chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was stored in refrigerator on 21Jan2022, expired on 13May2022 and administered on 7Jun2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vial was stored in refrigerator on 21Jan2022, expired on 13May2022 and administered on 7Jun2022) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 013F21A, 001C21A and 020B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, SIMVASTATIN (ZOCOR), LISINOPRIL and LISINOPRIL DIHYDRATE (PRINIVIL) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 11-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 10:47 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 10:47 AM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored in refrigerator on 21Jan2022, expired on 13May2022 and administered on 7Jun2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vial was stored in refrigerator on 21Jan2022, expired on 13May2022 and administered on 7Jun2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (vial was stored in refrigerator on 21Jan2022, expired on 13May2022 and administered on 7Jun2022).    The event did not cause the patient to seek medical care. It was unknown if there was any other potential cause. It was unknown if the patient experienced a similar event in the past.  Vial was initially stored in refrigerator on 21Jan2022 and the used vial was again stored in refrigerator on 7jun2022.  No treatment drug information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient got the Moderna vaccine and have had 3 more boosters; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the Moderna vaccine and have had 3 more boosters) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (patient received Pfizer vaccine and 5 booster shots). Past adverse reactions to the above products included No adverse event with Pfizer.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the Moderna vaccine and have had 3 more boosters) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the Moderna vaccine and have had 3 more boosters) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient had received Pfizer vaccine and 5 booster shots, then the patient went down and got the Moderna vaccine and had 3 more booster shots and in the next month, the patient would be getting the Johnson and Johnson vaccine and after a month, the patient would start getting more boosters again.  It was reported that in January, the patient would start all over again because the patient wanted to be sure that the patient was safe and all of patient's family and friends remained safe. The patient expected that everyone should be vaccinated and boosted atleast 10 to 20 times every year and people should not forget to get at least 4 or 5 flu vaccines either.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Psoriasis
Clinical narrative: Sore arm; Fatigue; FLARE UP/ITCHY AND FLAKY SCALP; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and PSORIASIS (FLARE UP/ITCHY AND FLAKY SCALP) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and Psoriatic arthritis.    There was no reported medical history.  Concurrent medical conditions included Psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS.) and Psoriatic arthritis.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Oral) at an unspecified dose. On 13-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and PSORIASIS (FLARE UP/ITCHY AND FLAKY SCALP). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) outcome was unknown and PSORIASIS (FLARE UP/ITCHY AND FLAKY SCALP) had not resolved.            Concomitant medication information was not provided by the reporter.  The patient had a flare up, itchy and flaky scalp a week before next injection of SKYRIZI (RISANKIZUMAB).   It was unknown if the patient was enrolled in COVID-19 vaccine trail.  Reporter causality for the event condition aggravated was reported as probable and for other events it was not reported with respect to SKYRIZI (RISANKIZUMAB).  Treatment information was not provided by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis, Upper respiratory tract infection
Clinical narrative: FEVER; SINUS INFECTION; UPPER RESPIRATORY INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (SINUS INFECTION), UPPER RESPIRATORY TRACT INFECTION (UPPER RESPIRATORY INFECTION) and PYREXIA (FEVER) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   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. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2022, the patient experienced SINUSITIS (SINUS INFECTION) and UPPER RESPIRATORY TRACT INFECTION (UPPER RESPIRATORY INFECTION). On an unknown date, the patient experienced PYREXIA (FEVER). In 2022, SINUSITIS (SINUS INFECTION) and UPPER RESPIRATORY TRACT INFECTION (UPPER RESPIRATORY INFECTION) had resolved. At the time of the report, PYREXIA (FEVER) had resolved.            Concomitant medications were not reported.  Treatment medications were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of sinus infection, upper respiratory infection and fever with HUMIRA (ADALIMUMAB) was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fall, Pain in extremity, Patella fracture, Somnolence
