chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 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: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID-19 Treatment (Brand: Paxlovid). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 07Dec2022, Treatment stop date: 13Dec2022).  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
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, 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) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing), notes: Autoimmune. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Dec2022 to 19Dec2022. Clincal course: After paxlovid, patient started initial symptoms again of scratchy sore throat, aches. Then after 2 days of that, Patient had sinus with head ache for 2 additional days it was all light symptoms but kept myself in quarantine for additional week with positive read.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
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 (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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: "High cholesterol" (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: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 28Sep2022 to 03Oct2022. Additional information: BNT162b2 was administered at 05:00 PM.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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 was not reported. Concomitant medication(s) included: TRAZODONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; OFF LABEL USE (non-serious), outcome "unknown"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Treatment of COVID-19; (Dec2022) Negative; (Dec2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received paxlovid for COVID 19 Treatment from 17Dec2022 to 21Dec2022. Rebound case. Tested negative, felt better for a day or two and then tested positive again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, 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).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID 19 Treatment (Brand: Paxlovid). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 13Dec2022, Treatment stop date: 18Dec2022, Lot number: GE1627, Administrator route: Oral).  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 drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: Er2614), in right arm, on 13Apr2021 as dose 2, single (Lot number: Ew0162), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: Ff2593) at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 09Sep2022 as dose 4 (booster), single (Lot number: As7140C), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's; "thyroid cancer" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After completing 5 days of  paxlovid and testing negative for two days; Positive, notes: I am testing positive again. Therapeutic measures  (PAXLOVID) were taken as a result of drug ineffective, covid-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a spontaneous report received from contactable reporter(s) (Other HCP), Program ID.  A 52-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 51 years for COVID-19 immunization. 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: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up". Therapeutic measures were taken as a result of rheumatoid arthritis.  Clinical course: It was reported that the patient reports 14 months ago had COVID booster that caused a rheumatoid arthritis flare up, unknown exact date. patient reports still has not return to their baseline before booster shot. patient reports since starting Xeljanz XR there has been improvement but still sore. doctor is aware. no missed doses reported. Xeljanz XR 11mg tablet by mouth once daily from 29Mar2022 to ongoing.  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 available information in the case, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Renal vasculitis
Clinical narrative: renal vasculitis following COVID-19 vaccination; This is a literature report.   A 62-year-old female patient received BNT162b2 (BNT162B2), 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: RENAL VASCULITIS (medically significant), 4 weeks after the suspect product(s) administration, outcome "unknown", described as "renal vasculitis following COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: Positive. Therapeutic measures were taken as a result of renal vasculitis.  Clinical Course: Reported cases of renal-associated AAV induced by COVID-19 vaccination. Despite the substantial benefits of the COVID-19 vaccine, autoimmune processes, particularly AAV, have been highlighted post-vaccination. AAV is a rare and life-threatening complication, and the objective of our case is to inform the clinicians to encourage the hasty recognition and diagnosis of vasculitis in timely correlation with the COVID-19 vaccine, a complete workup including imaging modalities of possible concurrent triggers, as well as timely appropriate management once found.; Sender's Comments: Based on the available information and on the compatibility with the drug's known safety profile, the company considers that a causal relationship between the reporter event -Renal vasculitis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: U
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: got hives two years a row from the flu shot; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer.  This case involves an unknown age and unknown gender patient who got hives two years a row from the flu shot after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu.  On an unknown date the patient had a non-serious event of got hives two years a row from the flu shot (urticaria) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Influenza A; Initial information received on 21-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced influenza A after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient Got his/her flu shot and just spent 3 days in the hospital with Influenza A (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (Influenza A).  At time of reporting, the outcome was Unknown.   Seriousness Criteria: Hospitalization for the event Influenza A.; Sender's Comments: Sanofi company comment dated 27-Dec-2022: This case involves an unknown age and unknown gender patient who experienced influenza A after receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of vaccine cannot be assessed. Additional information regarding additional risk factor, concomitant medications, medical treatment and family history, underlying medical history excluding other predisposing etiologies would be needed for complete assessment of the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who experienced flu after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect of INFLUENZA VACCINE produced by unknown manufacturer (lot number, formulation, dose, expiry date, strength: not reported) via unknown route in unknown administration site for flu.  On an unknown date the patient developed a serious event flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   It was reported that "Got my flu shot In November first week of December iwas hospitalized for five days still not totally well".  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.  Seriousness criteria: patient was hospitalized for this event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: ADMINISTERED MONOVALENT INSTEAD OF THE BIVALENT. NO ADVERESE SYMPTOMS REPORTED BY PATIENT
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arrhythmia, Back pain, Blood test, Chest X-ray, Chest pain
Clinical narrative: Pericarditis with effusion to heart and lungs.  Severe chest and back pain started 1 week after receiving vaccine.  Also had shortness of breath/difficulty breathing, high blood pressure, elevated heart rate, arrhythmia, nausea, fever, dizziness/light headedness, numbness/tingling in legs.    Ultimately led to inpatient hospitalization after emergency room visit.  After leaving hospital was  given colchicine for 6 weeks, ibuprofen, pantoprozol, and augmenten.  The severity of the pain and fatigue led to needing to take short term disability and a leave of absence from work.  5 weeks after hospitalization, back pain is still significant (as of 12/27).
