chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other company manufacturer (Pfizer) concerned a 26 year old female. The patient's height and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered to left arm on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 25 years old.  Concomitant medications included amoxicillin trihydrate/clavulanate potassium. The patient additionally received non-company suspect vaccine of elasomeran (Spikevax) (dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered to left arm on 23-OCT-2021 for prophylactic vaccination. Age at time of vaccination 26 years old.  On an unspecified date, the patient experienced covid-19 infection (confirmed covid-19 infection) (dose number in series 2). The patient received an unspecified medication for treatment of Covid-19 from 25-MAY-2022 to 29-MAY-2022.  On 06-JUN-2022, the patient tested positive for Covid-19 again with symptoms recurring (confirmed clinical vaccination failure) (dose number in series 1). Symptoms included headache, fever, chills, congestion and body aches.   The action taken with covid-19 vaccine ad26.cov2.s and elasomeran (Spikevax) was not applicable. The patient was recovering from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000236414.; Sender's Comments: V0: 20220634597-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 53 year old male. Initial information was processed along with the additional information received on 20-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, cancer, and allergy. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered for prophylactic vaccination. 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 second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211021A and expiry: unknown) dose was not reported, 1 total, administered on 02-DEC-2021 to left arm for prophylactic vaccination. Age at time of vaccination 53 years old. Concomitant medication included: Agios 120, investigational drug for more than 6 years. On an unspecified date, the patient experienced suspected covid-19 infection and suspected clinical vaccine failure (Dose number in series 2). The patient received Paxlovid for covid-19 treatment, from 30-MAY-2022 to 04-JUN-2022. It was reported that the patient was taking unspecified other medications/products within 2 weeks of starting COVID-19 treatment. On 10-JUN-2022 at 22:00, the patient experienced rebound infection, congestion, malaise, cough and sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000236425.; Sender's Comments: V0- 20220636220 -COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: ASYMPTOMATIC COVID-19; This spontaneous report received from a consumer concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alochol user, and non smoker, and other pre-existing medical conditions included: The patient was not pregnant. The patient had no known allergies. There was no history of drug abuse or illicit drug usage. 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 11-APR-2021 for prophylactic vaccination. Age at time of vaccination 67 years old. No concomitant medications were reported. On DEC-2021, the patient experienced asymptomatic covid-19. Laboratory data included: COVID-19 PCR test Negative, COVID-19 virus test Positive (Positive for 3 days), and SARS-CoV-2 rapid antibody test Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asymptomatic covid-19 on DEC-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: STILL DEALING WITH THE AFTER EFFECTS OF VACCINE; This spontaneous report received from a patient via social media via company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number, expiry date were not reported) dose, start therapy date were not reported for prophylactic vaccination. 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 still dealing with the after effects of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still dealing with the after effects of vaccine. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURE; This spontaneous report received from a patient via social media via a company representative, concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination.  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 additional dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) was not reported, 1 total, administered on an unspecified date  for prophylactic vaccination. 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 seizure. Reporter stated that "Patient my sil had a seizure hours after a covid booster. First one ever" (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220636274-covid-19 vaccine ad26.cov2.s-seizure. 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.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: HEART ISSUES (RAPID HEART BEAT REQUIRED MEDICAL ATTENTION); This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: heart transplant (Heart transplant 4 years ago, no heart issues post transplant). 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 prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart issues (rapid heart beat required medical attention). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issues (rapid heart beat required medical attention) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 prophylactic vaccination. 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 unspecified adverse event. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious. This case, from the same reporter is linked to 20220638820.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN (Experiencing severe pain ever since I took my booster on April first and its's affecting functionality of my left arm / Excruciating pain after Moderna booster) and LIMB DISCOMFORT (Affecting the functionality of left arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Experiencing severe pain ever since I took my booster on April first and its's affecting functionality of my left arm / Excruciating pain after Moderna booster) and LIMB DISCOMFORT (Affecting the functionality of left arm). At the time of the report, PAIN (Experiencing severe pain ever since I took my booster on April first and its's affecting functionality of my left arm / Excruciating pain after Moderna booster) and LIMB DISCOMFORT (Affecting the functionality of left arm) had not resolved. No concomitant medication was provided. Patient had experienced excruciating pain after Moderna booster. Treatment medication was not provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: Mild to moderate heart pain; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Mild to moderate heart pain) in a 27-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Mild to moderate heart pain) (seriousness criterion medically significant). At the time of the report, ANGINA PECTORIS (Mild to moderate heart pain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant product use was provided.  The patient got the vaccine months ago and have been getting mild to moderate heart pain since he got the vaccine. The patient had no heart pain prior.  