chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TBE
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received tick-borne encephalitis vaccine (TICOVAC), on 14Dec2024 as dose 3, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tick-borne encephalitis vaccine (DOSE 1, SINGLE; unknown manufacturer), for Immunization; Tick-borne encephalitis vaccine (DOSE 2, SINGLE; unknown manufacturer), administration date: Jun2024, for Immunization. The following information was reported: VERTIGO (non-serious) with onset 17Dec2024, outcome "unknown".  Additional information: The patient took Ticovac and had extreme vertigo on 17Dec2024 and she was looking to talk to someone about it. Patient stated that she received her third dose of Ticovac on Saturday, 14Dec2024, previously receiving her second dose back in June. She woke up on 17Dec2024 morning with severe vertigo and was trying to figure out if it could be related to ticovac. She stated that her doctor had given her medication because she had to go to physical therapy, specific medication was not specified. She saw online that this could be a rare side effect that had an incident rate of 0.001-0.1%. She further provided that her family all received Ticovac and that at this time, her daughter had not received her third dose yet.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Cervical lymphadenopathy; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Nov2024 at 15:00 as dose 1, single (Lot number: LM2212), in right deltoid for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 09Nov2024 (Lot number: U8523DA), in left arm. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 10Nov2024, outcome "recovered" (25Nov2024), described as "Cervical lymphadenopathy". The action taken for influenza vaccine was unknown. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Patient had no drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). The patient was not taking any other medications within 2 weeks of the event starting. Patient received OTC NSAID for cervical lymphadenopathy.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Muscle spasms, Myalgia
Clinical narrative: Uncontrolled painful muscle spasms on both hamstrings and quadriceps muscles.; Tender and sensitive hips joints, making it very uncomfortable to walk; Uncontrolled painful muscle spasms on both hamstrings and quadriceps muscles.; making it very uncomfortable to walk; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Oct2024 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2024; FLU [INFLUENZA VACCINE] taken for immunisation, on 24Sep2024 as dose number unknown, single. The following information was reported: ARTHRALGIA (non-serious) with onset 16Oct2024, outcome "not recovered", described as "Tender and sensitive hips joints, making it very uncomfortable to walk"; MUSCLE SPASMS (non-serious), MYALGIA (non-serious) all with onset 16Oct2024, outcome "not recovered" and all described as "Uncontrolled painful muscle spasms on both hamstrings and quadriceps muscles."; GAIT DISTURBANCE (non-serious) with onset 16Oct2024, outcome "not recovered", described as "making it very uncomfortable to walk". Therapeutic measures were taken as a result of muscle spasms, arthralgia, myalgia, gait disturbance.  Additional information: The symptoms started one day after the covid booster shot and have remained since and was still suffer with it today.  The symptoms come and go and are mildly but not completely controlled with 1000mg of acetaminophen. It was reported that when patient tries to exercise or stretch, muscles become very sore the day after and take several days before the soreness goes away. Patient could tell the difference between the sensitivity associated with adverse effect and muscle soreness from the exercise.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Gait disturbance, Muscle spasms, Myalgia, Tenderness
Clinical narrative: Uncontrolled painful muscle spasms on both hamstrings and quadriceps muscles.; Tender and sensitive hips joints, making it very uncomfortable to walk; Uncontrolled painful muscle spasms on both hamstrings and quadriceps muscles.; making it very uncomfortable to walk; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Oct2024 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2024; FLU [INFLUENZA VACCINE] taken for immunisation, on 24Sep2024 as dose number unknown, single. The following information was reported: ARTHRALGIA (non-serious) with onset 16Oct2024, outcome "not recovered", described as "Tender and sensitive hips joints, making it very uncomfortable to walk"; MUSCLE SPASMS (non-serious), MYALGIA (non-serious) all with onset 16Oct2024, outcome "not recovered" and all described as "Uncontrolled painful muscle spasms on both hamstrings and quadriceps muscles."; GAIT DISTURBANCE (non-serious) with onset 16Oct2024, outcome "not recovered", described as "making it very uncomfortable to walk". Therapeutic measures were taken as a result of muscle spasms, arthralgia, myalgia, gait disturbance.  Additional information: The symptoms started one day after the covid booster shot and have remained since and was still suffer with it today.  The symptoms come and go and are mildly but not completely controlled with 1000mg of acetaminophen. It was reported that when patient tries to exercise or stretch, muscles become very sore the day after and take several days before the soreness goes away. Patient could tell the difference between the sensitivity associated with adverse effect and muscle soreness from the exercise.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on 02Dec2024.  The information on the batch/lot number for BNT162b2 omicron (kp.2) has been requested and will be submitted if and when received.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Cough, Eructation, Productive cough
