chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Magnetic resonance imaging, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She had 5 covid shots and still got covid; She had 5 covid shots and still got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 61 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6203, Expiration Date: Jun2021), on 21Mar2021 as dose 2, single (Lot number: EN6208, Expiration Date: Jun2021), on 09Nov2021 as dose 3 (booster), single (Lot number: FH8028) and on 23Jun2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer, diagnosed about 12 years ago; "Kidney cancer", start date: 01Feb2022 (unspecified if ongoing); "removed 10% of her left kidney" (unspecified if ongoing); "aspiration pneumonia" (unspecified if ongoing). The patient had kidney cancer, removed 10% of her left kidney, she went in the hospital for throwing up and had aspiration pneumonia and they found a spot on her kidney. She went to a urologist and urologist told her she needed an MRI. Spot was more than 4cm and it needed to come out and was found to be stage one kidney cancer. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had 5 covid shots and still got covid". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Spot was more than 4cm and it needed to come out, notes: found to be stage one kidney cancer; SARS-CoV-2 test: positive, notes: still got covid. It was reported that the patient had 5 covid shots and still got covid. She knows breakthrough covid happens. She has heard and thought she was going to get passed it but she didn't and was not lucky. She thinks she is passed the worst part, the night of chills and fever and once past that then she is ok and over the hump. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received treatment with Paxlovid from 19Sep2023 and ongoing (will take for 5 days).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306774 Same patient, same product, different event, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Her daughter had 4 Pfizer covid shots and she has had covid twice now, once last year and once right now; Her daughter had 4 Pfizer covid shots and she has had covid twice now, once last year and once right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her daughter had 4 Pfizer covid shots and she has had covid twice now, once last year and once right now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pneumonia aspiration, Renal cancer stage I, Vomiting
Clinical narrative: stage one kidney cancer; had aspiration pneumonia; she went in the hospital for throwing up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (Pfizer covid vaccine first dose: 28Feb2021, Lot: EN6203, Expiration: unknown, NDC: unknown), administration date: 28Feb2021, when the patient was 59-year-old, for COVID-19 immunization; bnt162b2 (Pfizer covid vaccine second dose: 21Mar2021, Lot: EN6208, Expiration: possibly Jun 2021, NDC: unknown), administration date: 21Mar2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: PNEUMONIA ASPIRATION (hospitalization, medically significant) with onset 01Feb2023, outcome "unknown", described as "had aspiration pneumonia"; VOMITING (hospitalization) with onset 01Feb2023, outcome "unknown", described as "she went in the hospital for throwing up"; RENAL CANCER STAGE I (hospitalization, medically significant) with onset 01Feb2023, outcome "unknown", described as "stage one kidney cancer". The patient was hospitalized for renal cancer stage i, pneumonia aspiration, vomiting (start date: 2023). The event "stage one kidney cancer" required physician office visit. It was reported that the patient had kidney cancer, removed 10% of her left kidney. She went in the hospital for throwing up and had aspiration pneumonia and they found a spot on her kidney. She went to a urologist and urologist told her she needed an MRI. Spot was more than 4cm and it needed to come out and was found to be stage one kidney cancer. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging (2023): Spot was more than 4cm, notes: it needed to come out and was found to be stage one kidney cancer. Therapeutic measures were taken as a result of renal cancer stage i, pneumonia aspiration, vomiting.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306764 Same patient, same product, different event, different dose;
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 53-year-old male patient received bnt162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) Unknown results, notes: Strong covid test indication. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 13Sep2023 to 17Sep2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Back pain, Headache, Pyrexia
Clinical narrative: headache; body ache (lower back); slight fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 20Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (Dose: 3 (BOOSTER)), for COVID-19 Immunization; Covid-19 vaccine (Dose: 4 (BOOSTER)), for COVID-19 Immunization; Covid-19 vaccine (Dose: 5 (BOOSTER)), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "body ache (lower back)"; PYREXIA (non-serious), outcome "unknown", described as "slight fever".  Additional information: The patient did not tested covid prior vaccination. Side effects from covid vaccine: -headache -body ache (lower back) - slight fever note that she have not experienced these side effects since her second dose of the original vaccine in 2021. Usually do not react to boosters.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Anxiety, Bone pain, Depression, Feeling hot
