chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Reported symptoms: 10003239:ARTHRALGIA; 10016256:FATIGUE; 10022086:INJECTION SITE PAIN; 10047862:WEAKNESS;      Narrative:  Other Relevant HX: INTERVENTIONS REQUIRED FOR ADE; Use of Antypyretic (Specify):APAP 650mg PO q6h prn (has not taken any medication - recommended APAP)    IMPACT ON FUNCTION: reports that he received covid vaccine 2 days ago and developed joint pain, weakness, fatigue. "took me 3x longer to make my breakfast this morning and i  couldnt participate fully in PT". reports difficulty raising arm that was vaccinated.     reports that he is still able to eat/drink fluids normally - encouraged increase hydration  recommended to follow up w/ PCP if symptoms get worse or do not improve  Patient reported that he had never had a reaction to the covid vaccine prior  other: WEAKNESS; FATIGUE; INJECTION SITE PAIN
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities
Clinical narrative: Reported symptoms: 10003239:ARTHRALGIA; 10016256:FATIGUE; 10022086:INJECTION SITE PAIN; 10047862:WEAKNESS;      Narrative:  Other Relevant HX: INTERVENTIONS REQUIRED FOR ADE; Use of Antypyretic (Specify):APAP 650mg PO q6h prn (has not taken any medication - recommended APAP)    IMPACT ON FUNCTION: reports that he received covid vaccine 2 days ago and developed joint pain, weakness, fatigue. "took me 3x longer to make my breakfast this morning and i  couldnt participate fully in PT". reports difficulty raising arm that was vaccinated.     reports that he is still able to eat/drink fluids normally - encouraged increase hydration  recommended to follow up w/ PCP if symptoms get worse or do not improve  Patient reported that he had never had a reaction to the covid vaccine prior  other: WEAKNESS; FATIGUE; INJECTION SITE PAIN
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, body aches, chills
Age: 57.0
Sex: F
Vaccine: FLUA4, FLUC3
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Pt has a 2 inch red raised lump at the site of injection; Pt has a 2 inch red raised lump at the site of injection; This spontaneous case was retrieved on 15-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2699716-1), reported by other healthcare professional and concerned a 57-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  It was reported that on 21-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was 374869. The reported batch number was identified by Seqirus to be linked to the suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of the reported suspect product Fluad Quadrivalent.  Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, after receiving Flucelvax Quadrivalent, the patient experienced two inch red raised lump at the site of injection.  The outcome for the events 'Vaccination site erythema' and 'Vaccination site mass' was unknown.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 57-year-old patient was vaccinated with Flucelvax Quadrivalent vaccine. On the same day following vaccination, the patient experienced vaccination site mass and vaccination site erythema. Causality is assessed as possible for both events, due to chronological and anatomical plausibility.; Sender's Comments: A 57-year-old patient was vaccinated with Flucelvax Quadrivalent vaccine. On the same day following vaccination, the patient experienced vaccination site mass and vaccination site erythema. Causality is assessed as possible for both events, due to chronological and anatomical plausibility.