Clinical narrative: belching and bloating, that kind of thing; belching and bloating, that kind of thing; sometimes more of a cough or a phlegm sometimes; sometimes more of a cough or a phlegm sometimes; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 83-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "Afib", start date: May2023 (unspecified if ongoing), notes: prior to receiving the Comirnaty vaccine and was diagnosed with Afib in May, a year ago; "Gastroparesis" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE. The patient also took other concomitant therapy. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 2), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 3 BOOSTER), for COVID-19 immunisation. The following information was reported: ABDOMINAL DISTENSION (non-serious), ERUCTATION (non-serious), outcome "unknown" and all described as "belching and bloating, that kind of thing"; COUGH (non-serious), PRODUCTIVE COUGH (non-serious), outcome "unknown" and all described as "sometimes more of a cough or a phlegm sometimes". Additional information included: reporter stated that it seems like patient had more stomach and bowel issues or whatever than she ordinarily has. She didn't have diarrhea and it was "belching and bloating, that kind of thing." She didn't have Afib before receiving the Pfizer covid-19 vaccines. Upon clarifying if the caller developed Afib after receiving any vaccines, caller stated she is unsure as she receives a flu vaccine every year. The patient couldn't really explain how she feel, the patient just kind of wondered because she got kind of, stomach thing and she did not know. The patient do not have any interactions, she cannot really name any specific thing but sometimes more of a cough or a phlegm sometimes, she do not know that interferes or not. The patient did not know how even spell that, it is a thing with the stomach that stool goes down slowly.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "passed away". His mother passed away after receiving Pfizer COVID vaccine. It was unknown if therapeutic measures were taken as a result of death. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.   Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: passed away
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He does have covid 19 and started Paxlovid; He does have covid 19 and started Paxlovid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 60-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) 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 "He does have covid 19 and started Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. The patient had the shot when they came out, stated he took the very first Covid shots, where he had to take one Covid shot and then wait a couple of weeks and then take another Covid shot. Attempted to clarify manufacturer of Covid shots and stated there were two different companies were giving Covid shots and one company had a lot of side effects and one company did not. He thinks he got Pfizer Covid shots. 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 currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got very sick; This is a spontaneous report received from an Other HCP, Program ID:.  A 35-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got very sick".  Additional information: Patient reports that after they received their last covid vaccine they got very sick that lasted for days.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: chronic fatigue syndrome lessens to the point of feeling normal instead of exhausted / the newest vaccine helped for the longest; This is a spontaneous report received from a Consumer or other non HCP, Program ID:  A patient (age and gender not provided) 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 included: "Chronic fatigue syndrome" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunisation series, manufaturer unknown), for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2024, outcome "unknown", described as "chronic fatigue syndrome lessens to the point of feeling normal instead of exhausted / the newest vaccine helped for the longest". Additional information: The patient has chronic fatigue syndrome. Every time they get a covid booster, that condition lessens. To the point of feeling normal instead of exhausted. The latest vaccine, the newest from Pfizer, helped for the longest.
Sex: U
Vaccine: COVID19
Symptoms: Muscle atrophy
Clinical narrative: advanced muscle atrophy; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: MUSCLE ATROPHY (non-serious), outcome "unknown", described as "advanced muscle atrophy".