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Disability, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Pericarditis with effusion to heart and lungs.  Severe chest and back pain started 1 week after receiving vaccine.  Also had shortness of breath/difficulty breathing, high blood pressure, elevated heart rate, arrhythmia, nausea, fever, dizziness/light headedness, numbness/tingling in legs.    Ultimately led to inpatient hospitalization after emergency room visit.  After leaving hospital was  given colchicine for 6 weeks, ibuprofen, pantoprozol, and augmenten.  The severity of the pain and fatigue led to needing to take short term disability and a leave of absence from work.  5 weeks after hospitalization, back pain is still significant (as of 12/27).
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Heart rate increased, Hypertension, Hypoaesthesia, Impaired work ability
Clinical narrative: Pericarditis with effusion to heart and lungs.  Severe chest and back pain started 1 week after receiving vaccine.  Also had shortness of breath/difficulty breathing, high blood pressure, elevated heart rate, arrhythmia, nausea, fever, dizziness/light headedness, numbness/tingling in legs.    Ultimately led to inpatient hospitalization after emergency room visit.  After leaving hospital was  given colchicine for 6 weeks, ibuprofen, pantoprozol, and augmenten.  The severity of the pain and fatigue led to needing to take short term disability and a leave of absence from work.  5 weeks after hospitalization, back pain is still significant (as of 12/27).
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Paraesthesia, Pericardial effusion, Pericarditis, Pleural effusion
Clinical narrative: Pericarditis with effusion to heart and lungs.  Severe chest and back pain started 1 week after receiving vaccine.  Also had shortness of breath/difficulty breathing, high blood pressure, elevated heart rate, arrhythmia, nausea, fever, dizziness/light headedness, numbness/tingling in legs.    Ultimately led to inpatient hospitalization after emergency room visit.  After leaving hospital was  given colchicine for 6 weeks, ibuprofen, pantoprozol, and augmenten.  The severity of the pain and fatigue led to needing to take short term disability and a leave of absence from work.  5 weeks after hospitalization, back pain is still significant (as of 12/27).
