chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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 UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-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) at an unspecified dose. On 06-Sep-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had hives on 6 Sep 2021, the hives faded but started again around 11 Sep 2021. Hives were scattered around patient's body.  The reporter's causality for the event of hives was not provided for Rinvoq.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: Body temperature, Immunisation reaction, Influenza virus test, Malaise, Pyrexia
Clinical narrative: not doing very well; bad reaction; high fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not doing very well), IMMUNISATION REACTION (bad reaction) and PYREXIA (high fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect products included non-company products INFLUENZA VACCINE for Prophylactic vaccination, PNEUMOCOCCAL VACCINE for Prophylactic vaccination and DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    In May 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 13-Oct-2021, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form and dose of PNEUMOCOCCAL VACCINE (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced MALAISE (not doing very well), IMMUNISATION REACTION (bad reaction) and PYREXIA (high fever). At the time of the report, MALAISE (not doing very well) and IMMUNISATION REACTION (bad reaction) outcome was unknown and PYREXIA (high fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Oct-2021, Body temperature: High Fever. On an unknown date, Body temperature: Temperature was then back to normal.. On an unknown date, Influenza virus test: (Negative) Flu test was negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  On 13-OCT-2021 the patient experienced high fever, was not doing very well and had bad reaction same day following the administration of Influenza vaccine and Pneumococcal vaccine, (unknown latency) following the dose intake of with Dupilumab and administration of Moderna COVID-19-19 vaccine.  On an unknown date, the patient recovered from high fever (temperature was now back to normal).  It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not provided. It was not reported if the patient received a corrective treatment for the events (high fever, not doing very well, bad reaction).  Patient stated she was tested for flu and COVID and had a blood culture drawn her flu test was negative and SARS-CoV-2 test results were not received yet.  It was unknown if there were other lab data/results available.  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.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt for about 2 weeks after Moderna Covid Vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Arm hurt for about 2 weeks after Moderna Covid Vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products INFLUENZA VACCINE (SWINE FLU VACCINE (1976), MONOVALENT) for an unknown indication and 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 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, INFLUENZA VACCINE (SWINE FLU VACCINE (1976), MONOVALENT) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt for about 2 weeks after Moderna Covid Vaccine). At the time of the report, VACCINATION SITE PAIN (Arm hurt for about 2 weeks after Moderna Covid Vaccine) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient had arm hurt for about 2 weeks after Moderna Covid Vaccine. The patient stated that, the syringe backfired and 5cc's, 10 doses of the Swine flu vaccine, hit in his eye and a short time later he started to have some hemiparesis. The patient had received both doses of the Pfizer Covid 19 Vaccine and was due for a booster shot. The patient states that, he thinks most people had the same reaction to the Moderna COVID Vaccine with the sore arm. He thinks it was due to the super dose of the vaccine with Moderna.  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.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: pain; Fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN (pain) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Concentration impaired.   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. On an unknown date, the patient experienced PAIN (pain) and PYREXIA (Fever). At the time of the report, PAIN (pain) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The caller knows a lady who was the veterans' care coordinator in hospice. In November 2020 the patient had covid for about a couple of months and now she has concentration problems. In early 2021, 4 months after the patient was sick with covid, she took the two part Moderna covid vaccine. After the first shot she had a reaction to it- a fever and pain. The patient had a similar reaction to the second shot but not the same. The patient is over it now and fine.   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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. 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. Patient received 1st dose COVID-19 Vaccine manufactured by Moderna. The reporter's causality for the event of vaccination site swelling  with HUMIRA was a reasonable possibility. 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PLAQUE PSORIASIS BREAKTHROUGH FLARE ON ELBOWS AND UPPER RIGHT ARM; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS BREAKTHROUGH FLARE ON ELBOWS AND UPPER RIGHT ARM) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-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]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (PLAQUE PSORIASIS BREAKTHROUGH FLARE ON ELBOWS AND UPPER RIGHT ARM). At the time of the report, PSORIASIS (PLAQUE PSORIASIS BREAKTHROUGH FLARE ON ELBOWS AND UPPER RIGHT ARM) had not resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the event of Psoriasis flare-up was assessed as " Reasonable possibility" for cosuspect skyrizi. 