chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, SARS-CoV-2 test
Clinical narrative: bitter taste in mouth; Had 3 vaccinations for Covid and tested positive for covid; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (bitter taste in mouth) and COVID-19 (Had 3 vaccinations for Covid and tested positive for covid) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 010M20A and 026L20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 treatment.    Concurrent medical conditions included Sinus disorder, Macular degeneration and Cholesterol. Concomitant products included ATORVASTATIN for Hypercholesterolaemia, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Macular degeneration, AMOXICILLIN for Sinus infection.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 20-Apr-2022, the patient experienced DYSGEUSIA (bitter taste in mouth) and COVID-19 (Had 3 vaccinations for Covid and tested positive for covid). At the time of the report, DYSGEUSIA (bitter taste in mouth) had not resolved and COVID-19 (Had 3 vaccinations for Covid and tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         The bitter taste in mouth was felt to be constant all the time on 21-Apr-2022 and a little bit on 20-Apr-2022 for the patient. The patient took Paxlovid in the evening of 20-Apr-2022 and in the morning of 21-Apr-2022. It was reported that patient was on antibiotics for sinus infection. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain
Clinical narrative: Felt Pain; COVID; Fatigue caused due to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt Pain), COVID-19 (COVID) and FATIGUE (Fatigue caused due to vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In April 2021, the patient experienced FATIGUE (Fatigue caused due to vaccine). On an unknown date, the patient experienced PAIN (Felt Pain) and COVID-19 (COVID). In April 2021, FATIGUE (Fatigue caused due to vaccine) had resolved. At the time of the report, PAIN (Felt Pain) had not resolved and COVID-19 (COVID) outcome was unknown.            Concomitant Drugs were not reported. Treatment medications were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Herpes zoster, Illness, Musculoskeletal discomfort, SARS-CoV-2 test
Clinical narrative: All joint bother; Shingles; COVID-19; Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), MUSCULOSKELETAL DISCOMFORT (All joint bother), HERPES ZOSTER (Shingles) and COVID-19 (COVID-19) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 01-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF (40 mg,1 in 2 M). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF (40 mg,1 in 2 M). In January 2021, the patient experienced ILLNESS (Sick). On 26-Dec-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (All joint bother) and HERPES ZOSTER (Shingles). At the time of the report, ILLNESS (Sick) and COVID-19 (COVID-19) was resolving and MUSCULOSKELETAL DISCOMFORT (All joint bother) and HERPES ZOSTER (Shingles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter.  The patient was sick after second Covid vaccine dose.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with Humira for the events of sick , all joint bother, Covid-19 and shingles was not provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Additional follow-up received, added event of Shingles.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: After 3 months wating period post infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (After 3 months wating period post infection) 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 COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (After 3 months wating period post infection). At the time of the report, COVID-19 (After 3 months wating period post infection) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that event third dose hid bad and it was better than the second.  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
Symptoms: COVID-19
Clinical narrative: Had 2 Moderna vaccine got covid so no need for booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had 2 Moderna vaccine got covid so no need for booster) 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 first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had 2 Moderna vaccine got covid so no need for booster). At the time of the report, COVID-19 (Had 2 Moderna vaccine got covid so no need for booster) outcome was unknown.            Concomitant medications details were not reported.  It was reported that the patient had received 2 moderna vaccine and got COVID, so patient does not wanted to take the booster dose. Besides that the patient know some people that had major problems after receiving the booster dose of Pfizer biotech vaccine.  No treatment information 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.  Company comment: This spontaneous case concerns patient of unspecified age and gender with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. No additional details of clinical course, concomitant medication was provided. The event outcome was unknown. Ongoing pandemic remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns patient of unspecified age and gender with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. No additional details of clinical course, concomitant medication was provided. The event outcome was unknown. Ongoing pandemic remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis relapse (Ulcerative colitis flare up) since 2021.   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 once a week. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in 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.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed the event as possibly related to Moderna vaccine and as not reasonably possible 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: F
Vaccine: COVID19
Symptoms: Arthritis, Injection site swelling, Swelling