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Pericarditis with effusion to heart and lungs.  Severe chest and back pain started 1 week after receiving vaccine.  Also had shortness of breath/difficulty breathing, high blood pressure, elevated heart rate, arrhythmia, nausea, fever, dizziness/light headedness, numbness/tingling in legs.    Ultimately led to inpatient hospitalization after emergency room visit.  After leaving hospital was  given colchicine for 6 weeks, ibuprofen, pantoprozol, and augmenten.  The severity of the pain and fatigue led to needing to take short term disability and a leave of absence from work.  5 weeks after hospitalization, back pain is still significant (as of 12/27).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: ADMINISTERED MONOVALENT INSTEAD OF THE BIVALENT. NO ADVERESE SYMPTOMS REPORTED BY PATIENT
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: ADMINISTERED MONOVALENT INSTEAD OF THE BIVALENT. NO ADVERESE SYMPTOMS REPORTED BY PATIENT
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: ADMINISTERED MONOVALENT INSTEAD OF THE BIVALENT. NO ADVERESE SYMPTOMS REPORTED BY PATIENT
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: The shot went in very hard.  The person came at me with the needle, like a punch.  I jumped off the table.  It really hurt. I was unable to lift my arm above shoulder level.  It was painful when driving home.  It became very stiff. I could not do the usual activities of daily living, nor could I do  farm and household chores. I was not able to perform my work in an active way.  I am a personal trainer and group fitness instructor. I am a competitive swimmer.  I am a runner and a biker.  I have never ever had a sore shoulder. I saw my PCP Doctor.  I got a referral for physical therapy.  I went to 3 sessions.  It took over 6 months to heal.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: The shot went in very hard.  The person came at me with the needle, like a punch.  I jumped off the table.  It really hurt. I was unable to lift my arm above shoulder level.  It was painful when driving home.  It became very stiff. I could not do the usual activities of daily living, nor could I do  farm and household chores. I was not able to perform my work in an active way.  I am a personal trainer and group fitness instructor. I am a competitive swimmer.  I am a runner and a biker.  I have never ever had a sore shoulder. I saw my PCP Doctor.  I got a referral for physical therapy.  I went to 3 sessions.  It took over 6 months to heal.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Customer reported expired PNEUMOVAX 23 was administered to a patient who was either 66 or 67 years of age (exact age was unknown to the caller).; This spontaneous report was received from a pharmacist referring to an elderly female patient who was either 66 or 67 years old. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent condition, and concomitant drugs were not reported.   On 17-DEC-2022, the patient was vaccinated with a dose of expired Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection (lot#: T040202, expiration date: 11-SEP-2022, product qunatity: 1; strength, dose, route of administration, and anatomical location were not reported) (expired product administered). No additional adverse event reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient received expired Moderna Bivalent COVID-19 vaccine on 20DEC2022, after 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Bivalent COVID-19 vaccine on 20DEC2022, after 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu Shot. Past adverse reactions to the above products included No adverse event with Flu Shot.    On 20-Dec-2022 at 8:19 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Dec-2022 at 8:19 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Bivalent COVID-19 vaccine on 20DEC2022, after 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Bivalent COVID-19 vaccine on 20DEC2022, after 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Bivalent COVID-19 vaccine on 20DEC2022, after 12 hours post puncture).    No relevant concomitant medications were reported.   The vial was initially stored in the refrigerator on 19-Dec-2022 Date and time 10 am.  Date and time of administration of vaccine was 20-Dec-2022 at 8:19AM. Pre-drawn syringe stored in the refrigerated.   The vial did not undergo any temperature excursions. It was in the refrigerator the entire time if unknown, the vial exposed to room temperature for >24 hours  No treatment information was provided.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Bed rest, Influenza like illness
Clinical narrative: Flu like symptoms; Had to stay in bed and keep drinking fluids; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and BED REST (Had to stay in bed and keep drinking fluids) in an 80-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and BED REST (Had to stay in bed and keep drinking fluids). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and BED REST (Had to stay in bed and keep drinking fluids) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient also felt under the weather and had flu-like symptoms. No treatment information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 12 hours post fist puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post fist puncture) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 30-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 30-Jun-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post fist puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post fist puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post fist puncture).    No concomitant medications were reported.  It was reported that, the patient received dose after 12 hours post fist puncture. Patient did not report any side effects.  No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness and swelling on the injection site; redness and swelling on the injection site; tired for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness and swelling on the injection site), VACCINATION SITE SWELLING (redness and swelling on the injection site) and FATIGUE (tired for 3-4 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 006M20A and 040A21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pneumonia vaccine (he had reactions to other vaccines (Pneumonia vaccine) prior years,) and FLU. Past adverse reactions to the above products included No adverse event with FLU; and Reaction to previous exposure to any vaccine with Pneumonia vaccine. Concurrent medical conditions included Blood pressure high (High Blood Pressure for 3 years and controlled with Ramipril 3 years ago,). Concomitant products included RAMIPRIL for Blood pressure high, METOPROLOL, CLOPIDOGREL BISULFATE (PLAVIX) from 14-Jun-2022 to an unknown date, ACETYLSALICYLIC ACID (BABY ASPIRIN) and INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling on the injection site), VACCINATION SITE SWELLING (redness and swelling on the injection site) and FATIGUE (tired for 3-4 days). In March 2021, FATIGUE (tired for 3-4 days) had resolved. In November 2021, VACCINATION SITE ERYTHEMA (redness and swelling on the injection site) and VACCINATION SITE SWELLING (redness and swelling on the injection site) had resolved. Not Provided          It was reported that, after the first primary shot, the patient had redness and swelling on the injection site, and she was tired for 3-4 days. After the 2nd primary shot, she had redness and swelling (red Lump) on injection site and a little tired for 3-4 days. After the first Monovalent booster, she had redness and swelling on injection site for 1-2 days.  No treatment medications were reported.   This case was linked to MOD-2022-691336 (Patient Link).
