chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: arm hurt quite a bit after; felt a little sick; slight fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm hurt quite a bit after), MALAISE (felt a little sick) and PYREXIA (slight fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy (allergic to Penicillin), Drug allergy (allergic to Compazine), Allergy to molds and Grass allergy.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt quite a bit after), MALAISE (felt a little sick) and PYREXIA (slight fever). At the time of the report, PAIN IN EXTREMITY (arm hurt quite a bit after), MALAISE (felt a little sick) and PYREXIA (slight fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that she received all the moderna vaccine which she think total 6 doses. Her first dose was full dose.  She had only ever gotten symptoms after her first vaccine which was very typical reactions. Her arm hurt quite a bit after, had a slight fever, and felt a little sick. Within a day or two, she was fine. She has had no other reactions to any of her other vaccines.  Treatment information was not provided.  Reporter causality was not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever which reached up to 100.2F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever which reached up to 100.2F) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042558) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (Dose 1), Moderna Covid-19 vaccine (Dose 2), Moderna Covid-19 vaccine (Dose 3), Moderna Covid-19 vaccine (Dose 7), Moderna Covid-19 vaccine (Dose 5), Moderna Covid-19 vaccine (Dose 6) and Moderna Covid-19 vaccine (Dose 4). Past adverse reactions to the above products included No adverse effect with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    On 12-Sep-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 12-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PYREXIA (fever which reached up to 100.2F). At the time of the report, PYREXIA (fever which reached up to 100.2F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2024, Body temperature: reached up to 100.2F.         The patient had 7 doses with Moderna COVID-19 shots. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. The treatment medication was not reported by reporter.   Reporter did not allow further contact
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Underdose, Vaccination site discharge
Clinical narrative: they administered a Spikevax 2024-2025 vaccine to a patient on 10Sept and some of the vaccine leaked out of the arm (they are not sure how much leaked out); they administered a Spikevax 2024-2025 vaccine to a patient on 10Sept and some of the vaccine leaked out of the arm (they are not sure how much leaked out) / I believe there's a huge problem with the vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (they administered a Spikevax 2024-2025 vaccine to a patient on 10Sept and some of the vaccine leaked out of the arm (they are not sure how much leaked out)) and UNDERDOSE (they administered a Spikevax 2024-2025 vaccine to a patient on 10Sept and some of the vaccine leaked out of the arm (they are not sure how much leaked out) / I believe there's a huge problem with the vaccine.) in a 77-year-old patient of an unknown gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Sep-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 10-Sep-2024, the patient experienced VACCINATION SITE DISCHARGE (they administered a Spikevax 2024-2025 vaccine to a patient on 10Sept and some of the vaccine leaked out of the arm (they are not sure how much leaked out)) and UNDERDOSE (they administered a Spikevax 2024-2025 vaccine to a patient on 10Sept and some of the vaccine leaked out of the arm (they are not sure how much leaked out) / I believe there's a huge problem with the vaccine.). At the time of the report, VACCINATION SITE DISCHARGE (they administered a Spikevax 2024-2025 vaccine to a patient on 10Sept and some of the vaccine leaked out of the arm (they are not sure how much leaked out)) and UNDERDOSE (they administered a Spikevax 2024-2025 vaccine to a patient on 10Sept and some of the vaccine leaked out of the arm (they are not sure how much leaked out) / I believe there's a huge problem with the vaccine.) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test, Vaccination site discomfort
Clinical narrative: she describes those flu-like covid symptoms now; discomfort at the site of the puncture; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (she describes those flu-like covid symptoms now) and VACCINATION SITE DISCOMFORT (discomfort at the site of the puncture) in a 69-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042558) for COVID-19 prophylaxis.     The patient's past medical history included Atrial fibrillation (a month ago (around 12 June 2024) - she is currently on blood thinners.) in June 2024, COVID-19 and Thyroid nodule (Three thyroid nodules - Got biggest one biopsied and came back negative). Concurrent medical conditions included Rheumatoid arthritis (Treated with weekly shots of Enbrel (Ethanercept) since approx.. 8 years ago (self-administered)) and Acid reflux (esophageal) (Treated with Nexium). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), ETANERCEPT (ENBREL) for Rheumatoid arthritis.    