chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: Not feeling usual self; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and MALAISE (Not feeling usual self) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Nov-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MALAISE (Not feeling usual self). At the time of the report, COVID-19 (COVID-19) had resolved and MALAISE (Not feeling usual self) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  She had fever on 23-Mar-2021 which was resolved on 25-Apr-2021. She was not feeling her usual self for a few days. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, No adverse event
Clinical narrative: Opted to not get a second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Opted to not get a second dose) and NO ADVERSE EVENT (No adverse event) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Opted to not get a second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Opted to not get a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INTENTIONAL PRODUCT USE ISSUE (Opted to not get a second dose).    Concomitant medication was not reported. Treatment details were not reported.  After receiving first dose of Moderna vaccine patient opted to not get a second dose. The patient now presented and would like to receive his second dose but with the Pfizer BioNtech COVID 19.  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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In June 2021, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown. Not Provided          No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the event of Plaque psoriasis flare on legs 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. No treatment medicine were provided.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-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 Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In January 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 65-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 2 months after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown 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 a 65-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 2 months after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Pain; Fatigue extreme; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and FATIGUE (Fatigue extreme) 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 Ankylosing spondylitis.    No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Pain) and FATIGUE (Fatigue extreme). At the time of the report, PAIN (Pain) outcome was unknown and FATIGUE (Fatigue extreme) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Sluggishness; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025821A and 026B21A) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    The patient's past medical history included Cancer (The Patient had rare type of unrecalled cancer and it did not worsen while he was on Creon.) Previously administered products included for Product used for unknown indication: Spiriva handihaler and Oxycodone. Past adverse reactions to the above products included No adverse event with Oxycodone and Spiriva handihaler. Concurrent medical conditions included Drug allergy, Drug allergy, Non-tobacco user and Abstains from alcohol. Concomitant products included LISINOPRIL, PANTOPRAZOLE, SENNA ALEXANDRINA, METOPROLOL SUCCINATE, INSULIN LISPRO (HUMALOG) and INSULIN GLARGINE (LANTUS) for an unknown indication.   On 04-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 PANCREATIN (CREON) (Oral) 3 dosage form three times a day. On an unknown date, PANCREATIN (CREON) (Oral) dosage was changed to 2 dosage form three times a day, PANCREATIN (CREON) (Oral) dosage was changed to 3 dosage form three times a day and PANCREATIN (CREON) (Oral) dosage was changed to 2 dosage form three times a day. On 04-Mar-2021, the patient experienced SLUGGISHNESS (Sluggishness). On 04-Mar-2021, SLUGGISHNESS (Sluggishness) had resolved.            Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Flatulence, Headache, Hypophagia, Pain in extremity
Clinical narrative: COULD NOT EAT; GASSY STOMACH; Headache; Sore arm; FELT TIRED; This spontaneous case was reported by a consumer and describes the occurrence of HYPOPHAGIA (COULD NOT EAT), FLATULENCE (GASSY STOMACH), HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm) and FATIGUE (FELT TIRED) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025821A and 026B21A) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) capsule for an unknown indication.    The patient's past medical history included Whipple's operation in 2020. Concurrent medical conditions included Cancer (rare type of unrecalled cancer), Drug allergy (OXYCODONE ALLERGY MANIFESTED BY HALLLUCINATION), Drug allergy (SPIRIVA HANDIHALER ALLERGY MANIFESTED BY ANXIETY, BREATHING PROBLEM), Non-tobacco user and Abstains from alcohol. Concomitant products included LISINOPRIL, PANTOPRAZOLE, SENNA ALEXANDRINA, METOPROLOL SUCCINATE, INSULIN LISPRO (HUMALOG) and INSULIN GLARGINE (LANTUS) for an unknown indication.   On 04-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 PANCREATIN (CREON) (Oral) at an unspecified dose three times a day. On an unknown date, PANCREATIN (CREON) (Oral) dosage was changed to at an unspecified dose three times a day, PANCREATIN (CREON) (Oral) dosage was changed to at an unspecified dose three times a day and PANCREATIN (CREON) (Oral) dosage was changed to at an unspecified dose three times a day. On 01-Apr-2021, the patient experienced HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm) and FATIGUE (FELT TIRED). On 15-Dec-2021, the patient experienced HYPOPHAGIA (COULD NOT EAT) and FLATULENCE (GASSY STOMACH). On 02-Apr-2021, HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm) had resolved. On 03-Apr-2021, FATIGUE (FELT TIRED) had resolved. At the time of the report, HYPOPHAGIA (COULD NOT EAT) and FLATULENCE (GASSY STOMACH) had not resolved.            