chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC20
Symptoms: Product storage error
Clinical narrative: received vaccine after temperature excursion/minimum temperature reached  negative 0.3 degrees Celsius; received vaccine after temperature excursion/minimum temperature reached  negative 0.3 degrees Celsius; This is a spontaneous report received from an Other HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2024 as dose number unknown, single (Lot number: HN2630, Expiration Date: 31Aug2025) for immunisation, Device Lot Number: HN2630, Device Expiration Date: 31Aug2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 2024, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 28Aug2024, outcome "unknown" and all described as "received vaccine after temperature excursion/minimum temperature reached  negative 0.3 degrees Celsius".  Additional Context: The reporter informed that the NDC number of Prevnar 20 was 0005-2000-10. The reporter informed that there was a temperature excursion. There were 8 different excursion. The first excursion occurred on 28Aug2024 with minimum temperature reached  negative 0.3 degrees Celsius for 1 hour and 43 minutes. The second excursion occurred on 05Sep2024 with minimum temperature reached positive 0.1 degrees Celsius for 5 hours and 30 minutes. The third excursion occurred on 06Sep2024 with minimum temperature reached positive 0.4 degrees Celsius for 10 hours and 11 minutes. The fourth excursion occurred on 07Sep2024 with minimum temperature reached positive 0.6 Celsius for 9 hours and 16 minutes The fifth temperature excursion occurred on  08Sep2024 with minimum temperature reached positive 0.3 degrees Celsius for 10 hours and 41 minutes. The sixth temperature excursion occurred on 09Sep2024 with minimum temperature reached positive 0.6 degrees Celsius for 4 hours and 15 minutes. The seventh temperature excursion occurred on 19Sep2024 with minimum temperature reached positive 1.5 degrees Celsius for 1 hour and 59 minutes. The eighth temperature excursion occurred on 20Sep2024 with minimum temperature reached positive 0.1 degrees Celsius for 4 hours and 17 minutes. She was also calling to get stability, see if stable for use. Three patients have received this vaccine after these excursions. There were two different lot numbers involved. The second lot number product details were lot HA2258, Expiry 31Jan2025 with NDC 0005-2000-10.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400283548 same reporter/drug/event, different patient;US-PFIZER INC-202400283549 same reporter/drug/event, different patient;
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Head titubation, Loss of consciousness, Weight
Clinical narrative: losing consciousness; nodding on and off; caller's son got injected, maybe was a placebo, didn't work.; caller's son got injected, maybe was a placebo, didn't work.; This is a spontaneous report received from an Other HCP, Program ID.  A 23-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Jan2024 as dose 1, single (Batch/Lot number: unknown) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "preemie" (unspecified if ongoing); "brain bleeds" (unspecified if ongoing); "ligation to heart" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2024, outcome "unknown" and all described as "caller's son got injected, maybe was a placebo, didn't work."; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "losing consciousness"; HEAD TITUBATION (non-serious), outcome "unknown", described as "nodding on and off". The events "losing consciousness" and "nodding on and off" required emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: 2 pounds 2 ounces. Therapeutic measures were taken as a result of covid-19.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded. As there is limited information in the case provided, the causal association between the event loss of consciousness and the suspect drug cannot be excluded. The case will be reassessed once new information is available. 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-202400286555 same reporter, similar events, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over the body; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Oct2024 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: RASH (non-serious) with onset 24Oct2024, outcome "unknown", described as "Rash all over the body".  Additional information: The patient stated that they got a Pfizer COVID-19 shot (Clarified as Pfizer COVID-19 Vaccine) on Monday and by Thursday, it was an outbreak of rash all over the body so, they just want to report that and just want to ask if that was one of the side effects or was that like an allergic reaction to the medication. Also asking, what could have been in the Pfizer injection that might could have caused it.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia
Clinical narrative: large swelling in her lymph node under her arm; fever of 104; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 40-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 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: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2024, outcome "recovered" (2024), described as "fever of 104"; LYMPHADENOPATHY (non-serious) with onset 2024, outcome "recovered" (2024), described as "large swelling in her lymph node under her arm". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of lymphadenopathy, pyrexia.  Additional information: Patient reported that after the 2nd and 3rd vaccine, she developed large swelling in her lymph node under her arm, fever of 104.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: chills; muscle aches; fatigue; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Oct2024 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; influenza vaccine (INFLUENZA), on 23Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRILOSEC OTC. The following information was reported: CHILLS (non-serious) with onset 25Oct2024, outcome "recovered" (25Oct2024); FATIGUE (non-serious) with onset 25Oct2024, outcome "recovered" (25Oct2024); MYALGIA (non-serious) with onset 25Oct2024, outcome "recovered" (25Oct2024), described as "muscle aches". Therapeutic measures were taken as a result of chills, myalgia, fatigue.  Additional information: The Comirnaty and influenza vaccines were co-administered on 23Oct2024. On 25Oct2024 at 17:30, the patient experienced chills, muscle aches, fatigue. Patient took ibuprofen for symptoms. The symptoms resolved on same day as onset (25Oct2024). The patient did not received any other vaccines within 4 weeks prior to the suspect vaccine.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Abnormal faeces, Depression, Migraine, SARS-CoV-2 test, Somnolence
Clinical narrative: migraine; pooping liquid for 4 days and nights; depressed; sleeping for 22 hours; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Oct2024 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 21Oct2024 as dose number unknown single), in left arm. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN SINGLE), for Covid-19 vaccination. The following information was reported: DEPRESSION (non-serious) with onset 22Oct2024 at 09:00, outcome "not recovered", described as "depressed"; MIGRAINE (non-serious) with onset 22Oct2024 at 09:00, outcome "not recovered"; ABNORMAL FAECES (non-serious) with onset 22Oct2024 at 09:00, outcome "not recovered", described as "pooping liquid for 4 days and nights"; SOMNOLENCE (non-serious) with onset 22Oct2024 at 09:00, outcome "not recovered", described as "sleeping for 22 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, abnormal faeces, depression, somnolence.  Additional information: After 2 days of having a migraine and sleeping for 22 hours patient have been pooping liquid for 4 days and nights and having to go to her doctor for medicine to help her with the reaction to taking both the flu and COVID shots at the same time as have advertised on TV that it's safe to do. Patient was missing out on all the plans, had for the weekend until ended up like this and was worried about possibly giving it to anyone else; as some people suggested that she actually had COVID but tested negative for it every day since. She had gotten the Madera with no issues but this has left her in a very bad way and ruined her only good weekend that she had plans really depressed about it. Patient received treatment for the adverse event which includes steroid shot, loperamide2 mg caps and ondansetron HCl. Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. Patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea
Clinical narrative: Weakness; Severe diarrhea; chills; This is a spontaneous report received from a Consumer or other non HCP.  An 87-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Oct2024 at 10:30 as dose 1, single (Lot number: NDC00069-2432-10) at the age of 87 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Allergy: PCN" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Allergy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX taken for immunisation, on 05Oct2024 as dose 1, single; LEVOTHYROXINE; SPIRONOLACTONE. The following information was reported: DIARRHOEA (non-serious) with onset 14Oct2024 at 12:15, outcome "recovering", described as "Severe diarrhea"; ASTHENIA (non-serious) with onset 14Oct2024 at 12:15, outcome "recovering", described as "Weakness"; CHILLS (non-serious) with onset 14Oct2024 at 12:15, outcome "recovering". Therapeutic measures were not taken as a result of asthenia, diarrhoea, chills.  Additional information: The patient was not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient was taking any other medications within two weeks of the event starting.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: 4" redness/swelling, itching, persistent itch for more than a week; 4" redness/swelling, itching, persistent itch for more than a week; 4" redness/swelling, itching, persistent itch for more than a week; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 21May2024 at 00:15 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization. The following information was reported: SWELLING (non-serious), ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 21May2024, outcome "recovered with sequelae" (07Jun2024) and all described as "4" redness/swelling, itching, persistent itch for more than a week". Therapeutic measures were not taken as a result of swelling, erythema, pruritus.  Additional information: Patient had no known allergies. Reason why batch/lot is Unknown was reported as Misplaced/discarded. Patient did not receive any other vaccines on the same date 21May2024. Patient did not receive any other vaccines within 4 weeks prior to the vaccine on 21May2024. Patient was not taking any other medications within 2 weeks of the event starting. No Hospitalization Prolonged.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Pollakiuria, Vertigo, Weight decreased
