chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: CHOL
Symptoms: Oral administration complication
Clinical narrative: Ate after 45 minutes of vaccination with Vaxchora; A spontaneous report was received from a male patient of unknown age on 10AUG2023 who "ate after 45 minutes of vaccination with Vaxchora" (PT: Product administration error). The patient took Vaxchora (cholera vaccine live oral; lot number: unknown) as cholera prophylaxis.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient was informed that he was not supposed to eat or drink for an hour after Vaxchora administration. However, the patient forgot and drank water and ate two cheese sticks after 45 minutes of Vaxchora administration.  The outcome of the reported event was not applicable. Action taken with Vaxchora with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer ate after 45 minutes of vaccination with Vaxchora (product administration error). Further information regarding event is limited. The causality of product administration error is not applicable with Vaxchora. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer ate after 45 minutes of vaccination with Vaxchora (product administration error). Further information regarding event is limited. The causality of product administration error is not applicable with Vaxchora. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: CHOL
Symptoms: Labelled drug-drug interaction medication error, Oral administration complication
Clinical narrative: Took final dose of amoxicillin 24 hours before her Vaxchora administration; A spontaneous report was received from a nurse manager on 18SEP2023 along with the additional information received on 19SEP2023 regarding a 64-year-old female patient who took "took final dose of amoxicillin 24 hours before her Vaxchora administration" (PT: Labelled drug-drug interaction medication error). The patient took Vaxchora (cholera vaccine live oral; lot number: unknown) for immunisation and amoxicillin (thrice a day for 5 days) for a dental procedure.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient was on amoxicillin (unknown dose) for a dental procedure prior to Vaxchora and took the final dose of amoxicillin 24 hours before her Vaxchora administration. Reportedly, the patient received Vaxchora on 06SEP2023.  The outcome of the reported event was not applicable. The action taken with Vaxchora and amoxicillin with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took final dose of amoxicillin 24 hours before her Vaxchora administration (labelled drug-drug interaction medication error). Further information regarding event is limited. The causality of labelled drug-drug interaction medication error is not applicable with Vaxchora. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took final dose of amoxicillin 24 hours before her Vaxchora administration (labelled drug-drug interaction medication error). Further information regarding event is limited. The causality of labelled drug-drug interaction medication error is not applicable with Vaxchora. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: RVX
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Guillain-Barré syndrome; This serious case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a specified number of patients 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 guillain barre syndrome (Verbatim: Guillain-Barré syndrome) (serious criteria death and GSK medically significant). The reported cause of death was guillain barre syndrome.   It was unknown if the reporter considered the guillain barre syndrome to be related to RSV vaccine.     The company considered the guillain barre syndrome to be unrelated to RSV vaccine.   Additional Information: GSK receipt date: 30-JUL-2024 It was reported that among 28 reports of Guillain-Barre syndrome, 11 occurred following receipt of the Axrevy vaccine and 17 occurred following receipt of the Abrysvo vaccine. Two of 18 deaths were attributable to Guillain-Barre syndrome. The case is linked with US2024AMR096242 and US2024AMR096586, reported by the same reporter.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine. US-GSK-US2024AMR096242:same reporter US-GSK-US2024AMR096586:same reporter; Reported Cause(s) of Death: Guillain Barre syndrome
Sex: U
Vaccine: RVX
Symptoms: Death
Clinical narrative: Unknown cause of death; This serious case was reported by a consumer via other manufacturer and described the occurrence of unknown cause of death 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 unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to RSV vaccine.     The company considered the unknown cause of death to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 30-JUL-2024 It was reported that among 28 reports of Guillain-Barre syndrome, 11 occurred following receipt of the  Axrevy vaccine and 17 occurred following receipt of the Abrysvo vaccine. Two of 18 deaths were attributable to Guillain-Barre syndrome. This case is for 16 patients with unknown cause of death. The case is linked with US2024AMR096100 and US2024AMR096586, same reporter.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine. US-GSK-US2024AMR096100:same reporter US-GSK-US2024AMR096586:same reporter; Reported Cause(s) of Death: Unknown cause of death
