chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug level, Nausea, Suspected COVID-19, Tremor, Vaccination failure
Clinical narrative: TREMORS; NAUSEA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's height, and weight were not reported. The patient's past medical history included: cardiac transplant, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. Patient did not have any drug allergy. 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, 1 total, administered on 12-MAR-2021 for prophylactic vaccination. Age at time of vaccination 18 years old. The batch number was not reported and has been requested. The patient received non company co-suspect included: Paxlovid (nirmatrelvir/ritonavir) (form of admin, oral and batch number was not reported) dose was not reported, administered on 21-MAY-2022 till therapy end date 25-MAY-2022 for treatment of covid-19. The patient received Non-company suspect drugs included: tacrolimus (form of admin, route of admin, and batch number were not reported) dose was not reported, frequency, and therapy dates were not reported for cardiac transplant.  On MAY-2022, the patient experienced suspected covid-19 infection and hence suspected clinical vaccination failure. On 25-MAY-2022, the patient was presented to an emergency department with tremors and nausea. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. Laboratory data (dates unspecified) included: Drug (tacrolimus) level more than 60. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, action taken with tacrolimus was not reported and Paxlovid was treatment discontinued. The patient was recovering from nausea, and tremors, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint.; Sender's Comments: V0: 20220610106- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure, covid-19, tremors. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. 20220610106- covid-19 vaccine ad26.cov2.s nausea. The case causality is considered NOT RELATED. Rationale: vaccine taken on 21 march-2021 and nausea occurred on 25-may-2022, considering the long duration for the event to occur and also patient is on co-suspect medication of tacrolimus.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING AMOUNT; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a pharmacist concerned a 50 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received 2 doses (2 shots regimen) and first booster dose of (tozinameran) Pfizer Biontech Covid-19 vaccine, (dose number in series 1) (form of admin, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with Pfizer vaccine (dose number in series 1). The patient received second booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) 0.3 ml,1 total administered on 05-JUN-2022 at deltoid for prophylactic vaccination. The drug was associated with off label use. Age at time of vaccination 50 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUN-2022, The patient received a second booster dose of the Janssen COVID-19 vaccine, but he did not receive entirely, as it was only administered with 0.3ml which was off label dosing frequency and off label dosing amount (dose number in series 2). The reporter did not have information about the patient. It was reported that the patient had no side effect right after received the vaccine, and reporter did not have any information since the patient left the pharmacy 2 days ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing amount and off label dosing frequency was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Periarthritis, Vaccination site pain
Clinical narrative: RADIATING PAIN IN UPPER BODY FROM INJECTION SITE; FROZEN SHOULDER; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 total was administered in left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced radiating pain in upper body from injection site, frozen shoulder and pain at injection site (dose number in series 1). It was reported that, from the first injection the patient had pain at injection site and pain had not decreased but increased and it radiated all over upper body. The patient visited several doctors (physician office visit) about it (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered on unspecified date in JAN-2022 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second dose 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 had not recovered from pain at injection site, radiating pain in upper body from injection site, and frozen shoulder. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; TINGLING SENSATION (DESCRIBED LIKE NEEDLES WHEN YOUR LIMBS FALL ASLEEP) ON FACE, NOSE AND BACK OF HEAD; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had a lot of different vaccines and never had a reaction to vaccines before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, in NOV-2021, the patient immediately got a strange reaction to the vaccine which was later amplified when he actually had COVID (Coronavirus disease-19) on an unspecified date, in JAN-2022, which led to the suspected covid-19 infection and suspected clinical vaccination failure. Patient stated that it was a tingling sensation (described like needles when limbs fall asleep) that was mostly on his left face, nose and back of head and stated that during COVID (Coronavirus disease-19) the sensation did go into his extremities. On an unspecified date, the patient's MD (physician) did MRIs (Magnetic resonance imaging) and found nothing but he also stated that his sensation of needles on his face still persists. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation (described like needles when your limbs fall asleep) on face, nose and back of head, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235414.; Sender's Comments: V0: 20220625265 -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.