Clinical narrative: Sleepy; Painful joints; Pain in arm; Shoulder fracture; Broken knee cap; Fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall), SOMNOLENCE (Sleepy), UPPER LIMB FRACTURE (Shoulder fracture), PATELLA FRACTURE (Broken knee cap) and ARTHRALGIA (Painful joints) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 01-Dec-2021, received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced FALL (Fall), UPPER LIMB FRACTURE (Shoulder fracture) and PATELLA FRACTURE (Broken knee cap). On an unknown date, the patient experienced SOMNOLENCE (Sleepy), ARTHRALGIA (Painful joints) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, FALL (Fall), UPPER LIMB FRACTURE (Shoulder fracture) and PATELLA FRACTURE (Broken knee cap) was resolving, SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (Pain in arm) had not resolved and ARTHRALGIA (Painful joints) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.   Concomitant Drugs Not Reported.  It was reported that the patient experienced joint pain and reported going to physical therapy for knee pain and shoulder pain. Patient had arm pain. Patient fell and broke left shoulder and right knee cap in Jan 2022 and also stated that got really sleepy and had joint pain for four days after Covid-19 vaccination.   It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the events of Painful joints and arm pain was a reasonable possibility. The reporter's causality for the events of fall, Sleepy, Shoulder fracture and Broken knee cap was not reported with Rinvoq (upadacitinib) and Janssen Covid-19 Vaccine.   No treatment medication were provided.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Upper limb fracture
Clinical narrative: Sleepy; Painful joints; Pain in arm; Shoulder fracture; Broken knee cap; Fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall), SOMNOLENCE (Sleepy), UPPER LIMB FRACTURE (Shoulder fracture), PATELLA FRACTURE (Broken knee cap) and ARTHRALGIA (Painful joints) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 01-Dec-2021, received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced FALL (Fall), UPPER LIMB FRACTURE (Shoulder fracture) and PATELLA FRACTURE (Broken knee cap). On an unknown date, the patient experienced SOMNOLENCE (Sleepy), ARTHRALGIA (Painful joints) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, FALL (Fall), UPPER LIMB FRACTURE (Shoulder fracture) and PATELLA FRACTURE (Broken knee cap) was resolving, SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (Pain in arm) had not resolved and ARTHRALGIA (Painful joints) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.   Concomitant Drugs Not Reported.  It was reported that the patient experienced joint pain and reported going to physical therapy for knee pain and shoulder pain. Patient had arm pain. Patient fell and broke left shoulder and right knee cap in Jan 2022 and also stated that got really sleepy and had joint pain for four days after Covid-19 vaccination.   It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the events of Painful joints and arm pain was a reasonable possibility. The reporter's causality for the events of fall, Sleepy, Shoulder fracture and Broken knee cap was not reported with Rinvoq (upadacitinib) and Janssen Covid-19 Vaccine.   No treatment medication were provided.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Intervertebral disc operation
Clinical narrative: Intervertebral disc replacement; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC OPERATION (Intervertebral disc replacement) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Lumbar discectomy in July 2022. Concurrent medical conditions included Rheumatoid arthritis.   In July 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In July 2022, the patient experienced INTERVERTEBRAL DISC OPERATION (Intervertebral disc replacement) (seriousness criterion medically significant). At the time of the report, INTERVERTEBRAL DISC OPERATION (Intervertebral disc replacement) was resolving.            It was not known if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant and treatment medication information was reported.  The causality of co-suspect product RINVOQ with respect to adverse event was reported as not related.  Company Comment: This spontaneous case concerns a 55-year-old female patient with a medical history of Rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Intervertebral disc operation that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had a surgery to replace the disc on an unknow date in Jul 2022. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as resolving. Patients' medical history of Rheumatoid arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with a medical history of Rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Intervertebral disc operation that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had a surgery to replace the disc on an unknow date in Jul 2022. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as resolving. Patients' medical history of Rheumatoid arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I was vaxxed and boosted ( Moderna ), and I just got Covid on a plane; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I was vaxxed and boosted ( Moderna ), and I just got Covid on a plane) 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 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 (I was vaxxed and boosted ( Moderna ), and I just got Covid on a plane). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I was vaxxed and boosted ( Moderna ), and I just got Covid on a plane) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was provided.  It was reported that the patient  took Paxlovid and felt so much better but 4 days after treatment experiencing all Covid Symptoms.