chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary series completed; Manufacturer Unknown), administration date: 2022, for Covid-19 immunisation, reaction(s): "nylon sleeve on my arm", "fall asleep". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2022, outcome "recovered", described as "Flu-like symptoms". Additional information: The patient stated that they have had the first Booster (clarified as Pfizer COVID-19 Vaccine), she did have a reaction to that like almost like flu-like symptoms to that but then it went away after hours.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400281090 Same patient, different vaccine/dose/event.;US-PFIZER INC-202400281997 Same patient, different vaccine/dose/event.;US-PFIZER INC-202400281998 Same patient, different vaccine/dose/event.;
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site discomfort
Clinical narrative: Fall asleep; on the left arm where she got the shot, it felt like having like a nylon sleeve on her arm like all of the sudden there was something on her arm; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 2022, outcome "recovered", described as "Fall asleep"; VACCINATION SITE DISCOMFORT (non-serious) with onset 2022, outcome "recovered", described as "on the left arm where she got the shot, it felt like having like a nylon sleeve on her arm like all of the sudden there was something on her arm".  Additional information: When the patient first got the vaccine, she thought it was weird, but she did not know what it was but now it happened again after getting the COVID Vaccine again especially like fall asleep during and in the afternoon more than she usually do. The patient woke up and all of a sudden, it felt like it is on the left arm where she got the shot, it felt like having like a nylon sleeve on her arm like all of the sudden there was something on her arm, like a sleeve and she was like what is that feeling and she was like she had never felt that before and that coincided with the shot.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400281090 Same patient, different vaccine/dose/event;US-PFIZER INC-202400281996 Same patient, different vaccine/dose/event;US-PFIZER INC-202400281998 Same patient, different vaccine/dose/event;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Malaise
Clinical narrative: I have been feeling kind of lousy; glucose is elevated now; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 20Oct2024). The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; OZEMPIC. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset Oct2024, outcome "unknown", described as "I have been feeling kind of lousy"; BLOOD GLUCOSE INCREASED (non-serious) with onset Oct2024, outcome "unknown", described as "glucose is elevated now". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was vaccinated between 2pm and 3 pm. The patient had been feeling kind of lousy. She checked her glucose and  glucose was elevated since having the vaccine (Pfizer COVID Booster Vaccine). Patient's glucose has been just fine, everything has been just fine, nothing has changed other than when she went to get her COVID vaccine update. The patient thought that the pharmacy should be informed that it was definitely a side effect from the actual COVID vaccine.  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: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: noticed discoloration of the skin and discoloration got down to my elbow; arm got red and swollen; arm got red and swollen; It was itchy and lasted for about 2 weeks; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 60-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; Manufacturer unknown), for Covid-19 immunization; Flu (DOSE NUMBER UNKNOWN; Manufacturer unknown), for immunization. The following information was reported: PRURITUS (non-serious) with onset 2024, outcome "recovered" (2024), described as "It was itchy and lasted for about 2 weeks"; ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2024, outcome "recovered" (2024) and all described as "arm got red and swollen"; SKIN DISCOLOURATION (non-serious) with onset 2024, outcome "recovered" (2024), described as "noticed discoloration of the skin and discoloration got down to my elbow".  Additional information: The individual, aged 60, stated that patient had received pneumococcal vaccine three weeks, believing it to be Prevnar 20, a conjugated vaccine. Also reported that patient had their COVID-19 and flu vaccines in the previous weeks without similar reactions. Following the pneumococcal vaccine, patient arm became red and swollen, with noticeable skin discoloration that extended down to the elbow. It was itchy and lasted for about 2 weeks. Now it was back to normal. Patient inquired whether this was a common reaction to the vaccine. Verbal response provided: In individuals aged 60 and older, the most commonly reported solicited adverse reactions (>10%) were pain at the injection site (>50%), muscle pain and fatigue (>30%), headache (>20%), and arthralgia (>10%). Local reactions are usually mild or moderate in severity and generally resolve with a median duration of 1 to 2 days.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Inappropriate preparation of medication; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4LM9F, expiry date 10-OCT-2026) for prophylaxis.   On 21-SEP-2024, the patient received Arexvy. On 21-SEP-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate preparation of medication) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 23-SEP-2024 Pharmacist stated that Arexvy was not mixed first, an HCP (Health care professional) gave only the adjuvant by itself, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Like 2 days were I would stay in bed almost like an hypersensitive reaction.; My arm got swollen and was really painful.; My arm got swollen and was really painful.; This is a spontaneous report received from an Other HCP from medical information team.  