chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Electrolyte imbalance, Myalgia, Orthostatic hypotension, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10013573:DIZZINES; 10042772:SYNCOPE; Narrative: Patient presented with weakness, nonproductive cough, myalgia, loss of taste/smell, and orthostatic hypotension with positive COVID test a day prior to presentation. Electrolyte abnormalities corrected and fluids given. Patient did not qualify for remdesivir or dexamethasone treatment. Improved within a day and discharged home. Other Relevant HX: Other:
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: Reported Symptoms: 10013573:DIZZINES; 10042772:SYNCOPE; Narrative: Patient presented with weakness, nonproductive cough, myalgia, loss of taste/smell, and orthostatic hypotension with positive COVID test a day prior to presentation. Electrolyte abnormalities corrected and fluids given. Patient did not qualify for remdesivir or dexamethasone treatment. Improved within a day and discharged home. Other Relevant HX: Other:
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Reported Symptoms: 10037007:PRURITUS, 10037844:RASH; Narrative: Other Relevant HX: Other :
Age: 79.0
Sex: M
Vaccine: COVID19, HEPA
Symptoms: Arthralgia, Pain in extremity, Sleep disorder
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; Narrative: Other Relevant HX: 8/14/23 PACT CPP: "Patient reports since last COVID booster has had chronic arm pain and cannot sleep on the side - has not tried anything for the pain" No other documentation of arm pain from vaccines in 6/2022 in system. Patient did receive two vaccines in same arm according to documentation on that day (COVID booster and Hep A). Other:
Age: 83.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Reported Symptoms:  10029436:NO ADVERSE EFFECT;  Narrative:  The expiration date of the Tenivac vaccine led to nursing inadvertently administering an expired vaccine.  The format is 24SEP23 (expired 9/24/2023) and the vaccine was administered on 9/25/2023. Sanofi was contacted and they couldn't recommend administering the vaccine after expired but they didn't expect a loss of immune response one day after expiration. They stated that if a repeated dose was given to wait 28 days after the expired vaccine was given. Nursing discussed it with the patient's provider and they decided that a repeat dose was not necessary for the patient. Nurse educated their staff on the vaccine format and Sanofi filed a report on the confusing format of the expiration date. Othe Relevant HX:  Other: No adverse effects noted
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: This was a historical report patient informed PCP at clinic at first visit when initiating care. No other information was provided other than rash with flu shot. PCP flagged pt's chart with ADR to flu shots. Other Relevant HX: Other: RASH
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Reported Symptoms:  Narrative:  Above influenza vaccine was administered on 12:00 PM on 10/27/23.  Around midnight that night, the patient began having a rash/hives and presented to the ER. Patient complained of very itchy skin especially on upper extremities. Patient received IV diphenhydramine in the ER at 2:57 AM on 10/28/23. Patient was noted to be feeling better at 4:59AM. Patient was discharged home from ER at 5:30 AM on 10/28/23 will plan to continue diphenhydramine as needed at home. Other Relevant HX: Other:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Reported Symptoms:  10016558:FEVER; 10019211:HEADACHE; 10037844:RASH; Narrative:  Patient developed a rash, fever, and headache after the second dose of covid vaccine  Other Relevant HX:  Other:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Facial paralysis, Laboratory test normal, Vision blurred, Visual acuity reduced