Age: 57.0
Sex: F
Vaccine: FLUA4, FLUC3
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pt has a 2 inch red raised lump at the site of injection; Pt has a 2 inch red raised lump at the site of injection; This spontaneous case was retrieved on 15-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2699716-1), reported by other healthcare professional and concerned a 57-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  It was reported that on 21-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was 374869. The reported batch number was identified by Seqirus to be linked to the suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of the reported suspect product Fluad Quadrivalent.  Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, after receiving Flucelvax Quadrivalent, the patient experienced two inch red raised lump at the site of injection.  The outcome for the events 'Vaccination site erythema' and 'Vaccination site mass' was unknown.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 57-year-old patient was vaccinated with Flucelvax Quadrivalent vaccine. On the same day following vaccination, the patient experienced vaccination site mass and vaccination site erythema. Causality is assessed as possible for both events, due to chronological and anatomical plausibility.; Sender's Comments: A 57-year-old patient was vaccinated with Flucelvax Quadrivalent vaccine. On the same day following vaccination, the patient experienced vaccination site mass and vaccination site erythema. Causality is assessed as possible for both events, due to chronological and anatomical plausibility.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills
Clinical narrative: chills have been caller's response from the start, from the initial COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received bnt162b2 (BNT162B2 NOS), 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: CHILLS (non-serious), outcome "unknown", described as "chills have been caller's response from the start, from the initial COVID vaccine". Additional information: Patient confirmed that it was a Pfizer COVID vaccine.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills
Clinical narrative: chills have been caller's response from the start, from the initial COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received bnt162b2 (BNT162B2 NOS), 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: CHILLS (non-serious), outcome "unknown", described as "chills have been caller's response from the start, from the initial COVID vaccine". Additional information: Patient confirmed that it was a Pfizer COVID vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Ear infection, Fatigue
Clinical narrative: Ear infection; shingles; Dose 1 vaccination date 02Jul2021, Dose 2 vacciantion date 16Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Lot number: FC3182) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold sores" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: FA6780, Location of Injection: Arm Left), administration date: 02Jul2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Aug2021, outcome "unknown", described as "Dose 1 vaccination date 02Jul2021, Dose 2 vacciantion date 16Aug2021"; EAR INFECTION (non-serious) with onset 01Sep2021, outcome "not recovered"; HERPES ZOSTER (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shingles". The events "ear infection" and "shingles" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ear infection, herpes zoster.  Amendment: This follow up report is being submitted to amend previously reported information: To update Events and letter.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360474 Same product, patient, different AEs, different dose;
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes zoster, SARS-CoV-2 test
Clinical narrative: Ear infection; shingles; Dose 1 vaccination date 02Jul2021, Dose 2 vacciantion date 16Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Lot number: FC3182) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold sores" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: FA6780, Location of Injection: Arm Left), administration date: 02Jul2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Aug2021, outcome "unknown", described as "Dose 1 vaccination date 02Jul2021, Dose 2 vacciantion date 16Aug2021"; EAR INFECTION (non-serious) with onset 01Sep2021, outcome "not recovered"; HERPES ZOSTER (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shingles". The events "ear infection" and "shingles" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ear infection, herpes zoster.  Amendment: This follow up report is being submitted to amend previously reported information: To update Events and letter.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360474 Same product, patient, different AEs, different dose;
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear infection, Herpes zoster, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Ear infection; shingles; Dose 1 vaccination date 02Jul2021, Dose 2 vacciantion date 16Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Lot number: FC3182) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold sores" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: FA6780, Location of Injection: Arm Left), administration date: 02Jul2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Aug2021, outcome "unknown", described as "Dose 1 vaccination date 02Jul2021, Dose 2 vacciantion date 16Aug2021"; EAR INFECTION (non-serious) with onset 01Sep2021, outcome "not recovered"; HERPES ZOSTER (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shingles". The events "ear infection" and "shingles" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ear infection, herpes zoster.  Amendment: This follow up report is being submitted to amend previously reported information: To update Events and letter.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360474 Same product, patient, different AEs, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Ventricular extrasystoles
Clinical narrative: more and more palpitations; Fluctuating heart rate; heart issues (PVCs and pots disease); heart issues (PVCs and pots disease); My blood pressure is all over the place; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart issue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "more and more palpitations"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Fluctuating heart rate"; VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "heart issues (PVCs and pots disease)"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "My blood pressure is all over the place".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185235 same patient, same vaccine, similar events, different dose (4th);