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history. Patient experienced the unexpected non-serious AESI event of Covid-19. On unknown date, patient received unknown dose number and booster dose of mRNA-1273 vaccine. On unknown date patient experienced Covid-19. Allegedly, the event was described as, "I was "vaxxed " and boosted (Moderna), and I just got Covid on a plane. Patient took Nirmatrelvir + Ritonavir (Paxlovid) and felt better. However, 4 days after treatment it was reported that the patient experienced "all" Covid-19 symptoms and was tested positive. No other information surrounding the event was reported. The outcome of the event was unknown. 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.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history. Patient experienced the unexpected non-serious AESI event of Covid-19. On unknown date, patient received unknown dose number and booster dose of mRNA-1273 vaccine. On unknown date patient experienced Covid-19. Allegedly, the event was described as, "I was "vaxxed " and boosted (Moderna), and I just got Covid on a plane. Patient took Nirmatrelvir + Ritonavir (Paxlovid) and felt better. However, 4 days after treatment it was reported that the patient experienced "all" Covid-19 symptoms and was tested positive. No other information surrounding the event was reported. The outcome of the event was unknown. 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Magnetic resonance imaging, Oedema
Clinical narrative: Edema was back and even worse than before/Water retention and swelling; This spontaneous case was reported by a patient and describes the occurrence of OEDEMA (Edema was back and even worse than before/Water retention and swelling) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Edema peripheral (Severe in left, right ankle and foot which lasted for two weeks and could not wear a shoe) and Prostate surgery (Several years ago). Previously administered products included for Product used for unknown indication: BNT162B2 (Second vaccination) and BNT162B2 (First vaccination). Past adverse reactions to the above products included No adverse event with BNT162B2; and Penile haemorrhage with BNT162B2. Family history included Blood disorder (Major blood issues following the second Pfizer).   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 OEDEMA (Edema was back and even worse than before/Water retention and swelling). At the time of the report, OEDEMA (Edema was back and even worse than before/Water retention and swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Normal. On an unknown date, Computerised tomogram: Nothing abnormal. On an unknown date, Magnetic resonance imaging: Nothing abnormal.         It was reported that an emergency doctor had not known why the patient had blood clots coming from the penis. The patient had prostate surgery but not found any correlation between that and the sudden onset of the clots. The patient was sent to home with antibiotics and told to go back to the urologist. The patient never had edema in life, and it went away after a few months. It was reported that the daughter had huge blood clots and excessive bleeding for the two consecutive periods which were debilitating enough for daughter to unable leave house or work for a week each time. The patient had an episodes of water retention and swelling that could last for 10 days or more. The patient doctors could not explain why these sudden onset of health issues happened following the vaccinations. Treatment medications included water pills and homeopathic remedies (unspecified) for water retention and swelling. No treatment medications were specified for the edema that was back and even worse than before. It was reported that the patient tests were inconclusive as to whether the patient had bladder or kidney infections.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; patient received first dose of Moderna vaccine on May-2021 and second dose on Aug-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose of Moderna vaccine on May-2021 and second dose on Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose of Moderna vaccine on May-2021 and second dose on Aug-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose of Moderna vaccine on May-2021 and second dose on Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported.  Patient received third/booster dose in May 2022.  Treatment medication was not reported.   This case was linked to MOD-2022-627370 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatomyositis
Clinical narrative: Anti-MDA5 dermatomyositis; This literature-non-study case was reported in a literature article and describes the occurrence of DERMATOMYOSITIS (Anti-MDA5 dermatomyositis) in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:      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, the patient experienced DERMATOMYOSITIS (Anti-MDA5 dermatomyositis) (seriousness criterion medically significant). At the time of the report, DERMATOMYOSITIS (Anti-MDA5 dermatomyositis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered DERMATOMYOSITIS (Anti-MDA5 dermatomyositis) to be related.    No concomitant and treatment medications were reported.  Company Comment: This is a Literature-non-study case concerning a 45-year-old male patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Dermatomyositis (reported as Anti-MDA 5 dermatomyositis), which occurred on an unknown date after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Literature-non-study case concerning a 45-year-old male patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Dermatomyositis (reported as Anti-MDA 5 dermatomyositis), which occurred on an unknown date after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood triglycerides, Joint range of motion decreased, Joint range of motion measurement, Pain in extremity
