chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a female of unspecified age and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had covid-19. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1808609, expiry: Unknown) dose was not reported, 1 total, administered at left arm on 30-MAR-2021 for covid-19 prophylaxis.  No adverse events were reported following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: 1822811, expiry: Unknown) dose was not reported, 1 total (first booster) administered at left arm on 26-OCT-2021 for covid-19 prophylaxis.  No adverse events were reported following vaccination with second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1855190, expiry: UNKNOWN) dose was not reported, 1 total (second booster) administered at left arm on 24-MAY-2022 for covid-19 prophylaxis, which was off label use (off label dosing frequency) with no other side effects (Dose number in series 3). No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This report was linked as same reporter to 20220924630.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: SHAKING CHILLS; This spontaneous report received from a patient via media (JNJ) via a company representative and concerned a 67 year old of an unspecified sex, race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: lifelong asthmatic, respiratory condition and breast cancer survivor. The patient never had Covid-19 in the entire time. The patient received first shot of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 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, within a few hours of the first vaccine the patient had about 30 minutes of shaking chills. It was reported that "I took your CoVID vaccine for the first shot and then the first booster. I then switched to Pfizer and will do the additional booster when it is available. I know some people have issues but I had pretty much no side effects or adverse effects for that matter. I was 67 years old and a lifelong asthmatic with an additional respiratory condition and a breast cancer survivor. I had about 30 minutes of shaking chills within a few hours of the first vaccine and that was it. Just to give you some positive feedback. And. BTW, I have never had CoVID-19 this entire time" (dose number in series 1). The patient also received the first booster of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with first booster of covid-19 vaccine ad26.cov2.s (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking chills. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company manufacturer (Pfizer) concerned a 66 year old, male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered at left arm on 08-MAR-2021 12:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 65 years old.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient received additional dose of non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 2) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered at left arm on 15-NOV-2021 12:00 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2).  The patient received non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 3) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered at left arm on 16-MAY-2022 12:00 for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date in 2022 patient experienced COVID-19 for which patient received non-company suspect included: paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 25-AUG-2022 till 30-AUG-2022 for covid-19 treatment. Patient finished 5 days course of paxlovid and patient felt fine and tested negative for covid-19 and Five days later on 04-SEP-2022, 14:00 the patient symptoms returned much worse than prior to treatment (suspected covid-19 infection) (Dose number in series 3). On an unspecified date in 2022 Laboratory data included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, elasomeran was not applicable and with Paxlovid was withdrawn. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test abnormal, COVID-19, SARS-CoV-2 antibody test
Clinical narrative: COVID-19 INFECTION; ANTIBODIES VERY LOW; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart issues (serious). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection, and antibodies very low (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 antibody test Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection and antibodies very low was not reported. This report was non-serious. This case was associated with a product quality complaint: 90000251245.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, COVID-19 immunisation, Dizziness, Suspected COVID-19
Clinical narrative: This spontaneous report received from a health care professional via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: obesity, depression, and allergy (Drug not specified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received non-company suspect vaccine Pfizer BioNTech covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, administered on 10-DEC-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. The patient received non-company suspect drug nirmatrelvir/ritonavir (Paxlovid) (Form of admin, oral, batch number was not reported, expiry: UNKNOWN) dose was not reported, administered on 31-AUG-2022 to 03-SEP-2022 for covid-19 treatment. On 01-SEP-2022, the patient experienced bradycardia, dizziness and suspected covid-19 infection (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable, action taken with Paxlovid was treatment withdrawn on 03-SEP-2022. The outcome of the bradycardia, dizziness, revaccination with different covid-19 vaccine and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220925638-covid-19 vaccine ad26.cov2.s-bradycardia.The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, COVID-19, Off label use
Clinical narrative: COVID-19; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a other company (AbbVie) concerned a 48 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total (1 in 1 once) administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received additional dose of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total (1 in 1 once) administered on 15-MAR-2022 for covid-19 prophylaxis which was Off label dosing frequency (Dose number in series: 1).  The patient received non-company suspect drugs upadacitinib (Rinvoq) (form of admin unknown, oral, batch number and expiry was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced 103.4 (unspecified unit) of fever and had covid-19 (Dose number in series: 1). Laboratory data (dates unspecified) included: Body temperature 103.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with upadacitinib (Rinvoq) was withdrawn. The outcome of the covid-19 and off label dosing frequency was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total (1 in 1 once) administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination covid-19 vaccine ad26.cov2.s (Dose number in series: 2). This report was non-serious. This case, involving the same patient is linked to 20220928222.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Psoriasis