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Heart rate irregular, Palpitations, Postural orthostatic tachycardia syndrome, Ventricular extrasystoles
Clinical narrative: more and more palpitations; Fluctuating heart rate; heart issues (PVCs and pots disease); heart issues (PVCs and pots disease); My blood pressure is all over the place; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart issue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "more and more palpitations"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Fluctuating heart rate"; VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "heart issues (PVCs and pots disease)"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "My blood pressure is all over the place".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185235 same patient, same vaccine, similar events, different dose (4th);
Sex: U
Vaccine: RSV, RSV
Symptoms: Dizziness, Dizziness postural, Fatigue, Headache, Vertigo
Clinical narrative: dizziness; vertigo; fatigue; have been feeling poorly/am still miserable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An 82-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 13Nov2023 at 12:15 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 14Nov2023, outcome "not recovered"; FATIGUE (non-serious) with onset 14Nov2023, outcome "not recovered"; FEELING ABNORMAL (non-serious) with onset 14Nov2023, outcome "not recovered", described as "have been feeling poorly/am still miserable"; VERTIGO (non-serious) with onset 14Nov2023, outcome "not recovered".  Additional Information: The patient started side effects on Tuesday upon arising and have been feeling poorly. Ever since with dizziness vertigo (visited ENT MD) and fatigue ever since today, Friday 17Nov2023 03:30PM and still miserable.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV, RSV
Symptoms: Dizziness, Fatigue, Feeling abnormal, Vertigo
Clinical narrative: dizziness; vertigo; fatigue; have been feeling poorly/am still miserable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An 82-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 13Nov2023 at 12:15 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 14Nov2023, outcome "not recovered"; FATIGUE (non-serious) with onset 14Nov2023, outcome "not recovered"; FEELING ABNORMAL (non-serious) with onset 14Nov2023, outcome "not recovered", described as "have been feeling poorly/am still miserable"; VERTIGO (non-serious) with onset 14Nov2023, outcome "not recovered".  Additional Information: The patient started side effects on Tuesday upon arising and have been feeling poorly. Ever since with dizziness vertigo (visited ENT MD) and fatigue ever since today, Friday 17Nov2023 03:30PM and still miserable.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: weakness; was in bed all day; feeling pretty sick; flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced weakness (Verbatim: weakness), bedridden (Verbatim: was in bed all day), feeling unwell (Verbatim: feeling pretty sick) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the weakness was unknown and the outcome of the bedridden, feeling unwell and influenza-like symptoms were not reported.   It was unknown if the reporter considered the weakness, bedridden, feeling unwell and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the weakness, bedridden, feeling unwell and influenza-like symptoms to be related to Shingrix.   Linked case(s) involving the same patient:  US2023155557   Additional Information: GSK Receipt date: 09-NOV-2023 The reporter was the patient who stated she received Shingrix 2 dose series and had reactions.  After the second shot the reporter had weakness and was in bed all day after the injection feeling pretty sick, also reported having flu like symptoms. The reporter confirmed she received Shingrix and not other vaccine for Shingles but she did not recall the dates. No other information provided. The reporter did not consent to follow up. For tolerance of 1st dose refer case US2023155557.; Sender's Comments:  US-GSK-US2023155557:SAME PATIENT,  1st dose of Shingrix
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Influenza like illness, Malaise
Clinical narrative: weakness; was in bed all day; feeling pretty sick; flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced weakness (Verbatim: weakness), bedridden (Verbatim: was in bed all day), feeling unwell (Verbatim: feeling pretty sick) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the weakness was unknown and the outcome of the bedridden, feeling unwell and influenza-like symptoms were not reported.   It was unknown if the reporter considered the weakness, bedridden, feeling unwell and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the weakness, bedridden, feeling unwell and influenza-like symptoms to be related to Shingrix.   Linked case(s) involving the same patient:  US2023155557   Additional Information: GSK Receipt date: 09-NOV-2023 The reporter was the patient who stated she received Shingrix 2 dose series and had reactions.  After the second shot the reporter had weakness and was in bed all day after the injection feeling pretty sick, also reported having flu like symptoms. The reporter confirmed she received Shingrix and not other vaccine for Shingles but she did not recall the dates. No other information provided. The reporter did not consent to follow up. For tolerance of 1st dose refer case US2023155557.; Sender's Comments:  US-GSK-US2023155557:SAME PATIENT,  1st dose of Shingrix
Age: 76.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Pain, Product administered at inappropriate site, Sleep disorder
Clinical narrative: He got his vaccine, it hurt immediately after he got it as she hit something in there, and he thinks it went up too high in his shoulder.  That night no matter which way he would move it it hurt.  He cannot raise his arm still to this day as it hurts.  The shoulder itself hurts, he starts to hurt as he raises his arm up to his face, and can get it up a little and taking his shirt and coat on and off is hard for him to do.  He has taken Tylenol for his symptoms, which is not helping too much.  He has not contacted his doctor.  He just has pain moving his arm and cannot move it.    The injection was given up to the top of the shoulder.
