unknown and the outcome of the chronic obstructive pulmonary disease, respiratory syncytial virus infection and cough were not resolved and the outcome of the covid-19 was not reported.   It was unknown if the reporter considered the vaccination failure, chronic obstructive pulmonary disease, respiratory syncytial virus infection, cough and covid-19 to be related to Arexvy.     It was unknown if the company considered the vaccination failure, chronic obstructive pulmonary disease, respiratory syncytial virus infection, cough and covid-19 to be related to Arexvy.   Additional Information: GSK receipt date:11-JAN-2024 This case was reported by a patient via interactive digital media. The patient had Respiratory syncytial virus infection and also Chronic obstructive pulmonary disease. The cough was just terrible. The patient was tried all the Tussin brands and nothing helps and also the finished the steroids, antibiotics, and cough pills but patient not feel much better. The patient was going to the emergency room or walk in clinic this to see if they can help him/her. This was the worse any Covid patient had by far. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of RSV was unknown. The follow-up could not be possible as no contact details were available.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: she had a sore arm; never called her again to get the 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer (was a past cancer patient before Shingrix first shot) and diabetes (diabetic patient for 50 years).   In MAY-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: she had a sore arm) and incomplete course of vaccination (Verbatim: never called her again to get the 2nd dose). The outcome of the pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JAN-2024 This case was self-reported by the patient. The patient received Shingrix 1st dose and after that she had a sore arm but nothing weird, however her doctor had never called her again to get the second dose.  The reporter did not consented to the follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Immunisation reaction, Infection, Myalgia
Clinical narrative: Consistently elevated infection results; Persistent bone pain; Following vaccination, I have experienced numerous health issues; Persistent muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Consistently elevated infection results), BONE PAIN (Persistent bone pain), IMMUNISATION REACTION (Following vaccination, I have experienced numerous health issues) and MYALGIA (Persistent muscle pain) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Consistently elevated infection results), BONE PAIN (Persistent bone pain), IMMUNISATION REACTION (Following vaccination, I have experienced numerous health issues) and MYALGIA (Persistent muscle pain). At the time of the report, INFECTION (Consistently elevated infection results), BONE PAIN (Persistent bone pain), IMMUNISATION REACTION (Following vaccination, I have experienced numerous health issues) and MYALGIA (Persistent muscle pain) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not provided. After two years of receiving the vaccine, patient' quality of life had become unbearable. Treatment information was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; stinging pain; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: stinging pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: RA Receipt date: 11-JAN-2024 This case was reported by patient via (social media) interactive digital media. The patient reported that he/she did not get shingles until after he/she got the shingles vaccine.  He/she stated that thank God he/she knew what to do about the stinging pain.  The patient stated that If you start taking Acyclovir within a day or two of onset, shingles goes away within a few days.  Unfortunately, if you take it much later, it does not help much and he/she recommend getting on the medication ASAP and not getting the shingles vaccine. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only one of the two vials of Menveo; Administered only one of the two vials of Menveo; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA748A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administered only one of the two vials of Menveo) and inappropriate dose of vaccine administered (Verbatim: Administered only one of the two vials of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2024 The reporter stated that the patient potentially administered only one of the two vials of Menveo, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The clinic only had the liquid conjugate remaining and with that they could not unequivocally state that a patient was administered only one out of the two vials of Menveo.  The clinic was trying to track down if any patient had administered only one vial and what was the lot number administered of the lyophilized conjugate mixed with saline.  They were researching their EMRs for additional information. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Lethargy, Pain in extremity