Clinical narrative: HAIR LOSS; FATIGUE; PSORIASIS FLARE-UPS WITH NEW LESIONS AND IN NEW AREAS OF BODY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-FEB-2021 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: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose was not reported, 1 time every 12 weeks, therapy dates were not reported for moderate to severe chronic plaque psoriasis. Age at time of vaccination 50 years old. No concomitant medications were reported. On APR-2021, the patient experienced psoriasis flare-up. On an unspecified date, the patient experienced hair loss, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient had not recovered from hair loss, psoriasis flare-up, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Immune-mediated adverse reaction
Clinical narrative: STRONG IMMUNE RESPONSE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced strong immune response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strong immune response. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: LINGERING ISSUES; This spontaneous report received from a consumer concerned multiple patients. 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, and batch number were 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. No concomitant medications were reported.  On an unspecified date, the patient experienced lingering issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lingering issues. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURES; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total (first dose) administered, start therapy date were not reported 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.  It was reported that " including children who had seizures w/in 24 hours of the vax in the clinical trial are lying? Are you that stubborn you can't even see any of the proof? ". On an unspecified date, the patient experienced seizures. The drug latency was reported as 24 hours The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220927816-covid-19 vaccine ad26.cov2.s- Seizures. The event(s) has a compatible/suggestive 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via company concerned a 48 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received 2 doses of covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total (1 in 1 once), first dose administered on an unspecified date and second dose administered on 15-MAR-2021 for covid-19 prophylaxis which was Off label dosing frequency (Off label use) (Dose number in series: 1). At the same time the patient had treated with upadacitinib (Rinvoq). On an unspecified date, the patient experienced 103.4 (unspecified unit) of fever and had covid-19 (Dose number in series: 1). Laboratory data (dates unspecified) included: Body temperature 103.4. The patient received treatment with OTC medication and C-Pac antibiotics (Unspecified). The outcome of the covid-19 and off label dosing frequency was not reported. The patient had received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total (1 in 1 once) administered on an unspecified date for covid-19 prophylaxis as first booster dose. It was unknown whether patient had any adverse events following vaccination covid-19 vaccine ad26.cov2.s (Dose number in series: 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 3) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 03-JAN-2022 for covid-19 prophylaxis as a second booster which was an off label dosing frequency (Off label use) (Dose number in series: 3). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 48 years old. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220925988.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Off label use, Vertigo
Clinical narrative: VERTIGO; CONDITION AGGRAVATED; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned an adult female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis, moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe ulcerative colitis. The patient was previously received covid-19 vaccine ad26. cov2.s (dose 1) (dose number in series: 1) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2.s (dose number in series: 1). The patient was previously received covid-19 vaccine ad26. cov2.s (dose 2) (dose number in series: 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2.s (dose number in series: 2). The patient received booster covid-19 vaccine ad26.cov2.s (dose 3) (dose number in series 3) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported, 1 total administered for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The drug was associated with Off label use (off label dosing frequency) (dose number in series: 3). No concomitant medications were reported. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis, moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe ulcerative colitis. On an unspecified date, the patient experienced vertigo, condition aggravated (flare up) (dose number in series: 3). The patient experienced vertigo when moving from the laying position with her head turned toward the right and moved into a sitting position. She had spoken to her health care provider. Covid vaccine caused a flare up. Vertigo was a side effect of her taking upadacitinib. It was unknown if patient was enrolled in a covid-19 Vaccine Trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient recovered from condition aggravated, had not recovered from vertigo, and the outcome of off label dosing frequency was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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 not reported, batch number: 211D21A expiry: 08-SEP-2022) dose was not reported, administered on 12-SEP-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 12-SEP-2022, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This report was associated with product quality complaint: 90000251570, 90000251571.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: REALLY GOT SICK; HIGH FEVER; This spontaneous report received from a consumer via a company representative concerned a 29 year old male. 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, and batch number were not reported) dose, start therapy date were not reported 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 experienced really got sick, and high fever. Laboratory data (dates unspecified) included: Body temperature high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really got sick, and high fever. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. Concurrent medical conditions included Plaque psoriasis. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) had resolved. No concomitant medications were reported. In November 2020, the patient experienced pneumonia. On an unknown date, pneumonia got resolved. Action taken of co-suspect drug ADALIMUMAB (HUMIRA) was reported as drug discontinued. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of pneumonia with HUMIRA (ADALIMUMAB) was not provided. No treatment medications were reported. Company comment: This spontaneous case concerns a 47 years old female patient, no relevant medical history, who experienced, unexpected the serious (medically significant) event of pneumonia, which occurred approximately 14 months prior to the third dose of mRNA-1273, At the time of reporting event had resolved. No further details on clinical course, treatment received lab results were reported. Patient´s concomitant medication Adalimumab remains as risk factor for infections (as pneumonia). The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 47 years old female patient, no relevant medical history, who experienced, unexpected the serious (medically significant) event of pneumonia, which occurred approximately 14 months prior to the third dose of mRNA-1273, At the time of reporting event had resolved. No further details on clinical course, treatment received lab results were reported. Patient´s concomitant medication Adalimumab remains as risk factor for infections (as pneumonia). The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid 19 infection/ Congestion; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid 19 infection/ Congestion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    There was no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2022, the patient experienced COVID-19 (Covid 19 infection/ Congestion). At the time of the report, COVID-19 (Covid 19 infection/ Congestion) had not resolved.            Concomitant Drugs Not Reported. Humira was available in the form of solution for injection in pre-filled pen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter opinion of causality for the events of Respiratory tract congestion was not provided. No treatment details were reported.  Company Comment: This spontaneous case concerns a 33-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the third dose of mRNA-1273 vaccine. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as not resolved. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-640741 (Patient Link).; Sender's Comments: This spontaneous case concerns a 33-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the third dose of mRNA-1273 vaccine. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as not resolved. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID twice; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID twice) and DRUG INEFFECTIVE (Lack of efficacy) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID twice) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (contracted COVID twice) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      Concomitant medications were not reported.   Treatment medications were not reported.  Company comment: This is a spontaneous case concerning a full vaccinated female patient of an unknown age, with no medical history reported, who experienced the non-serious and unexpected AESI of COVID-19. The event and the 3 doses of mRNA-1273 vaccine were reported with no dates; hence, latency cannot be properly assessed. No further information on clinical presentation, course, treatment received, or other clinically relevant information, was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a full vaccinated female patient of an unknown age, with no medical history reported, who experienced the non-serious and unexpected AESI of COVID-19. The event and the 3 doses of mRNA-1273 vaccine were reported with no dates; hence, latency cannot be properly assessed. No further information on clinical presentation, course, treatment received, or other clinically relevant information, was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 virus test positive) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Psoriatic arthritis.    No known allergies.  Concurrent medical conditions included Crohn's disease (moderate to severe adult) and Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19 virus test positive). At the time of the report, COVID-19 (COVID-19 virus test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was reported that the primary reporter contact for lot number information was unsuccessful. It was reported that the Humira was taken as a solution for an injection in pre-filled pen. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality for the event of COVID positive was no reasonable possibility for Humira. No treatment medications were reported. Company comment-This spontaneous case concerns an elderly male patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (with positive SARS-CoV-2 test) that occurred in the context of mRNA-1273 vaccination. Latency can not be assessed as event onset date nor vaccination date was provided. No further information on risk factors, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly male patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (with positive SARS-CoV-2 test) that occurred in the context of mRNA-1273 vaccination. Latency can not be assessed as event onset date nor vaccination date was provided. No further information on risk factors, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Urticaria chronic, Vaccination site pain, Vaccination site warmth
Clinical narrative: chronic urticaria hives; having trouble in injection shoulder; having trouble in her injection shoulder that started slowly with a burning sensation & said recently that it's on fire & hot to the touch; trouble in her injection shoulder that started slowly with a burning sensation; This spontaneous case was reported by an attorney and describes the occurrence of URTICARIA CHRONIC (chronic urticaria hives), MUSCULOSKELETAL DISCOMFORT (having trouble in injection shoulder), VACCINATION SITE WARMTH (having trouble in her injection shoulder that started slowly with a burning sensation & said recently that it's on fire & hot to the touch) and VACCINATION SITE PAIN (trouble in her injection shoulder that started slowly with a burning sensation) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced URTICARIA CHRONIC (chronic urticaria hives), MUSCULOSKELETAL DISCOMFORT (having trouble in injection shoulder), VACCINATION SITE WARMTH (having trouble in her injection shoulder that started slowly with a burning sensation & said recently that it's on fire & hot to the touch) and VACCINATION SITE PAIN (trouble in her injection shoulder that started slowly with a burning sensation). At the time of the report, URTICARIA CHRONIC (chronic urticaria hives), MUSCULOSKELETAL DISCOMFORT (having trouble in injection shoulder), VACCINATION SITE WARMTH (having trouble in her injection shoulder that started slowly with a burning sensation & said recently that it's on fire & hot to the touch) and VACCINATION SITE PAIN (trouble in her injection shoulder that started slowly with a burning sensation) outcome was unknown.            No concomitant medications were reported. The patient received second booster. More recently patient started having trouble in her injection shoulder that started slowly with a burning sensation & said recently that it was on fire & hot to the touch. It was reported that patient took allergy medication for event chronic urticaria hives.