Age: 76.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: He got his vaccine, it hurt immediately after he got it as she hit something in there, and he thinks it went up too high in his shoulder.  That night no matter which way he would move it it hurt.  He cannot raise his arm still to this day as it hurts.  The shoulder itself hurts, he starts to hurt as he raises his arm up to his face, and can get it up a little and taking his shirt and coat on and off is hard for him to do.  He has taken Tylenol for his symptoms, which is not helping too much.  He has not contacted his doctor.  He just has pain moving his arm and cannot move it.    The injection was given up to the top of the shoulder.
Age: 76.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: He got his vaccine, it hurt immediately after he got it as she hit something in there, and he thinks it went up too high in his shoulder.  That night no matter which way he would move it it hurt.  He cannot raise his arm still to this day as it hurts.  The shoulder itself hurts, he starts to hurt as he raises his arm up to his face, and can get it up a little and taking his shirt and coat on and off is hard for him to do.  He has taken Tylenol for his symptoms, which is not helping too much.  He has not contacted his doctor.  He just has pain moving his arm and cannot move it.    The injection was given up to the top of the shoulder.
Age: 68.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Atrial fibrillation, Chest X-ray normal, Condition aggravated, Electrocardiogram abnormal, Laboratory test normal
Clinical narrative: pt had an episode of a fib on 11/19/23. Was treated with diltiazem on 11/19/23. Discontinued diltiazem on 11/22/23.
Age: 68.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Atrial fibrillation, Chest X-ray, Condition aggravated, Electrocardiogram
Clinical narrative: pt had an episode of a fib on 11/19/23. Was treated with diltiazem on 11/19/23. Discontinued diltiazem on 11/22/23.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt presents left arm with generalized redness at the site of the injection and is warm to the touch.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose Heplisav-B, 2nd Dose Engerix-B; Initial Report Received on 28-Jun-2023   A medical assistant reported that a 58-year-old female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose.    No medical history, allergies, or concomitant medications at the time of vaccination were reported.    On 17-May-2023, the patient received the first dose of HEPLISAV-B (Lot # 938794, expiration date 09-Aug-2023, and NDC # not reported) intramuscularly in the left deltoid.    On 14-Jun-2023, 29 days after having been vaccinated with HEPLISAV-B, the patient received Engerix-B as the second dose (Lot #, expiration date, and NDC # not reported). No concomitant medications were given. There were no adverse reactions witnessed with the patient.    No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Had 2 doses of Energix and then 1 dose of Heplisav-B; Initial Report Received on 28-Jun-2023   A nurse reported that a 79-year-old male (race and ethnicity not provided) received two doses of Engerix-B and then one dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.    No medical history or concomitant medications at the time of vaccination were reported. The patient had no known drug allergies.   On unknown dates, the patient received two doses of Engerix-B (no details provided).     On an unknown date, after having been vaccinated with two doses of Engerix-B, the patient received one dose of HEPLISAV-B (Lot #, expiration date,  route, and injection site not reported, NDC # 43528-002-01).     No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Received Heplisav-B While Pregnant; Initial Report Received on 14-Apr-2023   A retail pharmacist reported that a pregnant female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.    No medical history or concomitant medications were reported.    The last menstrual period date, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.     On an unknown date, the patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC?# 43528-002-01, route, and injection site not reported) while pregnant. Per the reporter, this was discovered while reviewing records. The patient did not have other adverse effects.     No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Received 2 Doses of Heplisav-B, Had Titers Drawn and Had A Negative Titer; Initial Report Received on 17-Jul-2023  Service Center reported that a female patient (age, race, and ethnicity unknown), received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and got a negative titer.  