chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: rash that started at face, went to ears and then entire body/Rash is every day after waking Erythemic in looks; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (rash that started at face, went to ears and then entire body/Rash is every day after waking Erythemic in looks) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 80777-0110-96) for COVID-19 prophylaxis.     Allergic rhinitis to molds, dusts, pollens, hazelnuts, almonds. Mild intermittent asthma.  Concurrent medical conditions included Allergic rhinitis, Asthma (Mild intermittent), Allergy to molds, Pollen allergy, Dust allergy and Allergy to nuts (hazelnuts, almonds).    On 04-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 08-Dec-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced RASH ERYTHEMATOUS (rash that started at face, went to ears and then entire body/Rash is every day after waking Erythemic in looks). The patient was treated with Levocetirizine dihydrochloride (Levocetirizine) for Erythematous rash, at a dose of 5 milligram once a day; Famotidine for Erythematous rash, at a dose of 20 milligram twice a day and Fexofenadine, Pseudoephedrine hydrochloride (Allegra d) for Erythematous rash, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (rash that started at face, went to ears and then entire body/Rash is every day after waking Erythemic in looks) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had rash at approximately 6 inches away from injection site at R deltoid, lasted about 4 days, still had on 26-Dec-2024. Rash was every day after waking, lasting approximately one hour.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash in spot where shot was given; Rash in spot where shot was given, itchiness; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for immunisation. The patient's relevant medical history included: "latex allergy" (unspecified if ongoing); "lanolin allergy" (unspecified if ongoing); "nickel allergy" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE; LEXAPRO; BUSPAR; PROPRANOLOL.The patient did not receive any other vaccines on the same date as Absrysvo. The patient did not receive any other vaccines within 4 weeks prior to Abrysvo. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 10Dec2024, outcome "not recovered", described as "Rash in spot where shot was given"; VACCINATION SITE PRURITUS (non-serious) with onset 10Dec2024, outcome "not recovered", described as "Rash in spot where shot was given, itchiness". Therapeutic measures were not taken as a result of vaccination site rash, vaccination site pruritus.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: had her period every week because of it; This is a spontaneous report received from a Consumer or other non HCP.  A female 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 and concomitant medications were not reported. The following information was reported: POLYMENORRHOEA (non-serious), outcome "unknown", described as "had her period every week because of it".  Additional information: Reporter's partner had her period every week because of vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400330063 same reporter/drug, different patient/AE;
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: arm sore; arm swollen; Arm red and itchy; Arm red and itchy; This is a spontaneous report and received from Consumer or other non HCPs.  An 82-year-old female patient (not pregnant) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 17Dec2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years for immunisation. The patient's relevant medical history included: "2x cancer survivor" (unspecified if ongoing); "BP" (unspecified if ongoing), notes: taking medications for BP.; "thyroid" (unspecified if ongoing), notes: taking medications for thyroid.; "Drug allergy" (unspecified if ongoing), notes: Name of Drug (not sure). The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 18Dec2024, outcome "recovering" and all described as "Arm red and itchy"; PAIN IN EXTREMITY (non-serious) with onset 18Dec2024, outcome "recovering", described as "arm sore"; PERIPHERAL SWELLING (non-serious) with onset 18Dec2024, outcome "recovering", described as "arm swollen". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, erythema, pruritus.  Additional information: The patient did not received any other vaccines on the same date as the vaccine(s). It was unknown if patient received any other vaccines within 4 weeks PRIOR to the vaccine(s) or if the patient was taking any other medications within 2 weeks of the event starting. Patient reached out to her daughter on 19Dec2024 about a reaction she had to the prevnar vaccine - arm sore, swollen, red and itchy. Patient was also may be taking other medications but reporter was not aware of the details.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a Consumer or other non HCP.  An adult 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 and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". It was unknown if therapeutic measures were taken as a result of myocarditis. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Illness, Nausea, Pain in extremity