On 01-Apr-2021, the patient experienced headache, sore arm and felt tired. On 15-Dec-2021, the patient could not eat, patient tapered down Creon to 2 capsules per meal and one capsule per snack when nearly ran out of Creon and had a gassy stomach. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623005 (Patient Link).   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She got sick after having COVID vaccine and after each booster; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She got sick after having COVID vaccine and after each booster) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Psoriasis.    The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Psoriasis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On 08-Apr-2022, the patient experienced ILLNESS (She got sick after having COVID vaccine and after each booster). At the time of the report, ILLNESS (She got sick after having COVID vaccine and after each booster) outcome was unknown.            Concomitant drugs were not reported.  The patient had received booster dose on unknown date.   The patient was sick on 08-Apr-2022, due to medication for a kidney condition that causes stones.  No treatment information mentioned.  She had outbreaks during her last Skyrizi treatment was 28-Nov-2022. Reporters causality of event of Sick with Skyrizi was not provided.  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.   This case was linked to MOD-2022-621668 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Wife fully vaccinated with Moderna has covid virus now.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Wife fully vaccinated with Moderna has covid virus now.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Wife fully vaccinated with Moderna has covid virus now.). At the time of the report, COVID-19 (Wife fully vaccinated with Moderna has covid virus now.) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant product use was reported.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Hypotension, Migraine, Tachycardia
Clinical narrative: Migraine; Low blood pressure; Profound tachycardia; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine), HYPOTENSION (Low blood pressure) and TACHYCARDIA (Profound tachycardia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Stent placement in 2021.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine), HYPOTENSION (Low blood pressure) and TACHYCARDIA (Profound tachycardia). At the time of the report, MIGRAINE (Migraine), HYPOTENSION (Low blood pressure) and TACHYCARDIA (Profound tachycardia) outcome was unknown. Not applicable    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Irregular.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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 medication was provided. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Anhidrosis, Psoriasis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANHIDROSIS (Anhidrosis) and PSORIASIS (Psoriasis flare-up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANHIDROSIS (Anhidrosis) and PSORIASIS (Psoriasis flare-up). At the time of the report, ANHIDROSIS (Anhidrosis) and PSORIASIS (Psoriasis flare-up) had not resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  The patient had flare up with itching and new spot since starting Skyrizi. He complained of cracked feet and extremely dry hands. He had inability to sweat, he explains that he works out weekly and must be aware of his heart rate due to not being able to sweat while exercising. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain, Toothache
Clinical narrative: Tooth pain; soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Tooth pain), PAIN (soreness) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 TOOTHACHE (Tooth pain), PAIN (soreness) and FATIGUE (Fatigue). At the time of the report, TOOTHACHE (Tooth pain), PAIN (soreness) and FATIGUE (Fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of tooth pain, soreness and fatigue was not provided. The reporter assessed events of tooth pain, soreness and fatigue as possibly related to Moderna Covid-19 vaccine.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623061, MOD-2022-623065.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) 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 ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment Drug 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, COVID19
Symptoms: Heart rate irregular, Tachycardia
Clinical narrative: Tachycardia; Irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and HEART RATE IRREGULAR (Irregular heartbeat) in a male patient of an unknown age 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 TACHYCARDIA (Tachycardia) and HEART RATE IRREGULAR (Irregular heartbeat). At the time of the report, TACHYCARDIA (Tachycardia) and HEART RATE IRREGULAR (Irregular heartbeat) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medication information was reported. No treatment medication 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: minor soreness; extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor soreness) and FATIGUE (extremely exhausted) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 13-Mar-2021, the patient experienced FATIGUE (extremely exhausted). On an unknown date, the patient experienced PAIN (minor soreness). At the time of the report, PAIN (minor soreness) and FATIGUE (extremely exhausted) had not resolved.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. It was reported that, after second vaccine the patient had minor soreness but second day felt extremely exhausted. The reporter's causality for the events of soreness and exhausted was not provided.  The reporter assessed events of soreness and exhausted as possibly related to Moderna Covid-19 vaccine.  No treatment details were reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623056, MOD-2022-623065 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 63-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that covid vaccine first dose caused dizziness.  No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-631087, MOD-2022-631095 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Live follow up contains no new information.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Discomfort, Pain
