chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Hypersomnia, Illness
Clinical narrative: I don't sleep a lot but I slept 10 hours last night; Muscle ache; Very tired; unable to even pick my head off the pillow; It went in to stomach situation; terrible diarrhea, uncontrollable; It went in to stomach situation; terrible diarrhea, uncontrollable; I actually also had a shot of the flu vaccine; I actually also had a shot of the flu vaccine; I was my very sick for 2 days; I don't sleep a lot but I slept 10 hours last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose number unknown (booster), single (Lot number: HG4633, Expiration Date: Dec2023) at the age of 79 years for covid-19 immunisation; for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 12Oct2023 as dose number unknown, single (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Oct2023, outcome "unknown" and all described as "I actually also had a shot of the flu vaccine"; ABDOMINAL DISCOMFORT (non-serious), DIARRHOEA (non-serious) all with onset 14Oct2023, outcome "unknown" and all described as "It went in to stomach situation; terrible diarrhea, uncontrollable"; MYALGIA (non-serious) with onset 14Oct2023, outcome "unknown", described as "Muscle ache"; FATIGUE (non-serious) with onset 14Oct2023, outcome "unknown", described as "Very tired; unable to even pick my head off the pillow"; SLEEP DISORDER (non-serious) with onset Oct2023, outcome "unknown", HYPERSOMNIA (non-serious) with onset 16Oct2023, outcome "unknown" and all described as "I don't sleep a lot but I slept 10 hours last night"; ILLNESS (non-serious) with onset Oct2023, outcome "recovered" (Oct2023), described as "I was my very sick for 2 days". Therapeutic measures were taken as a result of myalgia, fatigue, abdominal discomfort, diarrhoea, illness, sleep disorder, hypersomnia.  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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use, Product use issue, Sleep disorder
Clinical narrative: I don't sleep a lot but I slept 10 hours last night; Muscle ache; Very tired; unable to even pick my head off the pillow; It went in to stomach situation; terrible diarrhea, uncontrollable; It went in to stomach situation; terrible diarrhea, uncontrollable; I actually also had a shot of the flu vaccine; I actually also had a shot of the flu vaccine; I was my very sick for 2 days; I don't sleep a lot but I slept 10 hours last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose number unknown (booster), single (Lot number: HG4633, Expiration Date: Dec2023) at the age of 79 years for covid-19 immunisation; for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 12Oct2023 as dose number unknown, single (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Oct2023, outcome "unknown" and all described as "I actually also had a shot of the flu vaccine"; ABDOMINAL DISCOMFORT (non-serious), DIARRHOEA (non-serious) all with onset 14Oct2023, outcome "unknown" and all described as "It went in to stomach situation; terrible diarrhea, uncontrollable"; MYALGIA (non-serious) with onset 14Oct2023, outcome "unknown", described as "Muscle ache"; FATIGUE (non-serious) with onset 14Oct2023, outcome "unknown", described as "Very tired; unable to even pick my head off the pillow"; SLEEP DISORDER (non-serious) with onset Oct2023, outcome "unknown", HYPERSOMNIA (non-serious) with onset 16Oct2023, outcome "unknown" and all described as "I don't sleep a lot but I slept 10 hours last night"; ILLNESS (non-serious) with onset Oct2023, outcome "recovered" (Oct2023), described as "I was my very sick for 2 days". Therapeutic measures were taken as a result of myalgia, fatigue, abdominal discomfort, diarrhoea, illness, sleep disorder, hypersomnia.  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: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: Has migraines from fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (unspecified date) Positive; (unspecified date) Positive; Weight: (10May2020) 160 or 150. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: Caller stated she took all of the Pfizer covid 19 vaccines, she had the original, the reinforcer and got the boosters. She continually got covid virus and reported having covid 4 times. 07Sep was her last test and the antigens were negative and the proteins and peptides were positive. Patient took original vaccine then, got booster twice, both of them. Still tested positive 4 times, not 14 weeks, for 8 weeks every time, still had it. Caller stated, she still had Covid, after taking original vaccine and booster, twice. They changed name to long term Covid.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328893 same patient, product, different dose number/event;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: within 24hrs of injection was lethargic and tired. Pain at injection site.; within 24hrs of injection was lethargic and tired. Pain at injection site.; within 24hrs of injection was lethargic and tired. Pain at injection site.; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pregnancy induced nausea" (unspecified if ongoing). The patient was 1 trimester pregnant at the time of exposure to bnt162b2 omi xbb.1.5. The patient was 1 trimester pregnant at the event onset. The patient took concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 14Oct2023, outcome "unknown", described as "Maternal Exposure During Pregnancy, first trimester"; LETHARGY (non-serious), FATIGUE (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 15Oct2023, outcome "recovered" and all described as "within 24hrs of injection was lethargic and tired. Pain at injection site.". Therapeutic measures were not taken as a result of lethargy, fatigue, vaccination site pain.  