Clinical narrative: Reported Symptoms: 10005886:BLURRED VISION; 10013573:DIZZINESS; 10016044:FACIAL DROOP; Narrative: Patient presented with increased dizziness and blurry vision 1/12/23 and admitted to inpatient for CVA r/o. Found to have right eyelid droop with decreased acuity. CVA workup negative. Etiology unclear, patient discharged with outpatient ENT and urology follow up appointments. Other Relevant HX: Other: Right eyelid droop
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: Hospitalization due to COVID-19 infection requiring remdesivir and supportive care Other Relevant HX: Other: Hospitalization due to COVID-19 infection
Age: 59.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event
Clinical narrative: No adverse events or adverse outcome. No treatment required.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Just red bumps. May be allergic reaction. All over arms and little bit of the back of the neck.  No outcome or recovery yet. Email day of event.  No other vaccines within the past month
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2, FLUC4
Symptoms: Hyperhidrosis, Nausea, Neurogenic shock, Tachycardia, Tunnel vision
Clinical narrative: pt given flu and covid at same time. first, flu went fine. after second vaccine (covid). pt went shocky, felt faint, reported tunnel vision, sweaty, elevated pulse rate, low breathing. never lost consciousness, was responsive and coherent. alert and oriented. no epi pen used
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2, FLUC4
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Respiration abnormal, Shock
Clinical narrative: pt given flu and covid at same time. first, flu went fine. after second vaccine (covid). pt went shocky, felt faint, reported tunnel vision, sweaty, elevated pulse rate, low breathing. never lost consciousness, was responsive and coherent. alert and oriented. no epi pen used
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2, FLUC4
Symptoms: Tunnel vision
Clinical narrative: pt given flu and covid at same time. first, flu went fine. after second vaccine (covid). pt went shocky, felt faint, reported tunnel vision, sweaty, elevated pulse rate, low breathing. never lost consciousness, was responsive and coherent. alert and oriented. no epi pen used
Age: 76.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Rash, Rash macular, Rash pruritic, Skin warm
Clinical narrative: Skin rash/Splotchy dot-like rash, warm to touch, mildly itchy; Splotchy dot-like rash, warm to touch, mildly itchy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Nov2023 at 12:00 as dose number unknown, single (Lot number: HMO168) at the age of 76 years, in left arm for immunisation. The patient's relevant medical history included: "Coronary arteriosclerosis" (unspecified if ongoing); "Benign enlarged prostate" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "Allergy (past drug)" (unspecified if ongoing), notes: Not know. Concomitant medication(s) included: ADJUVANTED QUADRIVALENT INFLUENZA VACCINE, on 07Nov2023 as dose number unknown, single; SIMVASTATIN, start date: 2000; ATENOLOL, start date: 1987; ASPIRIN [ACETYLSALICYLIC ACID], start date: 2000; TAMSULOSIN, start date: 2022; RAMIPRIL, start date: 2000; SAW PALMETTO [SERENOA REPENS], start date: 2000. The following information was reported: RASH PRURITIC (non-serious) with onset 25Nov2023 at 16:45, outcome "recovering", described as "Skin rash/Splotchy dot-like rash, warm to touch, mildly itchy"; RASH MACULAR (non-serious) with onset 25Nov2023 at 16:45, outcome "recovering", described as "Splotchy dot-like rash, warm to touch, mildly itchy.". Therapeutic measures were not taken as a result of rash pruritic, rash macular.  Additional information: Skin rash on both arms and upper chest 9 days after receiving RSV vaccination. Splotchy dot-like rash, warm to touch, mildly itchy.