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: ADMINISTRATION OF 0.3ML OF JANSSEN COVID-19 VACCINE INSTEAD OF PFIZER; This spontaneous report received from a health care professional concerned a female of unspecified age. 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 not reported, batch number: 1822811 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On an unspecified date, the patient experienced administration of 0.3ml of JANSSEN COVID-19 VACCINE instead of pfizer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of 0.3ml of JANSSEN COVID-19 VACCINE instead of pfizer was not reported. This report was non-serious. This case, from the same reporter is linked to 20220626340.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: SORE ARM AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE) in a 56-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.    The patient's past medical history included Surgery (botched surgery from 30 years ago) in 1992. Concurrent medical conditions included Diarrhea (Since 1992, the patient had ongoing diarrhea that had gotten worse in 2022.) since 1992.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE). In March 2021, VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE) had resolved.            Concomitant information was not provided.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was linked to MOD-2022-584794, MOD-2022-584726, MOD-2022-584796 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Fatigue, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CELLULITIS (since receiving covid vaccine she has had 3-4 episodes of cellulitis after bites/sometime after primary and second dose she had a bite which progressed to cellulitis) and FATIGUE (feeling a little tired for a couple days after the first and second dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 prophylaxis.  It was reported that the patient did not want to provide past medical history and declined to provide names of concomitant medications. Patient did not had a positive COVID test. Concurrent medical conditions included Allergy to antibiotic (Cipro), Drug allergy (Crestor) and Gluten sensitivity (It was not an allergy).  On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CELLULITIS (since receiving covid vaccine she has had 3-4 episodes of cellulitis after bites/sometime after primary and second dose she had a bite which progressed to cellulitis) and FATIGUE (feeling a little tired for a couple days after the first and second dose). In 2021, FATIGUE (feeling a little tired for a couple days after the first and second dose) had resolved. At the time of the report, CELLULITIS (since receiving covid vaccine she has had 3-4 episodes of cellulitis after bites/sometime after primary and last dose she had a bite which progressed to cellulitis) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient was concomitantly receiving statin drug, low dose beta blocker, antibiotics and vitamins. The patent reported feeling a little tired for a couple days after second dose and stated that never had extreme hypersensitivity to insect bites, but since receiving COVID vaccine she had 3-4 episodes of cellulitis after bites.  After second dose patient had a bite which progressed to cellulitis. She had to sought medical treatment. It occurred again, but was not as bad. No treatment medication was reported.  This case was linked to MOD-2022-587456, MOD-2022-587428, MOD-2022-587455 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Fatigue
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CELLULITIS (since receiving covid vaccine she has had 3-4 episodes of cellulitis after bites/sometime after primary and second dose she had a bite which progressed to cellulitis) and FATIGUE (feeling a little tired for a couple days after the first and second dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 prophylaxis.  It was reported that the patient did not want to provide past medical history and declined to provide names of concomitant medications. Patient did not had a positive COVID test. Concurrent medical conditions included Allergy to antibiotic (Cipro), Drug allergy (Crestor) and Gluten sensitivity (It was not an allergy).  On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CELLULITIS (since receiving covid vaccine she has had 3-4 episodes of cellulitis after bites/sometime after primary and second dose she had a bite which progressed to cellulitis) and FATIGUE (feeling a little tired for a couple days after the first and second dose). In 2021, FATIGUE (feeling a little tired for a couple days after the first and second dose) had resolved. At the time of the report, CELLULITIS (since receiving covid vaccine she has had 3-4 episodes of cellulitis after bites/sometime after primary and last dose she had a bite which progressed to cellulitis) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient was concomitantly receiving statin drug, low dose beta blocker, antibiotics and vitamins. The patent reported feeling a little tired for a couple days after second dose and stated that never had extreme hypersensitivity to insect bites, but since receiving COVID vaccine she had 3-4 episodes of cellulitis after bites.  After second dose patient had a bite which progressed to cellulitis. She had to sought medical treatment. It occurred again, but was not as bad. No treatment medication was reported.  This case was linked to MOD-2022-587456, MOD-2022-587428, MOD-2022-587455 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: After the 1st shot patient got a little red and warm her arm; After the 1st shot patient got a little red and warm her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (After the 1st shot patient got a little red and warm her arm) and VACCINATION SITE ERYTHEMA (After the 1st shot patient got a little red and warm her arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Patient did not have any allergies. Patient never had COVID-19 positive test or diagnosis.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (After the 1st shot patient got a little red and warm her arm) and VACCINATION SITE ERYTHEMA (After the 1st shot patient got a little red and warm her arm). The patient was treated with PREDNISONE at an unspecified dose and frequency and PREDNISOLONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (After the 1st shot patient got a little red and warm her arm) and VACCINATION SITE ERYTHEMA (After the 1st shot patient got a little red and warm her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2022-587868 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Headache, Myalgia
