chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: The plastic adapter, the part that punctures the vial snapped, it bent and broke when we were trying to insert into the vial rubber; defective; The plastic adapter, the part that punctures the vial snapped, it bent and broke when we were trying to insert into the vial rubber; defective; The initial case was missing the following minimum criteria: [no adverse effect]. Upon receipt of follow-up information on [28Nov2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM0167, Expiration Date: Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE DEFECTIVE (non-serious) and all described as "The plastic adapter, the part that punctures the vial snapped, it bent and broke when we were trying to insert into the vial rubber; defective". Additional information: They were in the process of giving an Abrysvo vaccine and when they begin to insert the vaccine cap over top of the vial, the little plastic, the plastic adapter the part that punctures the vial snapped, it bent and broke when we were trying to insert into the vial rubber. Obviously at that point of time is very hard to seat it down properly and it would not draw the correct amount of, put in correct amount of saline into the vial to mix. Is there any way that they can get a replacement product of this defective one, they had saved a defective one for inspection.  Causality for "the plastic adapter, the part that punctures the vial snapped, it bent and broke when we were trying to insert into the vial rubber; defective" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID on 03Dec2023; Tested positive for COVID on 03Dec2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Lot number: HF9275) at the age of 36 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER), Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (BOOSTER), Manufacturer Unknown), for Covid-19 immunization. No other vaccine in four weeks. No other medications in two weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Dec2023 at 12:00, outcome "recovering" and all described as "Tested positive for COVID on 03Dec2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Dec2023) Positive, notes: Nasal Swab, Flowflex COVID-19 Antigen Home Test. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, Eye pain
Clinical narrative: Covid vaccine sprayed into my eye, in my face and on my arm.; Covid vaccine sprayed into my eye, in my face and on my arm.; Covid vaccine sprayed into my eye, in my face and on my arm.; eye and the area around it stung a little; 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 (PFIZER-BIONTECH COVID-19 VACCINE (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: ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), EXPOSURE VIA EYE CONTACT (non-serious) all with onset 03Dec2023, outcome "unknown" and all described as "Covid vaccine sprayed into my eye, in my face and on my arm."; EYE PAIN (non-serious) with onset 03Dec2023, outcome "unknown", described as "eye and the area around it stung a little".  Additional information: The reporter stated that "while my daughter was receiving a covid vaccine booster on 03Dec2023, a faulty syringe separated from the needle and Covid vaccine sprayed into my eye, in my face and on my arm. My eye and the area around it stung a little. The pharmacist that administered the vaccine at (withheld) said there's nothing to worry about. A (withheld) search didn't yield any results."  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-PV202300198267 Same reporter, drug and event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain, long lasting pain in my shoulder; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) 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: ARTHRALGIA (non-serious), outcome "unknown", described as "Pain, long lasting pain in my shoulder". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: has been burning when injected. I have so far experienced that with 3-4 patients; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Lot number: HM7010, Expiration Date: 10Apr2024) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "has been burning when injected. I have so far experienced that with 3-4 patients".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300198383 Same reporter/ product/ AE, different patients.;
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: has been burning when injected. I have so far experienced that with 3-4 patients; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1 single (Lot number: HM7010, Expiration Date: 10Apr2024) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "has been burning when injected. I have so far experienced that with 3-4 patients".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300198383 Same reporter/ product/ AE, different patients.;
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: developed PMR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72-year-old female 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: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "developed PMR". Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical Course: Caller was calling on behalf of her 71 years old sister. Her sister after getting three Pfizer Covid vaccines (clarified as Pfizer COVID-19 Vaccine) developed PMR (Polymyalgia rheumatica) and currently had no info regarding this, but she wanted to know about the PMR (Polymyalgia rheumatica). She got PMR (Polymyalgia rheumatica) probably that for over two years. Height and weight: Reporter stated, she don't know. She was calling about her sister but her sister lives in PRIVACY. When confirmed the Country as PRIVACY: Reporter stated: No, PRIVACY. Treatment of event: Reporter stated, She was on Prednisone for 2 years, that's all she knew.  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-202300414990 Same patient, same product, different dose.;
