chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Lip swelling, Psoriasis, Urticaria
Clinical narrative: FLARE OF PLAQUE PSORIASIS SPOT ON SIDE OF LEG/PSORIASIS FLARE-UP; HIVES WITH MODERNA INJECTION with HUMIRA (ADALIMUMAB); LIPS SWOLE UP WITH MODERNA INJECTION; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (LIPS SWOLE UP WITH MODERNA INJECTION), PSORIASIS (FLARE OF PLAQUE PSORIASIS SPOT ON SIDE OF LEG/PSORIASIS FLARE-UP) and URTICARIA (HIVES WITH MODERNA INJECTION with HUMIRA (ADALIMUMAB)) in a 48-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 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced LIP SWELLING (LIPS SWOLE UP WITH MODERNA INJECTION). On an unknown date, the patient experienced PSORIASIS (FLARE OF PLAQUE PSORIASIS SPOT ON SIDE OF LEG/PSORIASIS FLARE-UP) and URTICARIA (HIVES WITH MODERNA INJECTION with HUMIRA (ADALIMUMAB)). At the time of the report, LIP SWELLING (LIPS SWOLE UP WITH MODERNA INJECTION) and URTICARIA (HIVES WITH MODERNA INJECTION with HUMIRA (ADALIMUMAB)) had not resolved and PSORIASIS (FLARE OF PLAQUE PSORIASIS SPOT ON SIDE OF LEG/PSORIASIS FLARE-UP) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  On an unknown date, the patient experienced flare of plaque psoriasis spot on side of leg/psoriasis flare-up. In 2021, the patient experienced lips swole up with moderna injection and hives with moderna injection. on an unknown date, flare of plaque psoriasis spot on side of leg/psoriasis flare-up resolved. Covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On Apr 2021, patient received 1st dose covid-19 vaccine manufactured by moderna, lot number unknown, expiration date unknown.  Causality for humira (adalimumab) The reporter's causality for the event(s) of lips swole up with moderna injection and hives with moderna injection was not provided. The reporter's causality for the event(s) of flare of plaque psoriasis spot on side of leg/psoriasis flare-up with humira (adalimumab) was a reasonable possibility.  No treatment information was reported 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 received on 12-FEB-2021 and Dose-2 received on 02-MAR-2021) and NO ADVERSE EVENT (No adverse event) 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) for Ankylosing spondylitis. 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 02-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. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 received on 12-FEB-2021 and Dose-2 received on 02-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 received on 12-FEB-2021 and Dose-2 received on 02-MAR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Relevant concomitant medications were not reported. On 12-Feb-2021, he received first dose COVID-19 Vaccine manufactured by Moderna and on 02-Mar-2021, he received second dose COVID-19 Vaccine manufactured by Moderna. Treatment information 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-2021-623319 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Hypertension, Laboratory test, Onychoclasis
Clinical narrative: Weight gain; Blood pressure high; Splitting nails; Pain in arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), HYPERTENSION (Blood pressure high), ONYCHOCLASIS (Splitting nails), PAIN IN EXTREMITY (Pain in arm) 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 IBRUTINIB (IMBRUVICA) tablet for an unknown indication.    No Medical History information was reported.   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 IBRUTINIB (IMBRUVICA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), HYPERTENSION (Blood pressure high), ONYCHOCLASIS (Splitting nails), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). At the time of the report, WEIGHT INCREASED (Weight gain) and HYPERTENSION (Blood pressure high) outcome was unknown and ONYCHOCLASIS (Splitting nails), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160/90 mmHg and mmHg Increased. On an unknown date, Laboratory test: numbers are good. On an unknown date, Platelet count: Normal. On an unknown date, Weight: 5 pound weight gain. On an unknown date, White blood cell count: Normal.         No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Platelet count, Weight, Weight increased, White blood cell count
Clinical narrative: Weight gain; Blood pressure high; Splitting nails; Pain in arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), HYPERTENSION (Blood pressure high), ONYCHOCLASIS (Splitting nails), PAIN IN EXTREMITY (Pain in arm) 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 IBRUTINIB (IMBRUVICA) tablet for an unknown indication.    No Medical History information was reported.   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 IBRUTINIB (IMBRUVICA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), HYPERTENSION (Blood pressure high), ONYCHOCLASIS (Splitting nails), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). At the time of the report, WEIGHT INCREASED (Weight gain) and HYPERTENSION (Blood pressure high) outcome was unknown and ONYCHOCLASIS (Splitting nails), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160/90 mmHg and mmHg Increased. On an unknown date, Laboratory test: numbers are good. On an unknown date, Platelet count: Normal. On an unknown date, Weight: 5 pound weight gain. On an unknown date, White blood cell count: Normal.         No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Heart rate, Heart rate irregular, Inappropriate schedule of product administration