No treatment medication was provided.  Company comment: This spontaneous case reported by a consumer concerns a 27-year-old male patient with no reported medical history who experienced the unexpected serious (medically significant) event of Angina pectoris (Mild to moderate heart pain) which occurred unknown days after administration of an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. No details regarding medical history, clinical course, investigations, treatment, and event outcome are provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness of the event assessed as per medical judgement.; Sender's Comments: This spontaneous case reported by a consumer concerns a 27-year-old male patient with no reported medical history who experienced the unexpected serious (medically significant) event of Angina pectoris (Mild to moderate heart pain) which occurred unknown days after administration of an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. No details regarding medical history, clinical course, investigations, treatment, and event outcome are provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness of the event assessed as per medical judgement.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine Products) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in Prefilled pen. In May 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine Products). In June 2022, COVID-19 (COVID-19) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine Products) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive POSITIVE. In June 2022, SARS-CoV-2 test: negative Negative. No Concomitant and Treatment medications details were not reported. Company Comment: This spontaneous case concerns a 59-year-old, male patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred on unspecified interval after receiving the booster dose of mRNA-1273 vaccine. Interchange of vaccine products is noted in the case as patient received COVID-19 VACCINE NRVV AD26 (JNJ 78436735) as primary series of COVID-19 vaccination. Patient has recovered and tested negative for COVID-19 test a month after the event onset. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 59-year-old, male patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred on unspecified interval after receiving the booster dose of mRNA-1273 vaccine. Interchange of vaccine products is noted in the case as patient received COVID-19 VACCINE NRVV AD26 (JNJ 78436735) as primary series of COVID-19 vaccination. Patient has recovered and tested negative for COVID-19 test a month after the event onset. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Vestibulitis
Clinical narrative: vestibulitis; This spontaneous case was reported by a physician and describes the occurrence of VESTIBULITIS (vestibulitis) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VESTIBULITIS (vestibulitis). At the time of the report, VESTIBULITIS (vestibulitis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment drug were reported.   This case was linked to MOD-2022-590554 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Aplastic anaemia, COVID-19
Clinical narrative: Aplastic anemia; Covid; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Aplastic anemia) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced APLASTIC ANAEMIA (Aplastic anemia) (seriousness criterion medically significant) and COVID-19 (Covid). At the time of the report, APLASTIC ANAEMIA (Aplastic anemia) and COVID-19 (Covid) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product information was not reported.  Patient stated that she has seen reports about aplastic anemia, specifically, 18 instances studies, Where the vaccine is linked to aplastic anemia and COVID. patient stated that it is rare but has seen it in the studies.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a female patient (age not specified) with no medical history reported, who experienced the unexpected serious (medically significant) event of Aplastic anaemia and unexpected non-serious AESI of Covid-19 unspecified days after a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient has seen reports about aplastic anemia, specifically, 18 instances studies, Where the vaccine is linked to aplastic anemia and COVID. patient stated that it is rare but has seen it in the studies. The current pandemic situation of COVID-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient (age not specified) with no medical history reported, who experienced the unexpected serious (medically significant) event of Aplastic anaemia and unexpected non-serious AESI of Covid-19 unspecified days after a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient has seen reports about aplastic anemia, specifically, 18 instances studies, Where the vaccine is linked to aplastic anemia and COVID. patient stated that it is rare but has seen it in the studies. The current pandemic situation of COVID-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time/6 months later received a 2nd dose) in a 31-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time/6 months later received a 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time/6 months later received a 2nd dose) outcome was unknown. No concomitant medication information were given. It was reported that patient might received a false vaccination card "a phony card that is on the news" so discarded it and wanted to check the vaccination records over the phone. After receiving 1st dose of the Moderna COVID19 vaccine 6 months later patient received a 2nd dose. No treatment information were given. This case was linked to MOD-2022-589930 (Patient Link). Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (She had contracted Covid-19 despite vaccination and booster with Spikevax) in a female 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 COVID-19 (She had contracted Covid-19 despite vaccination and booster with Spikevax). At the time of the report, COVID-19 (She had contracted Covid-19 despite vaccination and booster with Spikevax) outcome was unknown. No concomitant medication were reported. No treatment information were provided. Company Comment: This spontaneous case concerns female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (reported as She had contracted Covid-19 despite vaccination and booster with Spikevax) on an unknown date after receiving booster dose of mRNA-1273 vaccine. Onset latency between vaccine and event cannot be established. SARS-CoV-2 test was not reported. The dates of administration for the current and previous doses of mRNA-1273 vaccines received by the patient were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (reported as She had contracted Covid-19 despite vaccination and booster with Spikevax) on an unknown date after receiving booster dose of mRNA-1273 vaccine. Onset latency between vaccine and event cannot be established. SARS-CoV-2 test was not reported. The dates of administration for the current and previous doses of mRNA-1273 vaccines received by the patient were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had Covid19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had Covid19) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (got covid on a cruise). Concurrent medical conditions included Blood pressure abnormal.   