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever; chills; muscle soreness; This is a spontaneous report received from an Other HCP, Program ID:.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as 30 ug, dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness". Additional information: Patient reports that whenever they get the covid shot they experience fever, chills and stays in bed for at least 2 days. they also experience muscle soreness after receiving the injection. no further information provided. lot number and expiration date are unknown.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dysphagia, Hypoaesthesia, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: experiencing hard to swallow with her throat; losing feeling with left foot, numbness of the left foot; Swelling and soreness of the throat; Swelling and soreness of the throat; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA330455 (Sanofi), AE-017009 (BioNTech).  A 92-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since 14Oct2024 (Lot number: 4F500A, Expiration Date: 31May2026) at 300 mg (300 mg bim), subcutaneous for dermatitis atopic; influenza vaccine (FLU [INFLUENZA VACCINE]), on 09Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Atopic dermatitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PHARYNGEAL SWELLING (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 14Oct2024, outcome "not recovered" and all described as "Swelling and soreness of the throat"; DYSPHAGIA (non-serious) with onset 14Oct2024, outcome "not recovered", described as "experiencing hard to swallow with her throat"; HYPOAESTHESIA (non-serious) with onset 14Oct2024, outcome "not recovered", described as "losing feeling with left foot, numbness of the left foot". The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of dysphagia, pharyngeal swelling, oropharyngeal pain. Additional information: It was reported that the patient  took the COVID and flu shot on 09Oct2024 and Dupixent on 14Oct2024. Patient was experiencing hard to swallow with her throat and losing feeling with left foor. Swelling and soreness of the throat and numbness of left foot. Corrective treatment: Unspecified (therapy) for dysphagia, pharyngeal swelling, and oropharyngeal pain; not reported for hypoaesthesia.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Illness, Influenza, Nausea
Clinical narrative: getting sick; get pretty bad flu symptoms; feeling bad; sick to stomach; lack of energy; This is a spontaneous report received from an Other HCP, Program ID.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, 30 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "getting sick"; INFLUENZA (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "get pretty bad flu symptoms"; FEELING ABNORMAL (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "feeling bad"; NAUSEA (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "sick to stomach"; ASTHENIA (non-serious), outcome "unknown", described as "lack of energy".  Additional information: patient reported that every time they get the covid shot they end up getting sick. They get pretty bad flu symptoms for about two days after getting the shot such as sick to stomach, lack of energy, and feeling bad.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had Covid later; I had Covid later; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 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: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "I had Covid later". Clinical course: Patient had Covid after Vaccine. During this inbound call for financial assistance, the patient stated the reason he had like to get the covid vaccine was, he had Covid this summer, and he have to had a few months wait, and the holidays were coming up, and he don't want to go through the holidays and wait till Jan and to get COVID, he meant the vaccine. Later stated that he had used Pfizer, he thought he had been up to date, he had got it like 2-3 years since they started, so he had. He had one vaccine back in Mar but because he had Covid later he wasn't able to get another vaccine for a while. Then continued, was it Mar or Apr, it was Apr his last one but he had always gotten Pfizer.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: MEN
Symptoms: Death, Epilepsy
Clinical narrative: epilepsy caused by the meningitis vaccine; Initial information received on 13-Dec-2024 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves an unknown age female patient who had epilepsy after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  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 an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) lot number, expiry date not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization) (strength, expiry date was unknown). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient developed epilepsy caused by the meningitis vaccine (epilepsy) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine  Final diagnosis was (fatal) epilepsy caused by the meningitis vaccine.  Reportedly, Her vaccine ultimately caused her death.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (epilepsy caused by the meningitis vaccine).  