Clinical narrative: sick; sore arms; headache; dizziness; nausea; throwing up; This is a spontaneous report received from an Other HCP, Program ID.  A 60-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 59 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms"; HEADACHE (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "throwing up".  Additional Information: Patient reported that when they got their last covid vaccine she got very sick after getting the injection. symptoms included sore arms, headache, dizziness, nausea, and throwing up. no further information provided. lot number and expiration date are unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: sick; sore arms; headache; dizziness; nausea; throwing up; This is a spontaneous report received from an Other HCP, Program ID.  A 60-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 59 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms"; HEADACHE (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "throwing up".  Additional Information: Patient reported that when they got their last covid vaccine she got very sick after getting the injection. symptoms included sore arms, headache, dizziness, nausea, and throwing up. no further information provided. lot number and expiration date are unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Oropharyngeal pain, Throat irritation
Clinical narrative: she started having issues with her throat. it has been a lot dryer, scratchy, and sore; she started having issues with her throat. it has been a lot dryer, scratchy, and sore; she started having issues with her throat. it has been a lot dryer, scratchy, and sore; This is a spontaneous report received from an Other HCP, Program ID.  A 55-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, (toppac), 30 ug single (Batch/Lot number: unknown) at the age of 55 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRY THROAT (non-serious), THROAT IRRITATION (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 2023, outcome "not recovered" and all described as "she started having issues with her throat. it has been a lot dryer, scratchy, and sore". Therapeutic measures were taken as a result of dry throat, throat irritation, oropharyngeal pain.  Additional information: patient reported that after getting covid she started having issues with her throat. it has been a lot dryer, scratchy, and sore. patient has tried using lozenges but has not felt any relief from her symptoms. no further information was provided. lot number and expiration date are unknown.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Headache, Mobility decreased, Myalgia
Clinical narrative: could not raise her leg -could not raise arm; contact with neck on pillow hurt, lay in the bed, her shoulders, arms, down legs both sides of her body, tothe top of her head she experienced pain described as severe and constant; got weak; all the muscles were unbelievably painful that her; Initial information received on 18-Dec-2024 regarding an unsolicited valid  non-serious case received from a consumer/Non-Healthcare Professional.  This case involves a 84 years old female patient who experienced could not raise her leg -could not raise arm, contact with neck on pillow hurt, lay in the bed, her shoulders, arms, down legs both sides of her body, tothe top of her head she experienced pain described as severe and constant, got weak and all the muscles were unbelievably painful that her after receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history included Herpes zoster. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Giant cell arteritis and Ear neoplasm malignant.  Concomitant medications included Varicella zoster vaccine rgE (CHO) (Shingrix) for Immunisation; Prednisone; and Hydrocodone bitartrate (Hydrocodone).  On 02-Oct-2024, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED, Suspension for injection (dose, strength, route, expiry, route and lot number not reported) in unknown administration site for prevention (prophylaxis).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On 04-OCT-2024 the patient developed a non-serious could not raise her leg -could not raise arm (hypokinesia), contact with neck on pillow hurt, lay in the bed, her shoulders, arms, down legs both sides of her body, tothe top of her head she experienced pain described as severe and constant (pain), got weak (asthenia) and all the muscles were unbelievably painful that her (myalgia) (latency 2 days).   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all events  At time of reporting, the outcome was Unknown for all events
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: could not raise her leg -could not raise arm; contact with neck on pillow hurt, lay in the bed, her shoulders, arms, down legs both sides of her body, tothe top of her head she experienced pain described as severe and constant; got weak; all the muscles were unbelievably painful that her; Initial information received on 18-Dec-2024 regarding an unsolicited valid  non-serious case received from a consumer/Non-Healthcare Professional.  This case involves a 84 years old female patient who experienced could not raise her leg -could not raise arm, contact with neck on pillow hurt, lay in the bed, her shoulders, arms, down legs both sides of her body, tothe top of her head she experienced pain described as severe and constant, got weak and all the muscles were unbelievably painful that her after receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history included Herpes zoster. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Giant cell arteritis and Ear neoplasm malignant.  Concomitant medications included Varicella zoster vaccine rgE (CHO) (Shingrix) for Immunisation; Prednisone; and Hydrocodone bitartrate (Hydrocodone).  On 02-Oct-2024, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED, Suspension for injection (dose, strength, route, expiry, route and lot number not reported) in unknown administration site for prevention (prophylaxis).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On 04-OCT-2024 the patient developed a non-serious could not raise her leg -could not raise arm (hypokinesia), contact with neck on pillow hurt, lay in the bed, her shoulders, arms, down legs both sides of her body, tothe top of her head she experienced pain described as severe and constant (pain), got weak (asthenia) and all the muscles were unbelievably painful that her (myalgia) (latency 2 days).   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all events  At time of reporting, the outcome was Unknown for all events