Additional information: Delivery date was reported as May2024. Vaccine was administered at Pharmacy or Drug Store. Other medications reported in two weeks was antinausea. Patient reported no history of COVID disease before and after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; 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)), on 14Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset Oct2023, outcome "unknown".  Additional information: It was reported that the patient did not take any other vaccine in four weeks and was not tested covid prior and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history.  No known allergies. The patient did not receive other medication in 2weeks.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The patient received Paxlovid for COVID-19 as treatment from 09Oct2023 to 13Oct2023, while the patient rebound of symptoms of congestion, headache, Chills, mild fever since 17Oct2023. The patient was recovering. 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: Chills, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Chills; Sweats; Fever; 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)), in Oct2023 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 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Chills", "Sweats", "Flu like symptoms", "Fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "Chills", "Sweats", "Flu like symptoms", "Fever"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "Chills", "tired", "Very bad headache", "Sweats", "side effects to both the second shot and both boosters; flu like symptoms", "Fever". The following information was reported: CHILLS (non-serious) with onset Oct2023, outcome "unknown"; PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "Fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "Flu like symptoms"; HYPERHIDROSIS (non-serious) with onset Oct2023, outcome "unknown", described as "Sweats".  Additional Information: Concern: reporter stated that  they had the Pfizer 2 weeks ago and every time they get it. Patient had every shot, every booster including the last booster. Except for the very first dose, they had side effects on everyone. Where patient have had flu like symptoms fever, chills, sweats the hyper thing that last about 24 hours and then patient was fine, but they have had them with every injection other than the first one and they just wanted to make aware of that.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200550445 same patient/product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: generalized 'ick' feeling of being unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received bnt162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obese" (unspecified if ongoing), notes: obese and have taken Levothyroxine for hypothyroidism; "hypothyroidism" (unspecified if ongoing), notes: obese and have taken Levothyroxine for hypothyroidism. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 27Mar2021, for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "generalized 'ick' feeling of being unwell".  Additional information: The patient had experienced what she believed to be a side effect from the COMIRNATY shot she received on 20Sep2023. Previously she had the Pfizer Covid shots on 27Mar2021. The only other side effect she had was after shot #2 (17Apr2021) that gave her a generalized 'ick' feeling of being unwell. She was obese and had taken Levothyroxine for hypothyroidism for over 20 years. Other than that she had no other prescriptions or conditions.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300173023 same patient, different dose number/events;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.It was reported that Pfizer / BioNTech was Vaccine dose number "2". Patient received Paxlovid from 05Oct2023 to 10Oct2023 for COVID 19 Treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient. A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 08Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Peanuts" (unspecified if ongoing); "Known Allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient reported receiving Paxlovid for COVID-19 treatment from 08Oct2023 to 12Oct2023. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "known allergies: CT contrast dye" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; SYNTHROID; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]; NUVARING. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 12:15 as dose 1, single (Lot number: HG4629) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose 6, Time: 10:30 AM,, lot number: GJ6743,, vaccine location: Right arm), administration date: 20Apr2023, when the patient was 78-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 5, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 4, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 3 MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID Treatment).  