At time of reporting, the outcome was Fatal for the event epilepsy caused by the meningitis vaccine.  Seriousness Criteria : This event was assessed as medically significant and was leading to death. It is unknown if an autopsy was done. The cause of death was reported as Epilepsy.; Sender's Comments: Sanofi Company Comment date 18-Dec-2024: This case involves an unknown age of female patient who had epilepsy and died following vaccination with after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] (latency unspecified). Furthermore, patient information regarding medical history, condition at the time of vaccination, Concomitant medications, underlying conditions, clinical course of the event, relevant investigations and test results  excluding other predisposing etiologies would be needed for complete assessment of the case. Cause of death was reported as Epilepsy. It is unknown if an autopsy was performed. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Epilepsy
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: administered post-excursion yes (with no reported adverse event); Initial information received on 13-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2024SA373804 and US-SA-2024SA373808 (cluster case).  This case involves a 14 years old female patient who was administered Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] post-excursion yes (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Dec-2024, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot U8518CA, expiry: 30-Jun-2025, with unknown strength) via unknown route in unknown administration site as immunization post-excursion (with no reported adverse event) (poor quality product administered) (Latency: same day) Human error: no.  Reportedly, 1st excursion on 04-Nov-2024, Max/low temperature reached: 48 degrees F with Duration of 30 minutes with extended stability data cover the excursion and 2nd excursion on 12-Dec-2024, due to an UTR issue with the fridge with Max/low temperature reached: negative 0.1 degrees C, Duration of 37 minutes and extended stability data does not cover the 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.; Sender's Comments:  US-SA-2024SA373804:02342097 US-SA-2024SA373808:02342104
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD was administered to a 59-year-old patient with no reported adverse event; Initial information received on 13-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] 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  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (dose, formulation, strength, route, lot number and expiry: unknown) with no reported adverse event (product administered to patient of inappropriate age) (latency same day) in unknown administration site for prophylactic vaccination.  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  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: 51.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Acute kidney injury, Agitation, Arthralgia, Back pain
Clinical narrative: Took vaccination on Nov 19th, 2-3 days site swelling and irritation progressed to fatigue then gradual hospitalization at emergency room.  I was then transferred by ambulance to the hospital with 3 days of stabilization for kidney failure from AKI that was a result of the Hep B vaccination. I went in the hospital on Dec 6th and discharged on the 13th. resulting in ongoing hospitalizations and numerous appointments with other specialists. heart problems and a list of other symptoms considering i almost died here a list of symptoms  Aches or pain in the muscles agitation back pain or stiffness or pain in neck or shoulder chills constipation diarrhea difficulty with moving feeling of warmth general feeling of discomfort or illness headache (mild), sore throat, runny nose, or fever (mild) increased sweating itching lack of appetite or decreased appetite nausea or vomiting redness of the face, neck, arms, and occasionally, upper chest sleepiness or unusual drowsiness sleeplessness stomach cramps or pain sudden redness of skin swelling of glands in the armpit or neck trouble with sleeping unable to sleep welts weight loss
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Constipation, Decreased appetite, Diarrhoea, Discomfort
Clinical narrative: Took vaccination on Nov 19th, 2-3 days site swelling and irritation progressed to fatigue then gradual hospitalization at emergency room.  I was then transferred by ambulance to the hospital with 3 days of stabilization for kidney failure from AKI that was a result of the Hep B vaccination. I went in the hospital on Dec 6th and discharged on the 13th. resulting in ongoing hospitalizations and numerous appointments with other specialists. heart problems and a list of other symptoms considering i almost died here a list of symptoms  Aches or pain in the muscles agitation back pain or stiffness or pain in neck or shoulder chills constipation diarrhea difficulty with moving feeling of warmth general feeling of discomfort or illness headache (mild), sore throat, runny nose, or fever (mild) increased sweating itching lack of appetite or decreased appetite nausea or vomiting redness of the face, neck, arms, and occasionally, upper chest sleepiness or unusual drowsiness sleeplessness stomach cramps or pain sudden redness of skin swelling of glands in the armpit or neck trouble with sleeping unable to sleep welts weight loss