Clinical narrative: HAD LOSS OF 80 PERCENT RANGE OF MOTION; AFTER COVID VACCINE RECEIVED EXPERIENCED PAIN IN SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (HAD LOSS OF 80 PERCENT RANGE OF MOTION) and PAIN IN EXTREMITY (AFTER COVID VACCINE RECEIVED EXPERIENCED PAIN IN SORE ARM) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's.    No Medical History information was reported.   In April 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg,1 in 2 week. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (HAD LOSS OF 80 PERCENT RANGE OF MOTION) and PAIN IN EXTREMITY (AFTER COVID VACCINE RECEIVED EXPERIENCED PAIN IN SORE ARM). At the time of the report, JOINT RANGE OF MOTION DECREASED (HAD LOSS OF 80 PERCENT RANGE OF MOTION) and PAIN IN EXTREMITY (AFTER COVID VACCINE RECEIVED EXPERIENCED PAIN IN SORE ARM) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Joint range of motion measurement: Loss of 80 percent range of motion.. On 01-Jun-2022, Blood triglycerides: Elevated triglyceride level was 317.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Patient received moderna third dose as a booster dose. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events with HUMIRA (ADALIMUMAB) was reported as not related.   Treatment information was not provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, Musculoskeletal discomfort
Clinical narrative: RIGHT SHOULDER WAS BOTHERING; CHEST PAIN; BACK PROBLEMS; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (BACK PROBLEMS), MUSCULOSKELETAL DISCOMFORT (RIGHT SHOULDER WAS BOTHERING) and CHEST PAIN (CHEST PAIN) 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 Psoriatic arthritis.    No known allergies and relevant medical history reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-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) at an unspecified dose. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULOSKELETAL DISCOMFORT (BACK PROBLEMS). In June 2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (RIGHT SHOULDER WAS BOTHERING) and CHEST PAIN (CHEST PAIN). The patient was treated with NITROGLYCERIN at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (BACK PROBLEMS), MUSCULOSKELETAL DISCOMFORT (RIGHT SHOULDER WAS BOTHERING) and CHEST PAIN (CHEST PAIN) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, Blood test: Did not find anything wrong. In June 2022, Electrocardiogram: Did not find anything wrong.         No concomitant drugs taken by the patient.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient received first booster dose on 27-Oct-2021 and second booster dose on 18-Apr-2022.  Reporter causality was not reported for back discomfort and not related for other events with respect to HUMIRA (ADALIMUMAB).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, COVID-19
Clinical narrative: Possible Anxiety attack; Patient experienced covid; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (Possible Anxiety attack) and COVID-19 (Patient experienced covid) in a 63-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.    Concurrent medical conditions included Rheumatoid arthritis.   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2022, the patient experienced COVID-19 (Patient experienced covid). On an unknown date, the patient experienced ANXIETY (Possible Anxiety attack). At the time of the report, ANXIETY (Possible Anxiety attack) outcome was unknown and COVID-19 (Patient experienced covid) was resolving.      Concomitant drugs were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The reporter's causality for the events of Possible Anxiety attack and Patient experienced covid with Humira was not provided. Treatment details were not given.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 63-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19,  which occurred after an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case reported by a patient, concerning a 63-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19,  which occurred after an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product administration interrupted
Clinical narrative: got sick [after first dose]; first dose >35 days ago , she couldn't go back to get the second dose. She still hasn't gotten the second dose.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (got sick [after first dose]) and PRODUCT ADMINISTRATION INTERRUPTED (first dose >35 days ago , she couldn't go back to get the second dose. She still hasn't gotten the second dose.) 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 24-Aug-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 ILLNESS (got sick [after first dose]) and PRODUCT ADMINISTRATION INTERRUPTED (first dose >35 days ago , she couldn't go back to get the second dose. She still hasn't gotten the second dose.). At the time of the report, ILLNESS (got sick [after first dose]) and PRODUCT ADMINISTRATION INTERRUPTED (first dose >35 days ago , she couldn't go back to get the second dose. She still hasn't gotten the second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    There was no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE ).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In May 2022, the patient experienced COVID-19 (COVID-19). In 2022, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The formulation for Humira was reported as Solution for injection in pre-filled pen. Reporter causality was not reported for the event COVID-19 with respect to Humira.  Treatment information was not provided by the reporter. Company comment: This spontaneous case concerns a 67-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19. Vaccination date was not reported; hence latency to a dose of mRNA-1273 vaccine, cannot be properly assessed. No information on previous Covid-19 vaccination available. No further details on clinical course, lab test results or treatment were reported. The outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19. Vaccination date was not reported; hence latency to a dose of mRNA-1273 vaccine, cannot be properly assessed. No information on previous Covid-19 vaccination available. No further details on clinical course, lab test results or treatment were reported. The outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Patient had COVID with terrible cough and was very drained and tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had COVID with terrible cough and was very drained and tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had COVID with terrible cough and was very drained and tired). At the time of the report, COVID-19 (Patient had COVID with terrible cough and was very drained and tired) had not resolved.            No concomitant medications was reported.  No treatment medications was reported.  The patient had COVID with terrible cough and was very drained and tired. Reporter assessed event COVID-19  as possibly related to Moderna COVID-19 vaccine. Reporter did not provided causality for event COVID-19 with Rinvoq. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Company Comment:    This is an spontaneous case concerning an unknown year-old  female patient with medical history of Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis who experienced the unexpected AESI of COVID-19, unknown days after 3 doses of mRNA-1273 vaccine.  At the time of the report, COVID-19 (COVID-19) had not resolved The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment:    This is an spontaneous case concerning an unknown year-old  female patient with medical history of Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis who experienced the unexpected AESI of COVID-19, unknown days after 3 doses of mRNA-1273 vaccine.  At the time of the report, COVID-19 (COVID-19) had not resolved The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose  12-MAR-2021 and Second dose  29-MAR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose  12-MAR-2021 and Second dose  29-MAR-2021) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no known allergies.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose  12-MAR-2021 and Second dose  29-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose  12-MAR-2021 and Second dose  29-MAR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were provided by the reporter. No treatment information were provided.   This case was linked to MOD-2022-627608 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Slight fever; Body aches; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Slight fever) and MYALGIA (Body aches) in a female 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 PYREXIA (Slight fever) and MYALGIA (Body aches). At the time of the report, PYREXIA (Slight fever) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient got the 2nd dose too soon, on 09Aug2022.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got the 2nd dose too soon, on 09Aug2022.) and NO ADVERSE EVENT (No adverse event) in a 27-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.     Patient's COVID positive test or diagnosis were reported as unknown.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were reported as unknown.    On 20-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got the 2nd dose too soon, on 09Aug2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got the 2nd dose too soon, on 09Aug2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got the 2nd dose too soon, on 09Aug2022.).    No concomitant medication was reported.   No treatment information was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Patient received vaccination with Moderna Covid 19 vaccine after it suffered a temperature excursion; vaccine was administered to 1 patient after the excursion happened; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccination with Moderna Covid 19 vaccine after it suffered a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (vaccine was administered to 1 patient after the excursion happened) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A and 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2022, 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccination with Moderna Covid 19 vaccine after it suffered a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (vaccine was administered to 1 patient after the excursion happened). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccination with Moderna Covid 19 vaccine after it suffered a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (vaccine was administered to 1 patient after the excursion happened) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccination with Moderna Covid 19 vaccine after it suffered a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (vaccine was administered to 1 patient after the excursion happened).    Product stored in freezer at the time of the excursion. Warm excursion: Maximum temperature reached 5.29° Celsius. Excursion duration was reported as 49 Minutes in total. Vial has already been used. No visual inspection noting any vaccine state change were frozen vials thawed, were thawed vials re-frozen, were they visualized at all. vials used in 1 patient. Vial Had previous excursions, but HCP could not provide information about this excursions.