On 19-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Had Covid19). At the time of the report, COVID-19 (Had Covid19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication included blood presure medication.  Patient's height was reported as 5 foot 1 inch.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 79-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred 7 months 18 days after the third dose of mRNA-1273 vaccine. There is Inappropriate schedule of product administration was noted in the case with dose interval of 38 days (interval between dose 1 and dose 2 longer than 35 days). SARS-CoV-2 test was positive after 7 months 18 days after the current vaccination. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement   This case was linked to MOD-2021-025671 (Patient Link).; Sender's Comments: This spontaneous case concerns a 79-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred 7 months 18 days after the third dose of mRNA-1273 vaccine. There is Inappropriate schedule of product administration was noted in the case with dose interval of 38 days (interval between dose 1 and dose 2 longer than 35 days). SARS-CoV-2 test was positive after 7 months 18 days after the current vaccination. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hot flush, Illness, Influenza
Clinical narrative: Sickness; Hot flashes; Flu; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), HOT FLUSH (Hot flashes) and INFLUENZA (Flu) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced ILLNESS (Sickness), HOT FLUSH (Hot flashes) and INFLUENZA (Flu). At the time of the report, ILLNESS (Sickness) and INFLUENZA (Flu) outcome was unknown and HOT FLUSH (Hot flashes) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant drugs not reported. No treatment medication information provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Anti-cyclic citrullinated peptide antibody positive, Rheumatoid factor, Rheumatoid factor decreased
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE (since the Moderna vaccines surprising to see how high my CCP went up. anti-citrullinated peptide antibody test (anti-CCP antibody test) is at 200. RF factor that was high is now way down) and RHEUMATOID FACTOR DECREASED (RF factor that was high is now way down) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 013M20A, 029A21A and 058E21A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis since February 2020. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE (since the Moderna vaccines surprising to see how high my CCP went up. anti-citrullinated peptide antibody test (anti-CCP antibody test) is at 200. RF factor that was high is now way down) and RHEUMATOID FACTOR DECREASED (RF factor that was high is now way down). At the time of the report, ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE (since the Moderna vaccines surprising to see how high my CCP went up. anti-citrullinated peptide antibody test(anti-CCP antibody test) is at 200. RF factor that was high is now way down) and RHEUMATOID FACTOR DECREASED (RF factor that was high is now way down) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2020, Anti-cyclic citrullinated peptide antibody: 24 24. In February 2020, Rheumatoid factor: positive (Positive) Positive. In June 2022, Anti-cyclic citrullinated peptide antibody: 200 now 200. In June 2022, Rheumatoid factor: now way down now way down. Patient had flare up in February 2020. It was reported that patient was unsure whether they had COVID and no flare ups during recent investigations. Patient reported that no medications were taken. No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Psoriasis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Residual Patches Psoriasis) and INJECTION SITE PRURITUS (Felt itchy after injection area) in an elderly 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. There were no reported medical history. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, received fourth 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) Solution for injection in prefilled pen, dose- CF. On an unknown date, the patient experienced PSORIASIS (Residual Patches Psoriasis) and INJECTION SITE PRURITUS (Felt itchy after injection area). At the time of the report, PSORIASIS (Residual Patches Psoriasis) had not resolved and INJECTION SITE PRURITUS (Felt itchy after injection area) had resolved. Not Provided. It was unknown whether the patient was enrolled in a COVID-19 Vaccine trail. No concomitant medications were reported. The primary reporter did not have the lot number information because the packaging was discarded. No treatment medications were reported for the events. The reporter considered that there was a causal relation between events of residual patches psoriasis and felt itchy after injection area and co-suspect Humira.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Inappropriate schedule of product administration, Nasopharyngitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (BAD ANXIETY), NASOPHARYNGITIS (COLDS) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Moderna vaccine 1st dose on 01-Jan-2021 and 2nd dose on 03-Mar-2021) in a 25-year-old male 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 Ulcerative colitis. Concurrent medical conditions included Ulcerative colitis (Moderate to severe). On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second 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) Solution for injection in pre-filled pen, Citrate Free. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Moderna vaccine 1st dose on 01-Jan-2021 and 2nd dose on 03-Mar-2021). On an unknown date, the patient experienced ANXIETY (BAD ANXIETY) and NASOPHARYNGITIS (COLDS). At the time of the report, ANXIETY (BAD ANXIETY) and NASOPHARYNGITIS (COLDS) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Moderna vaccine 1st dose on 01-Jan-2021 and 2nd dose on 03-Mar-2021) outcome was unknown. Not Provided. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The reporter causality for the events bad anxiety and cold with Humira was not reported. No treatment information was reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Experienced some achiness for 24 hours) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Tuberculosis since 2021 and Ulcerative colitis. Concomitant products included ADALIMUMAB (HUMIRA) for Ulcerative colitis, PREDNISONE from 19-Jul-2021 to January 2022 for an unknown indication. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Experienced some achiness for 24 hours). At the time of the report, PAIN (Experienced some achiness for 24 hours) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: liver levels were up Liver levels were up. Concomitant medication also included tuberculosis medication NOS. No treatment information was mentioned. Patient took prednisone for a while, and stopped it. Due to this, patient felt muscles and joint pain and had hurt everyday since withdrawal of prednisone. Patient was also on tuberculosis medication for past nine months and used to take Humira but discontinued. She was about to be finished with the course, but liver levels were up from tuberculosis medication. Once he got the booster, he experienced some achiness for 24 hours. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal dreams, Chills, Fatigue, Insomnia, Nightmare