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Took vaccination on Nov 19th, 2-3 days site swelling and irritation progressed to fatigue then gradual hospitalization at emergency room.  I was then transferred by ambulance to the hospital with 3 days of stabilization for kidney failure from AKI that was a result of the Hep B vaccination. I went in the hospital on Dec 6th and discharged on the 13th. resulting in ongoing hospitalizations and numerous appointments with other specialists. heart problems and a list of other symptoms considering i almost died here a list of symptoms  Aches or pain in the muscles agitation back pain or stiffness or pain in neck or shoulder chills constipation diarrhea difficulty with moving feeling of warmth general feeling of discomfort or illness headache (mild), sore throat, runny nose, or fever (mild) increased sweating itching lack of appetite or decreased appetite nausea or vomiting redness of the face, neck, arms, and occasionally, upper chest sleepiness or unusual drowsiness sleeplessness stomach cramps or pain sudden redness of skin swelling of glands in the armpit or neck trouble with sleeping unable to sleep welts weight loss
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Injection site irritation, Injection site swelling, Insomnia, Lymphadenopathy, Malaise
Clinical narrative: Took vaccination on Nov 19th, 2-3 days site swelling and irritation progressed to fatigue then gradual hospitalization at emergency room.  I was then transferred by ambulance to the hospital with 3 days of stabilization for kidney failure from AKI that was a result of the Hep B vaccination. I went in the hospital on Dec 6th and discharged on the 13th. resulting in ongoing hospitalizations and numerous appointments with other specialists. heart problems and a list of other symptoms considering i almost died here a list of symptoms  Aches or pain in the muscles agitation back pain or stiffness or pain in neck or shoulder chills constipation diarrhea difficulty with moving feeling of warmth general feeling of discomfort or illness headache (mild), sore throat, runny nose, or fever (mild) increased sweating itching lack of appetite or decreased appetite nausea or vomiting redness of the face, neck, arms, and occasionally, upper chest sleepiness or unusual drowsiness sleeplessness stomach cramps or pain sudden redness of skin swelling of glands in the armpit or neck trouble with sleeping unable to sleep welts weight loss
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia, Nausea, Neck pain
Clinical narrative: Took vaccination on Nov 19th, 2-3 days site swelling and irritation progressed to fatigue then gradual hospitalization at emergency room.  I was then transferred by ambulance to the hospital with 3 days of stabilization for kidney failure from AKI that was a result of the Hep B vaccination. I went in the hospital on Dec 6th and discharged on the 13th. resulting in ongoing hospitalizations and numerous appointments with other specialists. heart problems and a list of other symptoms considering i almost died here a list of symptoms  Aches or pain in the muscles agitation back pain or stiffness or pain in neck or shoulder chills constipation diarrhea difficulty with moving feeling of warmth general feeling of discomfort or illness headache (mild), sore throat, runny nose, or fever (mild) increased sweating itching lack of appetite or decreased appetite nausea or vomiting redness of the face, neck, arms, and occasionally, upper chest sleepiness or unusual drowsiness sleeplessness stomach cramps or pain sudden redness of skin swelling of glands in the armpit or neck trouble with sleeping unable to sleep welts weight loss
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Oropharyngeal pain, Pruritus, Pyrexia, Renal failure, Rhinorrhoea
Clinical narrative: Took vaccination on Nov 19th, 2-3 days site swelling and irritation progressed to fatigue then gradual hospitalization at emergency room.  I was then transferred by ambulance to the hospital with 3 days of stabilization for kidney failure from AKI that was a result of the Hep B vaccination. I went in the hospital on Dec 6th and discharged on the 13th. resulting in ongoing hospitalizations and numerous appointments with other specialists. heart problems and a list of other symptoms considering i almost died here a list of symptoms  Aches or pain in the muscles agitation back pain or stiffness or pain in neck or shoulder chills constipation diarrhea difficulty with moving feeling of warmth general feeling of discomfort or illness headache (mild), sore throat, runny nose, or fever (mild) increased sweating itching lack of appetite or decreased appetite nausea or vomiting redness of the face, neck, arms, and occasionally, upper chest sleepiness or unusual drowsiness sleeplessness stomach cramps or pain sudden redness of skin swelling of glands in the armpit or neck trouble with sleeping unable to sleep welts weight loss
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Somnolence, Urticaria, Vomiting, Weight decreased