Clinical narrative: Red, flushed hot face 5 days after injection; arm pain; chills; headache; shakes; Vague sense of a burning smell started within a day of injection; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), PAROSMIA (Vague sense of a burning smell started within a day of injection), LETHARGY (lethargy), HOT FLUSH (Red, flushed hot face 5 days after injection) and PAIN IN EXTREMITY (arm pain) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031048) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 10-Jan-2024, the patient experienced TREMOR (shakes), PAROSMIA (Vague sense of a burning smell started within a day of injection), LETHARGY (lethargy), PAIN IN EXTREMITY (arm pain), CHILLS (chills) and HEADACHE (headache). On 15-Jan-2024, the patient experienced HOT FLUSH (Red, flushed hot face 5 days after injection). At the time of the report, TREMOR (shakes), PAROSMIA (Vague sense of a burning smell started within a day of injection), LETHARGY (lethargy), HOT FLUSH (Red, flushed hot face 5 days after injection), PAIN IN EXTREMITY (arm pain), CHILLS (chills) and HEADACHE (headache) was resolving.            Concomitant medication was not provided. Treatment information was not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Tremor
Clinical narrative: Red, flushed hot face 5 days after injection; arm pain; chills; headache; shakes; Vague sense of a burning smell started within a day of injection; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), PAROSMIA (Vague sense of a burning smell started within a day of injection), LETHARGY (lethargy), HOT FLUSH (Red, flushed hot face 5 days after injection) and PAIN IN EXTREMITY (arm pain) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031048) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 10-Jan-2024, the patient experienced TREMOR (shakes), PAROSMIA (Vague sense of a burning smell started within a day of injection), LETHARGY (lethargy), PAIN IN EXTREMITY (arm pain), CHILLS (chills) and HEADACHE (headache). On 15-Jan-2024, the patient experienced HOT FLUSH (Red, flushed hot face 5 days after injection). At the time of the report, TREMOR (shakes), PAROSMIA (Vague sense of a burning smell started within a day of injection), LETHARGY (lethargy), HOT FLUSH (Red, flushed hot face 5 days after injection), PAIN IN EXTREMITY (arm pain), CHILLS (chills) and HEADACHE (headache) was resolving.            Concomitant medication was not provided. Treatment information was not reported.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 19cmx15cm induration at injection site painful  hard and hot
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Dad reported reaction of redness and swelling, along with heat to right thigh : 3.5 cm x 2.5 cm in diameter with no other symptoms.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Developed hives on arms, trunk, and face 2 wks after admin. Heavy rash Patient took benadryl, no other treatment needed.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: left arm sore when lifting above shoulder
Sex: F
Vaccine: FLUC4
Symptoms: Wrong product administered
Clinical narrative: Patient was given incorrect vaccine
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Feeling of body temperature change, Mobility decreased, Nausea, Pain
Clinical narrative: I puked the entire night. I only drank water and puked it all up until I was just vomiting bile. I was crying almost constantly because my whole body is in pain. When I went to the toilet my legs hurt too much to sit down. My fingers especially hurt like heck. I went through extreme hot and cold flashes that lasted a few minutes each back and forth for hours. I honestly felt like I was dying. It was much worse than COVID was for me. It's the next morning now. I slept about 2 hrs last night. I'm still in pain and feel nauseous all over. I might go to an urgent care later today.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary pain, Sleep disorder, Vomiting
Clinical narrative: I puked the entire night. I only drank water and puked it all up until I was just vomiting bile. I was crying almost constantly because my whole body is in pain. When I went to the toilet my legs hurt too much to sit down. My fingers especially hurt like heck. I went through extreme hot and cold flashes that lasted a few minutes each back and forth for hours. I honestly felt like I was dying. It was much worse than COVID was for me. It's the next morning now. I slept about 2 hrs last night. I'm still in pain and feel nauseous all over. I might go to an urgent care later today.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Rash
Clinical narrative: Mother verbalizes that the following day after administering the Gardasil vaccine, patient started with itching and rash on legs and torso. The mother reports that symptoms lasted approximately 2 weeks. Mother stated that she did not take the PT to the pediatrist.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site nodule
Clinical narrative: Painful nodule at injection site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: Headache, chills, body aches, sore throat
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Headache the day of, took an ibuprofen. Next morning woke up to pain at injection site. At 9am, vomited after eating breakfast and developed headache.  Took nothing, laid in bed and drank water. Headache, nausea and pain in right arm persisted until 1 pm that day.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nurse assessed pt vaccine records. Pt was not due for a varicella for another month. Nurse read the due date of the next dose of varicella vaccine in date, month, year form instead of month, date, year from and administered the dose too early.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache, dizziness, lightheaded
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt's mom stated they were new patients.  They did not provide a vaccination card.   Pro Quad, and Hepatitis A was inadvertently administered based on spacing.  During inputting of client, it was discovered that the patient was an existing patient.   The administration of Pro quad and Hepatitis A was too soon.
