chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: headache; Chills; soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 14:30 as dose 5 (booster), single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, on 21Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose number: 01, Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number: 02, Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number: 03, Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number: 04, Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 02Oct2023 at 23:30, outcome "recovering"; HEADACHE (non-serious) with onset 02Oct2023 at 23:30, outcome "recovering"; PAIN (non-serious) with onset 02Oct2023 at 23:30, outcome "recovering", described as "soreness". Therapeutic measures were not taken as a result of headache, chills, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1 and 2: Moderna and Dose 3= Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Feb2021 as dose 1, single (Lot number: 006m204), in left arm and on 19Mar2021 as dose 2, single (Lot number: 00182119), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Sep2022, outcome "unknown", described as "Dose 1 and 2: Moderna and Dose 3= Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid from 25Sep2023 to 30Sep2023.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster); received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster); received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single; Tested positive for Covid on 03Oct; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single. The following information was reported: COVID-19 (non-serious) with onset 03Oct2023, outcome "not recovered", described as "Tested positive for Covid on 03Oct"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "not recovered" and all described as "received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster)"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "not recovered", described as "received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single". The event "tested positive for covid on 03oct" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: I kept experiencing a tingling on my top lip, under the top lip like around my teeth, it is like a tingling but it is in the lip and it feels strange just like right in the fleshy part under my lip; There is a tingling and it almost feels like it is numb and it does not last that long; it frightens me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: PARAESTHESIA ORAL (non-serious), outcome "not recovered", described as "I kept experiencing a tingling on my top lip, under the top lip like around my teeth, it is like a tingling but it is in the lip and it feels strange just like right in the fleshy part under my lip"; HYPOAESTHESIA ORAL (non-serious), outcome "not recovered", described as "There is a tingling and it almost feels like it is numb and it does not last that long; it frightens me". Additional information: next couple of days after got the vaccine the patient experienced a tingling on top lip, under the top lip like around teeth, it was like a tingling but it was in the lip and it felt strange just like right in the fleshy part under lip, not quite on teeth though it was not by gums, it is in the fleshy part of the lip. Ii was a tingling and it almost felt like it was numb and it did not last that long, it lasted for few minutes, once or twice a day.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: caused me to be immunocompromised; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "caused me to be immunocompromised".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Panic attack
Clinical narrative: panic attack; their heart rate go up (after 15-30 minutes); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001192 (Novavax).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 4 (booster), 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 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 immunization, reaction(s): "heart rate go up (after 15-30 minutes)", "panic attack". The following information was reported: PANIC ATTACK (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "their heart rate go up (after 15-30 minutes)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient reported that they started treatment on unreported dates with four doses of the Pfizer BioNTech COVID-19 vaccine (primary series and two boosters) for COVID-19 immunisation. It was reported that after the last two boosters, on unreported dates, the patient had their heart rate go up (after 15-30 minutes) and had a panic attack.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Thrombosis, Visual acuity reduced
Clinical narrative: 3 shots I'm now possibly can die hospital says I have severe blood clots; short me Ory loss; reduced clarity of site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), 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 (DOSE1, SINGLE. MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE. MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: THROMBOSIS (life threatening), outcome "unknown", described as "3 shots I'm now possibly can die hospital says I have severe blood clots"; AMNESIA (non-serious), outcome "unknown", described as "short me Ory loss"; VISUAL ACUITY REDUCED (non-serious), outcome "unknown", described as "reduced clarity of site". Therapeutic measures were taken as a result of thrombosis.  Clinical course: patient report he/she had 3 shots and stated "I now possibly can die, hospital says I have severe blood clots in my leg. Info out there says your shots can cause this also short me Ory (memory) loss and reduced clarity of site thanks for hurting my family now. Hospital for blood thinner treatments hey goal always rush treatments had covid time 3 shots (as reported)".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: bad headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "bad headache"; FATIGUE (non-serious), outcome "unknown".  Additional information: Caller would like to get recommendations about the side effects of the vaccine, because she had really bad headache and fatigue before during the trials, she was working for the (Department name), she just got her booster shot and asking for some tips, she also took Aspirin.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Loss of consciousness
Clinical narrative: passed out; heart rate drop to 25; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization, medically significant), outcome "unknown", described as "passed out"; HEART RATE DECREASED (hospitalization, medically significant), outcome "unknown", described as "heart rate drop to 25". The patient age 75 just got her new booster. Immediately thereafter she passed out with a heart rate drop to 25. Taken by ambulance to hospital.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Cell death, Necrosis, Sperm concentration, Sperm concentration decreased
