chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis) 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.  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis). At the time of the report, PSORIASIS (Psoriasis) had not resolved.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Skin disorder
Clinical narrative: BUMPS, LIKE PIMPLES; PLAQUE PSORIASIS SPOT RESURFACED ON SCALP/PSORIASIS IN SCALP; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (BUMPS, LIKE PIMPLES) and PSORIASIS (PLAQUE PSORIASIS SPOT RESURFACED ON SCALP/PSORIASIS IN SCALP) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis and Psoriasis vulgaris.    Concomitant products included OMEPRAZOLE for an unknown indication.   In 2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced SKIN DISORDER (BUMPS, LIKE PIMPLES) and PSORIASIS (PLAQUE PSORIASIS SPOT RESURFACED ON SCALP/PSORIASIS IN SCALP). At the time of the report, SKIN DISORDER (BUMPS, LIKE PIMPLES) and PSORIASIS (PLAQUE PSORIASIS SPOT RESURFACED ON SCALP/PSORIASIS IN SCALP) 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.  The patient had liked to get medication delivered early to make sure took it on time. patient was receiving SKYRIZI for about a year since 2020 and it had been worked really well.  After that patient started getting bumps like pimples, itchy scalp and only get psoriasis scalp since Jul 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: palmer and plantar psoriasis; psoriasis/palm of hand and bottom of feet getting progressively worse; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis/palm of hand and bottom of feet getting progressively worse) and PSORIASIS (palmer and plantar psoriasis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No medical history was reported.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In July 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PSORIASIS (psoriasis/palm of hand and bottom of feet getting progressively worse). On an unknown date, the patient experienced PSORIASIS (palmer and plantar psoriasis). The patient was treated with APREMILAST (OTEZLA) at an unspecified dose and frequency. At the time of the report, PSORIASIS (psoriasis/palm of hand and bottom of feet getting progressively worse) and PSORIASIS (palmer and plantar psoriasis) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Action taken of co-suspect was reported as drug discontinued with respect to all the events.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of breakthrough psoriasis/palm of hand and bottom of feet getting progressively worse and palmer and plantar psoriasis with HUMIRA(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Live follow-up received additional event palmer and plantar psoriasis were added with all the relevant information, Action taken of both suspect vaccine and co-suspect was updated, Concomitant vaccine was added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Hidradenitis, Memory impairment, Weight decreased
Clinical narrative: Lost weight; Decreased appetite; Forgetfulness; Hidradenitis suppurativa; Headache; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost weight), DECREASED APPETITE (Decreased appetite), MEMORY IMPAIRMENT (Forgetfulness), HEADACHE (Headache) and HIDRADENITIS (Hidradenitis suppurativa) in a 62-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 Hidradenitis suppurativa.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In March 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced WEIGHT DECREASED (Lost weight), DECREASED APPETITE (Decreased appetite), MEMORY IMPAIRMENT (Forgetfulness) and HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, WEIGHT DECREASED (Lost weight) and HEADACHE (Headache) was resolving, DECREASED APPETITE (Decreased appetite) and MEMORY IMPAIRMENT (Forgetfulness) outcome was unknown and HIDRADENITIS (Hidradenitis suppurativa) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: Body weight: Lost.         Concomitant drugs not reported. Dose for Moderna vaccine was given as 1 in 1 Once and HUMIRA as Citrate Free. No medical history was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. For HUMIRA, the reporter causality for the events of Decreased appetite, Headache and  Hidradenitis was no reasonable possibility and the reporter causality for the events of Lost weight, Forgetfulness 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. Treatment drugs not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination Adverse Reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination Adverse Reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination Adverse Reaction). At the time of the report, IMMUNISATION REACTION (Vaccination Adverse Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: My husband had gland problems with Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My husband had gland problems with Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My husband had gland problems with Moderna). At the time of the report, VACCINATION COMPLICATION (My husband had gland problems with Moderna) outcome was unknown.        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 received in the Moderna were missed to be booked-in.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Inappropriate schedule of vaccine administered; sore were with all covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore were with all covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-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 an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (sore were with all covid-19 vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, VACCINATION SITE PAIN (sore were with all covid-19 vaccine) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-625693 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Migraine, Vaccination site pain
Clinical narrative: Inappropriate schedule of vaccine administered; Migraine; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), VACCINATION SITE PAIN (Vaccination site pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 62-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 Psoriatic arthritis.    No Medical History information was reported.   On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 11-Nov-2021, the patient experienced MIGRAINE (Migraine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with GABAPENTIN at an unspecified dose and frequency and KETOROLAC at an unspecified dose and frequency. In 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. In November 2021, MIGRAINE (Migraine) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.     Concomitant product use was not provided by the reporter.  In 2021, the patient experienced sore was with all Covid-19 vaccine.  On 11-Nov-2021, the patient experienced migraine.  In Nov-2021, the migraine resolved.  In 2021, the sore was with all Covid-19 vaccine and migraine resolved.  It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  Causality for Humira (Adalimumab) for the event of sore were with all covid-19 vaccine with Humira (Adalimumab) was no reasonable possibility.  The reporter's causality for the event of migraine onset 11-Nov-2021 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.   This case was linked to MOD-2021-625684 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Nausea, Stool analysis, Vaccination site pain