A patient (age and gender not provided) 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: HYPERSENSITIVITY (medically significant), outcome "unknown", described as "Like 2 days were I would stay in bed almost like an hypersensitive reaction."; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "My arm got swollen and was really painful.". Clinical Course: Patient's 3 first doses of COVID-19 vaccines were Pfizer and the reaction got stronger every time. Like 2 days were patient would stay in bed almost like an hypersensitive reaction. Patient's arm got swollen and was really painful. Patient wanted to know is it expected to get a stronger immune reaction after each dose.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information available , known drug safety profile and plausible temporal association, the causal relationship between the reported event HYPERSENSITIVITY  and suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202400282441 same reporter/patient/event, different vaccine dose;US-PFIZER INC-202400282442 same reporter/patient/event, different vaccine dose;
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Like 2 days were I would stay in bed almost like an hypersensitive reaction.; reaction got stronger every time; My arm got swollen and was really painful; My arm got swollen and was really painful; This is a spontaneous report received from an Other HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Like 2 days were I would stay in bed almost like an hypersensitive reaction.", "My arm got swollen and was really painful.", "My arm got swollen and was really painful.". The following information was reported: HYPERSENSITIVITY (medically significant), outcome "unknown", described as "Like 2 days were I would stay in bed almost like an hypersensitive reaction."; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "reaction got stronger every time"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "My arm got swollen and was really painful". Clinical course: Patient got 3 first doses of COVID-19 vaccines were Pfizer and the reaction got stronger every time. Like 2 days where they would stay in bed almost like an hypersensitive reaction. Their arm got swollen and was really painful. Patient stated that, is it expected to get a stronger immune reaction after each dose.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information available, known drug safety profile  and plausible temporal association, the causal relationship between the reported event HYPERSENSITIVITY  and suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202400282152 same patient/product, different dose;US-PFIZER INC-202400282442 same patient/product, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Pyrexia
Clinical narrative: Chills; Fever; Very limited mobility; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Shingrix, for Immunisation, reaction(s): "Paralyzed". The following information was reported: CHILLS (non-serious) with onset Oct2024, 12 hrs after the suspect product(s) administration, outcome "unknown"; PYREXIA (non-serious) with onset Oct2024, 12 hrs after the suspect product(s) administration, outcome "unknown", described as "Fever"; MOBILITY DECREASED (non-serious) with onset Oct2024, 12 hrs after the suspect product(s) administration, outcome "unknown", described as "Very limited mobility".  Additional information: The patient had the newest COVID vaccine (clarified as Pfizer COVID-19 Vaccine) on 17Oct2024 (reported as "Thursday last week"). The patient had a heck of a time about 12 hours in with reaction to it. The patient woke up and the patient's body was racked with chills and it followed through into the morning. The patient had fever and had very limited mobility. The patient mentioned, "when I had the Shingles vaccine, I woke up the day after the first Shingles vaccine almost completely paralyzed." The patient asked if there are some components in this particular vaccine that had a similar side effect to Shingrix.  Batch/lot number is not provided, and it cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised oedema, Lymphadenitis
Clinical narrative: my whole left side of my body swelled from my neck; All of the lymph nodes became inflamed; This is a spontaneous report received from a Nurse.  A 30-year-old female patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 2, single (Lot number: EL3247) at the age of 30 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, LOT NUMBER: EL0140), administration date: 28Dec2020, when the patient was 30-year-old, for COVID-19 Immunization, reaction(s): "It didn't feel well". The following information was reported: GENERALISED OEDEMA (non-serious), outcome "unknown", described as "my whole left side of my body swelled from my neck"; LYMPHADENITIS (non-serious), outcome "unknown", described as "All of the lymph nodes became inflamed". Therapeutic measures were not taken as a result of generalised oedema, lymphadenitis. Additional information: the patient's concomitant medication included birth control pills. There were no additional vaccines administered on same date of BNt162B2 vaccine and no other vaccinations within four weeks prior taking the BNt162B2 vaccine. During the second one, the patient's whole left side of body swelled from neck, like she didn't have collar bone, one couldn't see that underneath her armpits. All of the lymph nodes became inflamed, patient was swollen down to her foot. The patient didn't have an arch in her foot and it lasted for several days. No shortness of breath or anything like that but the patient personally don't want to get another COVID shot because of that reaction and her work was saying that she should get it. There were no investigations performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400284285 same patient and suspect drug, different dose and event;US-PFIZER INC-202400284106 same patient and suspect drug, different dose and event;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had the Pfizer shot/but I ended up catching it anyways; I had the Pfizer shot/but I ended up catching it anyways; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 63-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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 "unknown" and all described as "I had the Pfizer shot/but I ended up catching it anyways".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product packaging confusion