Sex: M
Vaccine: BCG
Symptoms: Disseminated Bacillus Calmette-Guerin infection, Immunoglobulins normal, Laboratory test normal, Lymphocyte count normal
Clinical narrative: disseminated BCG disease; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above, and refers to a 5-year-old male patient. His patients were consanguineous. He was hospitalized on several occasions for HSV infections by the age of 3 year. He sufferd from fungal infections, including mild oral candidiasis. The patient had R864C/R864C mutations.  On an unknown date, the patient was vaccinated with bcg live (BCG LIVE) (strength, dose, lot #, expiration date and route of administration were not provided) for tuberculosis bladder.  On an unknown date, the patient experienced  disseminated BCG disease (BCG-osis). On an unknown date, the levels od serum Ig, lymphocytes and nitroblue tetrazolium were normal. The outcome of the events was unknown.   The reporter considered disseminated BCG disease to be related to bcg live (BCG LIVE). Upon internal review, the event of disseminated BCG disease was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article. ; Sender's Comments:  US-009507513-2212USA006304:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore right arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm) and PYREXIA (fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 045B21A and 031B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore right arm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Sore right arm) and PYREXIA (fever) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2022-690818 (Patient Link).
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Influenza
Clinical narrative: l got the flu in hospital almost a week; still don't feel good; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves Adult and unknown gender patient who got the flu in hospital almost a week and still don't feel good after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Oct-2022, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (With unknown formulation, strength, route, lot number, Expiry date and at unknown administration site) for Influenza.  On an unknown date in 2022,  the patient was diagnosed with  flu (influenza)  and still don't feel good (feeling abnormal) (latency: 3 weeks) following the administration of Influenza Vaccine.  No lab data were reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both events.  At time of reporting, the outcome was Unknown for both events.  Seriousness criteria: hospitalized for flu (Influenza).; Sender's Comments: Sanofi company comment dated 27-Dec-2022: This case involves Adult and unknown gender patient who got the flu in hospital almost a week and still don't feel good after receiving Influenza Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: double pneumonia; 2 weeks later I got flu; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced double pneumonia and 2 weeks later got flu after receiving vaccine Influenza Vaccine.   The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, route, formulation, expiry date not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event of "double pneumonia (pneumonia)" and non-serious event "2 weeks later i got flu (influenza)" (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.    Outcome: Unknown for both the events.  Seriousness criteria: Medically significant for double pneumonia.; Sender's Comments: Sanofi company comment dated 27-Dec-2022: This case involves an unknown age and unknown gender patient who experienced double pneumonia and 2 weeks later got flu after receiving vaccine Influenza Vaccine. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and vaccination history, concurrent illnesses and concomitant vaccinations.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Laboratory test normal, No adverse event
Clinical narrative: The vaccine was administered before the end of the waiting period. About 3 days before the end of the period.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient has developed numbness and tingling to extremity which continues to persist.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was found after receiving this dose of the flu vaccine to have already received the flu vaccine in October 2022.Vaccines were given in flu Blitz , so their past list was only pulled after the Blitz. Consent was provided by the parents, who would have known if the patient had already received the vaccine.  No noted adverse effects have been noted from getting the second dose, it has been over 17 hours since dose was given. Medical team made aware of incident.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: positive COVID, hospitalized, fever, confusion
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: HA, SORE THROAT
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Hypoxia