Clinical narrative: necrosis of organs; cell death; low semen sperm count hard time retention; killing of my heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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: NECROSIS (medically significant), outcome "unknown", described as "necrosis of organs"; CELL DEATH (non-serious), outcome "unknown"; SPERM CONCENTRATION DECREASED (non-serious), outcome "unknown", described as "low semen sperm count hard time retention"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "killing of my heart". The patient underwent the following laboratory tests and procedures: Sperm concentration: low, notes: 38 39. Details were as follows:   The information on the batch/lot number for (BNT162B2 OMI XBB.1.5), has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease
Clinical narrative: Chronic kidney disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown". Clinical course: Caller has a schedule to get his booster tomorrow (03Oct2023), received a questionnaire from the pharmacy. One question is asking if he is allergic to Gentromicine. Caller mentioned that he has a Chronic Kidney disease and asking about the Gentromicine. Caller was already vaccinated with 1st and 2nd dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient is actively taking Paxlovid; patient is actively taking Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient is actively taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular
Clinical narrative: her arms have been hurting all the way down and have a red spot itchy; her arms have been hurting all the way down and have a red spot itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "contact dermatitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), RASH MACULAR (non-serious), outcome "unknown" and all described as "her arms have been hurting all the way down and have a red spot itchy". Additional information: The patient said she got the coverage 2023 vaccine Friday morning (unspecified date) at a pharmacy name in her town and at night her arms have been hurting all the way down and have a red spot itchy. She said it didn't seem like an allergic reaction, but it kept getting worse she went to urgent care last night and was told by the pharmacist that this is a normal reaction and sometimes some people get it really big.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Movement disorder, Pain, Pain in extremity
Clinical narrative: unable to move my arm in various positions without it hurting; the pain in my arm seems to be increasing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 30Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Sep2023, outcome "not recovered", described as "the pain in my arm seems to be increasing"; MOVEMENT DISORDER (non-serious) with onset 02Oct2023, outcome "unknown", described as "unable to move my arm in various positions without it hurting".  Additional information: The patient reported that "on 02Oct2023 the pain in my arm seems to be increasing and I'm unable to move my arm  in various positions without it hurting. I need my other arm to lift my arm up to put my eyedrops in. Can this be a normal side effect? What should I do?? I would like to talk to someone. Thank you."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pharyngeal swelling, Swollen tongue, Vomiting
Clinical narrative: Vomited; throat/tongue swelled up really badly; throat/tongue swelled up really badly; feel kind of sick; Initial information received on 22-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves Adult female patient who experienced vomited, throat/tongue swelled up really badly, and feel kind of sick after receiving vaccine Influenza Vaccine.  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 Vaccine produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed vomited (vomiting), throat/tongue swelled up really badly (pharyngeal swelling) (swollen tongue) and feel kind of sick (illness) (unknown latency) following the administration of Influenza Vaccine.  Reportedly, Patient says that for the 4th or 5th time, the side of their throat/tongue swelled up really badly, consulted their doctor who instructed them to take Benadryl the night before, the day of, and the day after shot; this past time they forgot to take their Benadryl this past dose and they vomited - thinks it's the 2nd time to have happened, thinks it might be from getting their flu shot - feel kind of sick after getting the flu shot.  Action taken was not applicable.  The patient was treated with diphenhydramine hydrochloride (Benadryl [Diphenhydramine Hydrochloride]) for Adverse events.  At time of reporting, the outcome was Unknown for the events.; Sender's Comments:  US-SA-2023SA293607:split case
Sex: U
Vaccine: FLUR4
Symptoms: Pyrexia
Clinical narrative: high fever; Initial information received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional from Sales Representative.  This case is linked to case 2023SA302695(CLUSTER).  This case involves Adult patient of unknown gender who experienced high fever after receiving influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history included Cardiac operation (recent heart surgery). The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza quadrivalent recombinant vaccine (strength, formulation, route, batch number and expiry date: unknown) in an unknown administration site for Immunization. Information on the batch number was requested  On an unknown date the patient developed high fever (pyrexia) (unknown latency).  It was reported that a staff member in a clinic gave Flublok Quadrivalent to 2 patient who developed fever high fever which last few days, and both of the patient were high risk patients as one of them had a recent heart surgery. They don't have any information about the patients or treatment done.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (high fever).  At time of reporting, the outcome was Unknown for the event high fever.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: fluzone hd qiv excursion this past weekend which brought the cumulative time of excursion to 112 hours with no reported adverse event; fluzone hd qiv was administered to 2 patients after a temperature excursion with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves temperature excursion as fluzone hd qiv excursion this past weekend which brought the cumulative time of excursion to 112 hours with no reported adverse event and fluzone hd qiv was administered to 2 patients after a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, batch number and expiry date: unknown), administered to 2 patients after a temperature excursion with no reported adverse event (poor quality product administered) (latency same day). Information on the batch number was requested  On an unknown date fluzone hd qiv excursion this past weekend which brought the cumulative time of excursion to 112 hours with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events   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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: Pyrexia
Clinical narrative: high fever; Initial information received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA296038(CLUSTER).  This case involves an unknown age and unknown gender patient who experienced high fever after receiving vaccine Influenza Quadrivalent Recombinant Vaccine [Flublok QIV].  The patient's past medical history included Cardiac operation with had a recent heart surgery. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Quadrivalent Recombinant Vaccine (lot number, strength, dose, form, expiry date not reported) via unknown route in unknown administration site as immunization.  On an unknown date the patient developed high fever (pyrexia) (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine.  It was reported that "a staff member in a clinic gave Flublok Quadrivalent to 2 patient who developed fever high fever which last few days, and both of the patient were high risk patients as one of them had a recent heart surgery. They don't have any information about the patients or treatment done"  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.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Diarrhoea, Muscle spasms
Clinical narrative: severe diarrhea; severe abdominal pain,still some cramping today; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 50 years old female patient who experienced severe diarrhea and severe abdominal pain,still some cramping today after receiving vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-2023, the patient received a dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection expiry date: 30-Jun-2024 lot UT8038MA via unknown route in the left arm for Immunisation.  On 24-SEP-2023 the patient developed severe diarrhea (diarrhoea) and severe abdominal pain,still some cramping today (abdominal pain) 2 days following the administration of Influenza Quadrival A-B Vaccine.  Reportedly, she received on Friday, 22Sep2023 and by Sunday at 4 AM she had severe diarrhea and severe abdominal pain. She almost went to the Emergency Room but just ate a liquid diet. She had improvement yesterday but still some cramping today and can at least eat some solids today.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events severe diarrhea, severe abdominal pain,still some cramping today.  At time of reporting, the outcome was Recovering / Resolving for the event severe diarrhea and severe abdominal pain,still some cramping today.
Age: 100.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of an expired vaccination with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA295989(CLUSTER).  This case involves a 100 years old male patient where reporter reported administration of an expired influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 25-Sep-2023, the patient received 0.7 ml TOTAL dose of suspect influenza quadrival a-b high dose hv vaccine (lot- UT7733CA and expiration date- 30-Jun-2023) via intramuscular route in the left arm (formulation, strength: not provided) for Immunisation (expired product administered) (latency- same day).  Reporting expired doses of FLUZONE HIGH DOSE QIV were administered to 2 patients, husband and wife. Caller reporting she didn't think they even had any doses left from last year in stock but a new MA administered the doses.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: technician administer their flu vaccine into their upper buttocks, lower back region while the patient was sitting down with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and gender patient to whom technician administer their influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] into their upper buttocks, lower back region while the patient was sitting down 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 quadrival A-B high dose HV vaccine (unknown formulation) (lot number, expiry date, strength, was unknown) via intramuscular route in unknown administration site for Influenza (Influenza immunisation) and technician administer their flu vaccine into their upper buttocks, lower back region while the patient was sitting down with no reported adverse event (product administered at inappropriate site) (Latency: same day). The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 65.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: nurse administered FLUZONE QIV instead of FLUZONE HD with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 65 years old male patient where nurse administered influenza quadrival a-b vaccine [Fluzone qiv] instead of 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 26-Sep-2023, the patient received 0.5 ml TOTAL dose of suspect influenza quadrival a-b vaccine Suspension for injection lot UT8055NAvia intramuscular route in the left arm ( strength and expiration date: not provided) for Immunisation (wrong product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 35.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired on 24Sep2023 and was given to a patient today with no reported adverse event; Initial information was received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 35 years old male patient who received diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] vaccine expired on 24sep2023 and was given to a patient today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine; measles vaccine, MUMPS VACCINE, rubella vaccine (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 27-Sep-2023, the patient received a Booster dose of 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT (Suspension for injection) (Frequency : Once, lot U7183AA, Expiry date : 24-Sep-2023, strength was unknown) via intramuscular route in the right deltoid for Immunization and vaccine expired on 24sep2023 and was given to a patient today with no reported adverse event (expired product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event vaccine expired on 24sep2023 and was given to a patient today with no reported adverse event.  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: 0.17