Medical history, allergies, and medications at the time of vaccination were not reported.   On an unspecified date, the patient received the first dose of HEPLISAV-B vaccine (Lot #; expiration date, NDC # not reported).  One month later, on an unknown date, the patient received the second dose of HEPLISAV-B vaccine (Lot #; expiration date, NDC # not reported).   On an unspecified date, after receiving 2 doses of the HEPLISAV-B vaccine, the patient got a negative titer. No additional information was reported.  Company Comment:  The company assessed the event as non-serious. The event was not immunologically confirmed as the time to serological marker testing and the serological marker results were not reported.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed as the time to serological marker testing and the serological marker results were not reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Received Heplisav-B That Was Stored at 14°C for 30 hours; Initial Report Received on 18-Jul-2023  A purchasing supervisor in the reported that a 49-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was stored at approximately 14°C for 30 hours.  Medical history and medications at the time of vaccination were not reported. The patient had no allergies.  On 19-Jun-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot #; expiration date, NDC # not reported).  On 17-Jul-2023, the patient received the second dose of HEPLISAV-B vaccine (Lot # 943241; expiration date 07-Sep-2025, NDC # 43528-003-05; route not reported) in the left deltoid. This second dose of HEPLISAV-B was stored at 14°C for 30 hours. No adverse reactions were reported.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received 2nd Dose 5 Months After Receiving First Dose; Initial Report Received on 25-Jul-2023    A personal assistant and registered x-ray technologist reported that a 54-year-old female (race and ethnicity not provided), received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization five months after receiving the first dose.     No medical history, allergies, or concomitant medications at the time of vaccination were reported.    On 01-Feb-2023, the patient received the first dose of HEPLISAV-B (Lot # 941591; expiration date, NDC?#, route, and injection site not reported).    One 23-Jun-2023, almost 5 months (143 days) after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 941060; expiration date, NDC?#, route, and injection site not reported).  Both doses were administered at a clinic. No adverse reactions were reported.    No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Received Heplisav-B as A Booster 1 Year Ago and 2nd Dose Heplisav-B Administered; Received Heplisav-B as A Booster 1 Year Ago and 2nd Dose Heplisav-B Administered; Initial report received on 14-Aug-2023  A consumer in the reported that he, a male (age, race, and ethnicity not provided), was vaccinated for hepatitis B as a child, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as a "booster dose" one year ago (2022), and had the second dose of HEPLISAV-B on 13 Aug 2023.  No relevant medical history, concomitant medications, or allergies at the time of vaccination were reported.  On an unspecified date, when the patient was a child, he was vaccinated for hepatitis B (no details provided).  One year ago (date not specified), the patient received the first dose of HEPLISAV-B (no details reported) as a "booster dose."  On 13-Aug-2023, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported).  No additional information was provided as the patient was in a hurry to go to work.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose Heplisav-B, and Received Second Dose Engerix; Initial report received on 17-Aug-2023  A pharmacist in the reported that a 22-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization for the first dose and ENGERIX as the second dose.  No relevant medical history or concomitant medications at the time of vaccination were reported. The patient had no known allergies.  On 28-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot # 941055, expiration date 29 Nov-2024, NDC # 43528-003-05; route and injection site not reported).   On 30-May-2023, 33 days after having been vaccinated with HEPLISAV-B, the patient received ENGERIX (no details provided) as the second dose. No adverse reactions were reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.   ?; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Received First Dose of Heplisav-B, and Second Dose of Engerix; Initial report received on 23-Aug-2023  A physician reported that a 25-year-old male patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Energix-B as the second dose.  