Clinical narrative: Took vaccination on Nov 19th, 2-3 days site swelling and irritation progressed to fatigue then gradual hospitalization at emergency room.  I was then transferred by ambulance to the hospital with 3 days of stabilization for kidney failure from AKI that was a result of the Hep B vaccination. I went in the hospital on Dec 6th and discharged on the 13th. resulting in ongoing hospitalizations and numerous appointments with other specialists. heart problems and a list of other symptoms considering i almost died here a list of symptoms  Aches or pain in the muscles agitation back pain or stiffness or pain in neck or shoulder chills constipation diarrhea difficulty with moving feeling of warmth general feeling of discomfort or illness headache (mild), sore throat, runny nose, or fever (mild) increased sweating itching lack of appetite or decreased appetite nausea or vomiting redness of the face, neck, arms, and occasionally, upper chest sleepiness or unusual drowsiness sleeplessness stomach cramps or pain sudden redness of skin swelling of glands in the armpit or neck trouble with sleeping unable to sleep welts weight loss
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Nodule, Pain in extremity, Swelling, Tenderness
Clinical narrative: Donor received the Tenivac immunization on 11/25/2024. Donor returned 11/30/2024 and stated she had symptoms develop on 11/27/24 morning following the immunization. Symptoms included: right arm pain, swelling, nodule formation in right axillary as well as tenderness. Donor also stated general nausea. Symptoms resolved on their own. Donor denies any further symptoms.
Age: 28.0
Sex: F
Vaccine: PNC20
Symptoms: Infection, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient came in with redness, swelling, inflammation, pain, elevated skin on the injection site. Redness and swelling started at the injection site and went down to wright above her right elbow and forearm. Patient was informed by Dr. that her arm was very infected was given antibiotics, antihistamines and a topical hydrocortisone cream.  She was also asked to use cool compress three times a day .
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Pt given concentrated covid 6 months-4 years vaccine, 0.3mL. Called pt to speak with parents  4 attempts made, My chart message sent and letter mailed to address on file notifying that pt was vaccinated with incorrect dose
Age: 72.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Patient received the flu and COVID vaccine on 10/18. Had a skin reaction develop at site of injection on left arm. Spreading down arm a bit. Painful. Not particularly itchy. Patient used topical antibiotics at home and was prescribed steroid cream Triamcinolone Acetonide Ointment on 11/27/2024.
Age: 28.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: hep b VACCINE EXPIRED prior to administration
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Age: 16; Received the Moderna 6months to 11Yrs dose
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccination error, administered repeat RSV vaccine. Vaccinated previously on 9/26/2023.  Patient reports no adverse effects.
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Pain in left arm even to the touch startig the day of vaccination and lastin for 15 days after vaccination
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Vaccination error
Clinical narrative: Vaccination error, administered repeat RSV vaccine. Vaccinated previously on 9/26/2023.  Patient reports no adverse effects.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore arm a few days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Vaccination site erythema
Clinical narrative: reported war, red vaccine area, no pain yet but experiencing diarrhea
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt received 2 doses of Arexvy, each within a month of each other. Only 1 dose is necessary per Guidelines. We discovered this error through an internal pharmacy reporting system. I tried contacting the patient to follow up on how he was feeling after receiving the vaccine and to notify him of the error, but he has not returned my calls at this point in time. I will continue to follow up with him to see how he is responding.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Was also previously vaccinated on 10-18-23 with Arexvy.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fainting
Age: 86.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: nausea,vomiting, pt also has spice food. post eating n/v
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blood glucose decreased, Dizziness, Dyspnoea, Exposure during pregnancy, Malaise
Clinical narrative: Pt states she is 28 weeks pregnant, 2nd pregnancy & denies any reaction like this previously. Pharmacist administered 2 specified vaccines w/o incident.  During recommended 15-minute post-vaccination monitoring period, pt began to feel nauseous, then generally "not well", while seated.  Had pt lie down, symptoms persisted and pt c/o feeling worse.  Began "feeling like I'm going to pass out" and having difficulty breathing.  This occurred over about 5 minutes before EMS was called and took over.  No loss of consciousness.  Pt told EMS her CGM indicated her blood sugar was "below 70", but did not provide an exact measurement.  Pt stated she had eaten a full breakfast.  Pt departed with EMS.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Nausea