On 06-Sep-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 06-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VACCINATION SITE DISCOMFORT (discomfort at the site of the puncture). On 07-Sep-2024, the patient experienced INFLUENZA LIKE ILLNESS (she describes those flu-like covid symptoms now). At the time of the report, INFLUENZA LIKE ILLNESS (she describes those flu-like covid symptoms now) and VACCINATION SITE DISCOMFORT (discomfort at the site of the puncture) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2024, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was feeling okay the day of the covid-19 shot, which was Friday 6th of September, just a light discomfort at the site of the puncture. Then, the day after which was Saturday 7th, she started feeling down, so she laid down. Since then, she had been feeling down all the time, like if she actually had covid. She got tested for covid and came back negative, but since she had covid before, she describes those flu-like covid symptoms now (though she said there were no respiratory symptoms). She describes being tired all the time. Feeling the joint pains, feeling weird. She also describes hazy, kind of distanced headaches. Reporter causality was not reported. Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Vaccination site pain, Vaccination site swelling
Clinical narrative: lethargy; slight headache; Swelling and pain at injection site; Swelling and pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), HEADACHE (slight headache), VACCINATION SITE SWELLING (Swelling and pain at injection site) and VACCINATION SITE PAIN (Swelling and pain at injection site) in a 69-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 14-Sep-2024, the patient experienced LETHARGY (lethargy), HEADACHE (slight headache), VACCINATION SITE SWELLING (Swelling and pain at injection site) and VACCINATION SITE PAIN (Swelling and pain at injection site). At the time of the report, LETHARGY (lethargy), HEADACHE (slight headache), VACCINATION SITE SWELLING (Swelling and pain at injection site) and VACCINATION SITE PAIN (Swelling and pain at injection site) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Myalgia, Pain in extremity
Clinical narrative: muscle pain/describes the pain as "shooting" and was in the lower right of her leg/throbbing sensation" in the calf.; joint pain; skin does not feel warm; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (muscle pain/describes the pain as "shooting" and was in the lower right of her leg/throbbing sensation" in the calf.), ARTHRALGIA (joint pain), FEELING COLD (skin does not feel warm) and MYALGIA (muscle pain) in a 32-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 11-Sep-2024, the patient experienced PAIN IN EXTREMITY (muscle pain/describes the pain as "shooting" and was in the lower right of her leg/throbbing sensation" in the calf.), ARTHRALGIA (joint pain), FEELING COLD (skin does not feel warm) and MYALGIA (muscle pain). On 13-Sep-2024, PAIN IN EXTREMITY (muscle pain/describes the pain as "shooting" and was in the lower right of her leg/throbbing sensation" in the calf.), ARTHRALGIA (joint pain), FEELING COLD (skin does not feel warm) and MYALGIA (muscle pain) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The pain as shooting, localized in the lower right leg, and experiencing a throbbing sensation in the calf area. Additionally, she noted that her skin did not feel warm. She was experiencing these symptoms since 11-SEP-2024, continuing through 13-SEP-2024. This reported incident pertains to her fifth vaccine dose, although she lacks information regarding the vaccine's lot number. She was neither pregnant nor breastfeeding at the time of vaccination. The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knee pain; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (knee pain) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 14-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced ARTHRALGIA (knee pain). At the time of the report, ARTHRALGIA (knee pain) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: red bump at the site of injection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE MASS (red bump at the site of injection) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 14-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VACCINATION SITE MASS (red bump at the site of injection). At the time of the report, VACCINATION SITE MASS (red bump at the site of injection) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. Caller stated his sister had since then visited with her HCP who provided a topical cream solution to treat the symptoms.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle fatigue, Pain
Clinical narrative: muscle fatigue; chills; body aches; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6208) at the age of 63 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: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021); MUSCLE FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021). Additional information: Caller is a consumer that stated that She had the other Pfizer Covid-19 vaccines and stated that she had a bad reaction to the first one and not to the other ones. She reported that every time a new one comes out she has a reaction. Her reaction to the first dose was what everyone else reported: muscle fatigue, chills, and body aches. She said that the symptoms were all gone in 24 hours.
