chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FM992) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Feb2021 as dose 1, single (Lot number: 012M20A), on 13Mar2021 as dose 2, single (Lot number: 002B21A) and on 24Oct2021 as dose 3 (booster), single (Lot number: 939906) for covid-19 immunisation. The patient's relevant medical history included: "coronary heart disease" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Feb2022, stop date: 15Aug2022; CLOPIDOGREL, start date: 01Feb2022; FAMOTIDINE, start date: 01Feb2022; FLUTICASONE, start date: 01Oct2021, stop date: 15Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence.No known allergies reported.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have long COVID even though I am vaccinated 3 times; I have long COVID even though I am vaccinated 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 58--old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart condition" (unspecified if ongoing), notes: So I have, and a heart, condition. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have long COVID even though I am vaccinated 3 times".   Clinical course: During the call, the patient stated that patient was sick, became disabled. Patient got Covid and had long Covid even though vaccinated 3 times. Patient was supposed to get vaccinated, get fourth shot yesterday for second booster and patient had a flare up again. So, it gave all kinds of weird symptoms when had long Covid. Patient petrified of it that had long Covid because just a couple of days ago on the news they were talking about long Covid and they gave another slew of symptoms that are associated with long Covid. If patient needed another thing to make scared to death about dementia. As needed anything else to tell, patient could potentially get dementia. The fear was real and then they said the long Covid was showing dementia, brain (inaudible) Those kinds of things. If patient hadn't been vaccinated 3 times, would have died from it for sure because patient had (inaudible) that are auto-immune related. Patient had a heart condition and so had no immune system virtually. Patient got it in the hospital, still got it (Covid).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200051653 same patient/event/drug, different dose;US-PFIZER INC-PV202200051654 same patient/event/drug, different dose;US-PFIZER INC-PV202200051655 same patient/event/drug, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have long COVID even though I'm vaccinated 3 times; I have long COVID even though I'm vaccinated 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have long COVID even though I'm vaccinated 3 times".  Clinical course: During the call, the patient stated that patient was sick, became disabled. Patient got Covid and had long Covid even though vaccinated 3 times. Patient was supposed to get vaccinated, get fourth shot yesterday for second booster and patient had a flare up again. So, it gave all kinds of weird symptoms when had long Covid. Patient petrified of it that had long Covid because just a couple of days ago on the news they were talking about long Covid and they gave another slew of symptoms that are associated with long Covid. If patient needed another thing to make scared to death about dementia. As needed anything else to tell, patient could potentially get dementia. The fear was real and then they said the long Covid was showing dementia, brain (inaudible) Those kinds of things. If patient hadn't been vaccinated 3 times, would have died from it for sure because patient had (inaudible) that are auto-immune related. Patient had a heart condition and so had no immune system virtually. Patient got it in the hospital, still got it (Covid).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200051652 master case, dose 1;
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Therapeutic product effect decreased
Clinical narrative: Drug effect decreased; Psoriasis flare-up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4516394-00.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at 40mg/0.4ml and second regimen (Batch/Lot number: unknown) at 80mg/0.8ml, all subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown", described as "Drug effect decreased"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare-up". The action taken for adalimumab was unknown.  Clinical course: Consumer of an elderly male with events of non-serious psoriasis came back and humira did not work as well as it use to with humira 80mg/0.8ml (adalimumab) and humira 40mg/0.4ml (adalimumab). On unknown dates, the patient experienced psoriasis came back and humira did not work as well as it use to. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Causality for HUMIRA 80MG/0.8ML(ADALIMUMAB)  The reporter considered "drug effect decreased" related to BNT162b2. The reporter's assessment of the causal relationship of "psoriasis flare-up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of PSORIASIS CAME BACK and HUMIRA DID NOT WORK AS WELL AS IT USE TO was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events "drug effect decreased, psoriasis flare-up" and the administration of the vaccine is unlikely.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Rash
Clinical narrative: immune response; breakouts all over the body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003004.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: IMMUNISATION REACTION (non-serious), outcome "unknown", described as "immune response"; RASH (non-serious), outcome "unknown", described as "breakouts all over the body".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Paraesthesia