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (Caused epileptic seizures to her two hours after taking vaccine) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On an unknown date, the patient experienced EPILEPSY (Caused epileptic seizures to her two hours after taking vaccine) (seriousness criterion medically significant) and PAIN (Lot of pain). At the time of the report, EPILEPSY (Caused epileptic seizures to her two hours after taking vaccine) and PAIN (Lot of pain) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. The patient experienced a lot of pain due to being behind on HUMIRA. Moderna Covid vaccine caused epileptic seizures to her two hours after taking vaccine. Seizures went on for six weeks. At the time of report she had them occasionally as of 08-Sep-2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for HUMIRA(ADALIMUMAB) for the event of epileptic seizures and pain was not provided. Regulatory Authority opinion was no reasonable possibility that the events of epileptic seizures and pain were related to HUMIRA (ADALIMUMAB). Treatment information was not provided. Company comment: This is a spontaneous case reported by a consumer. An elderly female patient, with concurrent medical condition of Rheumatoid arthritis, experienced medically significant event of epileptic seizure (AESI) two hours after receiving mRNA-1273 vaccine. Seizures went on for six weeks and still had them occasionally as of 8 Sep 2022. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a consumer. An elderly female patient, with concurrent medical condition of Rheumatoid arthritis, experienced medically significant event of epileptic seizure (AESI) two hours after receiving mRNA-1273 vaccine. Seizures went on for six weeks and still had them occasionally as of 8 Sep 2022. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AF7144B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 PRODUCT ADMINISTRATION ERROR (The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm).    No concomitant medication were reported. No treatment medication were reported.  The patient received bivalent Moderna COVID-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm.  The pharmacist did consult CDC guidelines and another 0.25ml dose was administered to the patient to equal a 0.5ml dose.   This case was linked to US-MODERNATX, INC.-MOD-2022-641683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-641683:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: Sleepiness; Sore; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleepiness) and PAIN (Sore) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 SOMNOLENCE (Sleepiness) and PAIN (Sore). At the time of the report, SOMNOLENCE (Sleepiness) and PAIN (Sore) outcome was unknown.            No concomitant medication was reported.  Patient wanted to know which side effect patient might have if patient would receive the new Bivalent Omicron vaccine because patient only experienced sleepiness and sore with the 3 previous Moderna vaccines. No treatment information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and COVID-19 (COVID-19) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03921A, 03921A, 001B21A and 031L20A) for COVID-19 vaccination.     Patient had no allergy.  Concomitant products included ATORVASTATINE [ATORVASTATIN] for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced TINNITUS (Tinnitus) and COVID-19 (COVID-19). At the time of the report, TINNITUS (Tinnitus) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: (Positive) Positive.         Patient was afraid and concerned about next shot. Patient would like to know if other people had reported having tinnitus and if there was a treatment for it. Treatment medications were not reported.  Company Comment: This is a spontaneous case concerning a 76-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately two and a half weeks after receiving the fourth dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 76-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately two and a half weeks after receiving the fourth dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.