chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, COVID-19, Dysgeusia, SARS-CoV-2 test
Clinical narrative: Accidental overdose; bad taste in his mouth, almost a bitterness; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DYSGEUSIA (bad taste in his mouth, almost a bitterness) and ACCIDENTAL OVERDOSE (Accidental overdose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 treatment.    No Medical History information was reported.   On 19-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) morning 3 DF, evening On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, the patient experienced COVID-19 (COVID-19). On 19-Apr-2022, the patient experienced DYSGEUSIA (bad taste in his mouth, almost a bitterness). On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Accidental overdose). At the time of the report, COVID-19 (COVID-19) and ACCIDENTAL OVERDOSE (Accidental overdose) outcome was unknown and DYSGEUSIA (bad taste in his mouth, almost a bitterness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         No information on concomitant medication were reported. Patient were double boosted with Covid vaccines. Stated he had four doses of Moderna vaccines. No treatment details 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: Malaise
Clinical narrative: NOT FELT WELL; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (NOT FELT WELL) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Rheumatoid arthritis.    Concurrent medical conditions included Hidradenitis suppurativa and Rheumatoid arthritis.   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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (NOT FELT WELL). At the time of the report, MALAISE (NOT FELT WELL) had not resolved.            No information on concomitant medication were reported. It was unknown if patient was enrolled in COVID-19 vaccine trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event (s) NOT FELT WELL was not provided. No treatment details 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: Dermatitis psoriasiform
Clinical narrative: PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS PSORIASIFORM (PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced DERMATITIS PSORIASIFORM (PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA). At the time of the report, DERMATITIS PSORIASIFORM (PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA) was resolving.            No information on concomitant medication were reported. It was unknown if patient was enrolled in COVID-19 vaccine trial. The reporter's causality for the event (s) PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment details 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: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Vaccination site pain
Clinical narrative: Revaccination with different COVID-19 vaccine; interchange of vaccine products; My third was moderna Needed one week to recover/Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and VACCINATION SITE PAIN (My third was moderna Needed one week to recover/Pain in arm) 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 TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and VACCINATION SITE PAIN (My third was moderna Needed one week to recover/Pain in arm). At the time of the report, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown and VACCINATION SITE PAIN (My third was moderna Needed one week to recover/Pain in arm) had resolved.            The patient's first 2 shots were BioNTech had pain in the arm where it was injection and 1 day off at the second shot. The third dose was Moderna and needed nearly one week to get 100% recovered.  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: Memory impairment
Clinical narrative: Memory impaired/MEMORY ISSUES; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impaired/MEMORY ISSUES) 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 Psoriatic arthritis.    No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-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) at an unspecified dose. On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory impaired/MEMORY ISSUES). At the time of the report, MEMORY IMPAIRMENT (Memory impaired/MEMORY ISSUES) had not resolved.            No concomitant medications were reported. The reporter causality for the event of Memory impaired was Not related for cosuspect humira. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain, Pyrexia
Clinical narrative: aches /pains; side effects; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches /pains), IMMUNISATION REACTION (side effects) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Additional Dose: additional dose of Pfizer was pretty rough, had a fever, aches and pains for about 5 days), Pfizer (Additional Dose: additional dose of Pfizer was pretty rough, had a fever, aches and pains for about 5 days) and Pfizer (Dose 2). Past adverse reactions to the above products included Ache with Pfizer; Fever with Pfizer; and No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Relapsing-remitting multiple sclerosis (living with RRMS for 25 years now), MS (been NEDA since 2015), Immunosuppression, Coronary artery disease, Polycystic kidney and Anxiety.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PAIN (aches /pains), IMMUNISATION REACTION (side effects) and PYREXIA (Fever). In 2022, PAIN (aches /pains), IMMUNISATION REACTION (side effects) and PYREXIA (Fever) had resolved.            The patient got the first 2 Pfizer and an additional dose of Pfizer and boosted in Jan with the Moderna vaccine. The last additional dose of Pfizer was pretty rough, had a fever, aches and pains for about 5 days. No relapse. The Moderna booster was much milder than the additional dose and side effects lasted about 3 days. No relapse and had to be off DMT for a month to get the shots. Now saying this, the patient had been NEDA since 2015, but always live with the anxiety that MS could reactivate at any time.   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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    There was no reported medical history.    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. In December 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (Fever). In 2021, PYREXIA (Fever) had resolved.      It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Formulation for HUMIRA was given as Solution for injection in pre-filled pen.  The reporter's causality for the events of Pyrexia was not provided with 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.
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Feeling abnormal, Muscular weakness
Clinical narrative: (increase in muscle weakness; decrease ind endurance; feeling worsening after each injection; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS ((increase in muscle weakness), EXERCISE TOLERANCE DECREASED (decrease ind endurance) and FEELING ABNORMAL (feeling worsening after each injection) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ALGLUCOSIDASE ALFA (LUMIZYME) for an unknown indication.    Concurrent medical conditions included Glycogen storage disease type II.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ALGLUCOSIDASE ALFA (LUMIZYME) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MUSCULAR WEAKNESS ((increase in muscle weakness), EXERCISE TOLERANCE DECREASED (decrease ind endurance) and FEELING ABNORMAL (feeling worsening after each injection). At the time of the report, MUSCULAR WEAKNESS ((increase in muscle weakness), EXERCISE TOLERANCE DECREASED (decrease ind endurance) and FEELING ABNORMAL (feeling worsening after each injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were provided. For LUMIZYME, it was unknow whether 0.2 micron inline filter was used during drug administration and where was the drug administration performed.  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 medicine were provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle tightness, Pain in extremity
Clinical narrative: TIGHTNESS IN LEFT HAND; PAIN IN LEGS; PAIN IN BOTH KNEES; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (TIGHTNESS IN LEFT HAND), PAIN IN EXTREMITY (PAIN IN LEGS) and ARTHRALGIA (PAIN IN BOTH KNEES) 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 Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-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) at an unspecified dose. On an unknown date, the patient experienced MUSCLE TIGHTNESS (TIGHTNESS IN LEFT HAND), PAIN IN EXTREMITY (PAIN IN LEGS) and ARTHRALGIA (PAIN IN BOTH KNEES). At the time of the report, MUSCLE TIGHTNESS (TIGHTNESS IN LEFT HAND), PAIN IN EXTREMITY (PAIN IN LEGS) and ARTHRALGIA (PAIN IN BOTH KNEES) had not resolved.            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.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   No treatment information was provided.  The reporter's causality for the events of tightness in left hand, pain in legs and pain in both knees with Humira (Adalimumab) was reasonable possibility.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of (/ARM PAIN THE SITE OF INJECTION/IT WAS WORSE AFTER COVID BOOSTER), (Vaccination site swelling/SWELLING AT SITE OF INJECTION AFTER COVID BOOSTER) and (Vaccination site erythema REDNESS AT SITE OF INJECTION AFTER COVID BOOSTER) in an 82-year-old female 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. Concurrent medical conditions included Penicillin allergy, Drug allergy (SIMVASTATIN) and Drug allergy (LIVALO). Concomitant products included PARACETAMOL (ACETAMINOFEN), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ATORVASTATIN, HYDROCHLOROTHIAZIDE, (TRIAMTERENE & HCTZ), OMEPRAZOLE, ALLOPURINOL, TRAMADOL, SIMVASTATIN and PITAVASTATIN CALCIUM (LIVALO) for an unknown indication. On 06-Aug-2021, the patient started (VENCLEXTA) (Oral) 100 milligram once a day. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced (Vaccination site pain/ARM PAIN ATA THE SITE OF INJECTION/IT WAS WORSE AFTER COVID BOOSTER), (Vaccination site swelling/SWELLING AT SITE OF INJECTION AFTER COVID BOOSTER) and (Vaccination site erythema/REDNESS AT SITE OF INJECTION AFTER COVID BOOSTER). At the time of the report, (Vaccination site pain/ARM PAIN AT THE SITE OF INJECTION/IT WAS WORSE AFTER COVID BOOSTER), (Vaccination site swelling/SWELLING AT SITE OF INJECTION AFTER COVID BOOSTER) and (Vaccination site erythema/REDNESS AT SITE OF INJECTION AFTER COVID BOOSTER) had not resolved. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. On 18-Apr-2022, patient saw her physician and her physician prescribed to take an antibiotic. She had not picked up the call yet as of 19-Apr-2022. She did not agree to have physician contacted. The reporter causality for the events of Vaccination site pain, Vaccination site swelling, Vaccination site erythema was 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rash, Vaccination site rash
Clinical narrative: Rash on scalp; Rash around injection site; Flu like symptoms after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms after second vaccine), VACCINATION SITE RASH (Rash around injection site) and RASH (Rash on scalp) in a 50-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 Plaque psoriasis.    No Medical History information was reported.   On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-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 November 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after second vaccine). On 07-Mar-2022, the patient experienced VACCINATION SITE RASH (Rash around injection site). On an unknown date, the patient experienced RASH (Rash on scalp). In November 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms after second vaccine) had resolved. At the time of the report, VACCINATION SITE RASH (Rash around injection site) and RASH (Rash on scalp) was resolving.            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: M
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation reaction
Clinical narrative: severe reaction; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (severe reaction) and DYSPNOEA (difficulty breathing) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Bronchitis (always had bronchitis frequently since he was a child).   On an unknown date, the patient received third 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 and second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (severe reaction) and DYSPNOEA (difficulty breathing). At the time of the report, IMMUNISATION REACTION (severe reaction) and DYSPNOEA (difficulty breathing) had resolved.            After the Moderna Booster the patient had a very severe reaction. He had difficulty breathing for 2 weeks, he was doing fine. The patient had the Moderna vaccine each time. The patient had always had bronchitis frequently since he was a child, this might be a preexisting condition.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction, Vaccination site pain