Clinical narrative: Dizziness; Tingling in hands and feet; Stomach pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000002984.  A 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: DIZZINESS (non-serious), outcome "unknown"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling in hands and feet"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pain".  Additional information: On 12Aug2022, it was reported that a patient started treatment on an unspecified date with PFIZER BIONTECH COVID-19 VACCINE at first dose for unspecific Indication. It was reported the patient experienced dizziness, tingling in hands and feet, and stomach pain. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Menstruation irregular
Clinical narrative: breast tenderness; irregular periods; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST TENDERNESS (non-serious), outcome "unknown"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "irregular periods".  Additional information: It was reported that the event took place after use of product.  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-202201108657 same report/product/ae, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I don't trust Pfizer after the Covid nonsense. my son had both shots and boosters and still got covid twice; I don't trust Pfizer after the Covid nonsense. my son had both shots and boosters and still got covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I don't trust Pfizer after the Covid nonsense. my son had both shots and boosters and still got covid twice".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Reason for takings: COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that very pleased with paxlovid. 3 pills twice a day for 5 days. Symptoms were reduced by 2/3 the next day the patient had the Pfizer vaccine and booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am 64yo & had 2pfizer vaccines + 2pfizer boosters/tested "Positive"; I am 64yo & had 2pfizer vaccines + 2pfizer boosters/tested "Positive"; retested "Negative" 1day after stopping Paxlovid but I am now "Positive" again 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 2022, outcome "not recovered", described as "retested "Negative" 1day after stopping Paxlovid but I am now "Positive" again 2 days later"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "not recovered" and all described as "I am 64yo & had 2pfizer vaccines + 2pfizer boosters/tested "Positive"". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: retested "Negative" 1day after stopping Paxlovid; (2022) Positive, notes: I am now "Positive" again 2 days later; (21Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: I am 64yo & had 2 Pfizer vaccines + 2 Pfizer boosters (as did my husband also 64). He tested "Positive" on 18Aug2022 and I tested "Positive" on 21Aug2022. Both of our 23yo twins tested "Positive" 1&3 days later. My husband and I each took 5-day regimen of Paxlovid. Two days after stopping Paxlovid he retested "Negative" & I retested "Negative" 1day after stopping Paxlovid but I am now "Positive" again 2 days later. Neither kid took Paxlovid & are both still "Positive" but had same symptoms as we did. Any guidance on Paxlovid & Rebound now?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200054572 same drug/different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 64-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "recovered" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Two days after stopping Paxlovid he retested; (18Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 and included Paxlovid. Clinical course: The reporter's husband (patient) had 2pfizer vaccines + 2pfizer boosters. He tested "positive" on 18Aug2022. He took 5-day regimen of Paxlovid. Two days after stopping Paxlovid he retested "negative".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200054571 same reporter/product, different patient;
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I did the vaccine got so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-AUG-2022 Reporters comment: This case was reported from the patient via interactive digital media. The patient stated that he/she received the vaccine got so sick. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: experienced some itching; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient got his/her Shingles shot two days ago from reporting and experienced some itching.  The patient did not had shingles, but the shot had made him/her itchy person. The patient just had the shot and now he/she was itching like crazy. Benadryl had not calm it down yet. The place of the injection did not hurt at all. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: LANDED IN THE HOSPITAL; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date was not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient landed in the hospital for an unspecified adverse event. Number of days hospitalized and discharge information was not reported. As per the patient, "Thanks for sharing the J and J shot landed me in the hospital too. I was told not to take another one either. I really need more info on this too" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of landed in the hospital was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220861145-covid-19 vaccine ad26.cov2.s-Landed in the hospital. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Lower limb fracture, Visual impairment
Clinical narrative: VISION WAS A DOWNFALL; BROKEN LEG TWICE; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: uveitis, and other pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, frequency, and therapy dates were not reported for uveitis. No concomitant medications were reported. On an unspecified date, the patient experienced vision was a downfall, and broken leg twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vision was a downfall and broken leg twice was not reported. This report was non-serious.