Sex: F
Vaccine: COVID19
Symptoms: Cholecystectomy, Palpitations, Syncope
Clinical narrative: Syncope; Gallbladder removed; heart palpitations; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (hospitalization), outcome "unknown"; CHOLECYSTECTOMY (hospitalization), outcome "unknown", described as "Gallbladder removed"; PALPITATIONS (hospitalization), outcome "unknown", described as "heart palpitations". It was unknown if therapeutic measures were taken as a result of syncope, palpitations. Therapeutic measures were taken as a result of cholecystectomy.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Influenza
Clinical narrative: Tiredness; Headache; Muscle pain; Joint pain; Decreased appetite; feeling unwell; flu; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, in Aug2024. Vaccination history included: Bnt162b2 (DOSE 1, LOT#: EN6206), for Covid-19 immunisation, reaction(s): "haven't had any problem"; Bnt162b2 (DOSE 2, LOT#: EN6204), for Covid-19 immunisation, reaction(s): "haven't had any problem"; Bnt162b2 (DOSE 3, LOT#: FG3527), for Covid-19 immunisation, reaction(s): "haven't had any problem"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4, LOT#: GJ3275), for Covid-19 immunisation, reaction(s): "haven't had any problem"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5, LOT#: GJ3268), for Covid-19 immunisation, reaction(s): "haven't had any problem". The following information was reported: DECREASED APPETITE (non-serious) with onset Sep2024, outcome "unknown"; HEADACHE (non-serious) with onset Sep2024, outcome "recovered" (Sep2024); ARTHRALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "Joint pain"; MYALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "Muscle pain"; FATIGUE (non-serious) with onset Sep2024, outcome "not recovered", described as "Tiredness"; MALAISE (non-serious) with onset Sep2024, outcome "unknown", described as "feeling unwell"; INFLUENZA (non-serious) with onset Sep2024, outcome "unknown", described as "flu". Therapeutic measures were taken as a result of arthralgia. Additional information: patient reported that she was having side effects from the shot she got on Tuesday (10Sep2024). She was still having tiredness, the headache have gone away finally. She had muscle pain, joint pain, decreased appetite and just feeling unwell. Patient felt like she had got the flu. Patient took ADVIL (LOT#: TY4W, expiry date: Nov2025) because of the joint pain. The patient had five shots before this one and she had not had any problem with any of them. This is the first time that the patient had any problem. No vaccine was administered on the same date with COMIRNATY (2024-2025 FORMULA). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Tiredness; Headache; Muscle pain; Joint pain; Decreased appetite; feeling unwell; flu; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, in Aug2024. Vaccination history included: Bnt162b2 (DOSE 1, LOT#: EN6206), for Covid-19 immunisation, reaction(s): "haven't had any problem"; Bnt162b2 (DOSE 2, LOT#: EN6204), for Covid-19 immunisation, reaction(s): "haven't had any problem"; Bnt162b2 (DOSE 3, LOT#: FG3527), for Covid-19 immunisation, reaction(s): "haven't had any problem"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4, LOT#: GJ3275), for Covid-19 immunisation, reaction(s): "haven't had any problem"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5, LOT#: GJ3268), for Covid-19 immunisation, reaction(s): "haven't had any problem". The following information was reported: DECREASED APPETITE (non-serious) with onset Sep2024, outcome "unknown"; HEADACHE (non-serious) with onset Sep2024, outcome "recovered" (Sep2024); ARTHRALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "Joint pain"; MYALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "Muscle pain"; FATIGUE (non-serious) with onset Sep2024, outcome "not recovered", described as "Tiredness"; MALAISE (non-serious) with onset Sep2024, outcome "unknown", described as "feeling unwell"; INFLUENZA (non-serious) with onset Sep2024, outcome "unknown", described as "flu". Therapeutic measures were taken as a result of arthralgia. Additional information: patient reported that she was having side effects from the shot she got on Tuesday (10Sep2024). She was still having tiredness, the headache have gone away finally. She had muscle pain, joint pain, decreased appetite and just feeling unwell. Patient felt like she had got the flu. Patient took ADVIL (LOT#: TY4W, expiry date: Nov2025) because of the joint pain. The patient had five shots before this one and she had not had any problem with any of them. This is the first time that the patient had any problem. No vaccine was administered on the same date with COMIRNATY (2024-2025 FORMULA). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: felt a little sick from them (Covid vaccine); like the flu; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2021 (unspecified if ongoing), notes: just went to the emergency room (ER); "pacemakers", start date: 1999 (unspecified if ongoing), notes: for 25 years; "Bradycardia" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunization, reaction(s): "felt a little sick from them (Covid vaccine)", "like the flu"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "felt a little sick from them (Covid vaccine)", "like the flu"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "felt a little sick from them (Covid vaccine)", "like the flu". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt a little sick from them (Covid vaccine)"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "like the flu".  Additional information: All of patient's Covid shots were all Pfizer, 2021 the first shot. Patient had Covid in 2021, it first came out the alpha strain and was very very sick. Her husband and she had to be hospitalized (Later clarified due to Covid). So, they got the Pfizer first, second, third, fourth, all of the shots up until this year. Patient always felt a little sick from them (Covid vaccine) like the flu. Patient had a Covid Pfizer vaccine since 2021, every year and she had all the boosters, couple times a year.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400256951 same patient and reporter, different dose and event;US-PFIZER INC-202400256965 same patient and reporter, different dose and event;
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). Concomitant medication(s) included: STATIN [SIMVASTATIN]; INFLUENZA VACCINE taken for immunisation, on 03Sep2024 as dose number unknown, single. The following information was reported: PERICARDITIS (medically significant) with onset 07Sep2024, outcome "recovering". Therapeutic measures were taken as a result of pericarditis.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was scheduled to get the 2nd adult dose of Hep B engerix but instead received a dose of Peds hep-b Engerix
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20
Symptoms: Injection site induration
Clinical narrative: R thigh induration, no signs of infection
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Vertigo
Clinical narrative: Extreme vertigo and nausea
Age: 42.0
Sex: M
Vaccine: COVID19, IPV, MMR
Symptoms: Discontinued product administered
Clinical narrative: Patient received Spikevax vaccine 3 days after CDC recommended to stop administering this vaccine in preparation for Fall 2024 Covid vaccine to come out.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: got flulaval trivalent 2024-2025 type.  developed induration/ warmth/ erythema the next day.  today (2d after vax given) has worsened left lateral thigh erythema/ warmth/ induration 5x7cm, and the outer edge of the erythema also is blistered (varying size blisters).  no fever.  no hip limited ROM or groin LAD.
Age: 66.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Discontinued product administered
Clinical narrative: Patient received Spikevax vaccine 4 days after CDC recommended to stop administering this vaccine in preparation for Fall 2024 Covid vaccine to come out.
Age: 89.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was to receive an Influenza vaccine and a Covid Vaccine. Patient was accidentally given 2 High Dose Influenza Vaccines.
Age: 88.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given the flu shot on 9/17/24 despite already receiving the same flu shot less than a month earlier on 8/23/24.   Patient was informed of the error on 9/18/24 and has not had any adverse reactions.  I advised patient to report to us and his primary care physician if any unusual adverse events occur within the next couple of weeks.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Back pain, Erythema, Fatigue
Clinical narrative: Friday 2/16/24, evening right knee pain, some swelling, could not bend knee; treated with rest, ice and seemed to be resolved within the week Saturday 3/2, treadmill but unusual whole body fatigue (no right leg pain or swelling) Saturday 3/9 about 1PM was sitting and tried to stand, right leg would not respond, could not move  right leg or walk, could not put any pressure on right leg, much pain, difficulty sleeping due to pain, took a Tylenol;  Sunday 3/11/24 somewhat better, could hobble, right leg (thigh, knee, calf) swelling, pain, no response to ice, took Tylenol;  3/12  and 3/13, somewhat better, limping, swelling; right thigh muscle tightness in IT band, lower back pain, right thigh, calf and foot all felt as if I had jumped down from a high place onto a very hard surface; difficulty sleeping, couldn?t get entire  right leg comfortable e.g. blanket was too much pressure for my leg; ankle hurt, foot had tingling pain;  3/17/24 extreme stiffness in right leg;  3/20/24 appointment with sports med doctor; right leg was swollen, some trouble walking, lower right thigh/knee very red and very hot; physical therapy prescribed to compress the swelling and ice?which did nothing;  3/21/24 still limping and right leg swelling, appointment with RN ortho/back specialist; prescribed PT but said the back would not cause any swelling 3/26/24 MRI of right knee; lower right thigh extremely swollen, red and hot; persistent fatigue 3/28/24 right leg was worse, could not put any weight on it 3/28-4/11 stopped Eliquis and took aspirin because the swelling, redness and ?heat? of the right thigh/knee were so significant; symptoms responded Physical therapy sessions:  4/15; 4/17; 4/22; 4/26; 5/3; 5/7; 5/10;  6:20; 7:23; 7:30; the only affect on my symptoms is increased fatigue from these mild exercises which pre-vaccination would not have affected me  As of 9/18/24 I still have fatigue but somewhat less; I have trouble running both my form and distance; there are occasional spontaneous pains in my right thigh and/or shin