Clinical narrative: Poison ivy; irregular heart beat; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Poison ivy), HEART RATE IRREGULAR (irregular heart beat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) 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 ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 02-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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ). On an unknown date, the patient experienced DERMATITIS CONTACT (Poison ivy) and HEART RATE IRREGULAR (irregular heart beat). At the time of the report, DERMATITIS CONTACT (Poison ivy), HEART RATE IRREGULAR (irregular heart beat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Irregular.         No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of poison ivy and irregular heart beat with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: vaccinated at 31 weeks pregnant and 35 weeks; No adverse event; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccinated at 31 weeks pregnant and 35 weeks) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccinated at 31 weeks pregnant and 35 weeks) and NO ADVERSE EVENT (No adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (vaccinated at 31 weeks pregnant and 35 weeks) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. The patient was vaccinated (Moderna) at 31 weeks pregnant and 35 weeks with her second daughter that was now 6 months old. The patient was breastfeed and hoped she was somewhat protected by her. At the very least. Her daughter would be exactly 30 months (2.5 years) in Nov-2021 (born on 5/01/19) . She had no health conditions, no known allergies, was up to date on all other vaccinations, stays at home with her. she just want to do everything I can to protect her children. 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.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a female patient of unknown age, with no medical history, who experienced no adverse event. The patient received 2 doses of mRNA-1273 vaccine, with an interval of 4 weeks, on the third trimester of gestation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a female patient of unknown age, with no medical history, who experienced no adverse event. The patient received 2 doses of mRNA-1273 vaccine, with an interval of 4 weeks, on the third trimester of gestation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had a pretty high fever/ Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a pretty high fever/ Fever) 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 PANCREATIN (CREON) for Cystic fibrosis.    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 PANCREATIN (CREON) (Oral) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (had a pretty high fever/ Fever). At the time of the report, PYREXIA (had a pretty high fever/ Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  The patient had reported that with the first dose of the Moderna Vaccine patient had a pretty high fever.  Treatment information 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever and body ache for a day; fever and body ache for a day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (fever and body ache for a day) and PYREXIA (fever and body ache for a day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products PANCREATIN (CREON) for Cystic fibrosis and Pancreatic insufficiency and COVID-19 VACCINE for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, PANCREATIN (CREON) (Oral) at an unspecified dose and first dose of COVID-19 VACCINE (Intramuscular) 1 dosage form. On an unknown date, received second dose of COVID-19 VACCINE (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (fever and body ache for a day) and PYREXIA (fever and body ache for a day). At the time of the report, MYALGIA (fever and body ache for a day) and PYREXIA (fever and body ache for a day) had resolved.            Concomitant drugs were not reported.  The patient had some side effects with the first dose itself, the second one was pretty ok. The patient had took Moderna booster dose half or full it was not really sure but patient did have mild side effects like fever and body ache for a day. It was manageable. Even if it required another booster patient would go for it.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment medications were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: DIARRHEA; FATIGUE; HEADACHE; CHILLS; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (DIARRHEA), FATIGUE (FATIGUE), HEADACHE (HEADACHE) and CHILLS (CHILLS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products MACITENTAN for Pulmonary hypertension secondary, SELEXIPAG for Pulmonary hypertension secondary and BOSENTAN for Pulmonary hypertension secondary.    Concurrent medical conditions included Pulmonary hypertension secondary. Concomitant products included SILDENAFIL and DILTIAZEM for an unknown indication.   On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MACITENTAN (Oral) 10 milligram once a day, SELEXIPAG (Oral) 1600 microgram twice a day and BOSENTAN (Oral) 125 milligram twice a day. On an unknown date, the patient experienced DIARRHOEA (DIARRHEA), FATIGUE (FATIGUE), HEADACHE (HEADACHE) and CHILLS (CHILLS). At the time of the report, DIARRHOEA (DIARRHEA), FATIGUE (FATIGUE), HEADACHE (HEADACHE) and CHILLS (CHILLS) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 12-Nov-2021, the patient received Moderna Covid booster.  On an unspecified date, the patient experienced fatigue, chills, headache, and diarrhea.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 81.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Alopecia, Immunisation reaction, Skin exfoliation, Vaccination site discomfort, Vaccination site pain