Clinical narrative: inappropriate use due to the inappropriate administration of FLUZONE HD to a patient under 65 years old with no adverse event; Initial information received on 08-Oct-2024 regarding an unsolicited valid non-serious case received from a physician.  This case is linked with US-SA-2024SA302455.  This case involves a 43 years old female patient and the reporter reported the administration of Fluzone HD (INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE) to a patient under 65 years old with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2024, patient under 65 years old was administered INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe 0.5 ml once lot U8515EA expiry- 30-JUN-2025 via intramuscular route in the left arm for Immunization (strength unknown) with no adverse event (product administered to patient of inappropriate age) (latency same day).   Physician reported that they administered FLUZONE HD to three patients under the age of 65 years old. Caller stated that the mistake occurred because the boxes for FLUZONE HD and FLUZONE were both white.  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.; Sender's Comments:  US-SA-2024SA302455:
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired vaccine TD, with no reported adverse event; Initial information received on 03-Oct-2024 (live follow up case with agency- 03-OCT-2024 processed together) regarding an unsolicited valid non-serious case received from a Patient.  This case involves an unknown age female patient who had received an expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Sep-2024, the patient received expired dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot-U8021BA, expiry date: 30-SEP-2024) (unknown strength, dosage and route) in unknown administration site for Prophylactic vaccination with no reported adverse event (expired product administered) (latency-same day).  Reportedly, the mother of the patient reported that her daughter received an expired vaccine Tenivac, which expired on the same day she received it. After visiting the urgent care center for the vaccination, the patient later realized the medication was expired.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD being given to 5-year-old patient with no reported adverse event; Initial information received on 04-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 5-year-old male patient and reporter stated that influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] being given to 5-year-old patient with no reported adverse event.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On 04-Oct-2024, the high dose of 0.5 ml of nfluenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe once with lot U8499CA and expiry date Jun-2025 via intramuscular route in the left deltoid for immunization being given to 5-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: itchiness would start in one area and resolve and begin in another area, reporting starting on forehead then resolved then started on legs then resolved/patient reports generalized itchiness; Initial information received on 08-Oct-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 92 years old male patient who had itchiness would start in one area and resolve and begin in another area, reporting starting on forehead then resolved then started on legs then resolved/patient reports generalized itchiness after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 04-Oct-2024, the patient received a dose of 0.5 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) (frequency : once, strength, expiry date, lot number not reported) via intramuscular route in the right deltoid for Immunization. The information on batch number corresponding to the one at time of event occurrence was requested.  On 05-OCT-2024 the patient developed mild itchiness would start in one area and resolve and begin in another area, reporting starting on forehead then resolved then started on legs then resolved/patient reports generalized itchiness (pruritus) (latency: 1 day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Reportedly "He had taken the flu vaccines in the last for many many years with HD.This year, I took it on Friday, and for 24 hours, from Saturday to Sunday. Caller said it was a generalized mild itch, from his forehead, then he would scratch it then it disappeared. Then it also went to his leg, he scratched it and disappeared again.It lasted for 24 hours.Patient said he had never had anything like this before.Patient denied rash and any other symptomsGeneralized itchiness that lasted 24 hours, no rash, no treatment. "  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (itchiness would start in one area and resolve and begin in another area, reporting starting on forehead then resolved then started on legs then resolved/patient reports generalized itchiness).  At time of reporting, the outcome was Recovered / Resolved on 06-Oct-2024 for the event itchiness would start in one area and resolve and begin in another area, reporting starting on forehead then resolved then started on legs then resolved/patient reports generalized itchiness.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse event following immunisation, Exposure during pregnancy
Clinical narrative: employees pregnant and received the FLUZONE TRIVALENT vaccine.(with no reported adverse event); Initial information received on 08-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to US-SA-2024SA273112.  This case involves a 33 years old female patient who was pregnant and received influenza USP trival A-B subvirion no preservative vaccine [Fluzone] (with no reported adverse event).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The gestation period at time of event onset was unknown. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date the patient was pregnant and received the fluzone trivalent vaccine (Suspension for injection) (lot number; strength; expiry date unknown) (with no reported adverse event) (exposure during pregnancy) (latency: same day) for Prophylactic Vaccination.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.; Sender's Comments:  US-SA-2024SA273112:
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 60.4F for duration: 86 hours and 35 mins, due to the fridge door being slightly opened on a hot day with no reported adverse event; vaccine administered post-excursion with no reported adverse event; Initial information received on 08-Oct-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 14 years old female patient to whom Punctured IPV (VERO) [IPOL] vaccine was administered post-excursion which was max/low temperature reached: 60.4f for duration: 86 hours and 35 mins, due to the fridge door being slightly opened on a hot day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE;HEPATITIS B VACCINE (HEPATITIS A VACCINE;HEPATITIS B VACCINE) for Immunisation.  On an unknown date the (Punctured) IPOL was max/low temperature reached: 60.4f for duration: 86 hours and 35 mins, due to the fridge door being slightly opened on a hot day with no reported adverse event (product storage error)   On 05-Aug-2024, 0.5 ml (dose 2) of suspect IPV (VERO), Suspension for injection (lot W1B511M; expiry date: 30-Sep-2025) via intramuscular route in the left deltoid for Immunization was administered to patient post-excursion with no reported adverse event (poor quality product administered)  (latency: same day).  Extended stability data does not cover the excursion. the temperature excursion is due to Human Error.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion due to the fridge door being slightly opened on a hot day and temperature reached: 60.4F for 86 hours and 35 mins with no reported AE; IPOL was administered to patient post-excursion with no reported AE; Initial information received on 08-Oct-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked with US-SA-2024SA303528.  This case involves a 12 years old male patient where reporter reported that temperature excursion due to the fridge door being slightly opened on a hot day and temperature reached: 60.4f for 86 hours and 35 mins with no reported ae and IPV (VERO) [IPOL] was administered to patient post-excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella zoster vaccine (Varicella vaccine); measles vaccine, mumps vaccine, rubella vaccine (MMR); and Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix) for Immunisation.  On 20-Aug-2024, the patient received 0.5 ml dose 4 of suspect IPV (VERO) Suspension for injection (Strength- standard) (lot- W1B511M and expiration date- 30-SEP-2025) via intramuscular route in the right deltoid for Immunisation and ipol was administered to patient post-excursion with no reported ae (poor quality product administered) (latency- same day).  On an unknown date reporter reported temperature excursion due to the fridge door being slightly opened on a hot day and temperature reached: 60.4f for 86 hours and 35 mins with no reported ae (product storage error).  Reportedly, Previous Excursion? None Human error? Yes. Administered post-excursion? Yes Does extended stability data cover the excursion? No, Product used : Used First time product used : No  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.; Sender's Comments:  US-SA-2024SA303528:
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL max/min temperature reached: 54° Fahrenheit/Duration out of labelled range: 36 Minutes/refrigerator malfunction/product administered/dispensed to a patient:Yes, with no reported adverse event; Initial information received on 08-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received punctured IPV (VERO) [IPOL] max/min temperature reached: 54° fahrenheit/duration out of labelled range: 36 minutes due to refrigerator malfunction and product was administered/dispensed to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2024, the patient received an unknown dose of punctured IPV (VERO) Suspension for injection (strength- unknown, lot W1B511M and expiry date- 08-Sep-2025) via unknown route in unknown administration site for immunization and max/min temperature reached: 54° Fahrenheit, duration out of labelled range: 36 minutes due to refrigerator malfunction with no reported adverse event (poor quality product administered) (latency- same day).   Reportedly, Medical Assistant (MA) reported a temperature excursion that was just noticed that occurred on 10-Sep-2024. Human error was not involved. Extended stability data cover did not conver the excursion for any punctured. Medical Assistant repored that patients have received the vaccines from the open IPOL vial since the excursion, but they didn't had any patient information at the time of call.   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: TD
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnant female had received Tenivac with no reported adverse event; Initial information received on 08-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves who was pregnant female had received Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant female had received Tenivac with no reported adverse event occurred at unknown gestation period.the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a unknown dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site for Immunization and pregnant female had received tenivac with no reported adverse event (exposure during pregnancy) (latency: same day).  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 0.92