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Gait disturbance, Gait inability, Insomnia, Joint swelling
Clinical narrative: Friday 2/16/24, evening right knee pain, some swelling, could not bend knee; treated with rest, ice and seemed to be resolved within the week Saturday 3/2, treadmill but unusual whole body fatigue (no right leg pain or swelling) Saturday 3/9 about 1PM was sitting and tried to stand, right leg would not respond, could not move  right leg or walk, could not put any pressure on right leg, much pain, difficulty sleeping due to pain, took a Tylenol;  Sunday 3/11/24 somewhat better, could hobble, right leg (thigh, knee, calf) swelling, pain, no response to ice, took Tylenol;  3/12  and 3/13, somewhat better, limping, swelling; right thigh muscle tightness in IT band, lower back pain, right thigh, calf and foot all felt as if I had jumped down from a high place onto a very hard surface; difficulty sleeping, couldn?t get entire  right leg comfortable e.g. blanket was too much pressure for my leg; ankle hurt, foot had tingling pain;  3/17/24 extreme stiffness in right leg;  3/20/24 appointment with sports med doctor; right leg was swollen, some trouble walking, lower right thigh/knee very red and very hot; physical therapy prescribed to compress the swelling and ice?which did nothing;  3/21/24 still limping and right leg swelling, appointment with RN ortho/back specialist; prescribed PT but said the back would not cause any swelling 3/26/24 MRI of right knee; lower right thigh extremely swollen, red and hot; persistent fatigue 3/28/24 right leg was worse, could not put any weight on it 3/28-4/11 stopped Eliquis and took aspirin because the swelling, redness and ?heat? of the right thigh/knee were so significant; symptoms responded Physical therapy sessions:  4/15; 4/17; 4/22; 4/26; 5/3; 5/7; 5/10;  6:20; 7:23; 7:30; the only affect on my symptoms is increased fatigue from these mild exercises which pre-vaccination would not have affected me  As of 9/18/24 I still have fatigue but somewhat less; I have trouble running both my form and distance; there are occasional spontaneous pains in my right thigh and/or shin
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Magnetic resonance imaging abnormal, Meniscal degeneration, Mobility decreased, Muscle tightness
Clinical narrative: Friday 2/16/24, evening right knee pain, some swelling, could not bend knee; treated with rest, ice and seemed to be resolved within the week Saturday 3/2, treadmill but unusual whole body fatigue (no right leg pain or swelling) Saturday 3/9 about 1PM was sitting and tried to stand, right leg would not respond, could not move  right leg or walk, could not put any pressure on right leg, much pain, difficulty sleeping due to pain, took a Tylenol;  Sunday 3/11/24 somewhat better, could hobble, right leg (thigh, knee, calf) swelling, pain, no response to ice, took Tylenol;  3/12  and 3/13, somewhat better, limping, swelling; right thigh muscle tightness in IT band, lower back pain, right thigh, calf and foot all felt as if I had jumped down from a high place onto a very hard surface; difficulty sleeping, couldn?t get entire  right leg comfortable e.g. blanket was too much pressure for my leg; ankle hurt, foot had tingling pain;  3/17/24 extreme stiffness in right leg;  3/20/24 appointment with sports med doctor; right leg was swollen, some trouble walking, lower right thigh/knee very red and very hot; physical therapy prescribed to compress the swelling and ice?which did nothing;  3/21/24 still limping and right leg swelling, appointment with RN ortho/back specialist; prescribed PT but said the back would not cause any swelling 3/26/24 MRI of right knee; lower right thigh extremely swollen, red and hot; persistent fatigue 3/28/24 right leg was worse, could not put any weight on it 3/28-4/11 stopped Eliquis and took aspirin because the swelling, redness and ?heat? of the right thigh/knee were so significant; symptoms responded Physical therapy sessions:  4/15; 4/17; 4/22; 4/26; 5/3; 5/7; 5/10;  6:20; 7:23; 7:30; the only affect on my symptoms is increased fatigue from these mild exercises which pre-vaccination would not have affected me  As of 9/18/24 I still have fatigue but somewhat less; I have trouble running both my form and distance; there are occasional spontaneous pains in my right thigh and/or shin
