chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: tiredness; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and 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 UPADACITINIB (RINVOQ) tablet for Psoriatic arthritis.    The patient's past medical history included Knee replacement in 2011. Concurrent medical conditions included Psoriatic arthritis, Non-smoker, Abstains from alcohol and Neck injury. Concomitant products included PREGABALIN (LYRICA) for Neck injury, METHOTREXATE for Psoriatic arthritis.   In 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced FATIGUE (tiredness). In 2021, HEADACHE (Headache) and PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if she was enrolled in a covid 19 vaccine trial.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624663 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up information received wherein added dosage regimen for RINVOQ, concomitant medication, medical history.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastric disorder, Inappropriate schedule of product administration, Pain in extremity, Respiratory disorder
Clinical narrative: 20-JAN-2021  - Dose 1 and 10-FEB-2021 - Dose 2; Stomach problems; Breathing problems; Diarrhea; Pain in arm / Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20-JAN-2021  - Dose 1 and 10-FEB-2021 - Dose 2), GASTRIC DISORDER (Stomach problems), RESPIRATORY DISORDER (Breathing problems), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm / Sore arm) in an 88-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 Crohn's disease.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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) Citrate free. In 2021, the patient experienced GASTRIC DISORDER (Stomach problems), RESPIRATORY DISORDER (Breathing problems), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm / Sore arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20-JAN-2021  - Dose 1 and 10-FEB-2021 - Dose 2). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20-JAN-2021  - Dose 1 and 10-FEB-2021 - Dose 2) outcome was unknown and GASTRIC DISORDER (Stomach problems), RESPIRATORY DISORDER (Breathing problems), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm / Sore arm) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623847 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Headache, Hepatic enzyme
Clinical narrative: Headache/ headaches have been stronger; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache/ headaches have been stronger) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis and ROSUVASTATIN for an unknown indication.    The patient's past medical history included Stomach ache (abdominal pain upper) and Headache. Concurrent medical conditions included Multiple sclerosis, Alopecia (Her hair came out in chunks) since March 2021 and Hair loss (She was having hair loss since starting the medication).   On 18-Mar-2021, the patient started TERIFLUNOMIDE (AUBAGIO) (Oral) 14 milligram once a day. In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ROSUVASTATIN (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache/ headaches have been stronger). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. In 2021, HEADACHE (Headache/ headaches have been stronger) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Hepatic enzyme: liver enzymes had increased and liver enzymes are good.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stopped rosuvastatin two months ago because her liver enzymes had increased (Hepatic enzyme increased) (onset: unknown date in 2021, latency: unknown). She had a lab work done since then and her liver enzymes were good now.  No concomitant 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: Anosmia
Clinical narrative: her smell is off; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (her smell is off) 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. On an unknown date, the patient experienced ANOSMIA (her smell is off). At the time of the report, ANOSMIA (her smell is off) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected non serious AESI of Anosmia , 3 weeks after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on detailed clinical course, relevant investigations, treatment, exact date of vaccination, details of the first dose and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected non serious AESI of Anosmia , 3 weeks after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on detailed clinical course, relevant investigations, treatment, exact date of vaccination, details of the first dose and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pruritus
Clinical narrative: From the chest down patient was itchy; Second covid vaccine and booster caused aches and pains and flu like symptoms; Second covid vaccine and booster caused aches and pains and flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (From the chest down patient was itchy), PAIN (Second covid vaccine and booster caused aches and pains and flu like symptoms) and INFLUENZA LIKE ILLNESS (Second covid vaccine and booster caused aches and pains and flu like symptoms) in a 72-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 Crohn's disease and Ankylosing spondylitis.    No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-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) Citrate free. In 2021, the patient experienced PAIN (Second covid vaccine and booster caused aches and pains and flu like symptoms) and INFLUENZA LIKE ILLNESS (Second covid vaccine and booster caused aches and pains and flu like symptoms). On an unknown date, the patient experienced PRURITUS (From the chest down patient was itchy). In 2021, PAIN (Second covid vaccine and booster caused aches and pains and flu like symptoms) and INFLUENZA LIKE ILLNESS (Second covid vaccine and booster caused aches and pains and flu like symptoms) had resolved. At the time of the report, PRURITUS (From the chest down patient was itchy) had not resolved. 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough COVID-19) in a 46-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 Rheumatoid arthritis.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced BREAKTHROUGH COVID-19 (Breakthrough COVID-19). In 2021, BREAKTHROUGH COVID-19 (Breakthrough COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyschezia, Enteritis, Stool analysis, Ultrasound ovary