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: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Tired; Arm soreness; Little headache; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Little headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Little headache). At the time of the report, FATIGUE (Tired), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Little headache) outcome was unknown.            The concomitant medication was not reported by reporter. On 11-Apr-2019, patient received Xeljanz XR tab 11 mg.  ~ The patient stated that she was tired, experienced arm soreness and had a little headache following each moderna covid-19 vaccine. ~ The treatment medication was not reported by reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Joint stiffness, Musculoskeletal stiffness, Myalgia, Sacral pain
Clinical narrative: Back stiffness; Vaccination site pain; Pain sacroiliac; Muscle pain; Fatigue; Spinal pain; Stiffness joints; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Back stiffness), VACCINATION SITE PAIN (Vaccination site pain), SACRAL PAIN (Pain sacroiliac), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and 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 MUSCULOSKELETAL STIFFNESS (Back stiffness), VACCINATION SITE PAIN (Vaccination site pain), SACRAL PAIN (Pain sacroiliac), MYALGIA (Muscle pain), FATIGUE (Fatigue), SPINAL PAIN (Spinal pain) and JOINT STIFFNESS (Stiffness joints). At the time of the report, MUSCULOSKELETAL STIFFNESS (Back stiffness), SACRAL PAIN (Pain sacroiliac), SPINAL PAIN (Spinal pain) and JOINT STIFFNESS (Stiffness joints) had not resolved and VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had resolved. 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.  No concomitant or treatment medication provided
Sex: M
Vaccine: COVID19
Symptoms: Spinal pain, Vaccination site pain
Clinical narrative: Back stiffness; Vaccination site pain; Pain sacroiliac; Muscle pain; Fatigue; Spinal pain; Stiffness joints; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Back stiffness), VACCINATION SITE PAIN (Vaccination site pain), SACRAL PAIN (Pain sacroiliac), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and 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 MUSCULOSKELETAL STIFFNESS (Back stiffness), VACCINATION SITE PAIN (Vaccination site pain), SACRAL PAIN (Pain sacroiliac), MYALGIA (Muscle pain), FATIGUE (Fatigue), SPINAL PAIN (Spinal pain) and JOINT STIFFNESS (Stiffness joints). At the time of the report, MUSCULOSKELETAL STIFFNESS (Back stiffness), SACRAL PAIN (Pain sacroiliac), SPINAL PAIN (Spinal pain) and JOINT STIFFNESS (Stiffness joints) had not resolved and VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had resolved. 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.  No concomitant or treatment medication provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: body pain; arm/leg stiffness/same side as injection; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (body pain) and MUSCULOSKELETAL STIFFNESS (arm/leg stiffness/same side as injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (body pain) and MUSCULOSKELETAL STIFFNESS (arm/leg stiffness/same side as injection). At the time of the report, PAIN (body pain) was resolving and MUSCULOSKELETAL STIFFNESS (arm/leg stiffness/same side as injection) outcome 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site warmth, Malaise
Clinical narrative: Injection site warmth/heat at injection site; Feeling unwell/did not feel good; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth/heat at injection site), MALAISE (Feeling unwell/did not feel good) and FATIGUE (Tiredness) 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 VENETOCLAX (VENCLEXTA) tablet for Chronic lymphocytic leukaemia.    No Medical History information was reported.   In September 2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 400 milligram once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth/heat at injection site), MALAISE (Feeling unwell/did not feel good) and FATIGUE (Tiredness). In 2021, INJECTION SITE WARMTH (Injection site warmth/heat at injection site) had resolved. At the time of the report, MALAISE (Feeling unwell/did not feel good) and FATIGUE (Tiredness) 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 injection site warmth, fatigue and malaise was not provided with VENCLEXTA(VENETOCLAX).  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: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Circumstance or information capable of leading to medication error, Interchange of vaccine products, No adverse event
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant and treatment medication provided This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: AE's following both Moderna doses; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (AE's following both Moderna doses) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced IMMUNISATION REACTION (AE's following both Moderna doses). At the time of the report, IMMUNISATION REACTION (AE's following both Moderna doses) outcome 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.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Aneurysm, Cold sweat, Dehydration, Feeling abnormal, Peripheral swelling