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Incorrect dose administered, Pyrexia
Clinical narrative: ear infection a week after the first dose; Fever for 2 days after the vaccination; 8 Month old baby received a first dose from a vial intended for 12-17 year old patients; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EAR INFECTION (ear infection a week after the first dose), PYREXIA (Fever for 2 days after the vaccination) and INCORRECT DOSE ADMINISTERED (8 Month old baby received a first dose from a vial intended for 12-17 year old patients) in an 8-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2022, the patient experienced PYREXIA (Fever for 2 days after the vaccination) and INCORRECT DOSE ADMINISTERED (8 Month old baby received a first dose from a vial intended for 12-17 year old patients). On 16-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR INFECTION (ear infection a week after the first dose). On 11-Aug-2022, PYREXIA (Fever for 2 days after the vaccination) had resolved. At the time of the report, EAR INFECTION (ear infection a week after the first dose) and INCORRECT DOSE ADMINISTERED (8 Month old baby received a first dose from a vial intended for 12-17 year old patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs was reported. Patient's mother called to report that she was notified by a pediatrician that her 8-month-old son received a first dose of Moderna COVID-19 vaccine from the wrong vial on 09Aug2022.  The vial was intended for 12- 17-year-old.MI agent searched the system and did not find the doctor's name or phone number within the database.Patient's mother reported that the pediatrician's office told her that they called Moderna and Pfizer and they suggested to revaccinate with Pfizer. The patient had not been re-vaccinated yet. No Treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Scab
Clinical narrative: shingles; scabbed over; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (shingles) and SCAB (scabbed over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles) and SCAB (scabbed over). At the time of the report, HERPES ZOSTER (shingles) and SCAB (scabbed over) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: gave a 0.25ml dose from the wrong vial (blue cap with a purple border); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (gave a 0.25ml dose from the wrong vial (blue cap with a purple border)). No concomitant medications were reported.  The medical assistant states that they gave 0.25ml dose to children under 5 year old from a vial that was meant for children 6 to 11 years old or as booster doses to adults. The vial had a blue cap and with a label with a purple border. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-637085 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-637085:Crosslinked case CMOD22-03640.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient caught Covid a week and a half ago after first dose of Moderna/ not contagious/ tested positive on 18 Aug 2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient caught Covid a week and a half ago after first dose of Moderna/ not contagious/ tested positive on 18 Aug 2022) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022, the patient experienced COVID-19 (Patient caught Covid a week and a half ago after first dose of Moderna/ not contagious/ tested positive on 18 Aug 2022). At the time of the report, COVID-19 (Patient caught Covid a week and a half ago after first dose of Moderna/ not contagious/ tested positive on 18 Aug 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.  Patient still tested positive at the time of the report.  Treatment details was not reported by the reporter.  Company Comment:  This is a spontaneous case, reported by a patient family member, concerning 2-year-old male patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred 22 days after receiving the first dose of mRNA-1273 vaccine. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-637089, US-MODERNATX, INC.-MOD-2022-637094, US-MODERNATX, INC.-MOD-2022-637095 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case, reported by a patient family member, concerning 2-year-old male patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred 22 days after receiving the first dose of mRNA-1273 vaccine. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-637089:Reporter case US-MODERNATX, INC.-MOD-2022-637094:Child 2 US-MODERNATX, INC.-MOD-2022-637095:Child 3
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient received 1st dose of moderna and week and a half ago caught COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022, the patient experienced COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID). At the time of the report, COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient was tested positive for COVID together with her siblings and were not contagious. No treatment information was provided.  Company Comment: This spontaneous case reported by patient family member concerns a one-year-old female patient, with no reported medical history, who experienced unexpected, non-serious AESI Covid19, around 3 weeks after receiving a first dose of mRNA-1273.  She tested positive for Covid19 alongside her siblings.  Clinical course and treatment not reported.  Outcome was unknown.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-637093, US-MODERNATX, INC.-MOD-2022-637094, US-MODERNATX, INC.-MOD-2022-637089 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by patient family member concerns a one-year-old female patient, with no reported medical history, who experienced unexpected, non-serious AESI Covid19, around 3 weeks after receiving a first dose of mRNA-1273.  She tested positive for Covid19 alongside her siblings.  Clinical course and treatment not reported.  Outcome was unknown.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-637093:Child 1 US-MODERNATX, INC.-MOD-2022-637094:Child 2 US-MODERNATX, INC.-MOD-2022-637089:Reporter case