Clinical narrative: mentions that these symptoms have occurred before but does not recall with which vaccine/have to go to the bathroom every 20 min; mentions that these symptoms have occurred before but does not recall with which vaccine/ lost 4 lbs overnight; mentions that these symptoms have occurred before but does not recall with which vaccine/Dehydration; mentions that these symptoms have occurred before but does not recall with which vaccine/sat down on the floor because the room started to go around; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-775581.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2023 as dose 5 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose 1, single), as dose 2, single), as dose 3, single) and as dose 4, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POLLAKIURIA (non-serious), outcome "unknown", described as "mentions that these symptoms have occurred before but does not recall with which vaccine/have to go to the bathroom every 20 min"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "mentions that these symptoms have occurred before but does not recall with which vaccine/ lost 4 lbs overnight"; DEHYDRATION (non-serious), outcome "unknown", described as "mentions that these symptoms have occurred before but does not recall with which vaccine/Dehydration"; VERTIGO (non-serious), outcome "unknown", described as "mentions that these symptoms have occurred before but does not recall with which vaccine/sat down on the floor because the room started to go around".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue
Clinical narrative: feels tired; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious courtesy case received from a Non-Healthcare Professional.  This case involves an unknown age female patient who felt tired after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2024, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, expiry date, lot number- not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence  On 07-OCT-2024 the patient felt tired (fatigue) (latency-1 day) following the administration of influenza vaccine.  Reportedly, Caller states they had a possible temperature excursion. During call caller states his wife was calling him. She got the flu shot and feels tired. It wasn't a Pfizer product, it was Sanofi. Caller was heard in background saying take Tylenol. Caller declines to report stating that was a known reaction to be slightly tired.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered FLUZONE HD to a patient under 65 years of age 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 was linked to US-SA-2024SA302455 and US-SA-2024SA305177.  This case involves unknown age and gender patient who was administered Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] under 65 years of age 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 an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot U8515EA, expiry date- 30-JUN-2025) via unknown route in unknown administration site for prophylactic vaccination (Immunisation), under 65 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, Caller stated that the mistake occurred because the boxes for Fluzone HD (high dose) and Fluzone are 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-2024SA302455:02253957 for patient #1 US-SA-2024SA305177:02253973 for patient #2
Sex: F
Vaccine: COVID19, FLU3
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who had tested positive for covid after receiving COVID-19 vaccine and influenza USP trival A-B high dose subvirion vaccine [fluzone high dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included amlodipine and lisinopril.  On an unknown date, the patient received high dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (unknown strength, lot and expiry date) via unknown route in Arm NOS (Not otherwise specified) and unknown dose of the suspect COVID-19 vaccine not produced by Sanofi Pasteur (unknown strength, lot and expiry date) via unknown route in unknown administration site for to prevent getting Covid (COVID-19).  On an unknown date the patient tested positive for covid (SARS-COV-2 test positive) (unknown latency) following the administration of influenza USP trival A-B high dose subvirion vaccine of COVID-19 vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.   Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Positive.  Reportedly, reporter stated that I had a covid vaccine shot on Thursday and I was experiencing symptoms of covid. I had also the flu vaccine at the same time but my wife had the same two shots the day before, she has tested positive for covid, I tested negative but I have the same symptoms as she does.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Approximately 36 hours after shot, developed an itchy/painful rash on both arms.; Initial information received on 08-Oct-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 39 years old female patient (61.23 kg) who had approximately 36 hours after shot, developed an itchy/painful rash on both arms after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Serum sickness.  On 07-Oct-2024, the patient received a dose 1 of Suspect Influenza Quadrivalent Recombinant Vaccine strength, expiry date, lot number not reported via intramuscular route in arm nos (not specified) for Prophylactic vaccination (Immunization). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On 08-OCT-2024 the patient had approximately 36 hours after shot, developed an itchy/painful rash on both arms. (rash pruritic) (latency : 36 hours approximately) following the administration of Influenza Quadrivalent Recombinant Vaccine.  Reportedly "I am taking medications that weaken my immune system (skyrizi and entyvio). "  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Approximately 36 hours after shot, developed an itchy/painful rash on both arms.).  At time of reporting, the outcome was Unknown for the event approximately 36 hours after shot, developed an itchy/painful rash on both arms.