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy (Vaccination failure and COVID-19) with the suspect vaccine bnt162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for COVID 19 treatment from 03Oct2023 to 08Oct2023. The patient experienced Covid rebound at 04:00 PM on 15Oct2023. The final outcome was recovering.  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: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP).  An elderly male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (life threatening), outcome "unknown", described as "Stroke". It was unknown if covid prior vaccination and if covid tested post vaccination. The individual (a neighbor) said that he felt the vaccine contributed to a stroke he had. Event resulted in life threatening illness (immediate risk of death from the event).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Hypersensitivity
Clinical narrative: allergies are off the chart today; 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 rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies are off the chart today". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter (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 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 "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she just recently tested positive for  Covid-19. 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: 50.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Influenza, Malaise, Seasonal allergy, Smear cervix
Clinical narrative: was having issues with seasonal allergies; not feeling well after getting shots; flu symptoms last week due to the flu shot; Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-hcp.  This case involves a 50-years-old female patient (48 kg) who was not feeling well after getting shots, had flu symptoms last week due to the flu shot and was having issues with seasonal allergies after receiving tetanus toxoid and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included sulfamethoxazole, trimethoprim (Bactrim); Furosemide; Ondansetron; Sulfamethoxazole, Trimethoprim; Spironolactone; salbutamol sulfate (Proair); Oxygen; Ambrisentan; sildenafil citrate (Sildenafil); Fluconazole; Mycophenolate Mofetil; paracetamol (Tylenol); diphenhydramine hydrochloride (Benadryl); pantoprazole sodium sesquihydrate (Pantoprazole Sodium); and treprostinil sodium (Remodulin) for Product used for unknown indication.  On 14-Sep-2023, the patient received unknown dose of suspects influenza vaccine produced by unknown manufacturer and tetanus toxoid produced by unknown manufacturer (strength, formulation, batch number, expiry date unknown) via unknown route in unknown administration site for Influenza immunization and Tetanus immunization respectively.  On 17-Sep-2023 the patient had not feeling well after getting shots (malaise) (latency: 3 days) following the administration of influenza vaccine and tetanus toxoid.  On an unknown date in Sep-2023 the patient had flu symptoms last week due to the flu shot (influenza) (unknown latency) following the administration of influenza vaccine and (tetanus toxoid.  On an unknown date in 2023 the patient was having issues with seasonal allergies (seasonal allergy) (unknown latency) following the administration of influenza vaccine and tetanus toxoid.  Relevant laboratory test results included: Smear cervix - on an unknown date in September 2023: [result unknown]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (not feeling well after getting shots, flu symptoms last week due to the flu shot, was having issues with seasonal allergies).  At time of reporting, the outcome was Unknown for all the events.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: given ACT-HIB on 13Oct2023, but the vaccine was already 6 days past its expiration date (with no reported adverse event); Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who was given act-hib on 13oct2023, but the vaccine was already 6 days past its expiration date (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 rotavirus vaccine live reassort oral 5V (Rotateq), diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (vero), tetanus vaccine toxoid (Pediarix) and pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 13-Oct-2023, the patient received 0.5 ml (dose 1) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection lot UJ784AA, expiry date: 07-Oct-2023 via intramuscular route in the left thigh for immunization (strength: unknown) but the vaccine was already 6 days past its expiration date (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 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 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: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .5ml and is labeled as "single dose", erroneously given full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: did not get the full dose added that there was 0.3 mL of the vaccine left in the syringe with no reported adverse event; Initial information received on 15-Oct-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a 3 years old female patient who did not get the full dose added that there was 0.3 ml of the influenza quadrival a-b vaccine [Fluzone qiv] left in the syringe 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 quadrival a-b vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength, and expiration date: not provided) for Immunisation (incorrect dose 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.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to chemicals, Gastrointestinal disorder, Respiratory disorder, Skin disorder