Clinical narrative: Weight loss; Inflammation; Nauseous; Tiredness; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss), INFLAMMATION (Inflammation), NAUSEA (Nauseous), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain) in a 56-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 and Rheumatoid arthritis.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced WEIGHT DECREASED (Weight loss), INFLAMMATION (Inflammation), NAUSEA (Nauseous), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, WEIGHT DECREASED (Weight loss) had not resolved and INFLAMMATION (Inflammation), NAUSEA (Nauseous), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Stool analysis: Unknown.  Concomitant product use was not provided by the reporter.  The patient lost 40 pounds in three months, sore arm with 1st vaccine, inflammation, nauseous when eats and tiredness with Humira. On unknown dates, the patient experienced lost 40 pounds in three months, inflammation and nauseous when eats. In 2021, the patient experienced sore arm with 1st vaccine and tiredness. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of lost 40 pounds in three months with Humira was no reasonable possibility. The reporter's causality for the event(s) of sore arm with 1st vaccine, inflammation, nauseous when eats and tiredness 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.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Weight loss; Inflammation; Nauseous; Tiredness; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss), INFLAMMATION (Inflammation), NAUSEA (Nauseous), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain) in a 56-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 and Rheumatoid arthritis.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced WEIGHT DECREASED (Weight loss), INFLAMMATION (Inflammation), NAUSEA (Nauseous), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, WEIGHT DECREASED (Weight loss) had not resolved and INFLAMMATION (Inflammation), NAUSEA (Nauseous), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Stool analysis: Unknown.  Concomitant product use was not provided by the reporter.  The patient lost 40 pounds in three months, sore arm with 1st vaccine, inflammation, nauseous when eats and tiredness with Humira. On unknown dates, the patient experienced lost 40 pounds in three months, inflammation and nauseous when eats. In 2021, the patient experienced sore arm with 1st vaccine and tiredness. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of lost 40 pounds in three months with Humira was no reasonable possibility. The reporter's causality for the event(s) of sore arm with 1st vaccine, inflammation, nauseous when eats and tiredness 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.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: General body pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-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) 40 milligram every two weeks. On 21-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PAIN (General body pain). On 21-May-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN (General body pain) had not resolved.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Psoriasis, Skin mass
Clinical narrative: COVID-19; Plaque psoriasis break out that looked like pimples/bad psoriasis flare; Lump on head; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Lump on head), COVID-19 (COVID-19) and PSORIASIS (Plaque psoriasis break out that looked like pimples/bad psoriasis flare) in a 32-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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SKIN MASS (Lump on head) and PSORIASIS (Plaque psoriasis break out that looked like pimples/bad psoriasis flare). In July 2021, the patient experienced COVID-19 (COVID-19). In 2021, SKIN MASS (Lump on head) and PSORIASIS (Plaque psoriasis break out that looked like pimples/bad psoriasis flare) had resolved. In August 2021, COVID-19 (COVID-19) had resolved.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Fatigue, Sinusitis, Vaccination site pain, Viral infection
Clinical narrative: Sinus infection; Viral infection; Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), VIRAL INFECTION (Viral infection), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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. In 2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced SINUSITIS (Sinus infection) and VIRAL INFECTION (Viral infection). In 2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, SINUSITIS (Sinus infection) and VIRAL INFECTION (Viral infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: Unknown.  Concomitant product use was not provided by the reporter.  The patient got booster and arm was sore, virus, fatigued and sinus infection with Humira (Adalimumab). On unknown dates, the patient experienced virus and sinus infection. In 2021, the patient experienced got booster and arm was sore and fatigued.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira (Adalimumab) for the events of got booster and arm was sore, virus, fatigued and sinus infection was not provided.  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: Immunisation reaction