Medical history at the time of vaccination was reported as unknown. The patient had an allergy to Motrin (ibuprofen), which gives him a rash. Concomitant medications was not reported.  On 26-Jun-2023, the patient received the first dose of HEPLISAV-B (Lot # 941580, expiration date 06 Jan 2025, NDC #43528-002-01; route and injection site not reported).   On 18-Aug-2023, 54 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received Energix-B (no details provided) as the second dose. The patient did not have any side effects.  No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Under 18 Years Old and Received Heplisav-B; Initial report received on 24-Aug-2023  A physician in the reported that a 17-year-old female patient (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history at the time of vaccination was reported as unknown. The patient had no known allergies.   Concomitant medications at the time of vaccination were not reported.   On unknown dates, the patient received an earlier 3-dose hepatitis B vaccine series (unknown brand and details) and was being re-vaccinated due to low titers (not specified).  On 14-Aug-2023, approximately one and a half months, she received a dose of HEPLISAV-B (Lot # 943006, expiration date 30-Sep-2025, and NDC # unknown) intramuscularly (injection site not reported). The patient did not report any side effects.   No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received an Expired Dose; Initial report received on 12-Sep-2023  A registered nurse reported that a female patient (age, race, and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and allergies at the time of vaccination were reported as unknown.   No concomitant medications at the time of vaccination were reported.  On 11-Sep-2023, the patient received an expired dose of HEPLISAV-B (Lot # 937229, expiration date 03 Sep-2023, NDC # unknown) intramuscularly (injection site not provided). The patient did not report any adverse effects.  No additional information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received the First Dose of Heplisav-B that had Expired One Day Prior to Administration; Initial Report Received on 03-Oct-2023  A registered nurse reported that a female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.  The patient has no known drug allergies.    No relevant concomitant medications were reported.    On 26-Sep-2023, the patient received the first dose of HEPLISAV-B (Lot #937782, expiration date 25-Sep-2023, NDC # not reported) intramuscularly in the left deltoid from a nurse.  The dose was one day expired.  No side effects have been reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave a Dose of Expired Heplisav-B; Initial Report Received on 12-Oct-2023  A pharmacist reported that a 23-year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  The patient has no allergies.  The patient had no previous reactions to other vaccines.  No relevant concomitant medications were reported.  On 11-Oct-2023, the patient received the first dose of HEPLISAV-B (Lot #937780, expiration date: 04-Sep-2023, NDC #43528-003-05) in the left deltoid.  The dose given was expired.  No adverse events were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired First Dose Administered; Initial Report Received on 16-Oct-2023  A pharmacist in the reported that a 39-year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  No relevant concomitant medications were reported.  On 16-Oct-2023, the patient received the first dose of HEPLISAV-B (Lot #938794, expiration date: 09-Oct-2023, NDC #43528-003-05), route not reported.  The dose given was expired.  No adverse events were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave A Patient a Dose of Heplisav-B Which Had Expired; Initial Report Received on 23-Oct-2023  A pharmacist reported that a patient (gender, race, and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  No relevant concomitant medications were reported.  On 23-Oct-2023, the patient received a dose of HEPLISAV-B (Lot #937780, expiration date: 14-Sep-2023, NDC #43578-003-05) in the left deltoid.  The dose given was expired.  No adverse events were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of Heplisav-B; Initial report received on 25-Oct-2023  A registered nurse reported that a 52-year-old female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had an allergy to lisinopril (cough).  On 18-Oct-2023, the patient received the first dose of HEPLISAV-B (Lot # 938794, expiration date 09 Oct 2023, and NDC # 43528-003-05; route not reported) in the right deltoid. The HEPLISAV-B dose was expired. No adverse reactions were reported.  No additional information was reported.