Age: 76.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Rash macular, Rash pruritic, Skin warm
Clinical narrative: Skin rash/Splotchy dot-like rash, warm to touch, mildly itchy; Splotchy dot-like rash, warm to touch, mildly itchy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Nov2023 at 12:00 as dose number unknown, single (Lot number: HMO168) at the age of 76 years, in left arm for immunisation. The patient's relevant medical history included: "Coronary arteriosclerosis" (unspecified if ongoing); "Benign enlarged prostate" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "Allergy (past drug)" (unspecified if ongoing), notes: Not know. Concomitant medication(s) included: ADJUVANTED QUADRIVALENT INFLUENZA VACCINE, on 07Nov2023 as dose number unknown, single; SIMVASTATIN, start date: 2000; ATENOLOL, start date: 1987; ASPIRIN [ACETYLSALICYLIC ACID], start date: 2000; TAMSULOSIN, start date: 2022; RAMIPRIL, start date: 2000; SAW PALMETTO [SERENOA REPENS], start date: 2000. The following information was reported: RASH PRURITIC (non-serious) with onset 25Nov2023 at 16:45, outcome "recovering", described as "Skin rash/Splotchy dot-like rash, warm to touch, mildly itchy"; RASH MACULAR (non-serious) with onset 25Nov2023 at 16:45, outcome "recovering", described as "Splotchy dot-like rash, warm to touch, mildly itchy.". Therapeutic measures were not taken as a result of rash pruritic, rash macular.  Additional information: Skin rash on both arms and upper chest 9 days after receiving RSV vaccination. Splotchy dot-like rash, warm to touch, mildly itchy.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU4, COVID19
Symptoms: Chest pain, Myocardial infarction
Clinical narrative: Heart attack 30-minutes after excellent physical exam by PCP + pfizer covid + high dose flu vaccine
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU4, COVID19
Symptoms: Blood test, Catheterisation cardiac, Electrocardiogram, Myocardial infarction
Clinical narrative: Heart attack 30-minutes after excellent physical exam by PCP + pfizer covid + high dose flu vaccine
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU4, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack 30-minutes after excellent physical exam by PCP + pfizer covid + high dose flu vaccine
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Ophthalmological examination, Visual impairment
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jan2021 at 08:00 as dose 1, single (Lot number: EL-1283), in arm, on 12Feb2021 at 15:00 as dose 2, single (Lot number: EL-3246), in arm and on 12Dec2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Mixed connective tissue disorder" (ongoing); "Sjogren's syndrome" (unspecified if ongoing); "Raynaud's syndrome" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing); "Auto immune disease", start date: 01Jan2006 (ongoing). Concomitant medication(s) included: METHOTREXATE oral taken for connective tissue disorder (ongoing); FOLIC ACID (ongoing). Vaccination history included: Flu shot, for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Oct2023, outcome "not recovered" and all described as "Tested positive". The event "tested positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Positive, notes: sick and tested positive for covid; (02Nov2023) Negative, notes: tested negative-felt fine; (03Nov2023) Negative, notes: tested negative-felt fine; (06Nov2023) Positive, notes: sick and tested positive; (08Nov2023) Positive; (11Nov2023) Negative; (12Nov2023) Negative; (17Nov2023) Unknown results. It was unknown if therapeutic measures were taken as a result of 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: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jan2021 at 08:00 as dose 1, single (Lot number: EL-1283), in arm, on 12Feb2021 at 15:00 as dose 2, single (Lot number: EL-3246), in arm and on 12Dec2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Mixed connective tissue disorder" (ongoing); "Sjogren's syndrome" (unspecified if ongoing); "Raynaud's syndrome" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing); "Auto immune disease", start date: 01Jan2006 (ongoing). Concomitant medication(s) included: METHOTREXATE oral taken for connective tissue disorder (ongoing); FOLIC ACID (ongoing). Vaccination history included: Flu shot, for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Oct2023, outcome "not recovered" and all described as "Tested positive". The event "tested positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Positive, notes: sick and tested positive for covid; (02Nov2023) Negative, notes: tested negative-felt fine; (03Nov2023) Negative, notes: tested negative-felt fine; (06Nov2023) Positive, notes: sick and tested positive; (08Nov2023) Positive; (11Nov2023) Negative; (12Nov2023) Negative; (17Nov2023) Unknown results. It was unknown if therapeutic measures were taken as a result of 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient Received Second Dose of Heplisav-B Two Weeks Early; Initial report received on 06-Nov-2023  A  pharmacist reported that a 39-year-old female patient (race and ethnicity not provided) received her second dose of HEPLISAV-B (hepatitis B vaccine) two weeks early.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On an unknown date in Oct-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC unknown).  On 03-Nov-2023, the patient received the second dose of HEPLISAV-B (Lot # 944609, expiration date 29 Jan-2026, NDC # 43528-003-05) intramuscularly in the left arm. The patient had reported no side effects.   