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Friday 2/16/24, evening right knee pain, some swelling, could not bend knee; treated with rest, ice and seemed to be resolved within the week Saturday 3/2, treadmill but unusual whole body fatigue (no right leg pain or swelling) Saturday 3/9 about 1PM was sitting and tried to stand, right leg would not respond, could not move  right leg or walk, could not put any pressure on right leg, much pain, difficulty sleeping due to pain, took a Tylenol;  Sunday 3/11/24 somewhat better, could hobble, right leg (thigh, knee, calf) swelling, pain, no response to ice, took Tylenol;  3/12  and 3/13, somewhat better, limping, swelling; right thigh muscle tightness in IT band, lower back pain, right thigh, calf and foot all felt as if I had jumped down from a high place onto a very hard surface; difficulty sleeping, couldn?t get entire  right leg comfortable e.g. blanket was too much pressure for my leg; ankle hurt, foot had tingling pain;  3/17/24 extreme stiffness in right leg;  3/20/24 appointment with sports med doctor; right leg was swollen, some trouble walking, lower right thigh/knee very red and very hot; physical therapy prescribed to compress the swelling and ice?which did nothing;  3/21/24 still limping and right leg swelling, appointment with RN ortho/back specialist; prescribed PT but said the back would not cause any swelling 3/26/24 MRI of right knee; lower right thigh extremely swollen, red and hot; persistent fatigue 3/28/24 right leg was worse, could not put any weight on it 3/28-4/11 stopped Eliquis and took aspirin because the swelling, redness and ?heat? of the right thigh/knee were so significant; symptoms responded Physical therapy sessions:  4/15; 4/17; 4/22; 4/26; 5/3; 5/7; 5/10;  6:20; 7:23; 7:30; the only affect on my symptoms is increased fatigue from these mild exercises which pre-vaccination would not have affected me  As of 9/18/24 I still have fatigue but somewhat less; I have trouble running both my form and distance; there are occasional spontaneous pains in my right thigh and/or shin
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Spinal X-ray, Spinal X-ray abnormal, Synovial cyst, Weight bearing difficulty
Clinical narrative: Friday 2/16/24, evening right knee pain, some swelling, could not bend knee; treated with rest, ice and seemed to be resolved within the week Saturday 3/2, treadmill but unusual whole body fatigue (no right leg pain or swelling) Saturday 3/9 about 1PM was sitting and tried to stand, right leg would not respond, could not move  right leg or walk, could not put any pressure on right leg, much pain, difficulty sleeping due to pain, took a Tylenol;  Sunday 3/11/24 somewhat better, could hobble, right leg (thigh, knee, calf) swelling, pain, no response to ice, took Tylenol;  3/12  and 3/13, somewhat better, limping, swelling; right thigh muscle tightness in IT band, lower back pain, right thigh, calf and foot all felt as if I had jumped down from a high place onto a very hard surface; difficulty sleeping, couldn?t get entire  right leg comfortable e.g. blanket was too much pressure for my leg; ankle hurt, foot had tingling pain;  3/17/24 extreme stiffness in right leg;  3/20/24 appointment with sports med doctor; right leg was swollen, some trouble walking, lower right thigh/knee very red and very hot; physical therapy prescribed to compress the swelling and ice?which did nothing;  3/21/24 still limping and right leg swelling, appointment with RN ortho/back specialist; prescribed PT but said the back would not cause any swelling 3/26/24 MRI of right knee; lower right thigh extremely swollen, red and hot; persistent fatigue 3/28/24 right leg was worse, could not put any weight on it 3/28-4/11 stopped Eliquis and took aspirin because the swelling, redness and ?heat? of the right thigh/knee were so significant; symptoms responded Physical therapy sessions:  4/15; 4/17; 4/22; 4/26; 5/3; 5/7; 5/10;  6:20; 7:23; 7:30; the only affect on my symptoms is increased fatigue from these mild exercises which pre-vaccination would not have affected me  As of 9/18/24 I still have fatigue but somewhat less; I have trouble running both my form and distance; there are occasional spontaneous pains in my right thigh and/or shin
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse side effects were reported/ No additional AE/No PQC.; HBP/vaccine Coordinator called to report that a patient who is pregnant received GARDASIL 9. Administered 9/9/2024.; This spontaneous report was received from a medical assistant and refers to a 21-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient became pregnant. On 09-SEP-2024, at her first trimester, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot #X024251, expiration date: 15-MAY-2026, administered for prophylaxis (strength, and route of administration were not provided) (Exposure during pregnancy). No adverse side effects were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage intracranial