Clinical narrative: Arthritis; Swelling; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), SWELLING (Swelling) and INJECTION SITE SWELLING (Injection site swelling) 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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic 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) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis), SWELLING (Swelling) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, ARTHRITIS (Arthritis) had not resolved, SWELLING (Swelling) was resolving and INJECTION SITE SWELLING (Injection site swelling) had resolved.            No concomitant medications were reported.  Patient received Humira (1156159).  Patient received booster dose.  No treatment medications were reported.  The reporter assessed all the events as possibly related to Moderna vaccine.  The reporter assessed the event of arthritis as reasonably possible with Humira and event of injection site swelling as not reasonably possible with Humira. The reporter did not provide any causality assessment for the event of swelling 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.  Company comment: This spontaneous case concerns an adult female patient of unknown age with concurrent condition of psoriatic arthritis, who experienced the unexpected non serious event of Arthritis , unknown days after receiving the first dose of mRNA-1273 vaccine. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event had not resolved.  Concurrent condition of psoriatic arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with concurrent condition of psoriatic arthritis, who experienced the unexpected non serious event of Arthritis , unknown days after receiving the first dose of mRNA-1273 vaccine. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event had not resolved.  Concurrent condition of psoriatic arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypertension, Injection site urticaria, Weight decreased
Clinical narrative: Blood pressure high; Weight loss; Injection site hives; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood pressure high), WEIGHT DECREASED (Weight loss), INJECTION SITE URTICARIA (Injection site hives) and COVID-19 (COVID-19) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In 2021, the patient received third 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) Citrate free. In January 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced HYPERTENSION (Blood pressure high), WEIGHT DECREASED (Weight loss) and INJECTION SITE URTICARIA (Injection site hives). At the time of the report, HYPERTENSION (Blood pressure high) and INJECTION SITE URTICARIA (Injection site hives) outcome was unknown, WEIGHT DECREASED (Weight loss) was resolving and COVID-19 (COVID-19) had resolved.            No concomitant medication were provided. 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: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The patient got vaccinated with Moderna and tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The patient got vaccinated with Moderna and tested positive for COVID-19) in a 58-year-old male patient 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 COVID-19 (The patient got vaccinated with Moderna and tested positive for COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (The patient got vaccinated with Moderna and tested positive for COVID-19) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided.  Given that the Moderna product was not reported as a co-suspect product and there is no other attribution to the Moderna product in this report from the other manufacturer, the Moderna product is not considered to be a suspect product in this report. (Both in case notes and I narrative supplement add).  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, Gastric disorder, Headache, Nausea, Respiratory disorder
Clinical narrative: COVID-19; Gastric disorder; Respiratory disorder; Nauseated; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), GASTRIC DISORDER (Gastric disorder), RESPIRATORY DISORDER (Respiratory disorder), NAUSEA (Nauseated) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19), GASTRIC DISORDER (Gastric disorder), RESPIRATORY DISORDER (Respiratory disorder), NAUSEA (Nauseated) and HEADACHE (Headache). At the time of the report, COVID-19 (COVID-19), GASTRIC DISORDER (Gastric disorder), RESPIRATORY DISORDER (Respiratory disorder), NAUSEA (Nauseated) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication was unknown.  On unknown dates, the patient experienced stomach problem, breathing problems, nauseated, COVID-19 and headache. Moderna COVID-19 vaccine (Elasomeran) was also considered suspect.   The patient had stomach problem, breathing problems with Rinvoq. She felt nauseated and had headache after taking rinvoq. She took five pills. She took the Moderna vaccination and got COVID.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Positive covid; Vaccinated with Sputnik, Moderna, Pfizer; Vaccinated with Sputnik, Moderna, Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive covid), COVID-19 IMMUNISATION (Vaccinated with Sputnik, Moderna, Pfizer) and INTERCHANGE OF VACCINE PRODUCTS (Vaccinated with Sputnik, Moderna, Pfizer) 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 an unknown indication and COVID-19 VACCINE NRVV AD26 (GAM-COVID-VAC), COVID-19 VACCINE NRVV AD5 (GAM-COVID-VAC) (SPUTNIK V) 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, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (GAM-COVID-VAC), COVID-19 VACCINE NRVV AD5 (GAM-COVID-VAC) (SPUTNIK V) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive covid), COVID-19 IMMUNISATION (Vaccinated with Sputnik, Moderna, Pfizer) and INTERCHANGE OF VACCINE PRODUCTS (Vaccinated with Sputnik, Moderna, Pfizer). At the time of the report, COVID-19 (Positive covid), COVID-19 IMMUNISATION (Vaccinated with Sputnik, Moderna, Pfizer) and INTERCHANGE OF VACCINE PRODUCTS (Vaccinated with Sputnik, Moderna, Pfizer) outcome was unknown.      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.       Relevant concomitant medications were not reported.  Patient was vaccinated with Sputnik, Moderna and Pfizer COVID-19 vaccine. Patient got positive with COVID-19.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in an adult male 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.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose: CF, Solution for injection in prefilled pen. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant drugs were not reported.  The reporter's causality for the event COVID with Humira was no reasonable possibility.  Treatment medications were not provided.  It was unknown date if patient was enrolled in a COVID-19 vaccine trial.  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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunisation reaction, SARS-CoV-2 test