Clinical narrative: Discomfort; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort) and PAIN (Pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DISCOMFORT (Discomfort) and PAIN (Pain). At the time of the report, DISCOMFORT (Discomfort) and PAIN (Pain) had not resolved.            No concomitant medications was reported. No treatment medications 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.   This case was linked to MOD-2022-623056, MOD-2022-623061.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation reaction
Clinical narrative: COVID VACCINE TWO MADE SICK; Loose bowels; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (COVID VACCINE TWO MADE SICK) and DIARRHOEA (Loose bowels) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In September 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (COVID VACCINE TWO MADE SICK) and DIARRHOEA (Loose bowels). At the time of the report, IMMUNISATION REACTION (COVID VACCINE TWO MADE SICK) had resolved and DIARRHOEA (Loose bowels) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in covid-19 vaccine trials.  No concomitant product reported by reporter. 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.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Vaccination complication
Clinical narrative: She is in bed (reporting negative AE) as a result of the Moderna shot.; She is in bed (reporting negative AE) as a result of the Moderna shot.; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (She is in bed (reporting negative AE) as a result of the Moderna shot.) and VACCINATION COMPLICATION (She is in bed (reporting negative AE) as a result of the Moderna shot.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Lyme disease.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (She is in bed (reporting negative AE) as a result of the Moderna shot.) and VACCINATION COMPLICATION (She is in bed (reporting negative AE) as a result of the Moderna shot.). At the time of the report, BEDRIDDEN (She is in bed (reporting negative AE) as a result of the Moderna shot.) and VACCINATION COMPLICATION (She is in bed (reporting negative AE) as a result of the Moderna shot.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant product use was reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Cough; Weakness generalized; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), COUGH (Cough) and ASTHENIA (Weakness generalized) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), COUGH (Cough) and ASTHENIA (Weakness generalized). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) was resolving and COUGH (Cough) and ASTHENIA (Weakness generalized) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Primary reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in an elderly 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in covid-19 vaccine trials. Patient was having significant flares on elbows and knees.  No concomitant product reported by reporter. 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration
Clinical narrative: Side effect of moderna some what more pronounced; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effect of moderna some what more pronounced) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   In June 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In July 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced IMMUNISATION REACTION (Side effect of moderna some what more pronounced). At the time of the report, IMMUNISATION REACTION (Side effect of moderna some what more pronounced) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that side effects of moderna somewhat more pronounced but over after 3 days and no problems since, no infection, despite multiple warnings from the  app.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Lymphadenopathy, Psoriasis, Tenderness
Clinical narrative: sweats; TENDERNESS ON RIGHT SIDE; DIFFICULT SLEEPING; FULL FLARE UP PLAQUE PSORIASIS FLARES IN THE SCALP AND GROIN AREAS AND APPEARANCE; SWOLLEN LYMPH NODES ON LEFT SIDE; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), TENDERNESS (TENDERNESS ON RIGHT SIDE), INSOMNIA (DIFFICULT SLEEPING), PSORIASIS (FULL FLARE UP PLAQUE PSORIASIS FLARES IN THE SCALP AND GROIN AREAS AND APPEARANCE) and LYMPHADENOPATHY (SWOLLEN LYMPH NODES ON LEFT SIDE) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, the patient experienced LYMPHADENOPATHY (SWOLLEN LYMPH NODES ON LEFT SIDE). On 12-Dec-2021, the patient experienced PSORIASIS (FULL FLARE UP PLAQUE PSORIASIS FLARES IN THE SCALP AND GROIN AREAS AND APPEARANCE). On 16-Dec-2021, the patient experienced HYPERHIDROSIS (sweats), TENDERNESS (TENDERNESS ON RIGHT SIDE) and INSOMNIA (DIFFICULT SLEEPING). On 16-Dec-2021, LYMPHADENOPATHY (SWOLLEN LYMPH NODES ON LEFT SIDE) had resolved. At the time of the report, HYPERHIDROSIS (sweats), TENDERNESS (TENDERNESS ON RIGHT SIDE), INSOMNIA (DIFFICULT SLEEPING) and PSORIASIS (FULL FLARE UP PLAQUE PSORIASIS FLARES IN THE SCALP AND GROIN AREAS AND APPEARANCE) was resolving.            No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of SWEATS, SWOLLEN LYMPH NODES ON LEFT SIDE, TENDERNESS ON RIGHT SIDE and DIFFICULT SLEEPING with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event(s) of FULL FLARE UP OF THE PLAQUE PSORIASIS IN THE SCALP AND GROIN AREAS AND APPEARANCE with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Live Significant Follow-up - Updated Event information, Suspect Drug Information, Narrative description and Medical History received.
