chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM; No adverse event; patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.), PRODUCT STORAGE ERROR (Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 038C21A and 036B) for COVID-19 prophylaxis.     Concurrent medical conditions included Cirrhosis of liver (Cirrohsis of the Liver related to Hepatitis C).   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2022 at 9:50 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2022 at 9:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.), PRODUCT STORAGE ERROR (Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM) 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 EXPIRED PRODUCT ADMINISTERED (patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.) and PRODUCT STORAGE ERROR (Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM).    Concomitant drugs were not reported. Patient reported no adverse reactions It was reported that the 1 individual monovalent vial of 5.5ml was initially stored in refrigerator on 3-Aug-2022 and was stored in refrigerator itself post puncture. The vial did not undergo any temperature excursion. Treatment medications were not provided.   This case was linked to MOD-2022-649966 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL).    Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pyrexia
Clinical narrative: Reaction right away after first primary dose/Reaction right away after 2nd primary dose; Fever right  after first primary dose/Fever right  after 2nd primary dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reaction right away after first primary dose/Reaction right away after 2nd primary dose) and PYREXIA (Fever right  after first primary dose/Fever right  after 2nd primary dose) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Reaction right away after first primary dose/Reaction right away after 2nd primary dose) and PYREXIA (Fever right  after first primary dose/Fever right  after 2nd primary dose). At the time of the report, IMMUNISATION REACTION (Reaction right away after first primary dose/Reaction right away after 2nd primary dose) and PYREXIA (Fever right  after first primary dose/Fever right  after 2nd primary dose) outcome was unknown.            It was reported that the patient was over 18 years of age. Patient received First and Second Monovalent Booster doses from Moderna Vaccine. No concomitant medications were reported. No treatment details were reported. Patient had no reactions after 1st and 2nd Booster doses.   Reporter did not allow further contact
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; child received bivalent booster for adults; child received bivalent booster for adults; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (child received bivalent booster for adults), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (child received bivalent booster for adults) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (child received bivalent booster for adults) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (child received bivalent booster for adults). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (child received bivalent booster for adults), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (child received bivalent booster for adults) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (child received bivalent booster for adults) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (child received bivalent booster for adults).    No concomitant medications were reported.  The reporter wanted to know what type of adverse reactions should be expected.  No treatment medications were reported.  Reporter did not allow further contact
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: No other AEs; GARDASIL 9 was inadvertenly administered to a 14 year old who had already completed a 2 dose series. Caller states the patient was ordered a Flu vaccine but she administered a GARDASIL 9 because that is what she usually administered; but she administered a GARDASIL 9 because that is what she usually administered; This spontaneous report was received from a medical assistant referring to a 14 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   The patient was ordered a flu vaccine (indication, dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported). However, on 09-SEP-2022, instead of the flu vaccine, the patient was inadvertently vaccinated with the third dose (as the patient already completed a 2 dose series) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection (lot # u029033, expiration date:13-MAR-2024) at a dose of 0.5 milliliter, intramuscular as prophylaxis (anatomical location not reported) (wrong product administered), because that is what the reporter usually administered (product confusion). No other adverse events (AEs) were reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE reported; Caller reported that PROQUAD got administered to a patient via intramuscular route instead of subcutaneous route today (09/15/2022).; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-SEP-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, quantity: 1, for prophylaxis (strength, lot #, and expiry date were not provided) via intramuscular route instead of subcutaneous route today (incorrect route of product administration).  No additional adverse event reported. No product quality complaint reported. No further information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Sleep apnoea syndrome
Clinical narrative: Sleep apnea; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP APNOEA SYNDROME (Sleep apnea) and COVID-19 (COVID-19) 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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced SLEEP APNOEA SYNDROME (Sleep apnea). At the time of the report, SLEEP APNOEA SYNDROME (Sleep apnea) had not resolved and COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medication 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.  Company comment: This spontaneous case concerns a 62-year-old male patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old male patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bone pain, Neck pain