Clinical narrative: Pt states she is 28 weeks pregnant, 2nd pregnancy & denies any reaction like this previously. Pharmacist administered 2 specified vaccines w/o incident.  During recommended 15-minute post-vaccination monitoring period, pt began to feel nauseous, then generally "not well", while seated.  Had pt lie down, symptoms persisted and pt c/o feeling worse.  Began "feeling like I'm going to pass out" and having difficulty breathing.  This occurred over about 5 minutes before EMS was called and took over.  No loss of consciousness.  Pt told EMS her CGM indicated her blood sugar was "below 70", but did not provide an exact measurement.  Pt stated she had eaten a full breakfast.  Pt departed with EMS.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a second RSV vaccine. Original was received 9/23/2023 and then another on 12/19/2024.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Eye pain, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Right side of face numb, lips numb,  pain in right eye and inside of nose, fingertips numb, nerve pain and discomfort , headaches
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Rhinalgia
Clinical narrative: Right side of face numb, lips numb,  pain in right eye and inside of nose, fingertips numb, nerve pain and discomfort , headaches
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Cyanosis, Livedo reticularis, Skin discolouration, Tachycardia
Clinical narrative: Skin discoloration of entire R arm described as blue/purple color with a mottling/lacy/reticular pattern
Age: 2.75
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given second dose of flu vaccine too early. First dose was administered on 10/28/24. Second dose was given 11/5/24. This was only 8 days apart and it should have been 4 weeks.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first shot of Shingrix on 9/29/2018 and second dose was given on 9/28/2020.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 29-SEP-2018).   On 28-SEP-2020, the patient received the 2nd dose of Shingrix. On 28-SEP-2020, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received first shot of Shingrix on 9/29/2018 and second dose was given on 9/28/2020.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-NOV-2024 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule The pharmacist asked if patient should be revaccinated with two additional doses. The reporter did not provided information about the Shingrix doses (lot number, expiration date). This case is linked with US2024145269, reported by same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; that experienced an excursion was administered to a patient; This spontaneous report was received from Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).     On 10-DEC-2024, one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # Y009106, expiration date: 06-NOV-2025 (strength, dose number, dose, route and anatomical location were not provided) for prophylaxis experienced a temperature excursion of -10°C to 8°C (7.3°C) during 1 hour.   On 13-DEC-2024, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)   No adverse event reported.
Age: 29.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anxiety, Exposure during pregnancy, Foetal hypokinesia, Hyperventilation, Wrong product administered
Clinical narrative: Patient's aunt reported that the patient is currently 29 weeks pregnant, and the patient mistakenly received the GARDASIL 9 vaccine as opposed to receiving the RHOGAM vaccine; The patient mistakenly received the GARDASIL 9 vaccine as opposed to receiving the RHOGAM vaccine; hyperventilating; very worried; This spontaneous prospective pregnancy report was received from the patient's aunt and refers to a 29-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included diabetes. Concomitant therapies were not reported.  The patient became pregnant with LMP of 13-MAY-2024 and EDD of 17-FEB-2025.  On 04-DEC-2024, the patient was mistakenly vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis, instead of receiving anti-d immunoglobulin (RHOGAM) (Wrong product administered).  Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 29 week(s).   On an unspecified date in December 2024 (reported as: the past week or so), the patient had not felt the baby moving around as much in her stomach (Captured in MARRS Case 2412USA007152). On 18-DEC-2024, the health care professional contacted the patient and informed her that she had received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  instead of receiving anti-d immunoglobulin (RHOGAM) vaccine. Since that day, the patient had been hyperventilating and very worried.  The pregnancy outcome was pending, but it was reported that the delivery was going to be induced on 26-JAN-025, since she had high risk (unspecified).  The outcome of hyperventilation, and anxiety were not reported. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not applicable.  The causal relationship between the events of hyperventilation, and anxiety and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-2412USA007152: