chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Contracted COVID-19/COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID-19/COVID-19) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-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 PANCREATIN (CREON) (Oral) at an unspecified dose. In 2021, the patient experienced COVID-19 (Contracted COVID-19/COVID-19). In 2021, COVID-19 (Contracted COVID-19/COVID-19) had resolved. Not Provided          No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 54-years-old female patient, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine. Patient had started with non-company product PANCREATIN (CREON) for an unknown indication. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was resolved. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 54-years-old female patient, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine. Patient had started with non-company product PANCREATIN (CREON) for an unknown indication. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was resolved. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Sex: M
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 male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) outcome was unknown.            No concomitant medications were reported. Adult male Patient with an event of non-serious Rheumatoid arthritis flare up in joints with HUMIRA. Patient received booster dose COVID-19 Vaccine  Moderna. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in No treatment information was reported.  Company comment: This spontaneous case concerns a male patient of around 65 years, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of around 65 years, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rotator cuff syndrome, Vaccination site pain
Clinical narrative: Torn rotator cuff on her right side; SORE ARM WITH SECOND COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (Torn rotator cuff on her right side) and VACCINATION SITE PAIN (SORE ARM WITH SECOND COVID-19 VACCINE) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In April 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM WITH SECOND COVID-19 VACCINE). On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Torn rotator cuff on her right side). In 2021, VACCINATION SITE PAIN (SORE ARM WITH SECOND COVID-19 VACCINE) had resolved. At the time of the report, ROTATOR CUFF SYNDROME (Torn rotator cuff on her right side) outcome was unknown.            Concomitant medication was not reported.  Patient reported she had a torn rotator cuff on her right side. She had only sore arm with second COVID-19 vaccine.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergy to vaccine, Dysgeusia, Headache, Swollen tongue
Clinical narrative: Swelling of tongue; Taste metallic; Allergy to vaccine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swelling of tongue), DYSGEUSIA (Taste metallic), ALLERGY TO VACCINE (Allergy to vaccine) and HEADACHE (Headache) in an adult female 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.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swelling of tongue), DYSGEUSIA (Taste metallic), ALLERGY TO VACCINE (Allergy to vaccine) and HEADACHE (Headache). At the time of the report, SWOLLEN TONGUE (Swelling of tongue) had not resolved, DYSGEUSIA (Taste metallic) outcome was unknown and ALLERGY TO VACCINE (Allergy to vaccine) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  The patient had a really bad headache after injection.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of ALLERGIC REACTION TO MODERNA VACCINE, TONGUE SWELLING, METAL TASTE IN MOUTH AFTER BEING INJECTED and BAD HEADACHE was not provided.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 72.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Pain at vaccination site caused by COVID vaccine; Pain at vaccination site caused by COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (Pain at vaccination site caused by COVID vaccine) and the second episode of VACCINATION SITE PAIN (Pain at vaccination site caused by COVID vaccine) in a 72-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.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced the first episode of VACCINATION SITE PAIN (Pain at vaccination site caused by COVID vaccine). In 2021, the patient experienced the second episode of VACCINATION SITE PAIN (Pain at vaccination site caused by COVID vaccine). In 2021, last episode of VACCINATION SITE PAIN (Pain at vaccination site caused by COVID vaccine) had resolved.            No concomitant medication provided. No treatment information mentioned.  Patient experienced pain at vaccination site caused by COVID vaccine on second shot and the booster. First dose was fine.  The reporters causality for events with Skyrizi was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: fluttering of the heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering of the heart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (fluttering of the heart) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (fluttering of the heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment Drug was provided by reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns a female patient of unknow age, with no reported medical history, who received a dose of mRNA-1273 vaccine  and experienced the serious (medically significant) unexpected AESI of cardiac flutter. Vaccination date and onset date of the event was not provided; hence, latency and temporal association cannot be properly assessed. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknow age, with no reported medical history, who received a dose of mRNA-1273 vaccine  and experienced the serious (medically significant) unexpected AESI of cardiac flutter. Vaccination date and onset date of the event was not provided; hence, latency and temporal association cannot be properly assessed. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Swelling
Clinical narrative: Swelling; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (Swelling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product HYALURONIC ACID (RESTYLANE) for an unknown indication.    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 and HYALURONIC ACID (RESTYLANE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SWELLING (Swelling). At the time of the report, SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that patient was out until the 17th. Also, a patient did Restylane under eyes. Patient got Moderna recently and had swelling and patient wanted to hyaluronidase. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Influenza like illness, Sinus congestion
Clinical narrative: Sinus congestion; Flu like symptoms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Sinus congestion), INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache). On an unknown date, the patient experienced SINUS CONGESTION (Sinus congestion). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, SINUS CONGESTION (Sinus congestion) and HEADACHE (Headache) was resolving.            Concomitant medication was not reported.  In Sep-2021, the patient experienced severe headaches after took Moderna vaccines both times and flu like symptoms after Moderna vaccines. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Vaccination site pain, Vaccination site papule
Clinical narrative: COLD; COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED; COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (COLD), VACCINATION SITE PAPULE (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) and VACCINATION SITE PAIN (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On 30-Nov-2021, the patient received second 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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 in 1 wk. On an unknown date, the patient experienced NASOPHARYNGITIS (COLD), VACCINATION SITE PAPULE (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) and VACCINATION SITE PAIN (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED). At the time of the report, NASOPHARYNGITIS (COLD) outcome was unknown and VACCINATION SITE PAPULE (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) and VACCINATION SITE PAIN (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) was resolving.            Concomitant medication was not reported.  On an unknown date patient had lack of effect with Humira.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Pain
Clinical narrative: INCREASED PAIN; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (INCREASED PAIN) and HEADACHE (HEADACHE) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Psoriatic arthritis.    Previously administered products included for Drug use for unknown indication: AMOXICILLIN, CEPHALOSPORIN NOS and CARBAMAZEPINE. Past adverse reactions to the above products included No adverse event with AMOXICILLIN, CARBAMAZEPINE and CEPHALOSPORIN NOS. Concurrent medical conditions included Sulfonamide allergy (SULFA ALLERGY), Allergy to antibiotic (CEPHALOSPORIN ALLERGY), Allergy to antibiotic (AMOXICILLIN) and Drug allergy (CARBAMAZEPINE). Concomitant products included DIPHENHYDRAMINE, FUROSEMIDE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), METFORMIN, PREDNISONE, PRENATAL + DHA, LANSOPRAZOLE (PREVACID), MONTELUKAST SODIUM (SINGULAIR), VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), VITAMIN D2 and POTASSIUM for an unknown indication.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (HEADACHE). In October 2021, the patient experienced PAIN (INCREASED PAIN). At the time of the report, PAIN (INCREASED PAIN) and HEADACHE (HEADACHE) outcome was unknown.            The reporters causality for the events of INCREASED PAIN BELIEVED RELATED TO BOOSTER VACCINE and HEADACHE was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Decreased appetite, Feeding disorder, Illness, Nausea
Clinical narrative: Unable to eat; Appetite lost; Nausea; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Unable to eat), DECREASED APPETITE (Appetite lost), NAUSEA (Nausea) and ILLNESS (Sickness) in a 62-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 Gout, Blood pressure high, Skin cancer, Non-smoker and Alcohol use (variety and occasionally) since 1976. Concomitant products included AMLODIPINE for Blood pressure high, ALLOPURINOL for Gout.   In 2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. In 2020, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced FEEDING DISORDER (Unable to eat), DECREASED APPETITE (Appetite lost) and NAUSEA (Nausea). In 2021, the patient experienced ILLNESS (Sickness). In April 2021, FEEDING DISORDER (Unable to eat), DECREASED APPETITE (Appetite lost) and NAUSEA (Nausea) had resolved. In 2021, ILLNESS (Sickness) had resolved.            The reporter did not have the lot number information and expiration date of Covid-19 vaccination because it was not on the vaccination card.  Action taken with Skyrizi for the event of sickness was unknown and that for the rest of the events was dose not changed.  The reporter did not provide any causality assessment for the event of sickness with Skyrizi and assessed the rest of the events to be not related to Skyrizi.  The reporter assessed the event of sickness as not related to Moderna vaccine and rest of the events as probably related to Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Paralysed; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysed) in a 19-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (Paralysed) (seriousness criterion medically significant). At the time of the report, PARALYSIS (Paralysed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment drug was provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 19-year-old female patient, with no reported medical history, experienced medically significant event of paralysis from waist down after second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event was not provided; hence, latency cannot be assessed. No further details regarding first dose, clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 19-year-old female patient, with no reported medical history, experienced medically significant event of paralysis from waist down after second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event was not provided; hence latency cannot be assessed. No further details regarding first dose, clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Rash
Clinical narrative: Skin breakout; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin breakout) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced RASH (Skin breakout) and FATIGUE (Fatigue). At the time of the report, RASH (Skin breakout) had not resolved and FATIGUE (Fatigue) had resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 38-year-old male 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.    Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) had not resolved.            IT was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No medical history was reported.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Malaise, Pain, Weight
Clinical narrative: Body pain; could not even move in her bed ,could only lay in 1 spot; feeling extremely ill; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body pain), HYPOKINESIA (could not even move in her bed ,could only lay in 1 spot), MALAISE (feeling extremely ill) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included DUPILUMAB (DUPIXENT) for Nasal polyps.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PAIN (Body pain), HYPOKINESIA (could not even move in her bed ,could only lay in 1 spot), MALAISE (feeling extremely ill) and HEADACHE (headache). On 18-Sep-2021, PAIN (Body pain) and HEADACHE (headache) had resolved. At the time of the report, HYPOKINESIA (could not even move in her bed ,could only lay in 1 spot) was resolving and MALAISE (feeling extremely ill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Weight: decreased. Lost 3 pounds.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  Patient took booster dose of Moderna COVID-19 vaccine. Patient reported that the events of headache and pain started on 17-SEP-2021 from 3 am to 5 am and  lasted for 24 hours. On 18-SEP-2021 , patient felt much better but lost 3 pounds.  The onset latency for the events with respect to first dose of Dupilumab was reported as one year 9 months 16 days.The causality for the events with respect to Dupilumab was reported as not provides. Patient also reported that she skipped her dose of dupixent which was due on 21-SEP-2021 until now.  The treatment medication was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Laboratory test, Peripheral swelling
Clinical narrative: Feet swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Feet swelling) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient started VENETOCLAX (VENCLEXTA) (unknown route) 100 milligram four times per day. 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. In 2021, the patient experienced PERIPHERAL SWELLING (Feet swelling). At the time of the report, PERIPHERAL SWELLING (Feet swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Counts had gone from 133 to 4,000.         IT was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved.            No concomitant medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment information was reported.  Company comment: This spontaneous case concerns an adult female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The event had not resolved. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an adult female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The event had not resolved. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Illness, Swelling
Clinical narrative: Swelling; Sickness; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ILLNESS (Sickness) and CONDITION AGGRAVATED (Condition aggravated) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Rheumatoid arthritis.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate Free. On an unknown date, the patient experienced SWELLING (Swelling), ILLNESS (Sickness) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, SWELLING (Swelling) and ILLNESS (Sickness) was resolving and CONDITION AGGRAVATED (Condition aggravated) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On unknown dates, the patient experienced oral conceptive caused to not eat. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Pyrexia
Clinical narrative: I even got sick on the Moderna; Fever; couldn't use his arm for 3 days because it hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I even got sick on the Moderna), PYREXIA (Fever) and PAIN IN EXTREMITY (couldn't use his arm for 3 days because it hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0168) 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 ILLNESS (I even got sick on the Moderna), PYREXIA (Fever) and PAIN IN EXTREMITY (couldn't use his arm for 3 days because it hurt). At the time of the report, ILLNESS (I even got sick on the Moderna), PYREXIA (Fever) and PAIN IN EXTREMITY (couldn't use his arm for 3 days because it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Live significant FU appended(events added)