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: patient was given a PENTACEL injection, but only received the liquid component, without the power reconstituted in it with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2-month-old female patient was given a diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] injection, but only received the liquid component, without the power reconstituted in it with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2023, the patient received a dose 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection strength, expiry date, lot number not reported via intramuscular route in the left thigh for immunization and patient was given a pentacel injection, but only received the liquid component, without the power reconstituted in it with no reported adverse event (product preparation error) on the same day.Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient was given a pentacel injection, but only received the liquid component, without the power reconstituted in it with no reported adverse event.  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: 10.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: health center manager gave TENIVAC that expired on 23Sep2023 to a patient with no reported adverse event; Initial information received from on 27-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 years old male patient to whom health center manager gave Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that expired on 23sep2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE (POLIO VACCINE) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 26-Sep-2023, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot U7183AA) via intramuscular route in the left deltoid as prophylactic vaccination that expired on 23-Sep-2023 with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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: 88.0
Sex: F
Vaccine: TD
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidentally received another dose of tenivac with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 88 years old female patient who accidentally received another dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine (flu vaccine VII) for Prophylactic vaccination.  On 27-Sep-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U7679AA and expiration date- 21-Mar-2025) via intramuscular route in the left deltoid (strength: not provided) for Immunisation (extra dose administered) (latency- same day).  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: they have administered expired ACTHIB to a patient, with no reported AE; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient to whom they have administered expired HIB (PRP/T) vaccine [ACT-HIB], with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A vaccine and pneumonia vaccine  for Immunisation.  On an unknown date, the patient received suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection via unknown route in unknown administration site for immunization, expiry date: 11-SEP-2023 (strength, dose, batch: unknown) administered expired acthib to a patient, with no reported ae (expired product administered) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.   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 and Regulatory Authority 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Atelectasis, COVID-19, Chest X-ray abnormal, Cough
Clinical narrative: no vaccine adverse event, but patient presented to the ED on 9/27/23 complaining of cough, congestion, runny nose x 2 days.  Tested COVID + in the ED.  Upon ED discharge 9/27/23  he was informed that he was ineligible for Paxlovid due to his anticoagulant use.  Advised to return for remdesivir treatment if he chose.  Patient returned to the ED ~ 3 hours later for remedesivir infusion.  He was stable prior to the infusion, but during the infusion became tachypenic.  Patient admitted to the ICU for observation.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Infusion, Intensive care, Pneumonitis, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: no vaccine adverse event, but patient presented to the ED on 9/27/23 complaining of cough, congestion, runny nose x 2 days.  Tested COVID + in the ED.  Upon ED discharge 9/27/23  he was informed that he was ineligible for Paxlovid due to his anticoagulant use.  Advised to return for remdesivir treatment if he chose.  Patient returned to the ED ~ 3 hours later for remedesivir infusion.  He was stable prior to the infusion, but during the infusion became tachypenic.  Patient admitted to the ICU for observation.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Tachypnoea
Clinical narrative: no vaccine adverse event, but patient presented to the ED on 9/27/23 complaining of cough, congestion, runny nose x 2 days.  Tested COVID + in the ED.  Upon ED discharge 9/27/23  he was informed that he was ineligible for Paxlovid due to his anticoagulant use.  Advised to return for remdesivir treatment if he chose.  Patient returned to the ED ~ 3 hours later for remedesivir infusion.  He was stable prior to the infusion, but during the infusion became tachypenic.  Patient admitted to the ICU for observation.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Laboratory test, Systemic lupus erythematosus, Thyroid cancer
Clinical narrative: Thyroid cancer,  lupus.  I do not have any family history of either problems?mother side or father side.  I am 58 ?Dec. 2022?at the time diagnosed lupus.
Age: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered at inappropriate site
Clinical narrative: patient husband left message stating that vaccine was given too high in arm (in shoulder joint)
Age: 32.0
Sex: F
Vaccine: HEP, HPV9, MMR, TDAP, UNK, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Throat tightness
Clinical narrative: Pt reported tightness in throat the night of vaccine administration, redness, pain, and warm to the touch at injection site for all vaccines administered except the skin test site.  Pt was seen by provider today with instructions to follow up in one week.  Pt was discharged
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia, Wheezing
Clinical narrative: right arm went numb,shortness of breath, diiness, felt faint, wheezing
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pain, Injection site rash
Clinical narrative: Patient got the Spikevax Covid-19, MRNA Vaccine on 9/29/23 at pharmacy. On 10/04/23 pt called and spoke to pharmacist on duty. She expressed her concerns of rash, inflammation and tender at site of injection. Pt also called her PCP that morning. The PCP prescribed Steroids for her discomfort. I reached out to the patient this morning  10/05/23 to follow up. she sated she felt a lot better after starting the steroid regimen.  i told let us know if there is anything else we can help with.
Age: 79.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient reports a redness and inflammation around the injection site, no fever or any other signs of infection at the moment of the report.  Patient was advised to contact her PCP ASAP.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: More lingering vaccination site muscle pain
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Paraesthesia, Tinnitus
Clinical narrative: ringing in ears, numbness and tingling in both arms and both hands