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st Shingrix dose on December 2021, 2nd dose administer today 23 July 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 3959S, expiry date 12-DEC-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2021).   On 23-JUL-2024, the patient received the 2nd dose of Shingrix. On 23-JUL-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received 1st Shingrix dose on December 2021, 2nd dose administer today 23 July 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 23-JUL-2024 The pharmacist reported that they had a patient that received 1st dose of Shingrix and that its already more than 2 years and probable the patient forgot this and came on the reporting day and they administered another one.  The reporter asked to check with us if they had to administer a 3rd dose to complete the series or if its enough with the 2nd dose that they gave on the reporting day. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 51.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: he received the pediatric hepatitis A vaccine, instead of the adult; he received the pediatric hepatitis A vaccine, instead of the adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 51-year-old male patient who received HAV (Havrix pediatric) (batch number 7PK53, expiry date 04-MAR-2026) for prophylaxis.   On 12-JUL-2024, the patient received the 1st dose of Havrix pediatric. On 12-JUL-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: he received the pediatric hepatitis A vaccine, instead of the adult) and adult use of a child product (Verbatim: he received the pediatric hepatitis A vaccine, instead of the adult). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUL-2024 The reporter had question, because one of their patient was an adult, and he received the pediatric hepatitis A vaccine, instead of the adult, which led to adult use of a child product and underdose. The reporter was just wondering what's steps should be take or what should they do. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash vesicular
Clinical narrative: swelling at the injection site; redness at the injection site; she developed a five-inch rash on her leg/she mentioned it looks like a shingles rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2024, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm). In JUL-2024, 1 day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site), injection site erythema (Verbatim: redness at the injection site) and vesicular rash (Verbatim: she developed a five-inch rash on her leg/she mentioned it looks like a shingles rash). The outcome of the injection site swelling and injection site erythema were not resolved and the outcome of the vesicular rash was resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema and vesicular rash to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site erythema and vesicular rash to be related to Shingrix.   Additional Information: GSK receipt date: 26-JUL-2024 The reporter was the patient. She received her second Shingrix dose last week. The day after vaccination, she had experienced redness and swelling at the injection site. She reported that two days after the vaccination, she developed a five-inch rash on her leg. She mentioned it looks like a shingles rash and was improved today (On the day of reporting). Nothing else were reported. The reporter did not consent to the follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster disseminated, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; disseminated shingles involving the eye; disseminated shingles involving the eye; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dialysis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria hospitalization and GSK medically significant), herpes zoster disseminated (Verbatim: disseminated shingles involving the eye) (serious criteria hospitalization and GSK medically significant) and ophthalmic herpes zoster (Verbatim: disseminated shingles involving the eye) (serious criteria hospitalization and GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster disseminated and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster disseminated and ophthalmic herpes zoster to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. The company considered the herpes zoster disseminated and ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix.   Additional Information: GSK receipt date: 26-JUL-2024 The pharmacist reported that the patient on dialysis who completed her 2-dose series of shingrix in 2021. However, she recently was hospitalized for disseminated shingles involving the eye. The pharmacist asked if there was data to suggest that patient might need to repeat the shingles vaccine series. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of herpes zoster disseminated and ophthalmic herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix Dose 1 and Shingrix Dose 2.  Herpes zoster disseminated and Ophthalmic herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingrix Dose 1 and Shingrix Dose 2.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Headache, Magnetic resonance imaging
Clinical narrative: balance issues; dizziness/weird dizziness; severe headaches/horrible headache; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (balance issues), DIZZINESS (dizziness/weird dizziness) and HEADACHE (severe headaches/horrible headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (balance issues), DIZZINESS (dizziness/weird dizziness) and HEADACHE (severe headaches/horrible headache). At the time of the report, BALANCE DISORDER (balance issues), DIZZINESS (dizziness/weird dizziness) and HEADACHE (severe headaches/horrible headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported after receiving the first two Moderna vaccines in Sept 2021, started experiencing weird dizziness and balance issues, horrible headaches combined with everyday dizziness. The patient had different tests (MRA, MRV, inner ear testing, plenty of blood work, etc.) and doctor visits. Everything came back normal, and nothing explained the symptoms.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-771788 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2024: Live follow-up received contains non-significant information included event verbatim updated and references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771788:Same reporter
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain
Clinical narrative: Patient reported severe headaches and body aches a couple of days after receiving the shot; Patient reported severe headaches and body aches a couple of days after receiving the shot; This is a spontaneous report received from a Physician from a sales representative.  An adolescent male patient received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", PAIN (non-serious), outcome "unknown" and all described as "Patient reported severe headaches and body aches a couple of days after receiving the shot". It was unknown if therapeutic measures were taken as a result of headache.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Dysarthria, Swelling
Clinical narrative: Slurred speech; Speaking weird; Swelling in her neck; This is a spontaneous report received from a Pharmacist.  A 76-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Jul2024 at 10:41 as dose number unknown, single (Lot number: HM9851, Expiration Date: 31Mar2025) at the age of 76 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic; "Heart transplant recipient" (unspecified if ongoing). Concomitant medication(s) included: DEXILANT; ZETIA. The following information was reported: DYSARTHRIA (non-serious), outcome "unknown", described as "Slurred speech; Speaking weird"; SWELLING (non-serious), outcome "unknown", described as "Swelling in her neck".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had the very first two Pfizer COVID vaccines/Caller is sick as a dog, has Covid; had the very first two Pfizer COVID vaccines/Caller is sick as a dog, has Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "had the very first two Pfizer COVID vaccines/Caller is sick as a dog, has Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It is caller and caller's husband's 2nd time taking Paxlovid. Has been like two years or more, took Paxlovid before in February, caller unknown which year, doesn't remember which year. Provider called in the Paxlovid then immediately, did help very much, more for caller than for caller's husband. Caller wonders if that has anything to do with caller taking the Pfizer COVID vaccine, caller had the very first two Pfizer COVID vaccines, did not take all of the extra ones and is not going to. Caller stated for all of this, the discount better be worth it. Caller feels terrible. Reporter phone number: Caller clarified the phone number in formal field is caller's husband's cell phone number, however caller requested to leave that phone number in formal field and declined to provide an additional phone number. Declined to provide additional reporter details and declined to complete report, stating caller feels like crap.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very ill; This is a spontaneous report received from a Consumer or other non HCP.  A female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: ILLNESS (disability), outcome "not recovered", described as "very ill". Therapeutic measures were taken as a result of illness. Clinical course: It was unknown if other vaccine was given on same date, if other vaccine in four weeks and if other medications in two weeks. A healthy female said she became very ill after receiving a covid-19 vaccination. She travels out of state for care as she cannot find a local doctor who can help her. Adverse event (AE) resulted in disability or permanent damage. AE treatment was ongoing care for months.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Alpha tumour necrosis factor, Blood immunoglobulin G, Cell marker, Flow cytometry, Gene sequencing
Clinical narrative: one of them was hospitalized for hypotension; This is a literature report.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ALL" (ongoing); "ALL chemotherapy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOTENSION (hospitalization), outcome "unknown", described as "one of them was hospitalized for hypotension". The patient underwent the following laboratory tests and procedures: Alpha tumour necrosis factor: Unknown results; Blood immunoglobulin G: Unknown results; Unknown results; Cell marker: Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Flow cytometry: Unknown results; Gene sequencing: Unknown results; Interferon gamma level: Unknown results; Interleukin level: Unknown results; Polymerase chain reaction: Unknown results; Red blood cell count: Unknown results; White blood cell count: Unknown results. Clinical course was reported as follows: patient enrolled were undergoing ALL chemotherapy. Vaccine related adverse events included fever in three patients; one of them was hospitalized for hypotension.  