Clinical narrative: Covid vaccination possible reaction/using restroom twice a day/having hard time moving bowel; Inflammation of in small intestine and ileum; This spontaneous case was reported by a consumer and describes the occurrence of DYSCHEZIA (Covid vaccination possible reaction/using restroom twice a day/having hard time moving bowel) and ENTERITIS (Inflammation of in small intestine and ileum) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced DYSCHEZIA (Covid vaccination possible reaction/using restroom twice a day/having hard time moving bowel) and ENTERITIS (Inflammation of in small intestine and ileum). At the time of the report, DYSCHEZIA (Covid vaccination possible reaction/using restroom twice a day/having hard time moving bowel) and ENTERITIS (Inflammation of in small intestine and ileum) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Stool analysis: Abnormal levels were slightly elevated. In 2021, Ultrasound ovary: Abnormal. Shadow on right ovary. In August 2021, Blood test: Abnormal Levels were slightly elevated..         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and NAUSEA (Nausea) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   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. On an unknown date, the patient experienced FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported. Patient has no known allergies. 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: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Psoriasis
Clinical narrative: On 07 May 2021 received 1st dose,  On 20 Sep 2021 received 2nd dose; PSORIASIS FLAREUP TO SCALP; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS FLAREUP TO SCALP) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 07 May 2021 received 1st dose, On 20 Sep 2021 received 2nd dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.  No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced PSORIASIS (PSORIASIS FLAREUP TO SCALP). On 20-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 07 May 2021 received 1st dose, On 20 Sep 2021 received 2nd dose). At the time of the report, PSORIASIS (PSORIASIS FLAREUP TO SCALP) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 07 May 2021 received 1st dose, On 20 Sep 2021 received 2nd dose) outcome was unknown.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided. The patient stated that the physician was increasing the dosages of SKYRIZI because she continued to have a flakey and itchy scalp. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Illness, Nasal congestion, Pyrexia
Clinical narrative: COVID-19; illness; *very* mild-low grade fever; headach; Slight congestion; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ILLNESS (illness), PYREXIA (*very* mild-low grade fever), HEADACHE (headach) and NASAL CONGESTION (Slight congestion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), ILLNESS (illness), PYREXIA (*very* mild-low grade fever), HEADACHE (headach) and NASAL CONGESTION (Slight congestion). At the time of the report, COVID-19 (COVID-19), ILLNESS (illness), PYREXIA (*very* mild-low grade fever), HEADACHE (headach) and NASAL CONGESTION (Slight congestion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines 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. No treatment medicines were reported.   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza
Clinical narrative: Influenza A virus infection; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Influenza A virus infection) in a 37-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) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 30-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. 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. On 23-Aug-2021, the patient experienced INFLUENZA (Influenza A virus infection). In September 2021, INFLUENZA (Influenza A virus infection) had resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the event of Influenza A virus infection was assessed as "Not reported" for cosuspect humira. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623880 (Patient Link).   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hidradenitis
Clinical narrative: Hidradenitis suppurativa flare during COVID vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare during COVID vaccination) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare during COVID vaccination). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare during COVID vaccination) was resolving.            No concomitant medication provided. No treatment information mentioned.  Patient reported a flare up after COVID vaccine of hidradenitis. Was tender and broke out under arms, breast and groin area.   The reporters causality for events with HUMIRA was considered to be 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