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Had the shot a week ago, and I'm still sick; Initial information received on 18-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a patient.   This case involves Adult female patient who experienced had the shot a week ago, and i'm still sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength lot number, expiry and route: unknown) in unknown administration site for prophylactic vaccination.  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient developed a non-serious had the shot a week ago, and i'm still sick (illness) (unknown latency).   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Had the shot a week ago, and I'm still sick).  At time of reporting, the outcome was Unknown for the event had the shot a week ago, and i'm still sick.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Nervous system disorder
Clinical narrative: Neurological side effects; Initial information received on 18-Dec-2024 regarding an unsolicited valid non-serious case received from Non Health Care Professional via Health Authorities.  This case involves a 14 years old male patient who had Severe Neurological side effects after receiving IPV (VERO) [IMOVAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Nov-2024, the patient received a dose of suspect IPV (VERO) Suspension for injection (unknown strength, dosage, expiry date, batch number and route) via unknown administration site for prophylactic vaccination.  On an unknown date in Nov-2024, the patient developed neurological side effects (nervous system disorder) (unknown latency) following the administration of IPV (VERO).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Syncope
Clinical narrative: anaphylactic allergic reaction; patient experienced was fainting, after receiving the unknown influenza vaccine; Initial information received on 19-Dec-2024 regarding an unsolicited valid  serious case received from a physician.  This case involves an unknown age female patient who experienced anaphylactic allergic reaction after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported).  Information on the batch number was requested corresponding to the one at time of event occurrence.  On an unknown date the patient developed anaphylactic allergic reaction (anaphylactic reaction) and was fainting (syncope) (unknown latency) following the administration of influenza vaccine.   Reportedly, the patient had been receiving the Fluzone Quadrivalent single-dose vaccine (with no preservatives/thimerosal), and she had tolerated that influenza vaccine very well. MD (Doctor of Medicine) stated that she does not know what particular ingredient in the unknown influenza vaccine the patient reacted to, but it is possible it could have been thimerosal. The purpose for the MD's call was to compare the excipient ingredients of last year's Fluzone Quadrivalent single-dose no-preservative vaccine with this year's Fluzone Trivalent single-dose vial no-preservative vaccine, to be sure that nothing has changed, because the patient tolerated last year's Fluzone Quadrivalent vaccine very well.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for the event anaphylactic allergic reaction.  Seriousness criteria: Both the events were assessed as medically significant.; Sender's Comments: Sanofi company comment dated 28-Dec-2024: This case involves an unknown age female patient who experienced anaphylactic allergic reaction after receiving influenza vaccine. Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Age: 1.25
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inappropriate use due to administration of adacel instead of daptacel with no reported adverse event; Initial information received on 20-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient with inappropriate use due to administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Dec-2024, inappropriate use due to administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection dose 0.5 ml 1x(once) (Strength: Standard) lot U8252AA expiry-31-May-2026 via intramuscular route in the left thigh for Immunization instead of daptacel 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: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only received the DTaP-IPV part and not the whole component (with no reported adverse event); Initial information received on 23-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(Prp/T) Vaccine [Pentacel (Vero)] and only the DTAP-IPV part and not the whole component (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included Hepatitis B Vaccine; Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix); Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) and Rotavirus Vaccine all for Product used for unknown indication.  On 15-Nov-2024, the patient received 0.5 ml (once) (Standard) dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(Prp/T) Vaccine (lot UK041AA) (unknown expiry date) via intramuscular route in the right thigh and only received the DTAP-IPV part and not the whole component (with no reported adverse event) (single component of a two-component product administered) (latency unknown).  