Clinical narrative: the muscle pains worsened in a disabling way; ruined my hair almost went bald; the nails of my feet and hands were split in half; my bones also hurt me as they had never hurt me; they dream me terrible; depression; anxiety; internal heat of my body is unbearable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 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: MYALGIA (disability), outcome "unknown", described as "the muscle pains worsened in a disabling way"; ALOPECIA (non-serious), outcome "unknown", described as "ruined my hair almost went bald"; ONYCHOCLASIS (non-serious), outcome "unknown", described as "the nails of my feet and hands were split in half"; BONE PAIN (non-serious), outcome "unknown", described as "my bones also hurt me as they had never hurt me"; NIGHTMARE (non-serious), outcome "unknown", described as "they dream me terrible"; DEPRESSION (non-serious), outcome "unknown"; ANXIETY (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "internal heat of my body is unbearable".  Clinical course: Patient reported that "vaccine ruined my hair almost went bald the nails of my feet and hands were split in half, the muscle pains worsened in a disabling way and my bones also hurt me as they had never hurt me and they dream me terrible, it gives me depression and anxiety constantly and the internal heat of my body is unbearable, the famous COVID vaccine that you took out was the worst thing that happened to me in my life and the worst thing they put me 2 ob".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nightmare, Onychoclasis
Clinical narrative: the muscle pains worsened in a disabling way; ruined my hair almost went bald; the nails of my feet and hands were split in half; my bones also hurt me as they had never hurt me; they dream me terrible; depression; anxiety; internal heat of my body is unbearable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 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: MYALGIA (disability), outcome "unknown", described as "the muscle pains worsened in a disabling way"; ALOPECIA (non-serious), outcome "unknown", described as "ruined my hair almost went bald"; ONYCHOCLASIS (non-serious), outcome "unknown", described as "the nails of my feet and hands were split in half"; BONE PAIN (non-serious), outcome "unknown", described as "my bones also hurt me as they had never hurt me"; NIGHTMARE (non-serious), outcome "unknown", described as "they dream me terrible"; DEPRESSION (non-serious), outcome "unknown"; ANXIETY (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "internal heat of my body is unbearable".  Clinical course: Patient reported that "vaccine ruined my hair almost went bald the nails of my feet and hands were split in half, the muscle pains worsened in a disabling way and my bones also hurt me as they had never hurt me and they dream me terrible, it gives me depression and anxiety constantly and the internal heat of my body is unbearable, the famous COVID vaccine that you took out was the worst thing that happened to me in my life and the worst thing they put me 2 ob".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: Reminded that I can get both flu and Covid vaccines at same time however I did that last year and got super sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 40-year-old female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "Reminded that I can get both flu and Covid vaccines at same time however I did that last year and got super sick".  Additional information: Patient stated that she can get both flu and Covid vaccines at same time however patient did that last year and got super sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: damage done to my body from the Covid 19 Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 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: INJURY (non-serious), outcome "unknown", described as "damage done to my body from the Covid 19 Pfizer vaccine".  Additional information: The patient asked who do to report damage done to the patient's body from the Covid 19 Pfizer vaccine.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14-month-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died after getting the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Caller wanted to know how dangerous was the new variant and the new vaccine. She said that a 14 month old died after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died after getting the vaccine
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue, Product quality issue
Clinical narrative: some sort of marking inside the canister; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT6702, Expiration Date: 31Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "some sort of marking inside the canister".  Additional information: The reporter mentioned that there is some sort of marking inside the canister of Prevnar 20. Stated that they cannot use this vaccine because it got some sort of particles or something inside of it. The particulate almost looks like some sort of issue. The vaccine was not given since they noticed the issues inside the canister before that was given. The same of the product is available to be returned. It was still intact.   The reporter considered "some sort of marking inside the canister" not related to pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "some sort of marking inside the canister" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident
Clinical narrative: aphasia; stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BABY ASPIRIN. Vaccination history included: Bnt162b2 (Primary immunization (Pfizer COVID shots)), for COVID-19 immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER); Pfizer COVID shots and booster), for COVID-19 immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Jul2022, outcome "recovering", described as "stroke"; APHASIA (non-serious), outcome "recovering".  Clinical course: The caller (patient's wife) said she had some concerns before they took the shot, she was advised by her pharmacist and doctor to contact Pfizer. She mentioned that she and her husband had Pfizer COVID shots and boosters in the past, however, the new one sounds like it's a little different. She noticed that it says it has formaldehyde, when she was in college, she blacked out from formaldehyde. She further said she had two shots without a reaction but didn't know whether they had formaldehyde in them or not. She said her husband had a stroke in Jul2022 and has aphasia but is doing fine. She said her husband takes 4 baby aspirin a day and she noticed that it said something about blood thinners. She was concerned and wanted to know additional medical information about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV
Symptoms: Insurance issue, Lung lobectomy
Clinical narrative: she had her lower right lobe of her lung removed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pf-06928316 (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG LOBECTOMY (medically significant) with onset 2022, outcome "unknown", described as "she had her lower right lobe of her lung removed". Last year the patient had her lower right lobe of her lung removed and this year she's got to have, within the next 2 or 3 weeks, her upper left lobe of her lung removed, and her insurance denied her the RSV vaccination. Which her doctor's wanted her to have.  The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Heart rate abnormal, Heart rate increased, Hypersensitivity
Clinical narrative: allergic reaction; full-body hives; facial swelling; dizziness; fast heart rate; high temperature(103.3); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2023, outcome "unknown", described as "allergic reaction"; DIZZINESS (non-serious) with onset Sep2023, outcome "unknown"; SWELLING FACE (non-serious) with onset Sep2023, outcome "unknown", described as "facial swelling"; HEART RATE INCREASED (non-serious) with onset Sep2023, outcome "unknown", described as "fast heart rate"; URTICARIA (non-serious) with onset Sep2023, outcome "unknown", described as "full-body hives"; PYREXIA (non-serious) with onset Sep2023, outcome "unknown", described as "high temperature(103.3)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had reaction had an allergic including: full-body hives, facial swelling, dizziness, fast heart rate. He also had a high temperature (103.3). Former participant was not enrolled in any Pfizer study at time of reaction. Vaccine was received in the community.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Urticaria
Clinical narrative: allergic reaction; full-body hives; facial swelling; dizziness; fast heart rate; high temperature(103.3); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2023, outcome "unknown", described as "allergic reaction"; DIZZINESS (non-serious) with onset Sep2023, outcome "unknown"; SWELLING FACE (non-serious) with onset Sep2023, outcome "unknown", described as "facial swelling"; HEART RATE INCREASED (non-serious) with onset Sep2023, outcome "unknown", described as "fast heart rate"; URTICARIA (non-serious) with onset Sep2023, outcome "unknown", described as "full-body hives"; PYREXIA (non-serious) with onset Sep2023, outcome "unknown", described as "high temperature(103.3)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had reaction had an allergic including: full-body hives, facial swelling, dizziness, fast heart rate. He also had a high temperature (103.3). Former participant was not enrolled in any Pfizer study at time of reaction. Vaccine was received in the community.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: my smell and taste are still off, smells and tastes bad; my smell and taste are still off, smells and tastes bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2020 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, Single; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DYSGEUSIA (non-serious), PAROSMIA (non-serious), outcome "not recovered" and all described as "my smell and taste are still off, smells and tastes bad". Additional information: The patient got the 2nd dose vaccine 3 years ago and patient's smell and taste were still off, smells and tastes bad.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID infection".  Clinical information: Patient stated shareholder and 2x vaccinated, boosted with your vaccines. Why am I not to get the new booster for 3 months after COVID infection ends, patient asked.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had covid for three weeks/with symptoms like head achs, being light headed and coughing up stuff; had covid for three weeks/with symptoms like head achs, being light headed and coughing up stuff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster),single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), COVID-19 (hospitalization) all with onset 2023, outcome "not recovered" and all described as "had covid for three weeks/with symptoms like head achs, being light headed and coughing up stuff". The events "had covid for three weeks/with symptoms like head achs, being light headed and coughing up stuff" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of covid-19; (2023) Positive, notes: still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient have had Covid twice now. And have had shots And boosters. The first time was not to bad. But now patient have had covid for three weeks now. And was bad enough to where patient had to go to the hospital and was given a I.V. and oxygen. Patient have taken pills three times now. One called Paxlovid and one called Azithromycin twice. coughing up stuff. It first started off being a yellowish color then a tan color.