Clinical narrative: Skin issues; This spontaneous case was received on 10-Oct-2023 from other health professional via agency (reference number SEQW23-03184) and concerned a female patient of unreported age.  The patient's concurrent condition included allergy to formaldehyde. The patient's concomitant medication were not reported.  On an unspecified date, the patient was vaccinated with Influenza virus vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date, a couple days after receiving influenza virus vaccine, the patient experienced some skin issues and did not have a severe reaction. The patient found out through testing their home that they had some chemicals that were causing her and her kids some issues, respiratory and GI (gastrointestinal). Additionally, the patient found out that she did have sensitive reaction to formaldehyde, as reported. The patient asked was it okay to take flu shot again and wanted to know about formaldehyde in Flucelvax. As reported, the patient was panicking and freaking out because in consent form there was a question: Have you ever had a reaction to formaldehyde?   On an unspecified date, the patient recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A female patient of unreported age was vaccinated with influenza virus vaccine. After unknown amount of time (reportedly, a couple of days after receiving the influenza vaccine), patient noticed some skin issues that were not severe. As reported, patient has an known allergy to formaldehyde. Concomitant medication and relevant diagnostic findings were not provided. Considering lack of information regarding chronology, vaccination date and event onset date, as well as other above mentioned relevant information, causal role of the suspect vaccine for the event of skin disorder is unassessable.; Sender's Comments: A female patient of unreported age was vaccinated with influenza virus vaccine. After unknown amount of time (reportedly, a couple of days after receiving the influenza vaccine), patient noticed some skin issues that were not severe. As reported, patient has an known allergy to formaldehyde. Concomitant medication and relevant diagnostic findings were not provided. Considering lack of information regarding chronology, vaccination date and event onset date, as well as other above mentioned relevant information, causal role of the suspect vaccine for the event of skin disorder is unassessable.
Sex: U
Vaccine: FLUA4
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness, Visual impairment
Clinical narrative: Visualize geometric figures while on computer; Couldn't get out of bed cause was stiff; Pain in every joint; This spontaneous case from was received on 12-Oct-2023 from other non-healthcare professional via  Communications (reference number SEQW23-03327) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.   On 04-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, anatomical location: not reported) as the doctor prescribed, as reported. The batch was not reported.  On 05-Oct-2023, one day after receiving Fluad Quadrivalent vaccine, the patient could not get out of bed because he was stiff and had felt pain in every joint.  On 06-Oct-2023, the patient visualized geometric figures while on the computer.  On 09-Oct-2023, the patient went to the ophthalmologist, and he said that it was not from the eyes and that there was nothing wrong with the retina.  At the time of initial reporting, the patient was recovering from the events of 'visual impairment', 'musculoskeletal stiffness', and 'arthralgia'. It was reported that the patient got better from the symptoms.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced stiffness and felt pain in every joint. As reported, the patient visualized geometric figures while on the computer. The patient went to the ophthalmologist, and he said that it was not from the eyes and that there was nothing wrong with the retina. The patient's medical history and concomitant medications were not reported. Information regarding additional laboratory findings and diagnostic data was not provided. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the event musculoskeletal stiffness, arthralgia and visual impairment, with the currently available information and chronological plausibility.; Sender's Comments: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced stiffness and felt pain in every joint. As reported, the patient visualized geometric figures while on the computer. The patient went to the ophthalmologist, and he said that it was not from the eyes and that there was nothing wrong with the retina. The patient's medical history and concomitant medications were not reported. Information regarding additional laboratory findings and diagnostic data was not provided. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the event musculoskeletal stiffness, arthralgia and visual impairment, with the currently available information and chronological plausibility.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6m-11yr covid vaccine.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dysarthria, Eyelid function disorder, Eyelid ptosis, Fatigue, Feeling hot