Age: 16.0
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: RIV3 was inadvertently administered to a patient <18 yrs of age with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional.  This case involves a 16 years old and unknown gender patient as riv3 (Influenza Trivalent Recombinant Vaccine [FlublokTIV]) was inadvertently administered to a patient <18 yrs of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2024, the patient was inadvertently administered dose 1 of suspect Influenza Trivalent Recombinant Vaccine Solution for injection 0.5 ml TOTAL via intramuscular route in unknown administration site for Influenza immunization (strength, batch and expiry date unknown)<18 yrs of age with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Aches; Fever 101; chills; vomited twice; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 45 years old female patient who experienced aches, fever 101, chills and vomited twice after receiving Influenza quadrival a-b multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient was not pregnant at the time of side effects.   On 08-Oct-2024, the patient received a dose 1 of suspect Influenza quadrival a-b multidose vaccine preserved Suspension for injection lot number not reported via intramuscular route in unknown administration site (route, strength and expiration date: not provided) for Antiviral prophylaxis.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On 09-Oct-2024 the patient developed aches (pain), fever 101 (pyrexia), chills and vomited twice (vomiting) (latency- 1 day).  Action taken- not applicable.  No corrective treatment was received for the events.  At time of reporting, the outcome was Recovered / Resolved on 10-Oct-2024 for all the events.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: fever according to the patient's mom which was yesterday; Initial information received on 02-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient who had fever according to the patient's mom which was yesterday after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Vomiting, Teething and Pyrexia.  Concomitant medications included COVID-19 vaccine for Immunisation.  On 30-Sep-2024, the patient received an unknown dose of suspect influenza quadrival A-B multidose vaccine preserved Suspension for injection lot number not reported via intramuscular route in the left thigh.  On 01-OCT-2024 the patient had fever according to the patient's mom which was yesterday (pyrexia) (latency- 1 day) following the administration of influenza quadrival A-B multidose vaccine preserved.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, stated during that time the patient had episodes and a history of vomiting and the caller does not have the date this occurred but it was before he received the covid vaccine. The patient is also teething and so he has been having in and out fevers and the patient's mom has been giving him Motrin. Caller verified the teething and fevers were also before the patient received the covid vaccine. Caller states no treatment was required for the reported event and stated the doctor reached out to the patient's mom this afternoon and the patient had a fever according to the patient's mom which was on 01-Oct-2024 and she gave him Motrin around 2:45 on 01-Oct-2024 and the patient is fever free; caller verified the patient was experiencing the fevers prior to receiving the covid vaccine.   Action taken was not applicable.  The patient was treated with Ibuprofen (Motrin) for Pyrexia.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: While administering a Fluzone HD the vaccine, vaccine ran down the patient's arm with no reported adverse event; While administering a Fluzone HD the vaccine, vaccine ran down the patient's arm with no reported adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom, while administering a influenza usp trival A-B high dose subvirion vaccine [Fluzone HD], vaccine ran down the patient's arm 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 an unknown dose of suspect influenza usp trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot UT8409CA, expiry date- 30-JUN-2025 ) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and while administering vaccine ran down the patient's arm with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency- same day).  Reportedly, Caller stated that While administering a Fluzone HD the vaccine started coming out of somewhere near the top of the prefilled syringe. The vaccine ran down the patient's arm and onto the arm of the chair.  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: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine was administered with no adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to US-SA-2024SA305245 (master case).   This case involves 66 years old female patient who was administered expired influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant: no other vaccines  On 09-Oct-2024, the patient received an expired dose of 0.7 ml once of suspect influenza quadrival A-B high dose HV vaccine (Strength- High-dose) (unknown formulation) (lot UT8131C, expiry date- 30-JUN-2024) via unknown route in the left arm for Immunization; with no adverse event (expired product administered) (latency- same day).  Reportedly, A Medical Assistant reported that they received expired 2023-2024 FLUZONE QUADRIVALENT High-dose and the vaccines were administered before realizing the issue to 3-people.  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-2024SA305245:02259596 (master case)
Age: 66.0
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: reported that they received expired 2023-2024 fluzone quadrivalent High-dose, were administered before realizing the issue with no reported adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited non-valid  non-serious case received from other healthcare professional.  This case involves 66 years old and unknown gender patient and reporter reported that they received expired 2023-2024 influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent], were administered before realizing the issue 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 09-oct-2024, the patient reporter reported that they received expired 2023-2024 0.7 ml of influenza quadrival A-B high dose HV vaccine (unknown formulation) once with lot UT8131C and expiry date 30-Jun-2024 via unknown route in left arm immunization were administered before realizing the issue with no reported adverse event (expired product administered) (Latency same day).  Reportedly, the reporter reported that they received expired 2023-2024 fluzone quadrivalent High-dose and the vaccines were administered before realizing the issue.   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.  Additional information was received on 10-Oct-2024 from other healthcare professional. Case was updated to non-valid to valid case. Patient age updated, therapy start date updated, product dosage information, strength, dose, frequency, administration site, indication update. Text amended accordingly.