The reporter considered "one of them was hospitalized for hypotension" related to BNT162b2.; Sender's Comments: Current information is very limited and does not allow a full medically meaningful assessment, especially lack of complete medical history, concomitant medications and event details including time lag between the onset of the event and vaccination date.  However, a possibly contributory role of BNT162B2 in triggering the onset of hypotention cannot be fully excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: Hypotension, Interferon gamma level, Interleukin level, Polymerase chain reaction, Red blood cell count
Clinical narrative: one of them was hospitalized for hypotension; This is a literature report.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ALL" (ongoing); "ALL chemotherapy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOTENSION (hospitalization), outcome "unknown", described as "one of them was hospitalized for hypotension". The patient underwent the following laboratory tests and procedures: Alpha tumour necrosis factor: Unknown results; Blood immunoglobulin G: Unknown results; Unknown results; Cell marker: Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Flow cytometry: Unknown results; Gene sequencing: Unknown results; Interferon gamma level: Unknown results; Interleukin level: Unknown results; Polymerase chain reaction: Unknown results; Red blood cell count: Unknown results; White blood cell count: Unknown results. Clinical course was reported as follows: patient enrolled were undergoing ALL chemotherapy. Vaccine related adverse events included fever in three patients; one of them was hospitalized for hypotension.  The reporter considered "one of them was hospitalized for hypotension" related to BNT162b2.; Sender's Comments: Current information is very limited and does not allow a full medically meaningful assessment, especially lack of complete medical history, concomitant medications and event details including time lag between the onset of the event and vaccination date.  However, a possibly contributory role of BNT162B2 in triggering the onset of hypotention cannot be fully excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: one of them was hospitalized for hypotension; This is a literature report.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ALL" (ongoing); "ALL chemotherapy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOTENSION (hospitalization), outcome "unknown", described as "one of them was hospitalized for hypotension". The patient underwent the following laboratory tests and procedures: Alpha tumour necrosis factor: Unknown results; Blood immunoglobulin G: Unknown results; Unknown results; Cell marker: Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Flow cytometry: Unknown results; Gene sequencing: Unknown results; Interferon gamma level: Unknown results; Interleukin level: Unknown results; Polymerase chain reaction: Unknown results; Red blood cell count: Unknown results; White blood cell count: Unknown results. Clinical course was reported as follows: patient enrolled were undergoing ALL chemotherapy. Vaccine related adverse events included fever in three patients; one of them was hospitalized for hypotension.  The reporter considered "one of them was hospitalized for hypotension" related to BNT162b2.; Sender's Comments: Current information is very limited and does not allow a full medically meaningful assessment, especially lack of complete medical history, concomitant medications and event details including time lag between the onset of the event and vaccination date.  However, a possibly contributory role of BNT162B2 in triggering the onset of hypotention cannot be fully excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: PNC20
Symptoms: Antibody test negative
Clinical narrative: her doctor checked her immunity levels and it was way up but he rechecked them again after a year and they are back down again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "her doctor checked her immunity levels and it was way up but he rechecked them again after a year and they are back down again".  Additional Information: The caller said she had a Prevnar 20 vaccine just over a year ago and her doctor checked her immunity levels and it was way up but he rechecked them again after a year and they were back down again so her doctor recommended that she gets a second shot of the medication and she would like to know if that was recommended and if there was something that she need to be mindful about. The caller stated that her immunity levels had gone down again after taking the medication  Batch/lot number is not provided, and it cannot be obtained.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Fatigue, Skin warm, Swelling
Clinical narrative: Started morning after shot with fatigue. That evening it was red, swollen and warm.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Influenza like illness, Peripheral swelling
Clinical narrative: swelling/redness on arm, flu like symptoms
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2019BI00734811 (Biogen).  A 45-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis".