Clinical narrative: Side effects of booster reaction; Experienced tiredness; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects of booster reaction), FATIGUE (Experienced tiredness) and VACCINATION SITE PAIN (Soreness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis and DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis.    No Medical History information was reported.   On 12-Oct-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 26-Oct-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every two weeks. On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced FATIGUE (Experienced tiredness) and VACCINATION SITE PAIN (Soreness at injection site). On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects of booster reaction). At the time of the report, IMMUNISATION REACTION (Side effects of booster reaction) outcome was unknown and FATIGUE (Experienced tiredness) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.            The patient developed a non-serious event on 09Dec2021, she missed a dupixent shot due to having side effects of booster reaction. 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: 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 a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Biontech and Biontech. Past adverse reactions to the above products included No adverse event with Biontech and Biontech.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment medications 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: Fatigue
Clinical narrative: Tired after COVID booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired after COVID booster dose) 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 Ankylosing spondylitis and Panuveitis.    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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tired after COVID booster dose). At the time of the report, FATIGUE (Tired after COVID booster dose) had resolved.            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: Injection site pain
Clinical narrative: Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, INJECTION SITE PAIN (Injection site pain) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication was not reported.  On an unknown date, the patient experienced injection site hurt. On an unknown date, injection site hurt resolved. Moderna COVID-19 Vaccine (Elasomeran) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  Primary reporter did not have the lot number information, because the packaging was discarded.   Treatment medication was not 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, Arthritis
Clinical narrative: Inflammatory response caused by vaccine set her into an arthritis flare; Arthritis bother when weather is inclimate/arthritis pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Inflammatory response caused by vaccine set her into an arthritis flare) and ARTHRALGIA (Arthritis bother when weather is inclimate/arthritis pain) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (Inflammatory response caused by vaccine set her into an arthritis flare) and ARTHRALGIA (Arthritis bother when weather is inclimate/arthritis pain). At the time of the report, ARTHRITIS (Inflammatory response caused by vaccine set her into an arthritis flare) was resolving and ARTHRALGIA (Arthritis bother when weather is inclimate/arthritis pain) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) 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.
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Stress; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Stress) 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 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-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]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced STRESS (Stress). At the time of the report, STRESS (Stress) had not resolved.            Concomitant medication was unknown.  On an unknown date, the patient experienced very stressed. Moderna COVID-19 vaccine (Elasomeran) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Primary reporter did not have the lot number information, because the packaging was discarded.  Treatment medication was unknown.  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE EVENT; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (NO ADVERSE EVENT) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Hysterectomy, Tonsillectomy and Chemotherapy (completed before starting Rinvoq). Previously administered products included for Product used for unknown indication: Enbrel (Enbrel allergy). Past adverse reactions to the above products included Rash with Enbrel. Concurrent medical conditions included Dizziness since 2020, Headache (minor headache most days that came and went) since October 2020, Food intolerance since 2020, Papular rash since 2020, Stomach ache since October 2020, Fibromyalgia since 2020, Skin breakout since October 2020, Diarrhea (occurred once or twice a week) since 2020, Muscle pain since 2020, Chest pain since 2020, Achilles tendonitis since 2020, Rheumatoid arthritis flare up (Joint aches and pains before Rinvoq but improved after Rinvoq) since 2020, Swelling of legs, Potassium supplementation, Breast cancer female (remission) since April 2019, Drug allergy (ENBREL allergy), Non-tobacco user and Abstains from alcohol. Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis, POTASSIUM for Supplementation therapy, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Swelling of legs.   In October 2020, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. On 20-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown.            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.   This case was linked to MOD-2021-621766 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up document contains no new information.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Catastrophic reaction
Clinical narrative: Catastrophic heart condition; Catastrophic heart condition; This spontaneous case was reported by a consumer and describes the occurrence of CATASTROPHIC REACTION (Catastrophic heart condition) and CARDIAC DISORDER (Catastrophic heart condition) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced CATASTROPHIC REACTION (Catastrophic heart condition) and CARDIAC DISORDER (Catastrophic heart condition). At the time of the report, CATASTROPHIC REACTION (Catastrophic heart condition) and CARDIAC DISORDER (Catastrophic heart condition) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Exostosis, Magnetic resonance imaging, Mobility decreased, Vaccination site pain