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (Booster), Single; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Nov2023, outcome "recovered" (04Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Nov2023) Positive, notes: Patient had positive home COVID test 28Nov2023; (04Dec2023) Negative, notes: negative home COVID test 04Dec2023; (06Dec2023) Positive, notes: 06Dec2023 and home test positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had positive home COVID test 28Nov2023, completed 5-day course of Paxlovid with resolution of symptoms and negative home COVID test 04Dec2023. The patient received Anti-viral drug Paxlovid started from 28Nov2023 to 02Dec2023 for the treatment of COVID-19. No known allergies.   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: 30.0
Sex: F
Vaccine: COVID19, 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 31-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years 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: "thyroid condition" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Anti-viral COVID-19 treatment with Paxlovid from 30Nov2023 to 04Dec2023. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 31-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 27Nov2023 to 01Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19 from 27Nov2023 to 02Dec2023.  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: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 42-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: I first tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (start date 30Nov2023, stop date 04Dec2023). Clinical course: No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Got the Pfizer product a few days ago and within 48 hours he has had 45 TIA's and he's never had them before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, 30 ug single (Lot number: HG4675, Expiration Date: 31Jan2024) for covid-19 immunisation; for covid-19 immunisation, Device Lot Number: HG4675, Device Expiration Date: 31Jan2024. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 2023, 48 hrs after the suspect product(s) administration, outcome "recovered" (2023), described as "Got the Pfizer product a few days ago and within 48 hours he has had 45 TIA's and he's never had them before". Therapeutic measures were taken as a result of transient ischaemic attack. Clinical Course: Reporter was calling for her father. He had Moderna for all previous doses. Got the Pfizer product a few days ago and within 48 hours he had 45 TIA's and he never had them before. They resolved themselves but she wished someone would have said something before. Reporter was asking if it was just temporary to have these or would they continue. He did not have any for the last two days. They put him on Plavix and a baby aspirin. Pfizer was unable to state if the TIA's would be a limited experience or would continue. Reporter stated, On newest Pfizer vaccine the one that just came out. The vaccine was for her father. He had the Moderna (COVID-19 vaccine) one the first time and then he went to (withheld) for his next one and the (withheld) said all they have was Pfizer. When asked if it could be mixed, they said yes. Reporter did not know that, but after her father had this one, Within 48 hours, he started to having TIA (Transient Ischemic attack). 48 hours later, he had multiple TIA's, they resolved themselves. Reporter asked, how long this would stay in his system and why was, would he continue to have TIA with this vaccine. Since he had 4 of them that we know of, the vaccine.   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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Previous ling surgery" (unspecified if ongoing); "history of smoking" (ongoing); "current nicotine vape user" (ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's 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 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (07Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2023) Negative, notes: Had mild Covid with paxlovid, recovered, tested negative on 7. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 29Nov2023 to 03Dec2023.  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
Clinical narrative: So the second time i got COVID-19; So the second time i got COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "So the second time i got COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 21Nov2023 to 26Nov2023.  Clinical course: It was reported that this was a positive effect. The first time the patient got covid-19 in Jul2022, her senses of smell and taste went away almost completely (~75%) and never returned to normal. So the second time she got COVID-19 most recently, she was terrified that those senses were going to completely diminish. By the second Paxlovid treatment her senses returned to 100% of what they were before, and they didn't seem to go away after finishing her treatment.