Age: 1.25
Sex: M
Vaccine: HEP, HPV9, MMRV
Symptoms: Wrong product administered
Clinical narrative: HPV given by mistake. Currently patient is fine without problems per mom.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Irritability, Pruritus, Urticaria
Clinical narrative: He got his vaccines, he was originally OK.  He did not spike any fever, was eating fine and his activity was normal.  On Sunday afternoon he started scratching his head so mom greased his head.  She then noticed that he had hives all over his body and she put some hydrocortisone cream and she monitored him.  As the started going by they were different spots, and then started getting smaller pin sized bumps, hives and redness.  They are from his face to his feet.  His mother gave him a bath and after the bath he had new spots that were red, diaper area, front back and all over his body.  Today is the 5th day and nothing seems to help after using Benadryl, hydrocortisone.  He is irritable, but mom does not believe he is in any pain.   She took him to the doctor as she was concerned how long it has lasted and the reaction.  His doctor felt it was a reaction to the vaccine and fits the timeframe or when it can happen.  He told her what to do to treat his condition buying it over the counter.   She was told that the reaction can last up to 7 days and it usually goes away and to monitor him for any other signs like shortness of breath.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Sore throat, nasal drainage, sore throat, chilled
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Ear pain, Erythema, Headache, Herpes zoster
Clinical narrative: Ear pain next night after injection and  day after that. Redness developed on lt head and neck  2 days later. Rash 3rd day  on neck and head lt side with nerve pain in jaw, ear, and temple area on lt side. Blisters developed.  Still have pain on head and ongoing painful nerve pain in ear, jaw and head even now which is 2 weeks from shot today. Urgent care visit jan 7 and Dr visit jan 9 . Both said I have shingles. Valtrex prescribed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in jaw, Rash
Clinical narrative: Ear pain next night after injection and  day after that. Redness developed on lt head and neck  2 days later. Rash 3rd day  on neck and head lt side with nerve pain in jaw, ear, and temple area on lt side. Blisters developed.  Still have pain on head and ongoing painful nerve pain in ear, jaw and head even now which is 2 weeks from shot today. Urgent care visit jan 7 and Dr visit jan 9 . Both said I have shingles. Valtrex prescribed.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: At noon on the sixteenth, the area of injection got warm and very itchy. Around 1630PM he noticed more warmth and itchiness and later on that night it began to swell in an area of approximation of about 6 inches across. Patient has been putting cortisone cream on the area which has helped to reduce the swelling. Some of the symptoms have subsided but still reports occasional itching and warmth at the injection site.  Patient has yet to seek medical treatment but was recommended to follow up with his PCM.
Age: 8.0
Sex: F
Vaccine: FLU4, HEPA, IPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Pt's mother stated, the pt was a new patient.  Stated they did not have a vaccination card.  Inadvertently administered, inactived polio, Pro quad and Hepatitis A, due to timing and spacing.  During client inputting, it was discovered, the patient was an existing patient.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood uric acid normal, C-reactive protein normal, Condition aggravated, Gout, Gouty arthritis
Clinical narrative: Severe migrating gouty arthritis in both feet and ankles. Prior episodes were in one joint only. The last episode was 5 years ago
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gouty arthritis
Clinical narrative: Severe migrating gouty arthritis in both feet and ankles. Prior episodes were in one joint only. The last episode was 5 years ago
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: ActHib vaccine administered intramuscularly in right thigh at 0945, then Varicella vaccine administered Sub-Q in the left arm at 0947, and then the MMR was administered Sub-Q in the right arm at 0950, when CHN moved to the right after the MMR was given, there was a noticeably red raised are on the left superior shoulder, redness surrounding the site of injection of the Varicella vaccine. Then it was noticed raised red areas on the right arm at MMR injection site, and above the site. Then a red area was developing on the left cheek after 4 minutes, then  there was red raised areas on right thigh around ACTHib injection site. EMS Emergency Center was called and notified at 0954. A red area was then starting on the left ear. Child had no stridor, no vomiting