No other information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Heplisav-B Was Administered Yesterday To A Patient Who Is 16; Initial report received on 06-Nov-2023  A  pharmacist reported that a 16-year-old male patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On 05-Nov-2023, the patient received the first dose of HEPLISAV-B (Lot # 943008, expiration date 30- Sep-2025, NDC # 43528-003-05) intramuscularly in the right arm from a pharmacist. It was reported that the patient was a foreign exchange student. No adverse side effects were experienced by the patient.   No other information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Heplisav-B Was Administered Subcutaneously; Initial report received on 06-Nov-2023  A pharmacy intern reported that a 67-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) subcutaneously for hepatitis B immunization.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On 06-Nov-2023, the patient received the first dose of HEPLISAV-B (Lot # 943009, expiration date 31-Oct-2025, NDC # 43528-003-01) subcutaneously in the left arm from a pharmacist. It was reported that a 1-inch, 25-guage needle was used for the injection. The reporter was not sure that it penetrated the muscle due to the length of the needle for the patient. It was given as a booster due to having low immunity after a previous vaccine series (name of that vaccine series is unknown per the reporter). No side effects reported from the injection.  No other information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives; Initial report received on 07-Nov-2023.  A clinical pharmacy specialist reported that a female (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed hives.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 30-Aug-2023, the patient received a dose of HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported). Concomitant vaccines administered included Shingrix (Zoster Vaccine Recombinant, Adjuvanted) (lot number, expiration date, NDC number, route, and site not reported).  On an unspecified date, "a couple of days" after having been vaccinated with HEPLISAV-B, the patient developed hives.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jul2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "TMJ" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Nov2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: other medication product included multivitamin, start date Jan2022, stop dateNov2023.  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.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Test positive COVID 16Nov2023; Test positive COVID 16Nov2023; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 03Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "EDS (Ehlers-Danlos syndrome)" (unspecified if ongoing); "Mast cell activation positive" (unspecified if ongoing), notes: Mast cell activation positive. The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "Known allergies: phenergan"; Benadryl, reaction(s): "Known allergies: Benadryl". Vaccination history included: Hpv vaccines, reaction(s): "Known allergies: HPV vaccines"; Bnt162b2 (Dose 1, Anaphlaxic after first 2 Pfizer vaccines), for COVID-19 immunization, reaction(s): "Anaphlaxic"; Bnt162b2 (Dose 2, Anaphlaxic after first 2 Pfizer vaccines), for COVID-19 immunization, reaction(s): "Anaphlaxic". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Nov2023, outcome "not recovered" and all described as "Test positive COVID 16Nov2023". The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) Mast cell activation positive; SARS-CoV-2 test: (Nov2023) Negative, notes: 4 days negative test; (Nov2023) Negative, notes: 4 days negative test; (Nov2023) Negative, notes: 4 days negative test; (Nov2023) Negative, notes: 4 days negative test; (16Nov2023) Positive; (25Nov2023) Positive, notes: Positive COVID test again symptoms worse than original onset. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anaphylaxis after first 2 Pfizer vaccine. Test positive COVID 16Nov2023 took Paxlovid. Paxlovid rebound Nov2023 reduced symptoms first 5 days fine 4 days negative test then rebound 25Nov2023 positive COVID test again symptoms worse than original onset. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Antigen test had become negative and is strongly positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Based on the information currently available, a causal association between the reported events and bnt162b2 cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose 1, single as dose 2, single as dose 3 (booster), single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, 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) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative, notes: Tested negative 5 days after starting Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Nov2023 to 17Nov2023.  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.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300410618 Same patient, different product, different event;
Sex: F
Vaccine: COVID19
Symptoms: Death, Ocular vascular disorder
Clinical narrative: The person is deceased; blood clot in the eye; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid/Thyroid disorder" (unspecified if ongoing); "Cholesterol high" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; LOVASTATIN taken for blood cholesterol increased; LOSARTAN taken for hypertension. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization. The following information was reported: DEATH (death) with onset 02Feb2023, outcome "fatal", described as "The person is deceased"; OCULAR VASCULAR DISORDER (non-serious) with onset 2023, outcome "unknown", described as "blood clot in the eye". The patient date of death was 02Feb2023. The reported cause of death was unknown. No autopsy was performed. Clinical course: Reporter was seeking information on blood clots associated with the Pfizer covid vaccine. She stated she had a 75 year old friend that had the Pfizer covid vaccine and within 10 days developed a blood clot in the eye and had never had problems with their eyes and this person was then deceased (further confirmed don't know the reason of death). Reporter did not had idea about treatment. Reporter did not have the product (Comirnaty) details (LOT#, expiration, NDC# and UPC#). Reporter stated, "Hospital, well the first was pharmacy. The first two was pharmacy then she had others at the hospital. Reporter stated, "had no idea what the reason for death. They do not know". Reporter did not know the time of vaccination, stated had to call her doctor. Reporter stated "she found it very peculiar that it happened 10 days after the 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.; Sender's Comments: Based on the limited information provided in this case, there is no evidence to support a causal relationship between the suspect product (bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) and the reported fatal event (DEATH). There is very limited information provided. Additional information is required to better this case, such as patients past medical history, family and social history, concomitant medications, lab investigations, diagnostic imaging, circumstances leading to the reported event and autopsy report, etc. This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300414016 Same reporter/drug, different patient.;; Reported Cause(s) of Death: The person is deceased
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: both caught covid and were sick for two weeks; both caught covid and were sick for two weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "both caught covid and were sick for two weeks".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300193965 same reporter/event different dose/patient;
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple myeloma" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR SODIUM] oral, start date: Jan2017; BACTRIM DS oral, start date: 03Jan2022; VALSARTAN oral, start date: 01Dec2022. Past drug history included: Azithromycin, reaction(s): "Allergy:Azithromycin"; Clindamycin, reaction(s): "Allergy:clindamycin"; Erythromycin base, reaction(s): "Allergy:erythromycin base"; Penicillin for Allergy:Penicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (23Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2023) Negative; (25Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for treatment of COVID-19 from 18Nov2023 to 22Nov2023 (Route of administration: Oral). Patient had mild URI symptoms, which resolved within 48 hrs of taking Paxlovid.   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.; Sender's Comments: A causal relationship to the suspect drug cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300411509 Same reporter/patient, different drug/events;
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Near death experience
Clinical narrative: allergic reaction and almost died.; allergic reaction and almost died; 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 received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to the vaccine" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (life threatening), outcome "unknown", described as "allergic reaction and almost died."; NEAR DEATH EXPERIENCE (life threatening), outcome "unknown", described as "allergic reaction and almost died". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Clinical course: Reporter considered event was caused by suspect product. Patient did not believe in the covid vaccine. She was forced to get it or lose her job. She had an allergic reaction and almost died. She was allergic to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: both caught covid and were sick for two weeks; both caught covid and were sick for two weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "both caught covid and were sick for two weeks". Clinical Course: The reporter considered event was caused by suspect product. He was not getting any shots this year. Last year his wife and him both had two vaccines and one booster and both caught covid and were sick for two weeks. They said get vaccinated and you won't catch covid. Lies, he don't trust any of it. It said nothing about negative aspects of the vaccine or how they may be nothing but water and completely ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300413979 same reporter, different patient, dose/events;
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired dose of PNEUMOVAX 23 was administered on 11/27/2023; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-NOV-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 mL once as prophylaxis (lot# W019533, expiration date: 30-SEP-2023; route of administration and anatomical location not provided) (expired product administered). It was confirmed that the patient involved had not reported any medical concerns or symptoms related to the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). No additional information was provided regarding this adverse event. There was no additional adverse event (AE) reported (no adverse event).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: New onset atrial fibrillation resulting in two (2) emergency department visits
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose of Havrix was administered to an adult patient; pediatric dose of Havrix was administered to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 61-year-old male patient who received HAV (Havrix pediatric) (batch number 943Y2, expiry date 05-APR-2025) for prophylaxis.   On 21-NOV-2023, the patient received the 2nd dose of Havrix pediatric. On 21-NOV-2023, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: pediatric dose of Havrix was administered to an adult patient) and adult use of a child product (Verbatim: pediatric dose of Havrix was administered to an adult patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 21-NOV-2022 The nurse called to report a pediatric dose of Havrix was administered to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow up via email agreed.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vision blurred