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe back ache; This spontaneous case was reported by a physician and describes the occurrence of BACK PAIN (severe back ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (severe back ache). At the time of the report, BACK PAIN (severe back ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  The patient took the first dose of Moderna COVID-19 Vaccine and felt fine for 5 days, after and with the 2nd dose 5 days later he was like debilitated for a few days with back ache and it wore off in 2 days. He stated that it was a severe back ache and he recovered, that he had no reaction to the 1st dose.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Illness, Myalgia
Clinical narrative: very ill; weakness; Headache; muscle pain; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (very ill), ASTHENIA (weakness), HEADACHE (Headache) and MYALGIA (muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced ILLNESS (very ill), ASTHENIA (weakness), HEADACHE (Headache) and MYALGIA (muscle pain). At the time of the report, ILLNESS (very ill), ASTHENIA (weakness), HEADACHE (Headache) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hiccups, Illness
Clinical narrative: Hiccups; Sick after covid booster shot; This spontaneous case was reported by a consumer and describes the occurrence of HICCUPS (Hiccups) and ILLNESS (Sick after covid booster shot) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced HICCUPS (Hiccups) and ILLNESS (Sick after covid booster shot). At the time of the report, HICCUPS (Hiccups) had not resolved and ILLNESS (Sick after covid booster shot) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No concomitant medication information was provided. Some people have had a serious reaction with the second shot of the Moderna vaccine. The wife of a friend of his stated her arm hurt really bad after the second Moderna shot and equated it to being in a car accident.  It w as a 6-10 inch area from shoulder to elbow and it lasted for 3-4 days.  She was 75 or 76 years old. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Generalized aching; Headache; Tiredness; Generalized aching; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN (Generalized aching), the second episode of PAIN (Generalized aching), the first episode of HEADACHE (Headache), the second episode of HEADACHE (Headache) and the first episode of FATIGUE (Tiredness) in a 57-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 product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced the first episode of PAIN (Generalized aching), the first episode of HEADACHE (Headache) and the first episode of FATIGUE (Tiredness). In February 2021, the patient experienced the second episode of PAIN (Generalized aching), the second episode of HEADACHE (Headache) and the second episode of FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In February 2021, last episode of PAIN (Generalized aching), the last episode of HEADACHE (Headache) and the last episode of FATIGUE (Tiredness) had resolved.     Concomitant product use was not provided by the reporter.  On an unknown date in Jan-2021, the patient experienced tiredness, body aches and headache after first covid-19 vaccinations. In Jan-2021, the tiredness, body aches and headache after first covid-19 vaccination was resolved.  On an unknown date in Feb-2021, the patient experienced tiredness, body aches and headache after second covid-19 vaccinations. In Feb-2021, the tiredness, body aches and headache after second covid-19 vaccination was resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira(Adalimumab) for the events of lymph nodes swollen under both arm pits/more on left arm where shot was given after covid booster shot, fever after covid booster shot, headache after covid booster shot, fatigue after covid booster shot, body aches after covid booster shot, tiredness after first covid-19 vaccinations, body aches after first covid-19 vaccinations, headache after first covid-19 vaccinations, tiredness after second covid-19 vaccinations, body aches after second covid-19 vaccinations and headache after second covid-19 vaccinations was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-630288 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Product dispensing error, Psoriasis, Vaccination site pain
Clinical narrative: RECEIVED THE CITRATE FREE VERSION/EXPECTING THE ORIGINAL/QUESTIONED IF PHYSICIAN CHANGED THE PRESCRIPTION/PHARMACIST UNSURE OF HOW IT WAS WRITTEN; Sore arm after covid booster; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up), VACCINATION SITE PAIN (Sore arm after covid booster) and PRODUCT DISPENSING ERROR (RECEIVED THE CITRATE FREE VERSION/EXPECTING THE ORIGINAL/QUESTIONED IF PHYSICIAN CHANGED THE PRESCRIPTION/PHARMACIST UNSURE OF HOW IT WAS WRITTEN) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received 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) (unknown route) at an unspecified dose. In 2020, the patient experienced PSORIASIS (Psoriasis flare-up). In 2021, the patient experienced VACCINATION SITE PAIN (Sore arm after covid booster). On an unknown date, the patient experienced PRODUCT DISPENSING ERROR (RECEIVED THE CITRATE FREE VERSION/EXPECTING THE ORIGINAL/QUESTIONED IF PHYSICIAN CHANGED THE PRESCRIPTION/PHARMACIST UNSURE OF HOW IT WAS WRITTEN). At the time of the report, PSORIASIS (Psoriasis flare-up), VACCINATION SITE PAIN (Sore arm after covid booster) and PRODUCT DISPENSING ERROR (RECEIVED THE CITRATE FREE VERSION/EXPECTING THE ORIGINAL/QUESTIONED IF PHYSICIAN CHANGED THE PRESCRIPTION/PHARMACIST UNSURE OF HOW IT WAS WRITTEN) outcome was unknown.            No concomitant and treatment medication were provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Significant follow-up appended(narrative updated) On 20-Apr-2022: Non Significant follow-up event verbatim updated