Clinical narrative: severe reaction with Moderna vaccine; hair was falling out; skin was falling off on his hands and feet; one time he did hit a tender spot on his tummy; he can feel it when he gives himself the injection and it is slightly uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (severe reaction with Moderna vaccine), ALOPECIA (hair was falling out), SKIN EXFOLIATION (skin was falling off on his hands and feet), VACCINATION SITE PAIN (one time he did hit a tender spot on his tummy) and VACCINATION SITE DISCOMFORT (he can feel it when he gives himself the injection and it is slightly uncomfortable) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   On 13-Jun-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. In 2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. 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 IMMUNISATION REACTION (severe reaction with Moderna vaccine), ALOPECIA (hair was falling out), SKIN EXFOLIATION (skin was falling off on his hands and feet), VACCINATION SITE PAIN (one time he did hit a tender spot on his tummy) and VACCINATION SITE DISCOMFORT (he can feel it when he gives himself the injection and it is slightly uncomfortable). At the time of the report, IMMUNISATION REACTION (severe reaction with Moderna vaccine), VACCINATION SITE PAIN (one time he did hit a tender spot on his tummy) and VACCINATION SITE DISCOMFORT (he can feel it when he gives himself the injection and it is slightly uncomfortable) had resolved and ALOPECIA (hair was falling out) and SKIN EXFOLIATION (skin was falling off on his hands and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  No treatment medication information 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, COVID19
Symptoms: Nasopharyngitis, Vaccination site pain
Clinical narrative: Cold; J&J COVID shot and Moderna booster made her arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (J&J COVID shot and Moderna booster made her arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (J&J COVID shot and Moderna booster made her arm hurt). At the time of the report, NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (J&J COVID shot and Moderna booster made her arm hurt) outcome was unknown. Not Provided          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: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Achy on covid vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy on covid vaccine.) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe ).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Achy on covid vaccine.). At the time of the report, PAIN (Achy on covid vaccine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. On unknown date, the patient experienced reaction to Humira syringe. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of reaction to Humira syringe and achy on covid vaccine with Humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Condition aggravated, Feeling abnormal, Sciatica
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SCIATICA (Back and thigh pain due to sciatica is flaring- up), FEELING ABNORMAL (Feeling bad), BACK DISORDER (Back problems have recently worsened during the time) and CONDITION AGGRAVATED (Condition aggravated) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis. The patient's past medical history included Back pain. Previously administered products included for Product used for unknown indication: Gabapentin. Past adverse reactions to the above products included No adverse event with Gabapentin. Concurrent medical conditions included Pruritus, Skin burning sensation, Pain in extremity, Sciatica, Neuropathy peripheral and Pain in thigh. In 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On 08-Sep-2021, the patient experienced SCIATICA (Back and thigh pain due to sciatica is flaring- up). In September 2021, the patient experienced FEELING ABNORMAL (Feeling bad), BACK DISORDER (Back problems have recently worsened during the time) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, SCIATICA (Back and thigh pain due to sciatica is flaring- up) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown and FEELING ABNORMAL (Feeling bad) and BACK DISORDER (Back problems have recently worsened during the time) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. On 22-Sep-2021, the patient started taking dupilumab at a loading dose of 600 mg once subcutaneously followed by maintenance dose of 300 mg every other week subcutaneously for atopic dermatitis. It was reported that patient was overworking her back and picking up heavy things at work; she recently started wearing a back brace while at work and has been doing Physical Therapy. Patient informed she takes gabapentin when her sciatic nerve problems flare but she had not been on gabapentin presently. 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODES IN UNDERARMS AND BREAST.; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (SWOLLEN LYMPH NODES IN UNDERARMS AND BREAST.) in a 44-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.    Concurrent medical conditions included Psoriatic arthritis. Concomitant products included METHOTREXATE for an unknown indication.