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was kept in refrigerator a week before administration; No adverse event; Vaccine expired on 20-May-2022 was administered on 16-Jun-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 was administered on 16-Jun-2022), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 was administered on 16-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 was administered on 16-Jun-2022), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 was administered on 16-Jun-2022) and PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration).    Concomitant drugs were not reported. The patient received first booster dose. The patients had not reported any adverse reactions. Number of doses/vials were 7 doses/1 vial. It was reported that the reporter did not know when the vial was initially stored but states that vaccines were usually put in refrigerator a week before administration.  The vial did not undergo any temperature excursion. Treatment medications were not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.; No adverse event; Expired vaccine administered to patients; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.).    Total 7 doses were given 1 vial. The reporter did not knowhow vial was stored but stated that vaccines are usually put in refrigerator a week before administration. The vial did not undergo any temperature excursions. Patient was given 1st booster dose. No concomitant medications were reported. No treatment  medications were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received second COVID-19 dose 6 months after the 1st dose.; No adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second COVID-19 dose 6 months after the 1st dose.) and NO ADVERSE EVENT (No adverse reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no other conditions.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second COVID-19 dose 6 months after the 1st dose.) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second COVID-19 dose 6 months after the 1st dose.) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.            No concomitant medications were reported. Patient's ethnicity reported.  It was reported that, the patient received the first dose of COVID-19 vaccine a about 2 years ago, might be over a year ago, might be less than 2 years and dose 2 of vaccine 6 months after the 1st dose.  Patient did not undergo any investigation.  No treatment medications were reported   This case was linked to MOD-2022-637114 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting/Unresponsive-Medium. Additional details: Patient fainted after immunization given. Patient had some numbness in arms but was otherwise ok. Informed us at the store later in day that she was ok.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient states that her shoulder became sore about 3 to 7 days after the injection.  It is still sore with limited range of motion.  Patient sought help from her primary care provider on 8/15/2022.  Pt. states arm/shoulder is improving but still sore with limited range of motion.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, C-reactive protein increased, Conjunctivitis, Electrocardiogram abnormal, Erythema
Clinical narrative: Currently Admitted to a local Hospital Admission date 8/31/2022-Current  Patient is a 4 y.o. female with past medical history of chronic constipation and recent history of COVID-19 infection (8/8) admitted for suspected MIS-C vs Kawasaki Disease. Patient has a 4 day history of persistent fever, new onset rash, swelling of her fingers, cervical lymphadenopathy, erythematous mucus membranes, strawberry tongue, erythematous lips, and bilateral conjunctivitis with no drainage. Initial work up notable for elevated inflammatory markers (Ferritin 481, CRP 38.2, ESR 28, Procalcitonin 1.02, Fibrinogen 408, and D-dimer 3130), leukopenia (WBC 4.34), thrombocytopenia (Platelets 106), and elevetated absolute lymphocyte count (0.91). Coagulation and cardiac studies are within normal limits (PT/PTT, INR, and NT-Pro BNP). ECG 9/1 shows sinus tachycardia. Patient will have an echocardiogram today to evaluate for cardiac involvement. Differential diagnosis includes Kawasaki vs MIS-C, however due to presentation 3 weeks after COVID-19 positivity the most likely diagnosis is MIS-C.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Inflammatory marker increased, International normalised ratio normal, Kawasaki's disease, Leukopenia