Clinical narrative: COVID+ 12/25/22.  Vaccination status - moderna x4 + Pfizer BIVALENT BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/25/2022 Discharge Date: Dec 27, 2022   Active Hospital Problems No active problems to display.   Resolved Hospital Problems   Diagnosis Date Noted Date Resolved POA ? COVID      DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 76 year old female with COPD, recent admission for Pneumonia, who presented with acute on chronic hypoxia related to COPD exacerbation secondary to COVID-19 infection. Patient was very short of breath on admission. She was started on steroids and nebulizers and improved. Patient slowly improved, she was transitioned from solumedrol to oral prednisone. She was able to wean back to her home O2. She then was considered stable for discharge. Social work was consulted due to some concerns about the patient's ability to care for her husband at home. Referral was made to community resources for the couple as they navigate caregiver social concerns. Patient then discharged home in stable condition.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID+ 12/25/22.  Vaccination status - moderna x4 + Pfizer BIVALENT BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/25/2022 Discharge Date: Dec 27, 2022   Active Hospital Problems No active problems to display.   Resolved Hospital Problems   Diagnosis Date Noted Date Resolved POA ? COVID      DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 76 year old female with COPD, recent admission for Pneumonia, who presented with acute on chronic hypoxia related to COPD exacerbation secondary to COVID-19 infection. Patient was very short of breath on admission. She was started on steroids and nebulizers and improved. Patient slowly improved, she was transitioned from solumedrol to oral prednisone. She was able to wean back to her home O2. She then was considered stable for discharge. Social work was consulted due to some concerns about the patient's ability to care for her husband at home. Referral was made to community resources for the couple as they navigate caregiver social concerns. Patient then discharged home in stable condition.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Dysstasia, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: On December 1, 2022 I began having sharp pain on l left side below ribs, which was worse when I ate or drank fluids. Pain was consuming, I couldn?t work, vomiting, stand or function at all until I was given blood thinners upon admission to hospital on 12/10/2022
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Venous thrombosis, Vomiting, Whole body scan, X-ray abnormal
Clinical narrative: On December 1, 2022 I began having sharp pain on l left side below ribs, which was worse when I ate or drank fluids. Pain was consuming, I couldn?t work, vomiting, stand or function at all until I was given blood thinners upon admission to hospital on 12/10/2022
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Fever and generalized weakness on 12/26/22 with a positive home COVID test.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial with expiration 1/31/24 was taken out of freezer with a 10-week expiration of 11/30/22, so the dose was expired by 12 days. The patient does not report any issues, but per CDC recommendation, will be revaccinated 1/9/23.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Heart rate increased, Myalgia, Tachycardia
Clinical narrative: Approximately 6 hours after the injection I began to experience tachycardia at rest. My resting heart rate increased to 115-120bpm. I had typical post vaccine symptoms such as muscle aches and fatigue but the tachycardia is the reason for this report. Tachycardia self-resolved at approximately 23 hours post vaccination.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Influenza like illness, Magnetic resonance imaging head abnormal
Clinical narrative: 2 days after vaccine I was sitting down for a presentation and slowly started to feel a tightness in my chest that turned into pain and had an ambulance called. There was an xray done at city hospital and the doctor found no cause. Immediately after that I got heavy flu like symptoms(fever phlegm expulsion and bad cough) which lasted 2 to 3 weeks and the pain in my chest persisted off and on along with pain running down my left arm on until August or September of 2022. After the flu like symptoms went away I've also had a case of sinusitis around November of 2021 which was found with an mri of my head. During that time(Nov 2021) I've also gotten a permanent case of tinnitus.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, Sinusitis, Tinnitus, X-ray normal
Clinical narrative: 2 days after vaccine I was sitting down for a presentation and slowly started to feel a tightness in my chest that turned into pain and had an ambulance called. There was an xray done at city hospital and the doctor found no cause. Immediately after that I got heavy flu like symptoms(fever phlegm expulsion and bad cough) which lasted 2 to 3 weeks and the pain in my chest persisted off and on along with pain running down my left arm on until August or September of 2022. After the flu like symptoms went away I've also had a case of sinusitis around November of 2021 which was found with an mri of my head. During that time(Nov 2021) I've also gotten a permanent case of tinnitus.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19 in the ER