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced LYMPHADENOPATHY (SWOLLEN LYMPH NODES IN UNDERARMS AND BREAST.). At the time of the report, LYMPHADENOPATHY (SWOLLEN LYMPH NODES IN UNDERARMS AND BREAST.) was resolving.            No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter declined to provide lot number information. 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: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Vaccination site erythema, Vaccination site hypersensitivity, Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site erythema; Vaccination site hypersensitivity; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE HYPERSENSITIVITY (Vaccination site hypersensitivity) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 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. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE HYPERSENSITIVITY (Vaccination site hypersensitivity) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE HYPERSENSITIVITY (Vaccination site hypersensitivity) and HEADACHE (Headache) outcome was unknown.            On an unknown date, the patient experienced headache, covid arm/lump and red, warm to touch with all three covid vaccines for covid.It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  Causality for Humira: The reporter's causality for the event of headache, covid arm/lump and red, warm to touch with all three covid vaccines for 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.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 74-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 Ankylosing spondylitis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In April 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome 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.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Cyst, Headache, Hypersomnia, Immunisation reaction
Clinical narrative: Symptom recurrence; Cyst; Sleep excessive; Headache; Vaccination related malaise; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (Symptom recurrence), IMMUNISATION REACTION (Vaccination related malaise), CYST (Cyst), HYPERSOMNIA (Sleep excessive) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and Hidradenitis.    No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen, Citrate free. In September 2021, the patient experienced IMMUNISATION REACTION (Vaccination related malaise), HYPERSOMNIA (Sleep excessive) and HEADACHE (Headache). On an unknown date, the patient experienced SYMPTOM RECURRENCE (Symptom recurrence) and CYST (Cyst). In September 2021, IMMUNISATION REACTION (Vaccination related malaise), HYPERSOMNIA (Sleep excessive) and HEADACHE (Headache) had resolved. At the time of the report, SYMPTOM RECURRENCE (Symptom recurrence) was resolving and CYST (Cyst) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: The body temperature value was 102..         On unknown dates, the patient experienced felt symptoms returned and cysts on neck. In september 2021, the patient experienced reaction after covid 19 vaccine, not feel well, slept 14 hours and headache. On 10 sep 2021, the patient experienced had teamprature 102. In september 2021, the reaction after covid 19 vaccine,not feel well, slept 14 hours, headache and had teamprature 102 resolved.  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: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Symptom recurrence
Clinical narrative: Symptom recurrence; Cyst; Sleep excessive; Headache; Vaccination related malaise; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (Symptom recurrence), IMMUNISATION REACTION (Vaccination related malaise), CYST (Cyst), HYPERSOMNIA (Sleep excessive) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and Hidradenitis.    No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen, Citrate free. In September 2021, the patient experienced IMMUNISATION REACTION (Vaccination related malaise), HYPERSOMNIA (Sleep excessive) and HEADACHE (Headache). On an unknown date, the patient experienced SYMPTOM RECURRENCE (Symptom recurrence) and CYST (Cyst). In September 2021, IMMUNISATION REACTION (Vaccination related malaise), HYPERSOMNIA (Sleep excessive) and HEADACHE (Headache) had resolved. At the time of the report, SYMPTOM RECURRENCE (Symptom recurrence) was resolving and CYST (Cyst) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: The body temperature value was 102..         On unknown dates, the patient experienced felt symptoms returned and cysts on neck. In september 2021, the patient experienced reaction after covid 19 vaccine, not feel well, slept 14 hours and headache. On 10 sep 2021, the patient experienced had teamprature 102. In september 2021, the reaction after covid 19 vaccine,not feel well, slept 14 hours, headache and had teamprature 102 resolved.  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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Pain
Clinical narrative: Hair thinning; Pain; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair thinning) and PAIN (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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced ALOPECIA (Hair thinning) and PAIN (Pain). At the time of the report, ALOPECIA (Hair thinning) had not resolved and PAIN (Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   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 23-Nov-2021: Updated event tab and added vaccine details.