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING with RINVOQ (UPADACITINIB).; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING with RINVOQ (UPADACITINIB).) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 UPADACITINIB (RINVOQ) (Oral) 15 Milligram, Extended release. In 2021, the patient experienced SWELLING (RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING with RINVOQ (UPADACITINIB).). At the time of the report, SWELLING (RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING with RINVOQ (UPADACITINIB).) had not resolved.            No concomitant drugs taken. In 2021, the patient experienced RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported. Causality for RINVOQ(UPADACITINIB): The reporter's causality for both the events were 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Live Significant follow up received: Event Drug effect decreased as reported term and causality was updated. New event swelling was added.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: Two women who just gave birth. One has the Moderna vaccine and the other has Pfizer; No Adverse event; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Two women who just gave birth. One has the Moderna vaccine and the other has Pfizer) and NO ADVERSE EVENT (No Adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Two women who just gave birth. One has the Moderna vaccine and the other has Pfizer) 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 (Two women who just gave birth. One has the Moderna vaccine and the other has Pfizer) 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.       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.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a female patient of unknown age, with no medical history reported, who experienced no adverse event. An unspecified dose of mRNA-1273 vaccine was received on an unknown 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 reported, who experienced no adverse event. An unspecified dose of mRNA-1273 vaccine was received on an unknown trimester of gestation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity, Paraesthesia, Weight bearing difficulty
Clinical narrative: No longer hold a cup of coffee; Felt a little uncomfortable; His arm has been tingling and painful; His arm has been tingling and painful; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT BEARING DIFFICULTY (No longer hold a cup of coffee), DISCOMFORT (Felt a little uncomfortable), PARAESTHESIA (His arm has been tingling and painful) and PAIN IN EXTREMITY (His arm has been tingling and painful) 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 WEIGHT BEARING DIFFICULTY (No longer hold a cup of coffee), DISCOMFORT (Felt a little uncomfortable), PARAESTHESIA (His arm has been tingling and painful) and PAIN IN EXTREMITY (His arm has been tingling and painful). At the time of the report, WEIGHT BEARING DIFFICULTY (No longer hold a cup of coffee), DISCOMFORT (Felt a little uncomfortable), PARAESTHESIA (His arm has been tingling and painful) and PAIN IN EXTREMITY (His arm has been tingling and painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient came to ER because of arm has been tingling and painful for over a week now. No longer hold a cup of coffee. Nurse gave him a full physical exam in the brown recliner, which made him self-conscious about having his shirt lifted up in front of strangers. Patient felt a little uncomfortable.  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 US-MODERNATX, INC.-MOD-2021-623953 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-623953:Same reporter
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthritis
Clinical narrative: Arthritis aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis aggravated) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, 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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (Arthritis aggravated) (seriousness criterion medically significant). At the time of the report, ARTHRITIS (Arthritis aggravated) 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.  Company Comment:  This spontaneous case concerns an adult male patient with relevant medical history of Psoriatic arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Arthritis (Arthritis aggravated) on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be established as date of event onset was not provided. Patient received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart. The relevant medical history of Psoriatic arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with relevant medical history of Psoriatic arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Arthritis (Arthritis aggravated) on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be established as date of event onset was not provided. Patient received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart. The relevant medical history of Psoriatic arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Immunisation reaction, Interchange of vaccine products
Clinical narrative: Dealing with long term effect; Receieved both moderna and pfizer vaccine; Receieved both moderna and pfizer vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Dealing with long term effect), INTERCHANGE OF VACCINE PRODUCTS (Receieved both moderna and pfizer vaccine) and COVID-19 IMMUNISATION (Receieved both moderna and pfizer vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Dealing with long term effect), INTERCHANGE OF VACCINE PRODUCTS (Receieved both moderna and pfizer vaccine) and COVID-19 IMMUNISATION (Receieved both moderna and pfizer vaccine). At the time of the report, IMMUNISATION REACTION (Dealing with long term effect) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Receieved both moderna and pfizer vaccine) and COVID-19 IMMUNISATION (Receieved both moderna and pfizer vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. 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: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: miscarriage; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (miscarriage) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Abortion spontaneous after receiving a dose of mRNA-1273 vaccine. The onset date of event and vaccination date were not reported. It was reported that the patient lost her baby 3 days after vaccination. Clinical course and treatment details were not reported. The last normal menstrual period (LMP) and obstetrical ultrasound dating were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Abortion spontaneous after receiving a dose of mRNA-1273 vaccine. The onset date of event and vaccination date were not reported. It was reported that the patient lost her baby 3 days after vaccination. Clinical course and treatment details were not reported. The last normal menstrual period (LMP) and obstetrical ultrasound dating were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at Covid 19 booster injection site), FATIGUE (Fatigue) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In October 2021, the patient experienced VACCINATION SITE PAIN (Soreness at Covid 19 booster injection site), FATIGUE (Fatigue) and PYREXIA (Fever). In October 2021, VACCINATION SITE PAIN (Soreness at Covid 19 booster injection site), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was reported. No treatment medication information was reported. The patient had covid-19 booster shot and experienced soreness at injection site, fever, fatigue that lasted only about 24 hrs. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Hypoacusis, Interchange of vaccine products, Tachycardia