Reportedly, HCP (Health care professional) said that in Nov-2024, they had 2 patients that were given PENTACEL. They discovered in Dec-2024 that one of them only received the DTaP-IPV part and not the whole component. They don't know which child only received the liquid component so they are asking if they need to revaccinate the 2 children. Infant was currently 7 months old but was 6 months old when he received PENTACEL    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate use due to the administration of the product to a patient who is not in the correct age range for the vaccine with no reported adverse event; Initial information received on 26-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old and unknown gender patient who had inappropriate use due to the administration of the Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] to a patient who is not in the correct age range for the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine conj (tet tox) (Acthib) for Immunisation; HPV vaccine VLP rL1 4v (yeast) (Gardasil) for Immunisation; Hepatitis a vaccine inact (Havrix) for Immunisation; Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation; Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for Immunisation; Varicella zoster vaccine (Varicella vaccine) for Immunisation; and Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) for Immunisation.  On 24-Dec-2024, the patient received a  dose of 0.5 ml of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) (expiry date, strength, lot number not reported) via intramuscular route in the left arm for Immunization and inappropriate use due to the administration of the product to a patient who is not in the correct age range for the vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Oedema, Pruritus, Skin discolouration, Urticaria
Clinical narrative: started getting spots on her feet and ankles; severe reactions of edema, hives, blisters, and incredible itching; severe reactions of edema, hives, blisters, and incredible itching; severe reactions of edema, hives, blisters, and incredible itching; severe reactions of edema, hives, blisters, and incredible itching; Initial information received on 26-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse (patient).  This case involves a 72 years old female patient who started getting spots on her feet and ankles, severe reactions of edema, hives, blisters, and incredible itching, after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Sep-2024, the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe dose 0.5 ml 1x(once) via intramuscular route in the right arm for Influenza (Influenza immunisation) (strength-high dose) (batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient started getting spots on her feet and ankles (rash macular), severe reactions of edema, hives, blisters, and incredible itching (oedema) (urticaria) (blister) (pruritus) (unknown latency).  Action taken: not applicable.  The patient was treated with Prednisone And Hydrocortisone for the events.  At time of reporting, the outcome was Unknown for all the events
Sex: U
Vaccine: RVX
Symptoms: Malaise
Clinical narrative: sick for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick for 3 days). The outcome of the sickness was resolved (duration 3 days).   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 05-DEC-2024 This case was reported by a patient via interactive digital media. The patient had received the RSV shot and sick for three days.
Age: 54.0
Sex: F
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Donor presented rash and bumps to right arm at armpit and inner arm area. Symptoms started 12/29/2024
Age: 72.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Cerebral artery embolism, Embolic stroke
Clinical narrative: Patient we gave him a flu shot on the 26th and then P20 and Comirnaty on the 27th at 0943 ? he was noted to have had a stroke approximately 1345 on the 27th.  The stroke is being considered embolic involoving cerebral artery with unknown cause (He does have cardiac issues and was not on anticoagulation)
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Facet joint block, Fatigue, Imaging procedure, Pain, Weight decreased
Clinical narrative: PATIENT REPORTS SHARP STABBING PAIN IN THE LOWER RIGHT SIDE FROM THE WAIST UP.  PAIN STARTED 7 TO 10 DAYS AFTER VACCINE AND HAS GOTTEN PROGRESSIVELY WORSE.  LOSS OF WEIGHT (5 LBS) AND FATIGUE. TREATMENT: SAID HE HAS BEEN PRESCRIBED FLEXERIL 10MG, WHICH WAS REDUCED TO 5MG, NAPROXEN 220MG (OTC) AND HAS LIDOCAINE 4% (SALONPAS) THAT HE HAS NOT USED YET. ALSO SAID HE HAS RECEIVED FACET INJECTIONS. HE SAID TREATMENTS SO FAR HAS NOT BEEN EFFECTIVE.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two Arexvy vaccinations on 10/25/23 and 12/27/24 when only one dose is currently recommended. Patient has not experienced any side effects at this time.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two Arexvy vaccinations on 12/16/23 and 12/29/24 when only one is recommended. Patient has not experienced any side effects at this time.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella-like rash erupted on face, trunk and extremities about 3 weeks after initial Varivax vaccine was administered, rash erupted in the context of a likely viral gastroenteritis.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Neuralgia, Pyrexia
Clinical narrative: PT REPORTS HEADACHE, FEVER OVER 102 , HOWEVER BROKE 12/29/24, A DAY AFTER RECEIVING THE VACCINE. PT ALSO REPORTS NEW EXCRUCIATING NERVE PAIN UNDER FEET
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patients reports developing a rash that covered the left side of upper body starting 3-5 days after receiving COVID vaccine. Patient reports still has slight rash , but it is improving (as of 12/30/24). The only treatment they have tried is occasional topical hydrocortisone 1% cream. No other s/sx of allergic reaction.  Patient has received Pfizer COVID vaccines in the past with no issues.