Clinical narrative: Joint inflammation; Pain bone; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Joint inflammation), BONE PAIN (Pain bone) and NECK PAIN (Neck pain) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Joint inflammation), BONE PAIN (Pain bone) and NECK PAIN (Neck pain). At the time of the report, ARTHRITIS (Joint inflammation) had resolved and BONE PAIN (Pain bone) and NECK PAIN (Neck pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events of bone pain and neck pain with Humira and Moderna vaccine.  The reporter assessed the event of arthritis as probably related to Moderna vaccine and not reasonably possible to Humira.  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 an adult female patient (unknown age) with medical history of rheumatoid arthritis, who experienced the adverse event of special interest of arthritis an unknown time after a dose of mRNA-1273. The medical history of rheumatoid arthritis, as well as the report that treatment medication of adalimumab was not working, is a confounding factor. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns an adult female patient (unknown age) with medical history of rheumatoid arthritis, who experienced the adverse event of special interest of arthritis an unknown time after a dose of mRNA-1273. The medical history of rheumatoid arthritis, as well as the report that treatment medication of adalimumab was not working, is a confounding factor. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Influenza, Vomiting
Clinical narrative: Arthritis in knees; Flu symptoms; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis in knees), INFLUENZA (Flu symptoms) and VOMITING (Throwing 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 Crohn's disease.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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, CF. On an unknown date, the patient experienced ARTHRITIS (Arthritis in knees), INFLUENZA (Flu symptoms) and VOMITING (Throwing up). At the time of the report, ARTHRITIS (Arthritis in knees) was resolving and INFLUENZA (Flu symptoms) and VOMITING (Throwing up) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  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.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult female patient with Chron´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event arthritis in knees, on an unknown date after the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events was reported as non serious and upgraded seriousness as per RA list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: COVID-19; Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included HIV disease (HIV Positive).   On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Sep-2021, the patient experienced COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms). On 18-Sep-2021, COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, SARS-CoV-2 test: (Positive) Positive.         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.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Depressed mood, Inflammation
Clinical narrative: Inflammation in left elbow and shoulders; Hand inflammation; After COVID vaccination felt run down for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (After COVID vaccination felt run down for a day or two), ARTHRITIS (Inflammation in left elbow and shoulders) and INFLAMMATION (Hand inflammation) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's medical history was not reported.  Concomitant products included METHOTREXATE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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) Solution for injection in pre-filled pen. In 2021, the patient experienced DEPRESSED MOOD (After COVID vaccination felt run down for a day or two). On an unknown date, the patient experienced ARTHRITIS (Inflammation in left elbow and shoulders) and INFLAMMATION (Hand inflammation). In 2021, DEPRESSED MOOD (After COVID vaccination felt run down for a day or two) had resolved. At the time of the report, ARTHRITIS (Inflammation in left elbow and shoulders) and INFLAMMATION (Hand inflammation) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The causality for event after COVID vaccination felt run down for a day or two with Humira(Adalimumab) was no reasonable possibility.  No treatment information was provided by the reporter.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: Company comment: This is a spontaneous case concerning a 78-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab and Mehotrexate, who experienced the serious (medically significant) unexpected event arthritis, on an unknown date after the second dose of mRNA-1273. Patient report inflammation in left elbow and shoulders. Additional Clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events was reported as non serious and upgraded seriousness as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, Pain, SARS-CoV-2 test, Swelling
Clinical narrative: SWOLLEN ALL THE TIME; ACHING ALL OVER; Flu like symptoms; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), SWELLING (SWOLLEN ALL THE TIME), PAIN (ACHING ALL OVER) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an 81-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 Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced COVID-19 (COVID-19) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced SWELLING (SWOLLEN ALL THE TIME) and PAIN (ACHING ALL OVER). At the time of the report, COVID-19 (COVID-19), SWELLING (SWOLLEN ALL THE TIME), PAIN (ACHING ALL OVER) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) Positive.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment 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; Sender's Comments: Company comment: This is a spontaneous case concerning a 81-year-old female patient with Ankylosing spondylitis on treatment with Adalimumab, who experienced the non-serious AESI COVID-19, on an unknown date on the same year after the second dose of mRNA-1273. A COVID-19 Test was performed with Positive result. Clinical course and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, 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 COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 29-Mar-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Race of the patient was reported as.  