Age: 46.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Acoustic stimulation tests, Deafness unilateral, Magnetic resonance imaging
Clinical narrative: 100% deaf in my left ear; Initial information received on 24-Jul-2024 regarding an unsolicited valid  serious courtesy case received from a consumer/non-hcp.  This case involves a 46 years old female patient who experienced 100% deaf in my left ear after receiving vaccines COVID-19 VACCINE and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 16-Jan-2023, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection (lot UJ943AB and expiry; unknown) (dose, strength: unknown) via intramuscular route in the right deltoid for prophylactic Vaccination.  On 06-Feb-2021, the patient received a Dose 2  dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot EL9264 via intramuscular route in the left deltoid.   On 15-Jan-2021 the patient received a Dose 1 dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot EL3248 and expiry; unknown) (dose, strength: unknown) via intramuscular route in the left deltoid for Covid-19 immunization.   On 06-Feb-2021, the patient received a Dose 2 (lot EL9264), On 22-Dec-2021 she also received Booster dose 3 (lot FE3594) and On 16-Jan-2023 she also received a Booster Dose 4 (6J6796) all in  left deltoid.   On 13-FEB-2023 the patient developed a serious 100% deaf in my left ear (deafness unilateral) (latency 28 days) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and 2 years 28 days following the administration of COVID-19 VACCINE.   This event was assessed as medically significant and was leading to disability.  Relevant laboratory test results included: Acoustic stimulation tests - On 13-Feb-2023:  [0 % hearing] Magnetic resonance imaging - On an unknown date:  [no result]  Action taken: not applicable for both suspects.  The patient was treated with CORTISONE (CORTISONE) for Deafness unilateral and PREDNISONE (PREDNISONE) for Deafness unilateral and cochlear implant was placed in Jun-2023.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event 100% deaf in my left ear.; Sender's Comments: Sanofi Company Comment dated 30-JUL-2024: This case involves a 46 years old female patient who experienced 100% deaf in my left ear after receiving vaccines COVID-19 VACCINE and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and 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: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to not using the Act-Hib lyophilized portion in the administration of the vaccine with no reported adverse event; Initial information received on 29-Jul-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 months old female patient where patient had inappropriate use due to not using the act-hib lyophilized portion in the administration of the 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 24-Jul-2024, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Powder and suspension for suspension for injection (lot- UJ984A) via intramuscular route in the left thigh (strength and expiration date: not provided) for Immunisation (single component of a two-component 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.
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was vaccinated with an expired vaccine. No signs or symptoms were reported by patient.
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with an expired vaccine. No signs or symptoms were reported by patient.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Multiple episodes of vasovagal syncope from    5 minutes after vaccine was given .
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT SITE OF INJECTION THE SIZE OF AN ORANGE (DID NOT SPREAD) ; OCCURED 1 DAY AFTER VACCINATION
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Magnetic resonance imaging
Clinical narrative: No smell and no taste
Age: 53.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Muscle ache, fever, chills, sweating, moderate fever, nausea, moderate low back pain.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle ache, fever, chills, sweating, moderate fever, nausea, moderate low back pain.
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 30.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: MOM NOTED LEFT ARM LOCALIZED SWELLING, REDNESS AND PAIN AT SITE OF VACCINATION ON 7/29/2024 WHEN HELPING CHILD DRESS, UNCLEAR WHEN REACTION STARTED
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Muscular weakness, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: fever-low grade; extreme soreness and hurting in area; heat feeling; weakness; feel the soreness settle in the surgery areas; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6204, Expiration Date: Jun2021) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression", start date: 01Sep1970 (ongoing), notes: Still taking medication; "Anxiety", start date: Jul2020 (ongoing), notes: Still taking medication; "allergies" (unspecified if ongoing), notes: many allergies; "Allergic to Hornet Family and Ticks" (unspecified if ongoing), notes: Highly allergic; "I have many allergies. Unable to breathe" (unspecified if ongoing), notes: many allergies; "My left arm, elbow and hand have had extensive surgery" (unspecified if ongoing). The patient's family history included: "Vaccination reaction" (unspecified if ongoing), notes: tetanus vaccine, mother. The patient took concomitant medications. Past drug history included: Cortisone, reaction(s): "Drug allergies"; Prednisone, reaction(s): "Drug allergies". Vaccination history included: Tetanus vaccine, administration date: 2017, when the patient was 59 years old, for immunization, reaction(s): "reaction", "Drug allergies"; Flu vaccine, for immunization, reaction(s): "weakness", "soreness", "heat feeling". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Mar2021, outcome "recovered", described as "feel the soreness settle in the surgery areas"; VACCINATION SITE WARMTH (non-serious) with onset 19Mar2021, outcome "recovered", described as "heat feeling"; MUSCULAR WEAKNESS (non-serious) with onset 19Mar2021, outcome "recovered", described as "weakness"; PYREXIA (non-serious), outcome "recovered", described as "fever-low grade"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "extreme soreness and hurting in area". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient reported she was given the first injection in her upper left arm. The patient's left arm, elbow and hand had extensive surgery. When the patient was given the shot, the patient immediately regretted choosing her left side. There was an immediate heat feeling and weakness that settled in every part of her surgery areas. The patient did not experience any kind of reaction per se but did feel the soreness settle in surgery areas. This lasted about 5 to 7 days. The patient ran a fever-low grade, but overall, the site of injection reacted similarly to a flu vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: fever-low grade; extreme soreness and hurting in area; heat feeling; weakness; feel the soreness settle in the surgery areas; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6204, Expiration Date: Jun2021) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression", start date: 01Sep1970 (ongoing), notes: Still taking medication; "Anxiety", start date: Jul2020 (ongoing), notes: Still taking medication; "allergies" (unspecified if ongoing), notes: many allergies; "Allergic to Hornet Family and Ticks" (unspecified if ongoing), notes: Highly allergic; "I have many allergies. Unable to breathe" (unspecified if ongoing), notes: many allergies; "My left arm, elbow and hand have had extensive surgery" (unspecified if ongoing). The patient's family history included: "Vaccination reaction" (unspecified if ongoing), notes: tetanus vaccine, mother. The patient took concomitant medications. Past drug history included: Cortisone, reaction(s): "Drug allergies"; Prednisone, reaction(s): "Drug allergies". Vaccination history included: Tetanus vaccine, administration date: 2017, when the patient was 59 years old, for immunization, reaction(s): "reaction", "Drug allergies"; Flu vaccine, for immunization, reaction(s): "weakness", "soreness", "heat feeling". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Mar2021, outcome "recovered", described as "feel the soreness settle in the surgery areas"; VACCINATION SITE WARMTH (non-serious) with onset 19Mar2021, outcome "recovered", described as "heat feeling"; MUSCULAR WEAKNESS (non-serious) with onset 19Mar2021, outcome "recovered", described as "weakness"; PYREXIA (non-serious), outcome "recovered", described as "fever-low grade"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "extreme soreness and hurting in area". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient reported she was given the first injection in her upper left arm. The patient's left arm, elbow and hand had extensive surgery. When the patient was given the shot, the patient immediately regretted choosing her left side. There was an immediate heat feeling and weakness that settled in every part of her surgery areas. The patient did not experience any kind of reaction per se but did feel the soreness settle in surgery areas. This lasted about 5 to 7 days. The patient ran a fever-low grade, but overall, the site of injection reacted similarly to a flu vaccine.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, Culture, SARS-CoV-2 test, Vaccination failure
Clinical narrative: rash on his leg; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient in his 40's received BNT162b2 (BNT162B2), on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "being run over by a car", start date: 2008, stop date: 2008; "traumatic arthritis", start date: 2008, stop date: 2008, notes: Treated with Meloxicam long term. He took for like 10 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1), administration date: 04Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "rash on his leg". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient developed a weird rash on his leg. The dermatologist cultured and it was negative for everything. They chalked it up to side effect to vaccine of unknown origin. It looked just like shingles but was not. This happened, he believed between Pfizer COVID-19 vaccine 2 and 3, but he was not sure.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400227363 same reporter/patient/suspect vaccine; different dose/event;
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: rash on his leg; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient in his 40's received BNT162b2 (BNT162B2), on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "being run over by a car", start date: 2008, stop date: 2008; "traumatic arthritis", start date: 2008, stop date: 2008, notes: Treated with Meloxicam long term. He took for like 10 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1), administration date: 04Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "rash on his leg". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient developed a weird rash on his leg. The dermatologist cultured and it was negative for everything. They chalked it up to side effect to vaccine of unknown origin. It looked just like shingles but was not. This happened, he believed between Pfizer COVID-19 vaccine 2 and 3, but he was not sure.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400227363 same reporter/patient/suspect vaccine; different dose/event;
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Culture, Rash
Clinical narrative: rash on his leg; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient in his 40's received BNT162b2 (BNT162B2), on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "being run over by a car", start date: 2008, stop date: 2008; "traumatic arthritis", start date: 2008, stop date: 2008, notes: Treated with Meloxicam long term. He took for like 10 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1), administration date: 04Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "rash on his leg". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient developed a weird rash on his leg. The dermatologist cultured and it was negative for everything. They chalked it up to side effect to vaccine of unknown origin. It looked just like shingles but was not. This happened, he believed between Pfizer COVID-19 vaccine 2 and 3, but he was not sure.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400227363 same reporter/patient/suspect vaccine; different dose/event;