Clinical narrative: Patient stated they received the vaccine on Friday (24Nov2023). Now she has blurry vision; She had sore arm at the injection site, and it was minor; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (Patient stated they received the vaccine on Friday (24Nov2023). Now she has blurry vision) and INJECTION SITE PAIN (She had sore arm at the injection site, and it was minor) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy (Patient was Allergic to sulfa.).    On 24-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In November 2023, the patient experienced VISION BLURRED (Patient stated they received the vaccine on Friday (24Nov2023). Now she has blurry vision) and INJECTION SITE PAIN (She had sore arm at the injection site, and it was minor). At the time of the report, VISION BLURRED (Patient stated they received the vaccine on Friday (24Nov2023). Now she has blurry vision) and INJECTION SITE PAIN (She had sore arm at the injection site, and it was minor) had not resolved.            Concomitant product use was not provided by the reporter.  Patient had previous doses Moderna vaccine, 1st dose received on 10-Feb-2021 and the lot number 015M20A. 2nd dose received on 10-Mar-2021 and the lot number 030A21A. 3rd dose received on 26-Nov-2021 and the lot number 058H21A. 4th dose received on 31-May-2022 and the lot number 004M21A. 5th dose received on 17-Jan-2023 and the lot number 042H22A.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient stated she was calling to report an adverse event to the Spikevax.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient stated she was calling to report an adverse event to the Spikevax.) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient stated she was calling to report an adverse event to the Spikevax.). At the time of the report, IMMUNISATION REACTION (Patient stated she was calling to report an adverse event to the Spikevax.) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment medication reported.
Age: 41.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 41 year old patient received Arexvy; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 41-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 95TA2, expiry date 10-DEC-2024) for prophylaxis.   On 15-NOV-2023, the patient received Arexvy. On 15-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 41 year old patient received Arexvy). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: RA Receipt Date: 21-NOV-2023 The healthcare professional reported that they had administered Arexvy to a 41-year-old patient, which led to inappropriate age at vaccine administration. The HCP asked for information about the administration of Arexvy to patients younger than 60 years of age. Permission to follow up was not requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Malaise, Nausea
Clinical narrative: she did not feel well; Both she and her husband had their backs hurting; She tried to eat breakfast but she felt a little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she did not feel well), BACK PAIN (Both she and her husband had their backs hurting) and NAUSEA (She tried to eat breakfast but she felt a little nauseous) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 30331914) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:None.  Previously administered products included for Drug use for unknown indication: Moderna (No lot number) on 19-Jan-2021, Moderna (No lot number) on 17-Feb-2021, Moderna (Lot number: 067F21A) on 20-Oct-2021 and Moderna (Lot number: AS7170B) on 19-Dec-2022. Past adverse reactions to the above products included No adverse reaction with Moderna, Moderna, Moderna and Moderna.    On 28-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Nov-2023, the patient experienced MALAISE (she did not feel well), BACK PAIN (Both she and her husband had their backs hurting) and NAUSEA (She tried to eat breakfast but she felt a little nauseous). At the time of the report, MALAISE (she did not feel well), BACK PAIN (Both she and her husband had their backs hurting) and NAUSEA (She tried to eat breakfast but she felt a little nauseous) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient was wondering because she did not have any problems when she got the previous doses of the vaccine but when she got the Spikevax, she did not feel well. She did not get up from the couch. She tried to eat breakfast, but she felt a little nauseous. Both she and her husband had their backs hurting. She now felt okay.   No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-751619.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751619:Husband case
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Her husband had their backs hurting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Her husband had their backs hurting) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Heart disorder (Controlled).    On 28-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced BACK PAIN (Her husband had their backs hurting). At the time of the report, BACK PAIN (Her husband had their backs hurting) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-751634.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751634:Wife case
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: So painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: So painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-NOV-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received shingles vaccine, and it was so painful. The follow-up could not be possible as no contact details were available.