Age: 29.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Keratitis
Clinical narrative: SUPERFICIAL KERATITIS; This spontaneous case was reported by a consumer and describes the occurrence of KERATITIS (SUPERFICIAL KERATITIS) in a 29-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 Hidradenitis suppurativa.    No Medical History information was reported.   On 15-Mar-2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 14-May-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. In May 2021, the patient experienced KERATITIS (SUPERFICIAL KERATITIS). At the time of the report, KERATITIS (SUPERFICIAL KERATITIS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: horrible allergies; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (horrible allergies) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Paranoid personality.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced HYPERSENSITIVITY (horrible allergies). At the time of the report, HYPERSENSITIVITY (horrible allergies) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  It was reported that the patient believed allergies were related to mold in the hotel (since would impact both of us in restroom) also happened a couple other places that were older or in generally dusty as well, but those did not impacted the patient as much. Patient was not Pfizer vaccine (Moderna) and patient felt that this impacted .  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bladder pain, Musculoskeletal disorder, Pain, Pain in extremity, Urinary incontinence
Clinical narrative: bladder always bothersome/lot pain with bladder; Pain; Urinary incontinence; left arm was really sore/Pain in arm; Musculoskeletal disorder/Bottom had started to bother; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER PAIN (bladder always bothersome/lot pain with bladder), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder/Bottom had started to bother), PAIN (Pain), URINARY INCONTINENCE (Urinary incontinence) and PAIN IN EXTREMITY (left arm was really sore/Pain in arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced MUSCULOSKELETAL DISORDER (Musculoskeletal disorder/Bottom had started to bother). On an unknown date, the patient experienced BLADDER PAIN (bladder always bothersome/lot pain with bladder), PAIN (Pain), URINARY INCONTINENCE (Urinary incontinence) and PAIN IN EXTREMITY (left arm was really sore/Pain in arm). At the time of the report, BLADDER PAIN (bladder always bothersome/lot pain with bladder), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder/Bottom had started to bother), PAIN (Pain) and URINARY INCONTINENCE (Urinary incontinence) outcome was unknown and PAIN IN EXTREMITY (left arm was really sore/Pain in arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality was not reported for the event(s) of bladder always bothersome/lot pain with bladder and could not get off the toilet, bottom had started to bother, pain, left arm was really sore and bladder always bothersome/lot pain with the Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gastrointestinal pain
Clinical narrative: Stomach pain; Gastrointestinal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and GASTROINTESTINAL PAIN (Gastrointestinal pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate To Severe Adult Crohn's Disease).   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-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) UNK, Citrate Free. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and GASTROINTESTINAL PAIN (Gastrointestinal pain). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and GASTROINTESTINAL PAIN (Gastrointestinal pain) was resolving.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had stomach pain and colon pain.  The reporter's causality for the event(s) of STOMACH PAIN and COLON PAIN was not provided for Humira.  No treatment medication 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, UNK
Symptoms: Chills, Laboratory test, Psoriasis, Pyrexia
Clinical narrative: Had areas of psoriasis / Psoriasis getting worse; Chills after getting COVID-19 vaccine; Fever after getting COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Had areas of psoriasis / Psoriasis getting worse), CHILLS (Chills after getting COVID-19 vaccine) and PYREXIA (Fever after getting COVID-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS/PSORIASIS).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-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) 40 milligram. On an unknown date, the patient experienced PSORIASIS (Had areas of psoriasis / Psoriasis getting worse), CHILLS (Chills after getting COVID-19 vaccine) and PYREXIA (Fever after getting COVID-19 vaccine). At the time of the report, PSORIASIS (Had areas of psoriasis / Psoriasis getting worse) had not resolved and CHILLS (Chills after getting COVID-19 vaccine) and PYREXIA (Fever after getting COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: COVID 19.         No concomitant medication provided. No treatment information mentioned.  In NOV2020, the patient experienced COVID 19. On unknown date, experienced chills, fever and psoriasis areas that got worse post taking the vaccine. 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   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Non significant follow up. No new information updated.