Concomitant medications details were not reported.  The reporter was the patient who was reporting for herself. The patient took a rapid test, that had any kind of lines, basically result was not clear. Patient  was confused on whether she was positive or not. Patient does not had any symptoms however clarified patient only had a minor sore throat Patient's test showed very faint. Patient assumed she and her husband got Covid from a wedding they attended together. They done the Rapid BINAX test after attending the wedding and patient was immediately positive however hers was faint. The patient concerned being on border of being positive and if the PCR test would be more definitive for her. The patient received all of the doses which were Moderna. reporter does not had their vaccination cards handy to provide lot, or expiration date.   The doctor prescribed medication Paxlovid.  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-2022-619120 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, 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 COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 29-Mar-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. Patient's age was reported as over 65. Concomitant medications details were not reported.  The reporter wife of the patient who was reporting for her husband. The patient tested positive with rapid test immediately, that showed very red and was very clear that patient was positive. Patient also  had a headache. They done the Rapid BINAX test after attending the wedding and patient was immediately positive. The patient received all of the doses which were Moderna. Reporter does not have their vaccination cards handy to provide lot, or expiration date. The doctor prescribed medication Paxlovid.  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-2022-619098 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Gait disturbance, Grip strength decreased, Loss of personal independence in daily activities
Clinical narrative: Activities of daily living impaired, difficult time with typing; Difficulty in walking, struggling to walk; Grip strength decreased, struggling to open things; Fatigued; COVID-19; Fatigued; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired, difficult time with typing), GAIT DISTURBANCE (Difficulty in walking, struggling to walk), GRIP STRENGTH DECREASED (Grip strength decreased, struggling to open things), the second episode of FATIGUE (Fatigued) and the first episode of FATIGUE (Fatigued) in a 55-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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.    No Medical History information was reported.   In April 2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) Citrate free and second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (Intramuscular) 1 dosage form. In April 2021, the patient experienced the first episode of FATIGUE (Fatigued). In November 2021, the patient experienced COVID-19 (COVID-19). In January 2022, the patient experienced the second episode of FATIGUE (Fatigued). On 26-Apr-2022, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired, difficult time with typing), GAIT DISTURBANCE (Difficulty in walking, struggling to walk) and GRIP STRENGTH DECREASED (Grip strength decreased, struggling to open things). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired, difficult time with typing) outcome was unknown, GAIT DISTURBANCE (Difficulty in walking, struggling to walk), GRIP STRENGTH DECREASED (Grip strength decreased, struggling to open things) and COVID-19 (COVID-19) was resolving and last episode of FATIGUE (Fatigued) had resolved.            No concomitant medications were provided. No treatment medications 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.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Exostosis, Inappropriate schedule of product administration, Rhinorrhoea
Clinical narrative: Bone spur; Severe arthritis in both hips; Patient took 2nd dose on 19th aug and 3rd dose on 28th Oct 2021; A lot of runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (A lot of runny nose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 19th aug and 3rd dose on 28th Oct 2021), EXOSTOSIS (Bone spur) and ARTHRITIS (Severe arthritis in both hips ) in a 75-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 Ankylosing spondylitis.    No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-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 ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced RHINORRHOEA (A lot of runny nose). On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 19th aug and 3rd dose on 28th Oct 2021). On an unknown date, the patient experienced EXOSTOSIS (Bone spur) and ARTHRITIS (Severe arthritis in both hips ). At the time of the report, RHINORRHOEA (A lot of runny nose) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 19th aug and 3rd dose on 28th Oct 2021), EXOSTOSIS (Bone spur) and ARTHRITIS (Severe arthritis in both hips ) outcome was unknown.            The reporter's causality for the event(s) of A LOT OF RUNNY NOSES AFTER LAST INJECTION OF COVID VACCINE, SEVERE ARTHRITIS IN BOTH HIPS WITH BONE SPURS unknown onset and SEVERE ARTHRITIS IN BOTH HIPS WITH BONE SPURS unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility.  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 mailbox were missed to be booked-in
Age: 64.0
Sex: F
Vaccine: COVID19
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 64-year-old female patient who received mRNA-1273  for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) Unknown. In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of COVID-19 was not provided with IMBRUVICA(IBRUTINIB).  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 is a spontaneous case reported by a consumer. A 64-year-old female patient, with concurrent medical condition of chronic lymphocytic leukemia, completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of COVID-19 . Vaccination dates and onset date of the event were not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 64-year-old female patient, with concurrent medical condition of chronic lymphocytic leukemia, completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of COVID-19 \. Vaccination dates and onset date of the event were not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Chills