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered
Clinical narrative: warm at the injection site; redness at the injection site; headaches; received an extra dose of Arexvy this year; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received first dose last year).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site warmth (Verbatim: warm at the injection site), injection site erythema (Verbatim: redness at the injection site), headache (Verbatim: headaches) and extra dose administered (Verbatim: received an extra dose of Arexvy this year). The outcome of the injection site warmth, injection site erythema, headache and extra dose administered were unknown.   It was unknown if the reporter considered the injection site warmth, injection site erythema and headache to be related to Arexvy.     It was unknown if the company considered the injection site warmth, injection site erythema and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-DEC-2024 The patient self reported this report and had headaches, redness at the injection site, and warm at the injection site after receiving Arexvy. She received an extra dose of Arexvy this year, which led to extra dose administered.
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Headache, Injection site erythema, Injection site warmth
Clinical narrative: warm at the injection site; redness at the injection site; headaches; received an extra dose of Arexvy this year; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received first dose last year).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site warmth (Verbatim: warm at the injection site), injection site erythema (Verbatim: redness at the injection site), headache (Verbatim: headaches) and extra dose administered (Verbatim: received an extra dose of Arexvy this year). The outcome of the injection site warmth, injection site erythema, headache and extra dose administered were unknown.   It was unknown if the reporter considered the injection site warmth, injection site erythema and headache to be related to Arexvy.     It was unknown if the company considered the injection site warmth, injection site erythema and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-DEC-2024 The patient self reported this report and had headaches, redness at the injection site, and warm at the injection site after receiving Arexvy. She received an extra dose of Arexvy this year, which led to extra dose administered.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Thrombosis
Clinical narrative: Death, uncertain if this is related to vaccination or not
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death, uncertain if this is related to vaccination or not
Age: 1.0
Sex: F
Vaccine: MMR, PNC20, VARCEL
Symptoms: Injection site reaction, Irritability, Rash erythematous, Rash pustular, Vomiting
Clinical narrative: 3 days after the vaccines, Patient had been acting fine and healthy, other than some occasional fussiness. After her afternoon nap, I noticed red dots forming on her legs while changing her diaper. There was no fever, but I called our doctor's office to let them know what was going on and get advise. I spoke to triage who told me protocol with a rash after the vaccines she received were to report to the ER. During our time waiting in the emergency room, the rash continued to progress with blister-like pustules beginning to form. We left the ER with instructions to continue monitoring and apply calamine lotion as needed. The rash stayed the same for a couple days and patient continued to be fussy, but tolerable. On December 24th, she had one episode of vomiting. Today is December 30th, and the rash is improving without further symptoms.
Age: 0.75
Sex: M
Vaccine: PNC15
Symptoms: Lethargy, Pyrexia, Somnolence, Vomiting
Clinical narrative: uncontrollable vomiting of 12 episodes lasting over 4 hours,  lethargic, fever, somnolence
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: an extra dose of FLUZONE NP was given to a patient with no reported adverse event; Initial information received on 23-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who received an extra dose of Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] 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 Meningococcal Vaccine for Immunisation.  On 03-Oct-2024 and 23-Dec-2024, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8485NA, Expiry: 30-Jun-2025, Strength: standard) via intramuscular route in the right arm as Influenza Immunization which was an extra dose with no reported adverse event (extra dose 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: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered only the DTAP-IPV part of PENTACEL to a patient, with no reported adverse event; Initial information received on 27-Dec-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 69 days old male patient who received only the dtap-ipv part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Dec-2024, the patient received 0.5 ml of dtap-ipv part of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection with no reported adverse event (single component of a two-component product administered) (latency same day) (lot UK194AA expiry 03-Jan-22026) (strength: unknown) via intramuscular route in the right thigh for prophylactic vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Product storage error