Clinical narrative: Pt was given her Annual Advocate employee Influenza vaccine yesterday afternoon at ~2:05 pm. Approximately 1 hour later, she was feeling very hot and the left side of her mouth started to become numb, This progressed over about 30 min to numbness in the cheek area and slight left eyelid droop. Barely noticeable droop but fairly significant delay when blinking. Right blink faster than left. Denied HA. No noticeable mouth droop but very slight delay or slur in her speech. Pt had a stroke in March of this year with some left-sided residual weakness that had been almost completely resolved prior to this episode. She does state that sometimes when she is very stressed she will feel the slight numbness/tingling in her face, but this is more pronounced. Strongly encouraged to go to ED. Cannot go to the ED (where we were at the time) due to her insurance. Informed we did not want her to drive. Pt preferred to wait and see if it would go away or progress any further. Had a full staff of 3 RN's 2 Dr's an NP and several MA's here in the office monitoring her. It did not get any worse than as described above, but she was very tired.  After about 45 min, she stated the numbness on the lips was getting better, still tired and left eye blink lagging a little bit. No limb numbness or weakness At ~8pm last night, contacted pt and she stated she was feeling better. Resting now. No mouth numbness. Still a little numbness around left eye and cheek. Had gone to her Chiropractor who worked with her ~1 hour and suggested NO MORE FLU SHOTS. She will also contact her Neurologist. When asked this morning how she was doing, it was about the same- very slight improvement. Eye still sl droopy. No more mouth/cheek tingling. However, she states she had to use her Albuterol inhaler last night and again this morning for some wheezing
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Impaired driving ability, Paraesthesia, Paraesthesia oral
Clinical narrative: Pt was given her Annual Advocate employee Influenza vaccine yesterday afternoon at ~2:05 pm. Approximately 1 hour later, she was feeling very hot and the left side of her mouth started to become numb, This progressed over about 30 min to numbness in the cheek area and slight left eyelid droop. Barely noticeable droop but fairly significant delay when blinking. Right blink faster than left. Denied HA. No noticeable mouth droop but very slight delay or slur in her speech. Pt had a stroke in March of this year with some left-sided residual weakness that had been almost completely resolved prior to this episode. She does state that sometimes when she is very stressed she will feel the slight numbness/tingling in her face, but this is more pronounced. Strongly encouraged to go to ED. Cannot go to the ED (where we were at the time) due to her insurance. Informed we did not want her to drive. Pt preferred to wait and see if it would go away or progress any further. Had a full staff of 3 RN's 2 Dr's an NP and several MA's here in the office monitoring her. It did not get any worse than as described above, but she was very tired.  After about 45 min, she stated the numbness on the lips was getting better, still tired and left eye blink lagging a little bit. No limb numbness or weakness At ~8pm last night, contacted pt and she stated she was feeling better. Resting now. No mouth numbness. Still a little numbness around left eye and cheek. Had gone to her Chiropractor who worked with her ~1 hour and suggested NO MORE FLU SHOTS. She will also contact her Neurologist. When asked this morning how she was doing, it was about the same- very slight improvement. Eye still sl droopy. No more mouth/cheek tingling. However, she states she had to use her Albuterol inhaler last night and again this morning for some wheezing
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Slow speech, Wheezing
Clinical narrative: Pt was given her Annual Advocate employee Influenza vaccine yesterday afternoon at ~2:05 pm. Approximately 1 hour later, she was feeling very hot and the left side of her mouth started to become numb, This progressed over about 30 min to numbness in the cheek area and slight left eyelid droop. Barely noticeable droop but fairly significant delay when blinking. Right blink faster than left. Denied HA. No noticeable mouth droop but very slight delay or slur in her speech. Pt had a stroke in March of this year with some left-sided residual weakness that had been almost completely resolved prior to this episode. She does state that sometimes when she is very stressed she will feel the slight numbness/tingling in her face, but this is more pronounced. Strongly encouraged to go to ED. Cannot go to the ED (where we were at the time) due to her insurance. Informed we did not want her to drive. Pt preferred to wait and see if it would go away or progress any further. Had a full staff of 3 RN's 2 Dr's an NP and several MA's here in the office monitoring her. It did not get any worse than as described above, but she was very tired.  After about 45 min, she stated the numbness on the lips was getting better, still tired and left eye blink lagging a little bit. No limb numbness or weakness At ~8pm last night, contacted pt and she stated she was feeling better. Resting now. No mouth numbness. Still a little numbness around left eye and cheek. Had gone to her Chiropractor who worked with her ~1 hour and suggested NO MORE FLU SHOTS. She will also contact her Neurologist. When asked this morning how she was doing, it was about the same- very slight improvement. Eye still sl droopy. No more mouth/cheek tingling. However, she states she had to use her Albuterol inhaler last night and again this morning for some wheezing