Clinical narrative: Body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and HEADACHE (headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products AMOXICILLIN for Infection and ADALIMUMAB (HUMIRA) injection for Ulcerative colitis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-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 AMOXICILLIN (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 09-May-2022, the patient experienced MYALGIA (Body ache) and HEADACHE (headache). At the time of the report, MYALGIA (Body ache) and HEADACHE (headache) had resolved.            No concomitant medication was reported. Dose number was reported as Dose 4. On an unknown date in 2022, the body aches and headache resolved. No treatment information was provided.   This case was linked to MOD-2022-587443 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine reached Beyond and was store in refrigerator till the date of administration.stability on 19Jun2021; 1 Dose administered after vaccine reached beyond use date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Dose administered after vaccine reached beyond use date (BUD)) and PRODUCT STORAGE ERROR (The vaccine reached Beyond and was store in refrigerator till the date of administration.stability on 19Jun2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Dose administered after vaccine reached beyond use date (BUD)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine reached Beyond and was store in refrigerator till the date of administration.stability on 19Jun2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Dose administered after vaccine reached beyond use date (BUD)) and PRODUCT STORAGE ERROR (The vaccine reached Beyond and was store in refrigerator till the date of administration.stability on 19Jun2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.   It was reported the off label stability date was 19-JUN-2021.  No treatment medication reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Second covid-19 vaccine she got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Second covid-19 vaccine she got sick) in a 74-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    The patient's past medical history included Surgery ("started in 1992".) in 1992. Concurrent medical conditions included Crohn's disease (Intestines out due to Crohn's disease in 2018.) since 2018.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Second covid-19 vaccine she got sick). At the time of the report, ILLNESS (Second covid-19 vaccine she got sick) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided by reporter.  No treatment drug was provided by reporter.   This case was linked to MOD-2022-587751 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, UNK
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: long term COVID; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (long term COVID) 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 Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (long term COVID). At the time of the report, POST-ACUTE COVID-19 SYNDROME (long term COVID) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  Formulation of Humira (Adalimumab) was reported as Solution for injection in pre-filled pen.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided by the reporter.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of long COVID and drug effect decreased were not provided (not reported).  Company Comment:  This spontaneous case concerns a male patient of an unknown age, on treatment with biologics Adalimumab for concurrent Ankylosing spondylitis, who experienced the unexpected non-serious event of Post-acute COVID-19 syndrome (long term COVID) that occurred on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine. Outcome was reported as not resolved.  No information was provided on any other doses of COVID-19 vaccination. Treatment with biologics Adalimumab (for concurrent Ankylosing spondylitis), an immunosuppressant, increases the risk for infection, thus, remains a confounder for the event for concurrent Ankylosing spondylitis The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a male patient of an unknown age, on treatment with biologics Adalimumab for concurrent Ankylosing spondylitis, who experienced the unexpected non-serious event of Post-acute COVID-19 syndrome (long term COVID) that occurred on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine. Outcome was reported as not resolved.  No information was provided on any other doses of COVID-19 vaccination. Treatment with biologics Adalimumab (for concurrent Ankylosing spondylitis), an immunosuppressant, increases the risk for infection, thus, remains a confounder for the event for concurrent Ankylosing spondylitis The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache
Clinical narrative: did not felt like eating; had a headache; was tired; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (did not felt like eating), HEADACHE (had a headache) and FATIGUE (was tired) in a 61-year-old female 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 DECREASED APPETITE (did not felt like eating), HEADACHE (had a headache) and FATIGUE (was tired). At the time of the report, DECREASED APPETITE (did not felt like eating), HEADACHE (had a headache) and FATIGUE (was tired) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant information were reported by the reporter. Patient was close to normal next day. No treatment information were reported by the reporter.   This case was linked to MOD-2022-587908, MOD-2022-587913, MOD-2022-587915, MOD-2022-587938 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). The patient was treated with ADALIMUMAB (HUMIRA) (subcutaneous) for Rheumatoid arthritis, at a dose of 1 dosage form. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) outcome was unknown.            Relevant concomitant medications were not reported. Patient received first, second and booster dose from Moderna COVID-19 vaccine.  Company comment: This spontaneous case concerns a female patient of an unknown age, with relevant medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) after receiving the booster dose of mRNA-1273 vaccine. The onset date of the event was not reported. Patient received 2 doses of mRNA-1273 vaccine (dates not reported). Patient took Adalimumab (Humira) as a treatment regimen. Clinical course was not reported. The outcome of event was unknown. The medical history of rheumatoid arthritis remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with relevant medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) after receiving the booster dose of mRNA-1273 vaccine. The onset date of the event was not reported. Patient received 2 doses of mRNA-1273 vaccine (dates not reported). Patient took Adalimumab (Humira) as a treatment regimen. Clinical course was not reported. The outcome of event was unknown. The medical history of rheumatoid arthritis remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pleural effusion
Clinical narrative: Fluid on lungs; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PLEURAL EFFUSION (Fluid on lungs) and COVID-19 (COVID-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-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 experienced PLEURAL EFFUSION (Fluid on lungs) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19) (seriousness criteria hospitalization and medically significant). At the time of the report, PLEURAL EFFUSION (Fluid on lungs) and COVID-19 (COVID-19) had not resolved.            No concomitant medication was provided by reporter.  On an unknown date, the patient experienced fluid in lungs, COVID-19 and might be Humira was no longer working. The patient had heath problems. The patient had fluid on lungs and was hospitalized for Covid-19. The physician had believed this might be the reason that Humira was no longer working. The patient was not enrolled in a COVID-19 vaccine trial.  No treatment drug was provided by reporter.  Causality for Humira: The reporters causality for the events of fluid in lungs, COVID-19 and might be Humira was no longer working was no reasonable possibility.  Company comment: This is a spontaneous case concerning a 49-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (hospitalization) unexpected events COVID-19 (AESI) and pleural effusion, on an unknown date after the second dose of mRNA-1273. Clinical course, diagnostic tests and hospitalization and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 49-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (hospitalization) unexpected events COVID-19 (AESI) and pleural effusion, on an unknown date after the second dose of mRNA-1273. Clinical course, diagnostic tests and hospitalization and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Report an adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Report an adverse event) 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 (Report an adverse event). At the time of the report, IMMUNISATION REACTION (Report an adverse event) 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.   Concomitant mediations were not reported Treatment information was not reported
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Irritable bowel syndrome
Clinical narrative: Irritable bowel syndrome; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) and COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe ulcerative colitis).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Citrate Free). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) and COVID-19 (COVID-19). At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) was resolving and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided by reporter.  It was unknown if patient was enrolled in COVID-19 vaccine trial. The formulation for Humira was reported as Solution for injection in pre filled pen.  No treatment medication was provided by reporter.  Company comment: This is a spontaneous case concerning a male adult patient with no reported medical history and with co-suspect medication of Adalimumab (Humira) for moderate to severe ulcerative colitis, who experienced the unexpected non-serious  event of Covid-19 and the unexpected non-serious event of irritable bowel syndrome. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the event Covid-19 was reported as resolved while the event irritable bowel syndrome the outcome was reported as resolving. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Live follow up received wherein outcome of event COVID-19 updated, the event verbatim COVID exposed might be covid positive was updated to Covid-19 and narrative updated. Sender's Comments: This is a spontaneous case concerning a male adult patient with no reported medical history and with co-suspect medication of Adalimumab (Humira) for moderate to severe ulcerative colitis, who experienced the unexpected non-serious  event of Covid-19 and the unexpected non-serious event of irritable bowel syndrome. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the event Covid-19 was reported as resolved while the event irritable bowel syndrome the outcome was reported as resolving. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Immunisation reaction, Malaise, Pain in extremity