Clinical narrative: Aneurysm; Swelling face; Swelling of legs; Weight gain; Feels bad/ Felt Horrible; Shaking; Cold sweat; Gagging; Dehydration; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), FEELING ABNORMAL (Feels bad/ Felt Horrible), SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swelling of legs) and WEIGHT INCREASED (Weight gain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DEHYDRATION (Dehydration). On 21-Nov-2021, the patient experienced FEELING ABNORMAL (Feels bad/ Felt Horrible), TREMOR (Shaking), COLD SWEAT (Cold sweat) and RETCHING (Gagging). On 22-Nov-2021, the patient experienced SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swelling of legs) and WEIGHT INCREASED (Weight gain). On an unknown date, the patient experienced ANEURYSM (Aneurysm). At the time of the report, DEHYDRATION (Dehydration) and ANEURYSM (Aneurysm) outcome was unknown and FEELING ABNORMAL (Feels bad/ Felt Horrible), SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swelling of legs), WEIGHT INCREASED (Weight gain), TREMOR (Shaking), COLD SWEAT (Cold sweat) and RETCHING (Gagging) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, Weight: 3 3 pounds.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021, FACE SWOLLEN, LEG SWOLLEN, WEIGHT GAIN, POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021, POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021 and POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021 with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of POSSIBLE DEHYDRATION and SPENIC ANEURYSM was not provided.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Retching, Swelling face, Tremor, Weight, Weight increased
Clinical narrative: Aneurysm; Swelling face; Swelling of legs; Weight gain; Feels bad/ Felt Horrible; Shaking; Cold sweat; Gagging; Dehydration; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), FEELING ABNORMAL (Feels bad/ Felt Horrible), SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swelling of legs) and WEIGHT INCREASED (Weight gain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DEHYDRATION (Dehydration). On 21-Nov-2021, the patient experienced FEELING ABNORMAL (Feels bad/ Felt Horrible), TREMOR (Shaking), COLD SWEAT (Cold sweat) and RETCHING (Gagging). On 22-Nov-2021, the patient experienced SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swelling of legs) and WEIGHT INCREASED (Weight gain). On an unknown date, the patient experienced ANEURYSM (Aneurysm). At the time of the report, DEHYDRATION (Dehydration) and ANEURYSM (Aneurysm) outcome was unknown and FEELING ABNORMAL (Feels bad/ Felt Horrible), SWELLING FACE (Swelling face), PERIPHERAL SWELLING (Swelling of legs), WEIGHT INCREASED (Weight gain), TREMOR (Shaking), COLD SWEAT (Cold sweat) and RETCHING (Gagging) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, Weight: 3 3 pounds.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021, FACE SWOLLEN, LEG SWOLLEN, WEIGHT GAIN, POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021, POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021 and POSSIBLE REACTION TO COVID VACCINE/SHAKING/COLD SWEATS/GAGGING/FELT HORRIBLE onset 21 Nov 2021 with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of POSSIBLE DEHYDRATION and SPENIC ANEURYSM was not provided.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Fatigue, Hepatic enzyme
Clinical narrative: Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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 CHILLS (Chills) and FATIGUE (Fatigue). In 2021, CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: liver level was high. On an unknown date, Hepatic enzyme: Elevated. 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 Chills was not provided and the reporter's causality for the event of fatigue was no reasonable possibility with HUMIRA(ADALIMUMAB). 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood folate, Blood folate increased, Hepatic function abnormal, Liver function test, Liver function test abnormal
Clinical narrative: Folic acid increased; ABNORMAL LIVER CELLS; Liver function test abnormal; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), LIVER FUNCTION TEST ABNORMAL (Liver function test abnormal), BLOOD FOLATE INCREASED (Folic acid increased) and HEPATIC FUNCTION ABNORMAL (ABNORMAL LIVER CELLS) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    Concomitant products included PREDNISONE for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and METHOTREXATE (Oral) at an unspecified dose. In April 2021, the patient experienced PAIN (Ache). In December 2021, the patient experienced LIVER FUNCTION TEST ABNORMAL (Liver function test abnormal) and HEPATIC FUNCTION ABNORMAL (ABNORMAL LIVER CELLS). On an unknown date, the patient experienced BLOOD FOLATE INCREASED (Folic acid increased). At the time of the report, PAIN (Ache), LIVER FUNCTION TEST ABNORMAL (Liver function test abnormal) and HEPATIC FUNCTION ABNORMAL (ABNORMAL LIVER CELLS) had resolved and BLOOD FOLATE INCREASED (Folic acid increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood folate: folic acid increased. On an unknown date, Liver function test: Abnormal.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  The reporter's causality for the event(s) of ABNORMAL LIVER CELLS, INCREASED PAIN, FOLIC ACID WAS INCREASED and FEVER was not provided. The reporter's causality for the event(s) of ACHE with RINVOQ(UPADACITINIB) was a reasonable possibility.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.    This case was linked to MOD-2021-620820, MOD-2022-623622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Patient information updated. Event added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Folic acid increased; ABNORMAL LIVER CELLS; Liver function test abnormal; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), LIVER FUNCTION TEST ABNORMAL (Liver function test abnormal), BLOOD FOLATE INCREASED (Folic acid increased) and HEPATIC FUNCTION ABNORMAL (ABNORMAL LIVER CELLS) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    Concomitant products included PREDNISONE for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and METHOTREXATE (Oral) at an unspecified dose. In April 2021, the patient experienced PAIN (Ache). In December 2021, the patient experienced LIVER FUNCTION TEST ABNORMAL (Liver function test abnormal) and HEPATIC FUNCTION ABNORMAL (ABNORMAL LIVER CELLS). On an unknown date, the patient experienced BLOOD FOLATE INCREASED (Folic acid increased). At the time of the report, PAIN (Ache), LIVER FUNCTION TEST ABNORMAL (Liver function test abnormal) and HEPATIC FUNCTION ABNORMAL (ABNORMAL LIVER CELLS) had resolved and BLOOD FOLATE INCREASED (Folic acid increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood folate: folic acid increased. On an unknown date, Liver function test: Abnormal.