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), INSOMNIA (Severe insomnia) and CHILLS (chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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, the patient experienced SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), INSOMNIA (Severe insomnia), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown and INSOMNIA (Severe insomnia) had resolved. Concomitant medication list was not provided. The patient wanted to report some side effects that patient had with both booster doses. It was reported that the patient took second booster 8 months apart. The patient's insomnia was reported to last for over 5 days. Treatment information was not provided. This case was linked to MOD-2022-590478 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sleep deficit
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), INSOMNIA (Severe insomnia) and CHILLS (chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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, the patient experienced SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), INSOMNIA (Severe insomnia), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown and INSOMNIA (Severe insomnia) had resolved. Concomitant medication list was not provided. The patient wanted to report some side effects that patient had with both booster doses. It was reported that the patient took second booster 8 months apart. The patient's insomnia was reported to last for over 5 days. Treatment information was not provided. This case was linked to MOD-2022-590478 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality sleep
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), INSOMNIA (Severe insomnia) and CHILLS (chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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, the patient experienced SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), INSOMNIA (Severe insomnia), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown and INSOMNIA (Severe insomnia) had resolved. Concomitant medication list was not provided. The patient wanted to report some side effects that patient had with both booster doses. It was reported that the patient took second booster 8 months apart. The patient's insomnia was reported to last for over 5 days. Treatment information was not provided. This case was linked to MOD-2022-590478 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal dreams, Chills, Fatigue, Insomnia, Nightmare
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Severe insomnia), POOR QUALITY SLEEP (the little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (excessive dreams) and FATIGUE (Fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Severe insomnia), POOR QUALITY SLEEP (the little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (excessive dreams), FATIGUE (Fatigue) and CHILLS (chills). At the time of the report, INSOMNIA (Severe insomnia) had resolved and POOR QUALITY SLEEP (the little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (excessive dreams), FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown. No concomitant drug reported. The patient received 2nd booster on an unknown date. The patient wanted to officially report some side effects that patient had with both booster doses. It was reported that the patient took second booster 8 months apart. The patient's insomnia was reported to last for over 5 days. No treatment information was provided by the reporter. This case was linked to MOD-2022-590462 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sleep deficit
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Severe insomnia), POOR QUALITY SLEEP (the little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (excessive dreams) and FATIGUE (Fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Severe insomnia), POOR QUALITY SLEEP (the little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (excessive dreams), FATIGUE (Fatigue) and CHILLS (chills). At the time of the report, INSOMNIA (Severe insomnia) had resolved and POOR QUALITY SLEEP (the little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (excessive dreams), FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown. No concomitant drug reported. The patient received 2nd booster on an unknown date. The patient wanted to officially report some side effects that patient had with both booster doses. It was reported that the patient took second booster 8 months apart. The patient's insomnia was reported to last for over 5 days. No treatment information was provided by the reporter. This case was linked to MOD-2022-590462 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality sleep
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Severe insomnia), POOR QUALITY SLEEP (the little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (excessive dreams) and FATIGUE (Fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Severe insomnia), POOR QUALITY SLEEP (the little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (excessive dreams), FATIGUE (Fatigue) and CHILLS (chills). At the time of the report, INSOMNIA (Severe insomnia) had resolved and POOR QUALITY SLEEP (the little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (excessive dreams), FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown. No concomitant drug reported. The patient received 2nd booster on an unknown date. The patient wanted to officially report some side effects that patient had with both booster doses. It was reported that the patient took second booster 8 months apart. The patient's insomnia was reported to last for over 5 days. No treatment information was provided by the reporter. This case was linked to MOD-2022-590462 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: had a bad Moderna shot; This spontaneous case was reported by an attorney and describes the occurrence of IMMUNISATION REACTION (had a bad Moderna shot) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a bad Moderna shot). At the time of the report, IMMUNISATION REACTION (had a bad Moderna shot) outcome was unknown.    The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided.  No treatment medication information provided.