Clinical narrative: horrendous, she had a typical reaction to the second shot, but this is ridiculous; not fell like eating/ did not felt well; she got a sore arm; tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21a and 001a21a) for COVID-19 prophylaxis.     Patient did not have allergies to medications, food and other products. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired). At the time of the report, IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous) outcome was unknown and MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) was resolving.     Concomitant medications were not reported. It was reported that, after the second dose, she got a sore arm, tired and did not feel like eating, and did not feel well, but on the second day was better. Treatment information was not provided.   This case was linked to MOD-2022-587915, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: horrendous, she had a typical reaction to the second shot, but this is ridiculous; not fell like eating/ did not felt well; she got a sore arm; tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21a and 001a21a) for COVID-19 prophylaxis.     Patient did not have allergies to medications, food and other products. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired). At the time of the report, IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous) outcome was unknown and MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) was resolving.     Concomitant medications were not reported. It was reported that, after the second dose, she got a sore arm, tired and did not feel like eating, and did not feel well, but on the second day was better. Treatment information was not provided.   This case was linked to MOD-2022-587915, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Diarrhoea, Erythema, Fatigue, Feeding disorder
Clinical narrative: horrendous, she had a typical reaction to the second shot, but this is ridiculous; not fell like eating/ did not felt well; she got a sore arm; tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21a and 001a21a) for COVID-19 prophylaxis.     Patient did not have allergies to medications, food and other products. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired). At the time of the report, IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous) outcome was unknown and MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) was resolving.     Concomitant medications were not reported. It was reported that, after the second dose, she got a sore arm, tired and did not feel like eating, and did not feel well, but on the second day was better. Treatment information was not provided.   This case was linked to MOD-2022-587915, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Illness, Night sweats, Pruritus, Pyrexia
Clinical narrative: horrendous, she had a typical reaction to the second shot, but this is ridiculous; not fell like eating/ did not felt well; she got a sore arm; tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21a and 001a21a) for COVID-19 prophylaxis.     Patient did not have allergies to medications, food and other products. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired). At the time of the report, IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous) outcome was unknown and MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) was resolving.     Concomitant medications were not reported. It was reported that, after the second dose, she got a sore arm, tired and did not feel like eating, and did not feel well, but on the second day was better. Treatment information was not provided.   This case was linked to MOD-2022-587915, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: horrendous, she had a typical reaction to the second shot, but this is ridiculous; not fell like eating/ did not felt well; she got a sore arm; tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21a and 001a21a) for COVID-19 prophylaxis.     Patient did not have allergies to medications, food and other products. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired). At the time of the report, IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous) outcome was unknown and MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) was resolving.     Concomitant medications were not reported. It was reported that, after the second dose, she got a sore arm, tired and did not feel like eating, and did not feel well, but on the second day was better. Treatment information was not provided.   This case was linked to MOD-2022-587915, MOD-2022-587908, MOD-2022-587938 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: horrendous, she had a typical reaction to the second shot, but this is ridiculous; not fell like eating/ did not felt well; she got a sore arm; tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21a and 001a21a) for COVID-19 prophylaxis.     Patient did not have allergies to medications, food and other products. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous), MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired). At the time of the report, IMMUNISATION REACTION (horrendous, she had a typical reaction to the second shot, but this is ridiculous) outcome was unknown and MALAISE (not fell like eating/ did not felt well), PAIN IN EXTREMITY (she got a sore arm) and FATIGUE (tired) was resolving.     Concomitant medications were not reported. It was reported that, after the second dose, she got a sore arm, tired and did not feel like eating, and did not feel well, but on the second day was better. Treatment information was not provided.   This case was linked to MOD-2022-587915, MOD-2022-587908, MOD-2022-587938 (Patient Link).