Clinical narrative: does not know which vaccines were administered after the temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 3-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date MAY-2025) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number BM4R5, expiry date APR-2026) for prophylaxis and HBV (Engerix B) (batch number 95D74, expiry date MAR-2025) for prophylaxis.   On 20-AUG-2024, the patient received the 4th dose of Infanrix (intramuscular, right thigh), the 1st dose of Havrix (intramuscular, right thigh) and the 3rd dose of Engerix B (intramuscular, left thigh). On an unknown date, an unknown time after receiving Infanrix, Havrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: does not know which vaccines were administered after the temperature excursion). The outcome of the incorrect storage of drug was 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: 02-DEC-2024 The patient received Infanrix, Havrix and Engerix B vaccines. The other health professional reported that she does not know which vaccines were administered after the temperature excursion to which patients which led to incorrect storage of drug. This was 1 of 15 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR153916:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153924:Original Case : US2024AMR153742 US-GSK-US2024AMR153925:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: the arm was a little sore and then it got a little more sore; she started shaking uncontrollably; she started feeling like achy from the head to the toe; she was achy from head to toe and a little feverish; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (the arm was a little sore and then it got a little more sore), TREMOR (she started shaking uncontrollably), PAIN (she started feeling like achy from the head to the toe) and PYREXIA (she was achy from head to toe and a little feverish) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine on 14-Jan-2021, Moderna Covid-19 vaccine on 11-Feb-2021 and Moderna Covid-19 vaccine on 05-Nov-2021. Past adverse reactions to the above products included No adverse effect with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    On 15-Dec-2024 at 11:30 AM, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 16-Dec-2024, the patient experienced PAIN IN EXTREMITY (the arm was a little sore and then it got a little more sore), TREMOR (she started shaking uncontrollably), PAIN (she started feeling like achy from the head to the toe) and PYREXIA (she was achy from head to toe and a little feverish). On 17-Dec-2024, PAIN IN EXTREMITY (the arm was a little sore and then it got a little more sore), TREMOR (she started shaking uncontrollably), PAIN (she started feeling like achy from the head to the toe) and PYREXIA (she was achy from head to toe and a little feverish) had resolved with sequelae.            No other issues and no other vaccines given in the last 4 weeks but mentioned later at the call that she did have an underlying issue. No concomitant medications were provided. She had uncontrollable shaking, which led her to believe she was having a seizure. Although the shaking ceased for a brief period of five seconds, it resumed, affecting her hands, arms, and upper torso for a duration of six hours. She expressed a fear of sleeping, concerned that she might not wake up. To cope, she remained on the couch, attempting to relax. However, when her husband stood up, she informed him of her persistent and uncontrollable shaking, describing the experience as frightening. She had never encountered such symptoms after her first three vaccinations. It had been approximately three years since her last COVID shot, and she decided to receive it this year due to underlying health issues. She mentioned that her doctor recommended the COVID vaccine but was uncertain about the necessity of annual vaccinations, as she had only received three doses. No treatment medication was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Biopsy, Blister, Depression
Clinical narrative: Rash over complete body, sudden onset of asthma, hives, itching red swollen blisters & extreme burning of skin. Now extreme eczema, tiredness, pain extreme itching. Bones crack easily. Hives Red rash over whole body seeping, oozing skin rash, hard to breath. Insomnia due to itching, pain- Tooth pain  3days after Covid 19 Booster, I developed a Rash all over my Body. Was burning, itching and hurting. I started having to breathe deeply to get enough oxygen. Went to numerous doctors was placed on permenant disability due eto onset of extreme asthma, was biopsied 2 times. Extreme eczema oozing red rash over entire body. Unable to work - Now bones easy to fracture - fatigued 24/7. Insomnia due to pain and itching constantly. Skin feels like raised leather.   I soms like no one wants to help me. Constant pain, quality of life is horrible. Have to stay out of sun and in a cool place or pain is unberable. Weakness, tired all the time - No relief from itching, pain, depressed due to pain.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Eczema, Erythema, Fatigue, Impaired work ability
Clinical narrative: Rash over complete body, sudden onset of asthma, hives, itching red swollen blisters & extreme burning of skin. Now extreme eczema, tiredness, pain extreme itching. Bones crack easily. Hives Red rash over whole body seeping, oozing skin rash, hard to breath. Insomnia due to itching, pain- Tooth pain  3days after Covid 19 Booster, I developed a Rash all over my Body. Was burning, itching and hurting. I started having to breathe deeply to get enough oxygen. Went to numerous doctors was placed on permenant disability due eto onset of extreme asthma, was biopsied 2 times. Extreme eczema oozing red rash over entire body. Unable to work - Now bones easy to fracture - fatigued 24/7. Insomnia due to pain and itching constantly. Skin feels like raised leather.   I soms like no one wants to help me. Constant pain, quality of life is horrible. Have to stay out of sun and in a cool place or pain is unberable. Weakness, tired all the time - No relief from itching, pain, depressed due to pain.