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: the vaccine was not diluted properly, so patient got higher amount of vaccine than recommended. pt experience no adverse events
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6m-11yrs covid vaccine.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, Complement factor C4, Dysstasia
Clinical narrative: Diagnosis- serum sickness like response.   1 week after vaccination, he developed a fever. 3 days later (10 days post vaccine) he broke out in what appeared to be full body hives, ped diagnosed post viral hives to an unknown virus and told to take antihistamines. The next day, he couldn't bear weight on his legs and his knees were painful and swollen, rash had changed to red circles with clearings in the middle so he was seen again. Suspicion of serum sickness like response and prescribed prednisilone which eased the knee swelling. As of 10/20/23 he is still experiencing symptoms.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Joint swelling, Pyrexia, Rash, Red blood cell sedimentation rate
Clinical narrative: Diagnosis- serum sickness like response.   1 week after vaccination, he developed a fever. 3 days later (10 days post vaccine) he broke out in what appeared to be full body hives, ped diagnosed post viral hives to an unknown virus and told to take antihistamines. The next day, he couldn't bear weight on his legs and his knees were painful and swollen, rash had changed to red circles with clearings in the middle so he was seen again. Suspicion of serum sickness like response and prescribed prednisilone which eased the knee swelling. As of 10/20/23 he is still experiencing symptoms.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Serum sickness-like reaction, Urticaria
Clinical narrative: Diagnosis- serum sickness like response.   1 week after vaccination, he developed a fever. 3 days later (10 days post vaccine) he broke out in what appeared to be full body hives, ped diagnosed post viral hives to an unknown virus and told to take antihistamines. The next day, he couldn't bear weight on his legs and his knees were painful and swollen, rash had changed to red circles with clearings in the middle so he was seen again. Suspicion of serum sickness like response and prescribed prednisilone which eased the knee swelling. As of 10/20/23 he is still experiencing symptoms.
Age: 64.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Hypersomnia
Clinical narrative: patient fell asleep and did not wake up for more than 24 hours to go to the bathroom, then fell asleep again for another undetermined length of time.  Patient came in today to report adverse reaction otherwise seems to be okay today
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: vaccine was not diluted properly, therefore patient got higher dose than recommended . not adverse effects
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Cyanosis, Injection site discolouration, Injection site haemorrhage, Injection site nodule
Clinical narrative: She called about 5pm and said she had just took bandaid off and there was dried bllod, and sall circular blue spot around the injection site,and a small knot about size of a pea. She said it was not really painful. When I gave the shot it bled quite a bit. I had put 2 bandaids on it. Sh e said she was taking tylenol for it, I had advised ibuprofen, but she said she could not take it due to stomach issues. SHe said she gets the flu shot every year and that has never happened. I told her to keep taking the tylenol q 6h, and I would follow up with her on 10/21 to make sure its not gotten any worse.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6m - 11yr covid vaccine.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .5ml and is labeled as "single dose", erroneously given full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6m-11yr covid vaccine.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.5ml dose instead of 0.25ml of the single dose vial 6 months through 11 years moderna covid vaccine
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: back pain, arm pain, sharp pains
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: vaccine was not diluted properly, so patient got higher then recommended dose of vaccine, not adverse events
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Syncope, Vomiting
Clinical narrative: Vomiting, fainting, unable to walk
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6m-11yr covid vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Pt received 0.5ml instead of 0.25ml Moderna 6m-11yr covid vaccine.