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: her blood sugar is high; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 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: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "her blood sugar is high".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: she is a little hard of hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: HYPOACUSIS (non-serious), outcome "unknown", described as "she is a little hard of hearing". Additional information:A caller said she wants to go and get her Pfizer COVID booster, but most of the pharmacies in her area only have Moderna. She keeps asking when they are going to have Pfizer and if they will get it, and they're telling her it's not approved. She wants to know when it will be approved, why it's not, and whether Moderna and Pfizer boosters are interchangeable. She mentioned all of her shots have been Pfizer shots to date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dermatitis atopic, Diarrhoea, Fatigue, Headache
Clinical narrative: she is still feeling very tired 4 days later; chills; headache; diarrhea; Initial information received on 11-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 85 years old female patient who experienced chills, headache, diarrhea and she is still feeling very tired 4 days later after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RSV Vaccine for Prophylactic vaccination (immunization) ; and dupilumab (Dupixent) for Dermatitis atopic.  On 07-Sep-2023, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (immunization).Information on the batch number was requested.  On 07-SEP-2023 the patient developed chills, headache, diarrhea (diarrhoea) ln the same day following the administration of Influenza Vaccine. On an unknown date she is still feeling very tired 4 days later (fatigue) (unknown latency) following the administration of Influenza Vaccine.  Reportedly, The patient reported that she received vaccinations for both flu and RSV on 9/7/2023 and then later that night she had chills, headache, and diarrhea. The patient stated that these symptoms lasted for the next few days, but she is still feeling very tired 4 days later Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events chills, headache, diarrhea, she is still feeling very tired 4 days later.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event chills, headache, diarrhea and was Not Recovered / Not Resolved for the event she is still feeling very tired 4 days later.
Sex: M
Vaccine: FLUX
Symptoms: Death, Illness, Lung disorder, Pneumonia
Clinical narrative: received the sanofi flu shot and then passed away one month later from pneumonia; both illnesses that attack the lungs; Initial information was received on 15-Sep-2023 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case involves an unknown age male patient who received the sanofi flu shot and then passed away one month later from pneumonia and both illnesses that attack the lungs after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient developed a serious event of received the sanofi flu shot and then passed away one month later from pneumonia (unknown latency) following the administration of influenza vaccine.   On an unknown date the patient developed a non-serious event of both illnesses that attack the lungs (illness) (unknown latency) following the administration of influenza vaccine. Final diagnosis was (fatal) received the sanofi flu shot and then passed away one month later from pneumonia.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (received the sanofi flu shot and then passed away one month later from pneumonia, both illnesses that attack the lungs).  At time of reporting, the outcome was Fatal for the event received the sanofi flu shot and then passed away one month later from pneumonia and was Unknown for the event both illnesses that attack the lungs. It is unknown if an autopsy was done. The cause of death was reported as Pneumonia.  Seriousness criteria : This event was assessed as medically significant and was leading to death (received the sanofi flu shot and then passed away one month later from pneumonia) .; Sender's Comments: Sanofi Company Comment dated 21-Sep-2023: This case involves an unknown age male patient who received the sanofi flu shot and then passed away one month later from pneumonia and both illnesses that attack the lungs after receiving vaccine influenza vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, with no time to onset, the role of the individual suspect vaccine cannot be assessed. Case will be re-evaluated post further update on the missing information; Reported Cause(s) of Death: received the sanofi flu shot and then passed away one month later from pneumonia