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  The reporter's causality for the event(s) of ABNORMAL LIVER CELLS, INCREASED PAIN, FOLIC ACID WAS INCREASED and FEVER was not provided. The reporter's causality for the event(s) of ACHE with RINVOQ(UPADACITINIB) was a reasonable possibility.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.    This case was linked to MOD-2021-620820, MOD-2022-623622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Patient information updated. Event added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Pain in arm due to COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm due to COVID vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Pain in December 2020, Pneumonia in December 2020, Appetite lost in December 2020 and Taste loss in December 2020.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In April 2021, the patient experienced VACCINATION SITE PAIN (Pain in arm due to COVID vaccine). At the time of the report, VACCINATION SITE PAIN (Pain in arm due to COVID vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive.         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, UNK
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea; Injection site painful after covid 19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site painful after covid 19 vaccination) 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.    The patient's past medical history included Stomach cramps and Stomach pain.   On 21-Mar-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 20-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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site painful after covid 19 vaccination). At the time of the report, DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site painful after covid 19 vaccination) had resolved.     No concomitant medication information was reported. No treatment medication information was 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: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase, Pruritus
Clinical narrative: Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) 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) for Rheumatoid arthritis.    Patient was not enrolled in covid-19 vaccine trial.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood alkaline phosphatase: High.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  The concomitant medication was not reported.  On an unknown date the lab data was reported as Blood alkaline phosphatase increased.The reporter causality for the events with respect to Humira was provided as not reported.  The treatment medication was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue
Clinical narrative: Depressed state; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depressed state) and FATIGUE (Fatigue) in a 58-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 Plaque psoriasis.    The patient's past medical history included Bipolar disorder.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced DEPRESSION (Depressed state). In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, DEPRESSION (Depressed state) was resolving.            No concomitant medications were reported. No treatment drugs 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: Carditis
Clinical narrative: characteristic of heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (characteristic of heart inflammation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDITIS (characteristic of heart inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (characteristic of heart inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. 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.  Company comment: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the expected serious (medically significant) AESI of Carditis, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on risk factors, detailed clinical course, investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the expected serious (medically significant) AESI of Carditis, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on risk factors, detailed clinical course, investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Soreness in right arm; Fatigue; Stiffness with colder temperatures; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness with colder temperatures), VACCINATION SITE PAIN (Soreness in right arm) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and INFLUENZA VACCINE 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, UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and INFLUENZA VACCINE (unknown route) at an unspecified dose. In October 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness with colder temperatures). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in right arm) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness with colder temperatures) had not resolved and VACCINATION SITE PAIN (Soreness in right arm) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  In October 2021, patient had been having stiffness with colder temperatures. She said when she took the flu shot and COVID vaccine at the same time, she had soreness in her right arm and had fatigue.  Reporters causality of events with Rinvoq was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in