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: administered a MENQUADFI  after the excursion with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to 12 cluster cases US-SA-2024SA304909 (master case)  This case involves a 11 years old male patient who was administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (lot UJ975AA; Expiration Date : 23-NOV-2024) via unknown route in unknown administration sit for Immunization after the excursion with no reported adverse event (poor quality product administered) (same day latency).    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.; Sender's Comments:  US-SA-2024SA304909:Cluster
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: administering menquadfi vaccines that are no longer suitable to patients because of a temperature excursion with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to US-SA-2024SA304872 (Master case).  This case involves a 16 years old female patient to whom had administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] that are no longer suitable because of a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot UJ975AA and expiry date: 23-Nov-2024, strength: standard) via unknown route in unknown administration site as immunization and administering menquadfi vaccines that are no longer suitable to patients because of a temperature excursion with no reported adverse event (poor quality product administered) (same day latency).   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.; Sender's Comments:  US-SA-2024SA304872:Master case
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: had a temperature excursion/administered a Menquadfi after the excursion, with no reported adverse event; had a temperature excursion/administered a Menquadfi after the excursion, with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had a temperature excursion/administered a Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after the excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On an unknown date, the patient received a  unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) lot U7996BB, Expiry date: 30-Apr-2026, strength was unknown via unknown route in unknown administration site for Immunization and had a temperature excursion/administered a menquadfi after the excursion, with no reported adverse event (product storage error) (unknown latency) and (poor quality product administered) (latency: same day).  Reportedly " This situation is pre-assessed as a medication error/an inappropriate use due to administering MENQUADFI vaccines that are no longer suitable to patients because of a temperature excursion."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB vaccine was administered to a patient,with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who received expired HIB (PRP/T) Vaccine [ACT-HIB] vaccine was administered to a patient,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation; Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr vaccin) for Immunisation; and Hepatitis a vaccine (Hepatitis A) for Immunisation.  On 08-Oct-2024, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) Vaccine lot UJ975AB, Expiry date:06-Oct-2024, strength was unknown via unknown route in the left thigh for Immunization and expired acthib vaccine was administered to a patient,with no reported adverse event (expired product administered) (latency : same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: menquadfi was not viable on 07oct2024 due to transit taking too long, their healthcare providers had already administered it to three patients with no reported adverse event; menquadfi was not viable on 07oct2024 due to transit taking too long, their healthcare providers had already administered it to three patients with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2024SA304971.  This case involves a 16 years old female patient who was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] which was not viable on 07oct2024 due to transit taking too long with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2024, the patient received a 0.5 ml dose once of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (Strength: standard) (lot number and expiry not reported) via intramuscular route in the left deltoid as immunization which was not viable due to transit taking too long with no reported adverse event (poor quality product administered) (Latency: same day).  On an unknown date the Meningococcal A-C-Y-W135 (T Conj) Vaccine was not viable due to it transit time,with no reported adverse event (product storage error) (unknown latency).  Reportedly, healthcare providers had already administered it to three patients. no other vaccines was given to patient.  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.; Sender's Comments:  US-SA-2024SA304971:02257453
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: informed that the shipment of Menquadfi was not viable due to transit taking too long had already administered to patients,with no reported adverse event; informed that the shipment of Menquadfi was not viable due to transit taking too long had already administered to patients,with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA305171.  This case involves a 11 years old male patient who had informed that the shipment of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was not viable due to transit taking too long had already administered to patients,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel) ; Influenza vaccine (Fluzone) and HPV vaccine VLP rL1 4v (yeast) (Gardasil) for all Immunisation.  On 07-Oct-2024, the patient received a dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) strength, expiry date, lot number not reported via intramuscular route in the right arm for Immunization and informed that the shipment of menquadfi was not viable due to transit taking too long had already administered to patients,with no reported adverse event (product storage error) (unknown latency) and (poor quality product administered) (latency : same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to MENQUADFI, that was actually not suitable for use due to it transit time, was given to a patient."   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.; Sender's Comments:  US-SA-2024SA305171:02257418