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: excursions exceeded 72 hours of went below 0 C with no reported adverse event; patient was given a (Fluzone QIV) vaccine that had undergone a temp excursion with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 66 years old male patient who reported excursions exceeded 72 hours of went below 0 c and patient was given a influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose]  that had undergone a temp excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient reported excursions exceeded 72 hours of went below 0 c with no reported adverse event (product storage error) (unknown latency).  On 11-Sep-2023, the patient received 0.5ml dose of suspect influenza quadrival A-B multidose vaccine preserved, Suspension for injection (lot U8049AA; strength, expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (Immunization) that had undergone a temp excursion with no reported adverse event (poor quality product administered) (latency: on same day).  The situation occurred due Refrigerator malfunction and Human error not involved.  Action taken : not applicable.  Outcome : Unknown.   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: 76.0
Sex: U
Vaccine: FLU4
Symptoms: Device connection issue, No adverse event, Syringe issue
Clinical narrative: patient did not get a dose of FLUZONE HD after administration because the product leaked on the part where the needle meets the syringe when the administering staff injected the plunger with no adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 76 years old and unknown gender patient who did not get a dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] after administration because the product leaked on the part where the needle meets the syringe when the administering staff injected the plunger with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2023 at 4:30 PM , the patient received a  dose 0.5 ml of suspect  influenza quadrival A-B high dose HV vaccine, injection, (lot UT8072DA; Expiration Date :30-Jun-2024: strength not reported) via intramuscular route in the deltoid nos (not otherwise specified) for Immunization and did not get a dose of Fluzone hd after administration because the product leaked on the part where the needle meets the syringe when the administering staff injected the plunger with no adverse event (incorrect dose administered) (latency: same day)  It was reported by nurse from their department injected a patient with FLUZONE HD but it leaked on the part where the needle meets the syringe and patient was not able get any of the vaccine.   Action taken : not applicable.  Outcome : Unknown.   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: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: she had threw up for 3 to 4 times; have went to the washroom twice; Initial information received on 12-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves a 81 years old female patient who had threw up for 3 to 4 times and have went to the washroom twice after receiving 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 Food allergy.   On 11-Sep-2023, the patient received 0.5 ml dose of suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for immunization (strength, formulation, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient had she had threw up for 3 to 4 times (vomiting) and have went to the washroom twice (diarrhoea) (unknown latency).  Reportedly, Patient was suspecting that the FLU VACCINE had pork that may have caused her symptoms, but after knowing that the FLU VACCINE does not have any pork component, patient told staff that maybe she ate a lot of chocolates that caused the vomiting and diarrhoea staff confirmed that the patient is not allergic to chocolate.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (vomiting, diarrhoea).  Outcome was Unknown for the event vomiting and diarrhoea.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired TENIVAC was administered to a patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered to a patient 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 diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Immunization and expired tenivac was administered to a patient with no reported adverse event (expired product administered) (unknown latency).  Action taken with diphtheria and tetanus toxoids (Tenivac) was not applicable.  Outcome: Unknown.  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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired pentacel was administered to a patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient to whom expired pentacel was administered with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Sep-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection lot UJ752AAA, expiry date: 09-Sep-2023 via unknown route in unknown administration site for prophylactic vaccination (strength and dose: unknown), expired pentacel was administered to a patient 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.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient did receive an expired adacel dose with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age male patient who receive an expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] dose 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 expired dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (latency: on same day). Information on the batch number was requested.  Reporter stated originally she reported that no patient's received an expired dose, however after speaking with her MA(medical advisor) it became known that a patient did receive an expired ADACEL dose.  Action taken: not applicable.  Outcome: Unknown.   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.