Clinical narrative: intercranial hemorrage; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Sep-2024 and was forwarded to Moderna on 16-Sep-2024.      This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE INTRACRANIAL (intercranial hemorrage) in a 54-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-May-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HAEMORRHAGE INTRACRANIAL (intercranial hemorrage) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE INTRACRANIAL (intercranial hemorrage) was resolving.            No concomitant medications were reported. It was reported that the patient had no prior high blood pressure, diabetes, or fall. No treatment medications were reported.  Company comment:  This spontaneous case concerns a 54  year  old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI Haemorrhage intracranial. The event occurred 9 days after receiving the Spikevax 2023 - 2024 vaccine; no information about previous immunisation schedule was provided. The outcome of the event was recovering. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax 2023  2024 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: a lot of pain in the arm where the vaccine was administered; injection site swelling and redness around the area/ some bump in the place where the vaccine was administered; injection site swelling and redness around the area/ circle of redness around the place where she got the vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 14Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization, reaction(s): "No previous reactions"; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization, reaction(s): "No previous reactions". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2024, outcome "unknown", described as "a lot of pain in the arm where the vaccine was administered"; VACCINATION SITE ERYTHEMA (non-serious) with onset Sep2024, outcome "unknown", described as "injection site swelling and redness around the area/ circle of redness around the place where she got the vaccine"; VACCINATION SITE SWELLING (non-serious) with onset Sep2024, outcome "unknown", described as "injection site swelling and redness around the area/ some bump in the place where the vaccine was administered".  Additional information: The caller said his wife took the new COVID vaccine on Saturday (14Sep2024) and was having a lot of pain in her arm and also a bump in the place where the vaccine was administered. Had a lot of pain in the arm and also some injection site swelling and redness around the area. The caller also said that his wife had a circle of redness around the place where she got the vaccine and he would like to knew why it happened and what they could do to minimize the pain and redness. They have previously been vaccinated with Pfizer and Moderna, no previous reactions. Caller would like to know if this was something normal. Caller would like to knew if they could take pain killers to alleviate their symptoms. Response to use of fever reducing drugs and pain relievers. Caller was referred to HCP.  Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19, FLUA3
Symptoms: Pyrexia
Clinical narrative: Low fever 8 hours after vaccination; This is a spontaneous report received from a Nurse.  A 76-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Sep2024 at 17:15 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 11Sep2024 as dose 1, single), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Allergy". The following information was reported: PYREXIA (non-serious) with onset 12Sep2024, outcome "recovered" (12Sep2024), described as "Low fever 8 hours after vaccination". Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient received vaccine on left shoulder. The patient experienced event fever on 12Sep2024 at 03:00. Event not caused prolonged hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: gastrointestinal issues; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset 14Sep2024, outcome "unknown", described as "gastrointestinal issues". It was unknown if therapeutic measures were taken as a result of gastrointestinal disorder.  Additional information: Patient made a social media post about having gastrointestinal issues the day after receiving updated booster. Patient is an over 40 year-old transman. Patient (social media name) did not confirm vaccine manufacturer on social media. Patient encouraged to report event. It was unknown if the patient received any other vaccines on the same date as the vaccine or within 4 weeks prior to the vaccine. It was unknown if the patient took any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: he has some arm pain and it's tender/little bit of pain on his arm where the vaccine was administered; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 75-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 14Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization, reaction(s): "No previous reactions"; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization, reaction(s): "No previous reactions". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2024, outcome "unknown", described as "he has some arm pain and it's tender/little bit of pain on his arm where the vaccine was administered".  Additional information: The patient mentioned that he and his wife received doses of the COVID-19 vaccine on Saturday (14Sep2024). He had some arm pain and it was tender. He had a little bit of pain on his arm but his wife had lots of pain in her arm and also some bump in the place where the vaccine was administered.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Achy; tired; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Achy"; FATIGUE (non-serious), outcome "unknown", described as "tired". Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400257630 same patient, different vaccine doses/events;