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder, Illness, Neuropathy peripheral
Clinical narrative: occipital neuropathy on the left side of my brain; bad side effect in left eye/my left eye going to change, it stopped working; I am just sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old patient received bnt162b2 (BNT162B2), on 31Jul2021 as dose 2, single (Lot number: FA7485) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "occipital neuropathy on the left side of my brain"; EYE DISORDER (non-serious), outcome "unknown", described as "bad side effect in left eye/my left eye going to change, it stopped working"; ILLNESS (non-serious), outcome "unknown", described as "I am just sick". The events "occipital neuropathy on the left side of my brain", "bad side effect in left eye/my left eye going to change, it stopped working" and "i am just sick" required physician office visit and emergency room visit. Clinical course: Got a bad side effect in left eye; patient did have occipital neuropathy on the left side of brain; The pain went from the neck through the middle of patient's brain. Went to the ER. the last doctor patient checked, they told it did have occipital neuropathy on the left side of his brain. Patient had CNS7074, had SK9890 could not see. Patient had it on 31Jan2022 That was all. Patient had the second dose and had no problem with that. Patient was in advocate and advocating the vaccine. Patient got the 1st dose, second dose, and then wanted to take the third dose, there was no medical reason. They were mandate at the that time to take the vaccine. Patient had no problem with metformin. When patient had the vaccine, went home and slept and when woke up in the morning, left eye going to change, it stopped working, brain like something was working in patient brain, patient got up and had the side effect, went to the pharmacy where had this problem, explained this problem and they were just making fun and then they just asked patient to go to the ER and patient went to the ER.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke due to Pfizer vaccine; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on (05Dec2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer covid-19 vaccine (Dose 1, single, Lot number: EM9809), administration date: 05Jan2021, for Covid-19 immunization; pfizer covid-19 vaccine (Dose 2, single, Lot number: EN6203), administration date: 26Feb2021, for Covid-19 immunization, reaction(s): "1st Dose COVID-19 Date: 01/05/21 //  2nd Dose COVID-19 Date 02/26/21"; pfizer covid-19 vaccine (Dose 3 (Booster), single, Lot number: 30145BA), administration date: 06Oct2021, for Covid-19 immunization; pfizer covid-19 vaccine (Dose 4 (Booster), single, Lot number: FK9895), administration date: 22Apr2022, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 09Jan2023, outcome "not recovered", described as "Stroke due to Pfizer vaccine". Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: No surgery was planned before taking the suspect.  As per reporter, issues occurred after use of a Pfizer product.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: made me immune compromised; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly 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 and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "made me immune compromised". Additional information: Pfizer vaccines (also reported as Comirnaty) made me immune compromised.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Respiratory paralysis
Clinical narrative: Have a paralyzed right lung; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot (I am a post-polio victim so I've always gotten the flu shot), for immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN, Manufacturer Unknown), administration date: Sep2023, for Covid-19 Immunization. The following information was reported: LUNG DISORDER (medically significant), outcome "unknown", described as "Have a paralyzed right lung". Clinical courses is as follows: Patient called for assistance with RSV vaccine. The patient stated "The dilemma I'm having is I am a post-polio victim so I've always gotten the flu shot I got my covid shot when I went to my one of my follow up doctors' appointments in Sep he gave me my regular flu shot and then he told me I have to get my covid at the pharmacy and to get the RSV shot became I have a paralyzed right lung."  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: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: has been burning when injected. I have so far experienced that with 3-4 patients; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Lot number: HM7010, Expiration Date: 10Apr2024) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "has been burning when injected. I have so far experienced that with 3-4 patients".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300434730 Same reporter/ product/ AE, different patients.;US-PFIZER INC-202300434731 Same reporter/ product/ AE, different patients.;US-PFIZER INC-202300434732 Same reporter/ product/ AE, different patients.;
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Dyspnoea, Exercise tolerance decreased, Fatigue, Muscle atrophy