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine
Clinical narrative: allergic to flubok; Initial information received on 12-Oct-2024 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult female patient of an unknown age who experienced allergic to flubok after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok].  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 Influenza Quadrivalent Recombinant Vaccine (strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site as immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On an unknown date the patient had allergic to flubok (hypersensitivity) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine administered post excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to US-SA-2024SA269367 (master case).  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] post 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 in 2024, the patient was administered with a  dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK010AA, expiry date- 28-FEB-2025; lot numbers-UJ995AA, UK006AA) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation), post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, from 24-AUG-2024 to 05-SEP-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.   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-2024SA269367:master case
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was administered after excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA269367 (Master).  This case involves Infant and unknown gender patient who received HIB (PRP/T) Vaccine [ACT-HIB] after 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 in 2024, the patient received a unknown dose of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) lot UK010AA/UK006AA/UJ995AA, expiry date, strength was unknown via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and vaccine was administered with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly "From 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination."   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-2024SA269367:Master case
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriately administered to Infant (unknown gender) patient that are no longer viable to use post temperature excursion, with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to Master case id US-SA-2024SA269367 for 26 patients.  This case involves Hib (Prp/T) Vaccine [Act-Hib] which was inappropriately administered to Infant (unknown gender) patient that are no longer viable to use post 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 suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (strength: not reported) which was inappropriately administered, that are no longer viable to use post temperature excursion, with no reported adverse event (poor quality product administered) (lot: UK010AA, Expiry date: 28-Feb-2025 other lot UJ995AA, UK006AA) via unknown route in unknown administration site for immunization.  Reportedly from 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age.   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-2024SA269367:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine administered after excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2024SA269367 (master case).  This case involves Infant and unknown gender patient to whom HIB (PRP/T) Vaccine [ACT-HIB] vaccine administered after 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 in 2024, the patient received HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UK010AA (other lot UJ995AA, UK006AA) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation) (strength, dose, expiry date unknown) after excursion with no reported adverse event (poor quality product administered) (same day latency).  Reportedly from  24-Aug-2024 to 05-Sep-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age.    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-2024SA269367:master case
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Frozen shoulder; Initial information received on 15-Oct-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 75 years old female patient who experienced frozen shoulder, after receiving vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2024, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength, lot number, expiry date: not reported) via intramuscular route in unknown administration site for Flu immunization.  On 12-Oct-2024 the patient developed frozen shoulder (periarthritis) (latency: 2 days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  No lab data reported.  Action taken : not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Recovering / Resolving for the event.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Injection site pain, Pain
Clinical narrative: felt a strong pain on my left arm/should (where injection was administrated); felt a strong weakness on my left arm/should (where injection was administrated); Initial information received on 15-Oct-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case involves a 55 years old male patient who felt a strong pain on left arm/should (where injection was administrated) and felt a strong weakness after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2024, the patient received a 1 dosage form (DF) total of suspect Influenza Vaccine injection produced by unknown manufacturer (lot number, strength and expiry not reported) via subcutaneous route in the left arm as Yearly flu vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On 09-OCT-2024 the patient took the vaccine shot and, at night, when went to the gym, felt a strong weakness and pain on my left arm/should (where injection was administrated) (vaccination site pain) and (muscular weakness) (Latency: same day). Since that night, the pain has not gone away. It is not as bad as then but still hurts when I stretch or try to place my left arm behind.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the events.