Clinical narrative: She had the moderna booster on tuesday and developed side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She had the moderna booster on tuesday and developed side effects) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She had the moderna booster on tuesday and developed side effects). At the time of the report, IMMUNISATION REACTION (She had the moderna booster on tuesday and developed side effects) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Patient took the Moderna booster and had side effects. Her side effects started that day, into the night and the next day.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm after all three covid vaccines; Minor fatigue; Muscle soreness; vaccine related issues/vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccine related issues/vaccination site pain), PAIN IN EXTREMITY (Sore arm after all three covid vaccines), FATIGUE (Minor fatigue) and MYALGIA (Muscle soreness) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Achilles tendonitis (right), Bone spur, Rheumatoid arthritis (moderate to severe) and Meniscus tear (right).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (vaccine related issues/vaccination site pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after all three covid vaccines), FATIGUE (Minor fatigue) and MYALGIA (Muscle soreness). At the time of the report, VACCINATION SITE PAIN (vaccine related issues/vaccination site pain) and FATIGUE (Minor fatigue) outcome was unknown and PAIN IN EXTREMITY (Sore arm after all three covid vaccines) and MYALGIA (Muscle soreness) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  The patient had very minor fatigue. Her muscle soreness had improved. Right achilles tendonitis/bone spur that was longstanding had greatly improved since being on RINVOQ. She had vaccine related issues, sore arm after all three Covid vaccines. The 3rd COVID-19 vaccine was unspecified.   This case was identified as part of a retrospective clean-up activity  received in the Moderna were missed to be booked-in.   This case was linked to MOD-2021-626071 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Therapeutic response unexpected, Vaginal discharge
Clinical narrative: I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain; I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain; I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain; This spontaneous case was reported by a patient and describes the occurrence of VAGINAL DISCHARGE (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain), THERAPEUTIC RESPONSE UNEXPECTED (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) and DYSMENORRHOEA (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Amenorrhea (had not had any period in 2 years).   On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced VAGINAL DISCHARGE (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) and DYSMENORRHOEA (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain). At the time of the report, VAGINAL DISCHARGE (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain), THERAPEUTIC RESPONSE UNEXPECTED (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) and DYSMENORRHOEA (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) outcome was unknown.            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.   This case was linked to MOD-2021-626054 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Generalised oedema, Hypoaesthesia, Pain, Rash erythematous
Clinical narrative: I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain; I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain; I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain; This spontaneous case was reported by a patient and describes the occurrence of VAGINAL DISCHARGE (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain), THERAPEUTIC RESPONSE UNEXPECTED (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) and DYSMENORRHOEA (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Amenorrhea (had not had any period in 2 years).   On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced VAGINAL DISCHARGE (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) and DYSMENORRHOEA (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain). At the time of the report, VAGINAL DISCHARGE (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain), THERAPEUTIC RESPONSE UNEXPECTED (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) and DYSMENORRHOEA (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) outcome was unknown.            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.   This case was linked to MOD-2021-626054 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Therapeutic response unexpected, Vaginal discharge
Clinical narrative: whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash; lot of pain; whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash; whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash; This spontaneous case was reported by a patient and describes the occurrence of GENERALISED OEDEMA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash), PAIN (lot of pain), HYPOAESTHESIA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) and RASH ERYTHEMATOUS (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERALISED OEDEMA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash), PAIN (lot of pain), HYPOAESTHESIA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) and RASH ERYTHEMATOUS (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 10-Oct-2021, GENERALISED OEDEMA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash), PAIN (lot of pain), HYPOAESTHESIA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) and RASH ERYTHEMATOUS (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The patient took Benadry(treatment) and event left for two days then from 10 Oct 2021 to 27 Oct 2021 patient was fine. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-626007 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Generalised oedema, Hypoaesthesia, Pain, Rash erythematous
Clinical narrative: whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash; lot of pain; whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash; whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash; This spontaneous case was reported by a patient and describes the occurrence of GENERALISED OEDEMA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash), PAIN (lot of pain), HYPOAESTHESIA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) and RASH ERYTHEMATOUS (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERALISED OEDEMA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash), PAIN (lot of pain), HYPOAESTHESIA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) and RASH ERYTHEMATOUS (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 10-Oct-2021, GENERALISED OEDEMA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash), PAIN (lot of pain), HYPOAESTHESIA (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) and RASH ERYTHEMATOUS (whole side of my body was numb, red and swollen/ My left arm, I got it swollen up/ got a big rash/ red rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The patient took Benadry(treatment) and event left for two days then from 10 Oct 2021 to 27 Oct 2021 patient was fine. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-626007 (Patient Link).
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Recieved a dose of Moderna and then a dose of purple cap Pfizer; No Adverse Event; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Recieved a dose of Moderna and then a dose of purple cap Pfizer) and NO ADVERSE EVENT (No Adverse Event) in a 13-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Recieved a dose of Moderna and then a dose of purple cap Pfizer) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Recieved a dose of Moderna and then a dose of purple cap Pfizer) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for INTERCHANGE OF VACCINE PRODUCTS (Recieved a dose of Moderna and then a dose of purple cap Pfizer).    No concomitant medication provided. No treatment information mentioned.  Patient took Moderna first and then purple cap Pfizer dose.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Limb discomfort, Muscular weakness
Clinical narrative: Weakness; Weakness of arms; Arms felt heavy and dead; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MUSCULAR WEAKNESS (Weakness of arms), LIMB DISCOMFORT (Arms felt heavy and dead) and INJECTION SITE PAIN (Injection site tenderness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Previously administered products included for Product used for unknown indication: ZOLOFT (Zoloft allergy manifested by depression), CIPRO (Cipro allergy manifested by vomiting) and BACTRIM (Bactrim allergy manifested by vomiting). Past adverse reactions to the above products included Depression with ZOLOFT; and Vomiting with BACTRIM and CIPRO. Concurrent medical conditions included Smoker (About 20 cigarettes per day) since 2009, Alcohol use (A dhot of liquor once or twice a month), Perianal discomfort (Perianal disease), Crohn's aggravated (Crohn's flare up), Topical adhesive allergy (Adhesive allergy manifested by burning and itching on skin), Allergic reaction to antibiotics (Cipro allergy manifested by vomiting), Allergic reaction to antibiotics (Bactrim allergy manifested by vomiting) and Allergic reaction to drug (Zoloft allergy manifested by depression). Concomitant products included BUSPIRONE for Anxiety, PREDNISONE for Crohn's disease, PANTOPRAZOLE for Hyperacidity, BACLOFEN for Spasms.   On 01-Jun-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) 40 milligram. On 01-Jun-2021, the patient experienced ASTHENIA (Weakness), MUSCULAR WEAKNESS (Weakness of arms), LIMB DISCOMFORT (Arms felt heavy and dead) and INJECTION SITE PAIN (Injection site tenderness). On 04-Jun-2021, INJECTION SITE PAIN (Injection site tenderness) had resolved. In June 2021, ASTHENIA (Weakness), MUSCULAR WEAKNESS (Weakness of arms) and LIMB DISCOMFORT (Arms felt heavy and dead) had resolved.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  On 01-Jun-2021, the patient experienced weakness, injection site tenderness and arms felt heavy and dead. On 04-Jun-2021, the injection site tenderness was resolved. In Jun-2021, the weakness and arms felt heavy, and dead resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira 40mg/0.4ml (Adalimumab) for the events of injection site tenderness, arms felt heavy and dead, onset 01-Jun-2021 was not provided.  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.   This case was linked to MOD-2021-626111 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) had not resolved.      No concomitant medication details were provided. No treatment medication details were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Mania
Clinical narrative: Anaphylactic reaction; Felt maniac for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Reactive airways disease and Allergic reaction (adverse reactions to many different medications and ingredients.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant) and MANIA (Felt maniac for 12 hours). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown and MANIA (Felt maniac for 12 hours) had resolved.            Concomitant medication was not reported.  Patient had many allergic reactions and adverse reactions to various medications and ingredients and reaction to everything.  Patient stated after receiving Moderna COVID-19 vaccine, she had bad allergic reactions and felt maniac for 12hours after both the doses. After second dose she felt like having anaphylactic reaction. Treatment details not reported. After first dose she took half a dose of liquid Benadryl.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 69-year-old female patient with medical history of reactive airway disease and multiple allergic reactions, who experienced the unexpected, serious (medically significant) event of anaphylactic reaction an unknown time after the second dose of mRNA-1273. The patient describes that she felt like she was having an anaphylactic reaction, although information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The medical history reactive airway disease and multiple allergic reactions could be confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old female patient with medical history of reactive airway disease and multiple allergic reactions, who experienced the unexpected, serious (medically significant) event of anaphylactic reaction an unknown time after the second dose of mRNA-1273. The patient describes that she felt like she was having an anaphylactic reaction, although information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The medical history reactive airway disease and multiple allergic reactions could be confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.