Clinical narrative: re-immerging of Ulcerative colitis; fatigue; shortness of breath; muscle atrophy; Can only run 2-3 miles at 11 mint now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 21Jul2021 as dose 1, single (Lot number: FA6780) at the age of 49 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis", start date: 2015 (ongoing); "Cold sores", start date: 2010 (ongoing). The patient's concomitant medications were not reported. The following information was reported: EXERCISE TOLERANCE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Can only run 2-3 miles at 11 mint now"; FATIGUE (non-serious) with onset 01Aug2021, outcome "not recovered"; MUSCLE ATROPHY (non-serious) with onset 01Aug2021, outcome "not recovered"; COLITIS ULCERATIVE (medically significant) with onset 01Aug2021, outcome "unknown", described as "re-immerging of Ulcerative colitis"; DYSPNOEA (non-serious) with onset 01Aug2021, outcome "not recovered", described as "shortness of breath". The events "fatigue" and "shortness of breath" required physician office visit. Therapeutic measures were not taken as a result of colitis ulcerative, fatigue, dyspnoea, muscle atrophy.  Clinical course: Since covid vaccine was running 4-6 miles a day at sub 10 min miles. Can only run 2-3 miles at 11 mint now. Patient had been sick for 2 years Covid twice, shingles, ear infection(1SEP2021) & patient ulcerative colitis came back something just feels off in his body, patient have always been healthy until the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Transient ischaemic attack
Clinical narrative: killed my mom two years ago/strokes; TIAs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An 100-year-old female patient received bnt162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (death) with onset 2021, outcome "fatal", described as "TIAs"; CEREBROVASCULAR ACCIDENT (death) with onset 2021, outcome "fatal", described as "killed my mom two years ago/strokes". The patient date of death was 2021. Reported cause of death: "killed my mom two years ago/strokes", "TIAs". It was not reported if an autopsy was performed. Clinical course: it killed reporter's mom two years ago she died from the covid vaccine, she was 100 and the second one just knocked her out into strokes, she got TIAs after the second on like right after that week and she died of a stroke a week and half later."  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: killed my mom two years ago/strokes; TIAs
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Back pain, Frequent bowel movements, Headache, Jaundice
Clinical narrative: frequent evacuation; gastrointestinal upset; back pain; jaundice; prickling in finger tips, hands and heels; significant malaise; within 18 hours headache began; Initial information was received on 05-Dec-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional (Patient).  This case involves a 57 years old female patient who experienced within 18 hours headache began, frequent evacuation, significant malaise, gastrointestinal upset, back pain, jaundice and prickling in finger tips, hands and heels after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.   On 03-Dec-2023, the patient received a unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE  (Suspension for injection) (lot UT8076MA,strength, expiry date was unknown) via intramuscular route in unknown administration site for prophylactic vaccination(Immunization).  On 03-DEC-2023 the patient developed within 18 hours headache began (headache), frequent evacuation (frequent bowel movements), significant malaise (malaise) , gastrointestinal upset (abdominal discomfort), back pain, jaundice and prickling in finger tips, hands and heels (paraesthesia) (latency : same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (within 18 hours headache began, frequent evacuation, significant malaise, gastrointestinal upset, back pain, jaundice, prickling in finger tips, hands and heels).  At time of reporting, the outcome was Recovering / Resolving for all the events.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Paraesthesia
Clinical narrative: frequent evacuation; gastrointestinal upset; back pain; jaundice; prickling in finger tips, hands and heels; significant malaise; within 18 hours headache began; Initial information was received on 05-Dec-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional (Patient).  This case involves a 57 years old female patient who experienced within 18 hours headache began, frequent evacuation, significant malaise, gastrointestinal upset, back pain, jaundice and prickling in finger tips, hands and heels after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.   On 03-Dec-2023, the patient received a unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE  (Suspension for injection) (lot UT8076MA,strength, expiry date was unknown) via intramuscular route in unknown administration site for prophylactic vaccination(Immunization).  On 03-DEC-2023 the patient developed within 18 hours headache began (headache), frequent evacuation (frequent bowel movements), significant malaise (malaise) , gastrointestinal upset (abdominal discomfort), back pain, jaundice and prickling in finger tips, hands and heels (paraesthesia) (latency : same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (within 18 hours headache began, frequent evacuation, significant malaise, gastrointestinal upset, back pain, jaundice, prickling in finger tips, hands and heels).  At time of reporting, the outcome was Recovering / Resolving for all the events.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD was given to a patient under 65 with no reported adverse event; Initial information received from on 30-Nov-2023 regarding an unsolicited valid  non-serious case received from nurse.  