Clinical narrative: J&J taken previouslyand Moderna taken on Apr-2021; J&J taken previouslyand Moderna taken on Apr-2021; permanent tachycardia; hear problems; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (permanent tachycardia), HYPOACUSIS (hear problems), COVID-19 IMMUNISATION (J&J taken previouslyand Moderna taken on Apr-2021) and INTERCHANGE OF VACCINE PRODUCTS (J&J taken previouslyand Moderna taken on Apr-2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced TACHYCARDIA (permanent tachycardia) and HYPOACUSIS (hear problems). On an unknown date, the patient experienced COVID-19 IMMUNISATION (J&J taken previouslyand Moderna taken on Apr-2021) and INTERCHANGE OF VACCINE PRODUCTS (J&J taken previouslyand Moderna taken on Apr-2021). At the time of the report, TACHYCARDIA (permanent tachycardia) had not resolved and HYPOACUSIS (hear problems), COVID-19 IMMUNISATION (J&J taken previouslyand Moderna taken on Apr-2021) and INTERCHANGE OF VACCINE PRODUCTS (J&J taken previouslyand Moderna taken on Apr-2021) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       She stated she unfortunately, received the Moderna vaccine last in April. She stated she had negative side effects from the shot and she does not ever want the Moderna vaccine again. Patient had permanent tachycardia and hear problems 1.5 weeks after and she was surprised and wished she would have gotten Pfizer. She reported others she knows doing well with the Pfizer Vaccine. She questions since they are both mRNA could she now receive the Pfizer COVID booster dose after previously having J&J.She wished she would have gotten Pfizer in the first place. She stated that she has several friends who are also wanting to know this information and she felt that this would be the best way to go.   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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, COVID-19, Influenza like illness
Clinical narrative: knee was brothering; COVID-19; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (knee was brothering), COVID-19 (COVID-19) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 72-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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 an unknown date, the patient experienced ARTHROPATHY (knee was brothering), COVID-19 (COVID-19) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, ARTHROPATHY (knee was brothering) and COVID-19 (COVID-19) was resolving and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain aggravated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain aggravated) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain aggravated). At the time of the report, PAIN (Pain aggravated) 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Impaired work ability
Clinical narrative: Severely Depressed; Couldnt go back to work; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Severely Depressed) and IMPAIRED WORK ABILITY (Couldnt go back to work) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (Severely Depressed) and IMPAIRED WORK ABILITY (Couldnt go back to work). At the time of the report, DEPRESSION (Severely Depressed) and IMPAIRED WORK ABILITY (Couldnt go back to work) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Patient started severely depressed and no medication helped after vaccination. Patient did not have any history of depression and was not on any medications prior receiving the vaccine.  Treatment Medication use information was not provided by reporter.  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-2021-623958 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Uveitis
Clinical narrative: Uveitis flare up/ eye flare; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis flare up/ eye flare) 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 Panuveitis and Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE) and Panuveitis (NON-INFECTIOUS INTERMEDIATE, POSTERIOR AND PANUVEITIS). Concomitant products included METHOTREXATE for an unknown indication.   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, Solution for injection in pre-filled pen. On an unknown date, the patient experienced UVEITIS (Uveitis flare up/ eye flare) (seriousness criterion medically significant). At the time of the report, UVEITIS (Uveitis flare up/ eye flare) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning an adult female patient with relevant medical condition of Non-infectious intermediate, posterior and panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis, reported as uveitis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event was not resolved. The medical condition of Non-infectious intermediate, posterior, and panuveitis remains as a confounder for uveitis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an adult female patient with relevant medical condition of Non-infectious intermediate, posterior and panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis, reported as uveitis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event was not resolved. The medical condition of Non-infectious intermediate, posterior, and panuveitis remains as a confounder for uveitis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.