Clinical narrative: light symptoms; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (light symptoms) and COVID-19 (COVID-19) 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 an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (light symptoms) and COVID-19 (COVID-19). At the time of the report, IMMUNISATION REACTION (light symptoms) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Attention deficit hyperactivity disorder, COVID-19, Fatigue, Vaccination site pain
Clinical narrative: Attention deficit-hyperactivity disorder; Anxiety; COVID-19; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder), ANXIETY (Anxiety), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate To Severe Adult Crohn's Disease).   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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) at an unspecified dose. On 28-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness). On 01-Jan-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder) and ANXIETY (Anxiety). The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) at an unspecified dose and frequency. In May 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 30-May-2021, FATIGUE (Tiredness) had resolved. In 2022, COVID-19 (COVID-19) had resolved. At the time of the report, ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder) and ANXIETY (Anxiety) had not resolved.            There was no reported medical history.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Concomitant medications details were not reported.  The reporter's causality for the events of Attention deficit-hyperactivity disorder, Vaccination site pain, Tiredness, Anxiety and COVID-19 was not reported for 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.   This case was linked to MOD-2022-624068 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Headache, Pain, SARS-CoV-2 test
Clinical narrative: felt bad; Achy; Headache; Delta Covid virus variant. C; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), PAIN (Achy), HEADACHE (Headache) and COVID-19 (Delta Covid virus variant. C) in a female patient of an unknown age 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 first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad), PAIN (Achy), HEADACHE (Headache) and COVID-19 (Delta Covid virus variant. C). At the time of the report, FEELING ABNORMAL (felt bad), PAIN (Achy), HEADACHE (Headache) and COVID-19 (Delta Covid virus variant. C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive, Delta Covid virus variant.         Concomitant product use was not provided by the reporter.  It was reported that the entire facility at patient part time job was positive for Covid and they were all vaccinated. no specific identifiers were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Liver disorder
Clinical narrative: Liver problems; COVID shots made patient really sick both times; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (Liver problems) and ILLNESS (COVID shots made patient really sick both times) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2022, 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. On an unknown date, the patient experienced LIVER DISORDER (Liver problems) and ILLNESS (COVID shots made patient really sick both times). At the time of the report, LIVER DISORDER (Liver problems) and ILLNESS (COVID shots made patient really sick both times) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pleurisy
Clinical narrative: Pleurisy; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PLEURISY (Pleurisy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PLEURISY (Pleurisy). At the time of the report, COVID-19 (COVID-19) and PLEURISY (Pleurisy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of pleurisy, COVID-19 was assessed as reasonable possibility for cosuspect humira. 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   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow-up received includes: New event(pleurisy) added.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and Crohn's disease.    Concurrent medical conditions included Crohn's disease and Hidradenitis suppurativa.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.  Company Comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Swelling of the throat; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (Swelling of the throat) 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Swelling of the throat). At the time of the report, PHARYNGEAL SWELLING (Swelling of the throat) outcome was unknown.            No concomitant medications were reported.  It was reported that patient received the booster, the 4th one before the bivalent one.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; repeat of her 3rd dose was given/received the 3rd dose twice and is not immunocompromised; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INCORRECT DOSE ADMINISTERED (repeat of her 3rd dose was given/received the 3rd dose twice and is not immunocompromised) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2022, the patient 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) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (repeat of her 3rd dose was given/received the 3rd dose twice and is not immunocompromised). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (repeat of her 3rd dose was given/received the 3rd dose twice and is not immunocompromised) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were provided.  