Sex: F
Vaccine: COVID19
Symptoms: Endodontic procedure, Malaise, Psoriasis
Clinical narrative: Did not feel well after root canal; Psoriasis worse; Did not feel well after root canal; This spontaneous case was reported by a consumer and describes the occurrence of ENDODONTIC PROCEDURE (Did not feel well after root canal), PSORIASIS (Psoriasis worse) and MALAISE (Did not feel well after root canal) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1.785 milligram. On an unknown date, the patient experienced ENDODONTIC PROCEDURE (Did not feel well after root canal), PSORIASIS (Psoriasis worse) and MALAISE (Did not feel well after root canal). At the time of the report, ENDODONTIC PROCEDURE (Did not feel well after root canal), PSORIASIS (Psoriasis worse) and MALAISE (Did not feel well after root canal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient's psoriasis had worsened after she had taken Moderna vaccine for COVID and did not feel well after a recent root canal.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality with Skyrizi for the events of did not feel well after root canal  and psoriasis worse 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 21-Jan-2022: Additional follow up received event information was updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Depression
Clinical narrative: feeling anxious; Depressed state; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (feeling anxious) and DEPRESSION (Depressed state) in a 75-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 March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANXIETY (feeling anxious) and DEPRESSION (Depressed state). At the time of the report, ANXIETY (feeling anxious) and DEPRESSION (Depressed state) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6.         No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In January 2021, the patient experienced COVID and on an unknown date, COVID resolved. For HUMIRA, the reporter causality for the events of Feeling anxious and Depressed was no reasonable possibility and for the event of COVID 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. No treatment medicine were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Skin disorder
Clinical narrative: Skin become worse; Scalp and feet being worse; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Skin become worse) and CONDITION AGGRAVATED (Scalp and feet being worse) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (Skin become worse) and CONDITION AGGRAVATED (Scalp and feet being worse). At the time of the report, SKIN DISORDER (Skin become worse) had resolved and CONDITION AGGRAVATED (Scalp and feet being worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.
Sex: U
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: ASTHMA SYMPTONMS WORSE; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (ASTHMA SYMPTONMS WORSE) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 05-May-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 05-May-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included Allergy to molds with PFIZER BIONTECH COVID-19 VACCINE; Chemical sensitivity with PFIZER BIONTECH COVID-19 VACCINE; and No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Asthma (Taking DPXT since Jun-2021 for Asthma).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ASTHMA (ASTHMA SYMPTONMS WORSE). At the time of the report, ASTHMA (ASTHMA SYMPTONMS WORSE) outcome was unknown.            No concomitant medication was reported. The patient was usually better or about the same since taking DPXT but asthma did not got worse. patient got the Pfizer covid-19 vaccine for first two dosage and Moderna booster and it temporarily made asthma symptom worse. Over the last month the patient was having cough, chest tightness and shortness of breath and using rescue inhaler more than two times per week over last month. 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.