Clinical narrative: COVID BUT NO SYMPTOMS; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (COVID BUT NO SYMPTOMS) and CHILLS (Chills) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No known allergies.  No relevant medical history.    On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) Booster dose. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (COVID BUT NO SYMPTOMS) and CHILLS (Chills). At the time of the report, ASYMPTOMATIC COVID-19 (COVID BUT NO SYMPTOMS) and CHILLS (Chills) had resolved.     Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of COVID but no symptoms and chills with Skyrizi (Risankizumab) was no reasonable possibility.  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.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inflammation, Magnetic resonance imaging
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) and COVID-19 (COVID-19) in a 25-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 Hidradenitis suppurativa and Crohn's disease.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced INFLAMMATION (Inflammation). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, INFLAMMATION (Inflammation) and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: Inflammation.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 is a spontaneous case reported by a consumer. A 25-year-old female patient, in treatment with Adalimumab for Crohn's disease, received a dose of mRNA-1273 vaccine and experienced non serious events of COVID-19 (AESI) and inflammation. Vaccination date and onset date of the events were not provided, latency cannot be assessed. In 2021, Magnetic resonance imaging showed Inflammation. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 25-year-old female patient, in treatment with Adalimumab for Crohn's disease, received a dose of mRNA-1273 vaccine and experienced non serious events of COVID-19 (AESI) and inflammation. Vaccination date and onset date of the events were not provided, latency cannot be assessed. In 2021, Magnetic resonance imaging showed Inflammation. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
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 70-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 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) Citrate free. In July 2020, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the event COVID was reasonable possibility. No treatment medication was 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: Arthralgia, Migraine, Pain in extremity, Periarthritis
Clinical narrative: Migraine; Frozen shoulder; Shoulder pain; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), PERIARTHRITIS (Frozen shoulder), PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Shoulder pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Vertigo from June 2021 to July 2021, Cough in December 2021, Illness in December 2021, Head cold in December 2021 and Sore throat in December 2021.   On 03-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced MIGRAINE (Migraine), PERIARTHRITIS (Frozen shoulder) and ARTHRALGIA (Shoulder pain). At the time of the report, MIGRAINE (Migraine), PERIARTHRITIS (Frozen shoulder) and ARTHRALGIA (Shoulder pain) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  In Jan-2022, the patient had Moderna vaccine and had a sore arm and two migraines every month. No treatment 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Immunisation reaction, Influenza like illness
Clinical narrative: Flu like symptoms; severe brain fog; Covid vaccine related issues; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (severe brain fog), IMMUNISATION REACTION (Covid vaccine related issues) and COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) 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) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (severe brain fog), IMMUNISATION REACTION (Covid vaccine related issues) and COVID-19 (COVID-19). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (severe brain fog), IMMUNISATION REACTION (Covid vaccine related issues) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported.  Reported that patient experienced severe brain fog as an COVID after effect. She had Flu like symptoms following each vaccine and booster. She could not remember any of the dates but said that she got them as soon as they were available.  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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation reaction, Obesity, Skin disorder
Clinical narrative: first covid vaccine caused all symptoms; Obesity; Skin disorder/ spots on arms and behind ears; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (first covid vaccine caused all symptoms), OBESITY (Obesity), SKIN DISORDER (Skin disorder/ spots on arms and behind ears) and COVID-19 (COVID-19) in a 30-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 (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced IMMUNISATION REACTION (first covid vaccine caused all symptoms), OBESITY (Obesity) and SKIN DISORDER (Skin disorder/ spots on arms and behind ears). At the time of the report, IMMUNISATION REACTION (first covid vaccine caused all symptoms) had resolved, OBESITY (Obesity) had not resolved and SKIN DISORDER (Skin disorder/ spots on arms and behind ears) and COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Reported that patient had some spots on arms and behind ears but mostly 95 percent healed, it was mainly cosmetic. First Covid-19 vaccine caused all symptoms besides breathing issues.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for the events of spots on arms and behind ears, obesity, first covid vaccine caused all symptoms and covid-19 was not provided with Skyrizi (risankizumab).  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.   This case was linked to MOD-2022-630547 (Patient Link).