Clinical narrative: Currently Admitted to a local Hospital Admission date 8/31/2022-Current  Patient is a 4 y.o. female with past medical history of chronic constipation and recent history of COVID-19 infection (8/8) admitted for suspected MIS-C vs Kawasaki Disease. Patient has a 4 day history of persistent fever, new onset rash, swelling of her fingers, cervical lymphadenopathy, erythematous mucus membranes, strawberry tongue, erythematous lips, and bilateral conjunctivitis with no drainage. Initial work up notable for elevated inflammatory markers (Ferritin 481, CRP 38.2, ESR 28, Procalcitonin 1.02, Fibrinogen 408, and D-dimer 3130), leukopenia (WBC 4.34), thrombocytopenia (Platelets 106), and elevetated absolute lymphocyte count (0.91). Coagulation and cardiac studies are within normal limits (PT/PTT, INR, and NT-Pro BNP). ECG 9/1 shows sinus tachycardia. Patient will have an echocardiogram today to evaluate for cardiac involvement. Differential diagnosis includes Kawasaki vs MIS-C, however due to presentation 3 weeks after COVID-19 positivity the most likely diagnosis is MIS-C.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mucosal disorder, Multisystem inflammatory syndrome in children, N-terminal prohormone brain natriuretic peptide normal, Peripheral swelling
Clinical narrative: Currently Admitted to a local Hospital Admission date 8/31/2022-Current  Patient is a 4 y.o. female with past medical history of chronic constipation and recent history of COVID-19 infection (8/8) admitted for suspected MIS-C vs Kawasaki Disease. Patient has a 4 day history of persistent fever, new onset rash, swelling of her fingers, cervical lymphadenopathy, erythematous mucus membranes, strawberry tongue, erythematous lips, and bilateral conjunctivitis with no drainage. Initial work up notable for elevated inflammatory markers (Ferritin 481, CRP 38.2, ESR 28, Procalcitonin 1.02, Fibrinogen 408, and D-dimer 3130), leukopenia (WBC 4.34), thrombocytopenia (Platelets 106), and elevetated absolute lymphocyte count (0.91). Coagulation and cardiac studies are within normal limits (PT/PTT, INR, and NT-Pro BNP). ECG 9/1 shows sinus tachycardia. Patient will have an echocardiogram today to evaluate for cardiac involvement. Differential diagnosis includes Kawasaki vs MIS-C, however due to presentation 3 weeks after COVID-19 positivity the most likely diagnosis is MIS-C.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Procalcitonin increased, Prothrombin time normal, Pyrexia, Rash
Clinical narrative: Currently Admitted to a local Hospital Admission date 8/31/2022-Current  Patient is a 4 y.o. female with past medical history of chronic constipation and recent history of COVID-19 infection (8/8) admitted for suspected MIS-C vs Kawasaki Disease. Patient has a 4 day history of persistent fever, new onset rash, swelling of her fingers, cervical lymphadenopathy, erythematous mucus membranes, strawberry tongue, erythematous lips, and bilateral conjunctivitis with no drainage. Initial work up notable for elevated inflammatory markers (Ferritin 481, CRP 38.2, ESR 28, Procalcitonin 1.02, Fibrinogen 408, and D-dimer 3130), leukopenia (WBC 4.34), thrombocytopenia (Platelets 106), and elevetated absolute lymphocyte count (0.91). Coagulation and cardiac studies are within normal limits (PT/PTT, INR, and NT-Pro BNP). ECG 9/1 shows sinus tachycardia. Patient will have an echocardiogram today to evaluate for cardiac involvement. Differential diagnosis includes Kawasaki vs MIS-C, however due to presentation 3 weeks after COVID-19 positivity the most likely diagnosis is MIS-C.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased, Serum ferritin increased, Sinus tachycardia, Strawberry tongue, Thrombocytopenia
Clinical narrative: Currently Admitted to a local Hospital Admission date 8/31/2022-Current  Patient is a 4 y.o. female with past medical history of chronic constipation and recent history of COVID-19 infection (8/8) admitted for suspected MIS-C vs Kawasaki Disease. Patient has a 4 day history of persistent fever, new onset rash, swelling of her fingers, cervical lymphadenopathy, erythematous mucus membranes, strawberry tongue, erythematous lips, and bilateral conjunctivitis with no drainage. Initial work up notable for elevated inflammatory markers (Ferritin 481, CRP 38.2, ESR 28, Procalcitonin 1.02, Fibrinogen 408, and D-dimer 3130), leukopenia (WBC 4.34), thrombocytopenia (Platelets 106), and elevetated absolute lymphocyte count (0.91). Coagulation and cardiac studies are within normal limits (PT/PTT, INR, and NT-Pro BNP). ECG 9/1 shows sinus tachycardia. Patient will have an echocardiogram today to evaluate for cardiac involvement. Differential diagnosis includes Kawasaki vs MIS-C, however due to presentation 3 weeks after COVID-19 positivity the most likely diagnosis is MIS-C.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: Currently Admitted to a local Hospital Admission date 8/31/2022-Current  Patient is a 4 y.o. female with past medical history of chronic constipation and recent history of COVID-19 infection (8/8) admitted for suspected MIS-C vs Kawasaki Disease. Patient has a 4 day history of persistent fever, new onset rash, swelling of her fingers, cervical lymphadenopathy, erythematous mucus membranes, strawberry tongue, erythematous lips, and bilateral conjunctivitis with no drainage. Initial work up notable for elevated inflammatory markers (Ferritin 481, CRP 38.2, ESR 28, Procalcitonin 1.02, Fibrinogen 408, and D-dimer 3130), leukopenia (WBC 4.34), thrombocytopenia (Platelets 106), and elevetated absolute lymphocyte count (0.91). Coagulation and cardiac studies are within normal limits (PT/PTT, INR, and NT-Pro BNP). ECG 9/1 shows sinus tachycardia. Patient will have an echocardiogram today to evaluate for cardiac involvement. Differential diagnosis includes Kawasaki vs MIS-C, however due to presentation 3 weeks after COVID-19 positivity the most likely diagnosis is MIS-C.