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave our Patient a Dose of Heplisav-B Which Expired; Initial report received on 30-Oct-2023.  A pharmacist reported that a 59 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine had expired.  No relevant medical history was reported. No known drug allergies were reported.    No relevant concomitant medications were reported.    On 27-Oct-2023, the patient received a dose of HEPLISAV-B (Lot #937228, expiration date 30-Aug-2023, and NDC # 43578000301) intramuscularly in the right deltoid.   On 27-Oct-2023, the patient was vaccinated with HEPLISAV-B which expired on 30-Aug-2023. The patient did not report any side effects.  No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient Received an Expired Dose of Heplisav-B; Initial report received on 30-Oct-2023.  A nurse in the reported that a 63-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 30-Oct-2023, the patient received the second dose of HEPLISAV-B (Lot #937234, expiration date 12-Sep-2023, and NDC #43528-003-05) from a nurse (route and site not specified).  The dose was expired.  No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: F
Vaccine: RVX
Symptoms: Electrocardiogram abnormal, Heart rate increased, Hypertension, White blood cell count increased
Clinical narrative: elevated white cell count; my blood pressure was 160/92; My resting pulse was 136 / I had an EKG which was abnormal; This non-serious case was reported by a non-health professional via call center representative and described the occurrence of hypertension in a 61-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number 72S24, expiry date 31-OCT-2023) for prophylaxis.   Concurrent medical conditions included menopause, esophageal acid reflux and anxiety. Concomitant products included estradiol, pantoprazole sodium sesquihydrate (Pantoprazole Sodium) and duloxetine hydrochloride.   On 31-OCT-2023, the patient received RSV vaccine. On 01-NOV-2023, 1 days after receiving RSV vaccine, the patient experienced hypertension (Verbatim: my blood pressure was 160/92) and high pulse rate (Verbatim: My resting pulse was 136 / I had an EKG which was abnormal). On an unknown date, the patient experienced white blood cell count increased (Verbatim: elevated white cell count). The patient was treated with metoprolol tartrate. On 01-NOV-2023, the outcome of the high pulse rate was resolved. The outcome of the hypertension was not resolved and the outcome of the white blood cell count increased was not reported.   It was unknown if the reporter considered the hypertension, high pulse rate and white blood cell count increased to be related to RSV vaccine.     It was unknown if the company considered the hypertension, high pulse rate and white blood cell count increased to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 10-NOV-2023 The non- health professional (patient) had self- reported this case.  The patient reported that the resting pulse was 136.  The patient reported that the blood pressure was 160/92. She never had the high blood pressure.  Now she was treated with Metoprolol Tartrate 25 mg. She reported that in the emergency room, she had an electrocardiogram which was abnormal and the bloodwork had an elevated white cell count. The seriousness criteria for heart rate and hypertension was intervention required. Her doctor ordered an echocardiogram which she had 48 hours after the reaction. That was normal. On 6th December 2023, she have an appointment with a cardiologist. She reported that she never had a reaction to any medication. The reporter consented to follow-up.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: itching after her flu shot, it started at the injection site and spread to all over her body.; itching after her flu shot, it started at the injection site; Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves Elderly female patient who had itching after her flu shot, it started at the injection site and spread to all over her body while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Methylprednisolone and Dupilumab (Dupixent) for Nasal polyps.  On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (Unknown formulation, lot number, strength and expiry date) via unknown route in unknown administration site for prophylactic vaccination. Information regarding batch number has been requested.  On an unknown date the patient developed a non-serious itching after her flu shot, it started at the injection site and spread to all over her body. (pruritus) (vaccination site pruritus) (unknown latency) following the administration of Influenza Vaccine.  Action taken: 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 both the events.