This case involves a 43 years old female patient and reporter reported Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] was given to a patient under 65 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Sep-2023, the patient received 0.7 ml total of suspect Influenza Quadrival A-B High Dose Hv Vaccine (with an unknown formulation, strength, expiry date, lot number) (Frequency: once) via unknown route in unknown administration site for influenza immunization.  On an unknown date in Sep-2023, the patient received Influenza Quadrival A-B High Dose Hv Vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, Nurse requested for information on what should they do if FLUZONE HD was given to a patient under 65. Will it harm the patient! Information provided based from Healthy adults under 65 years of age and was also sent via email per Nurse's request. Batch/lot number requested, not available at the time of call. Follow-up with caller possible.  This situation is pre-assessed as a medication error/an inappropriate use due to administration of vaccine to a patient under 65 years of age.   Action taken: not applicable.   Outcome: 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: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discharge, No adverse event
Clinical narrative: half of the vaccine leaked out of the injection site with no reported adverse event; Initial information received on 30-Nov-2023 regarding an unsolicited valid non-serious case received via pharmacist.  This case involves a 48-year-old male patient and the reporter stated influenza quadrival A-B vaccine [Fluzone QIV] half of the vaccine leaked out of the injection site with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Nov-2023, the patient received a 0.5 ml dose of suspect influenza quadrival A-B vaccine, suspension for injection (strength: unknown) (lot: U8201EA, Expiry date: 20-Jun-2024) via intramuscular route in the right deltoid for immunization and half of the vaccine leaked out of the injection site with no reported adverse event (incorrect dose administered) (latency: same day)  Reportedly, he administered the medication to the patient, there was no issues or leakage during the medication preparation, but when he injected it into the patient's deltoid, for some reason, perhaps it was because of the patient's body fat or body mass said the pharmacist, approximately half of the vaccine leaked out of the injection site. Pharmacist also asks if they should use the alternate deltoid as the injection site for re-vaccination  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: Incorrect route of product administration, No adverse event
Clinical narrative: accidental IV administration of Fluzone Quadrivalent with no reported adverse event; Initial information received on 01-Dec-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and reporter reported accidental iv administration of Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] 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 Vaccine Suspension for injection (with an unknown strength, expiry date, lot number) via intravascular not otherwise specified route in unknown administration site for immunization.  On an unknown date, the reporter reported accidental iv administration of Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] with no reported adverse event (incorrect route of product administration) (latency: same day).  It was reported, The pharmacist states that she would like to know if there is any information about accidental IV administration of Fluzone Quadrivalent (she thinks it is involving the prefilled syringe) and what to monitor. She would also like to know if there is a recommendation to readminister the vaccine and if so, at what time. She confirmed that this did occur with a patient. When the pharmacist was asked for additional information, she states that she is not taking care of the patient and that she is just handling the drug information question and finding out what "we would do". She states that she doesn't have any details and would not be able to provide much information. This is all the information she provided at the time of her call.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, Injection site discharge, No adverse event, Underdose
Clinical narrative: they are not sure if half of the medication leaked out or less since it leaked out of the patient's arm; during the injection half of the medication was administered, and half of the medication spilled out with no reported adverse event; during the injection half of the medication was administered, and half of the medication spilled out with no reported adverse event; Initial information received on 04-Dec-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 46-year-old male patient and the reporter stated that they are not sure if half of the medication leaked out or less since it leaked out of the patient's arm after receiving influenza quadrival A-B vaccine [Fluzone Quadrivalent] and during the injection half of the medication was administered, and half of the medication spilled out with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength: unknown) (lot: UT8129KA, expiry date: 30-Jun-2024) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious they are not sure if half of the medication leaked out or less since it leaked out of the patient's arm (exposure via skin contact) and during the injection half of the medication was administered, and half of the medication spilled out with no reported adverse event (accidental exposure to product) and (incorrect dose administered) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: 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.