Patient told her daughter that she wanted a 4th booster, the new one and found somewhere that was doing it. On Tuesday, 20-Sep-2022, patient received what she thought was her 4th booster (new one), until she received a call either this morning or yesterday from facility informing that repeat of her 3rd dose was given and she must wait 2 months to receive the Bivalent.  Patient daughter informed that she immediately told her mother to contact her healthcare provider and patient daughter is concerned for her mother as she received the 3rd dose twice and is not immunocompromised. She asks if this will cause her mother any harm, she's worried for her, because she is the only living relative, her father died when she was 9.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: getting the Moderna shot the two that they have to bleed; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (getting the Moderna shot the two that they have to bleed) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concomitant products included WARFARIN for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (getting the Moderna shot the two that they have to bleed) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (getting the Moderna shot the two that they have to bleed) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that the only thing I was told the doctor in the emergency room stated this was the 8th patient he had and taking warfarin and getting the Moderna shot the two that they have to bleed and they stated we ddi not enough about the vaccines.  No medical history information was reported  No treatment medication information was reported. Company comment- This spontaneous case concerns a patient of unknown gender and age, with no reported medical history, who experienced unexpected, serious (medically significant) event of Haemorrhage, which occurred at an unknown time with regards to vaccination with mRNA-1273. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-649136 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown gender and age, with no reported medical history, who experienced unexpected, serious (medically significant) event of Haemorrhage, which occurred at an unknown time with regards to vaccination with mRNA-1273. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: 2 months ago he started to feel his arm tingling; Had cramps in this arm; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (2 months ago he started to feel his arm tingling) and MUSCLE SPASMS (Had cramps in this arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025LC20A, 032L20A and 033421A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced PARAESTHESIA (2 months ago he started to feel his arm tingling) and MUSCLE SPASMS (Had cramps in this arm). At the time of the report, PARAESTHESIA (2 months ago he started to feel his arm tingling) and MUSCLE SPASMS (Had cramps in this arm) outcome was unknown.      No concomitant medication was provided by reporter.  Patient had no allergies. The patient never tested positive for Covid19. The patient visited the neurologist, but they just had done an MRI and no treatment. Doctor thought the nerve might be pinched. Patient received concomitant medication but had not specified.  No treatment medication was provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He tested positive for Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (He tested positive for Covid-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57144B) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Sep-2022, the patient experienced COVID-19 (He tested positive for Covid-19). At the time of the report, COVID-19 (He tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         On 25-Jan-2021, patient received first dose of Moderna vaccine (monovalent). Lot number was provided as 011L20. On 28-Feb-2021, patient received second dose of Moderna vaccine (monovalent). Lot number was 002A21A On 27-Oct-2021, patient received first booster dose of Moderna vaccine (monovalent). Lot number was 045C21A. On:20-Apr-2022, patient received second booster dose of Moderna vaccine (monovalent). Lot number was 045L21A. On 09-Sep-2022, patient also received flu 65 shot. No treatment medications were reported.  Company Comment:  This is a spontaneous case, reported by a patient family member, concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 9 days after receiving a dose of mRNA-1273.222 as the fifth dose of COVID-19 vaccine. Patient also had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 34 days and 2 booster dose of Moderna COVID-19 vaccine with no reported adverse event, prior to mRNA-1273.222 vaccination. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a patient family member, concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 9 days after receiving a dose of mRNA-1273.222 as the fifth dose of COVID-19 vaccine. Patient also had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 34 days and 2 booster dose of Moderna COVID-19 vaccine with no reported adverse event, prior to mRNA-1273.222 vaccination. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) 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 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Sep-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 22-Sep-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not reported.  CC: This is a spontaneous case concerning a female patient of unknown age, with no medical history reported, who received a dose of mRNA-1273 vaccine at 38 weeks age of gestation (Maternal exposure during pregnancy), and no adverse event was reported. No other information regarding the outcome of the pregnancy was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age, with no medical history reported, who received a dose of mRNA-1273 vaccine at 38 weeks age of gestation (Maternal exposure during pregnancy), and no adverse event was reported. No other information regarding the outcome of the pregnancy was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.