Clinical narrative: Back pain; Mobility issues; Sore arm after vaccination; Bone spur; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MOBILITY DECREASED (Mobility issues), EXOSTOSIS (Bone spur) and VACCINATION SITE PAIN (Sore arm after vaccination) in a 73-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.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a week. On 12-Jan-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose once a week. On 29-Mar-2021, the patient experienced EXOSTOSIS (Bone spur). On an unknown date, the patient experienced BACK PAIN (Back pain), MOBILITY DECREASED (Mobility issues) and VACCINATION SITE PAIN (Sore arm after vaccination). At the time of the report, BACK PAIN (Back pain), MOBILITY DECREASED (Mobility issues), EXOSTOSIS (Bone spur) and VACCINATION SITE PAIN (Sore arm after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Magnetic resonance imaging: Bone spurs.         Concomitant product use was not provided by the reporter.  On unknown dates, the patient experienced back pain, sore arm, and mobility issues. On 29-Mar-2021, the patient had bone spurs. 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.   This case was linked to MOD-2022-623336 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Illness, Inflammation
Clinical narrative: Inflamatory illness; Inflamatory illness; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflamatory illness) and ILLNESS (Inflamatory illness) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflamatory illness) and ILLNESS (Inflamatory illness). At the time of the report, INFLAMMATION (Inflamatory illness) and ILLNESS (Inflamatory illness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       12 to 20 year old patient developed killing inflammatory illness related to Pfizer Moderna .  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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash erythematous
Clinical narrative: Feels overloaded; A Lot of red rash/ a lot of red rash from  increasing dose, the rash comes and goes but was really bad when it was 72 degrees. It was subsiding some; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (Feels overloaded) and RASH ERYTHEMATOUS (A Lot of red rash/ a lot of red rash from  increasing dose, the rash comes and goes but was really bad when it was 72 degrees. It was subsiding some) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product EPOPROSTENOL SODIUM for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension.   On 29-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient started EPOPROSTENOL SODIUM (Intravenous) 1.5 milligram. On an unknown date, the patient experienced FEELING ABNORMAL (Feels overloaded) and RASH ERYTHEMATOUS (A Lot of red rash/ a lot of red rash from  increasing dose, the rash comes and goes but was really bad when it was 72 degrees. It was subsiding some). At the time of the report, FEELING ABNORMAL (Feels overloaded) outcome was unknown and RASH ERYTHEMATOUS (A Lot of red rash/ a lot of red rash from  increasing dose, the rash comes and goes but was really bad when it was 72 degrees. It was subsiding some) was resolving.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant 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: COVID-19, Gastroenteritis viral
Clinical narrative: COVID-19; STOMACH VIRUS; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and GASTROENTERITIS VIRAL (STOMACH VIRUS) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and GASTROENTERITIS VIRAL (STOMACH VIRUS). At the time of the report, COVID-19 (COVID-19) and GASTROENTERITIS VIRAL (STOMACH VIRUS) had resolved.            Concomitant medication was not reported. 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 mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: inflammation of the heart; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (inflammation of the heart) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (inflammation of the heart) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (inflammation of the heart) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided. Treatment medication was not 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  Company comment  This spontaneous case reported by a consumer, concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series.. Patient had previously received a dose with Pfizer vaccine with no adverse events reported. Interchange of vaccine products was noted. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment were reported. The event outcome was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series.. Patient had previously received a dose with Pfizer vaccine with no adverse events reported. Interchange of vaccine products was noted. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment were reported. The event outcome was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINORRHOEA (runny nose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product SELEXIPAG tablet for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included RIVAROXABAN and SILDENAFIL CITRATE for an unknown indication.   On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started SELEXIPAG (Oral) 200 microgram twice a day. On 07-Apr-2022, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unspecified date, the patient experienced seasonal allergies, sinusitis and runny nose when she bends over her legs are shaky so she had to use her walker in the house. She also had swollen legs which have resolved with diuretics and bottom of left foot was dark like she has walked in dirt. The patient received her second Moderna COVID booster shot on Thursday 07-APR-2022 and has had a runny nose ever since. She was taking some over the counter medication for it.   The action taken with selexipag, and elasomeran was not reported. The patient recovered from swollen legs, had not recovered from runny nose, and the outcome of seasonal allergies, sinusitis, legs are shaky and bottom of left foot is dark like she has walked in dirt was not reported. The reporter provided no causality assessment. Company causality between selexipag, and seasonal allergies, sinusitis, legs are shaky, swollen legs, bottom of left foot is dark like she has walked in dirt, and runny nose was not related.  She was taking some over the counter medication for runny nose as treatment.   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.