chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain in extremity, Varicose vein
Clinical narrative: Chills; Legs hurt; Woke up drenched in sweat; Varicose veins; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Woke up drenched in sweat), VARICOSE VEIN (Varicose veins), CHILLS (Chills) and PAIN IN EXTREMITY (Legs hurt) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HYPERHIDROSIS (Woke up drenched in sweat), VARICOSE VEIN (Varicose veins) and PAIN IN EXTREMITY (Legs hurt). On 09-Nov-2021, the patient experienced CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Woke up drenched in sweat), VARICOSE VEIN (Varicose veins), CHILLS (Chills) and PAIN IN EXTREMITY (Legs hurt) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of CHILLS, WOKE UP DRENCHED IN SWEAT, LEGS HURT and VARICOSE VEINS was not provided for SKYRIZI. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for B-cell lymphoma NOS.    Previously administered products included for Drug use for unknown indication: IODINE. Past adverse reactions to the above products included Iodine allergy with IODINE. Concurrent medical conditions included Iodine allergy and Penicillin allergy (penicillin v potassium allergy). Concomitant products included RIZATRIPTAN BENZOATE (MAXALT), COLECALCIFEROL, FISH OIL (FISH OIL + VITAMIN D3), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ALLOPURINOL and SIMVASTATIN for an unknown indication.   On 12-Oct-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 100 milligram four times per day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEART RATE INCREASED (Rapid heart beat). At the time of the report, HEART RATE INCREASED (Rapid heart beat) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: Rapid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: horrible rash; horribly high fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (horrible rash) and PYREXIA (horribly high fever) 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) (Transmammary) at an unspecified dose. On an unknown date, the patient experienced RASH (horrible rash) and PYREXIA (horribly high fever). At the time of the report, RASH (horrible rash) and PYREXIA (horribly high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Breastfed patient got horrible rash and horribly high fever after mother received Moderna Covid Vaccine.  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.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Injection site itching; Injection site rash; Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), the first episode of VACCINATION SITE RASH (Injection site rash) and the second episode of VACCINATION SITE RASH (Injection site rash) 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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a week. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), the first episode of VACCINATION SITE RASH (Injection site rash) and the second episode of VACCINATION SITE RASH (Injection site rash). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) had not resolved and last episode of VACCINATION SITE RASH (Injection site rash) was resolving.            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
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Weak; Nausea; Vomiting; Fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weak), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Fever) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product MACITENTAN for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and MACITENTAN (Oral) at an unspecified dose. On an unknown date, the patient experienced ASTHENIA (Weak), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weak), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided.  No treatment medication was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Osteoarthritis, Pain, Pain in extremity, Pruritus
Clinical narrative: flare up/possible osteoarthritis; Fibromyalgia; Itchiness; Pain flare up; Rash; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (flare up/possible osteoarthritis), FIBROMYALGIA (Fibromyalgia), PRURITUS (Itchiness), PAIN (Pain flare up) and RASH (Rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 20-Mar-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) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced OSTEOARTHRITIS (flare up/possible osteoarthritis), FIBROMYALGIA (Fibromyalgia), PRURITUS (Itchiness), PAIN (Pain flare up) and RASH (Rash). At the time of the report, OSTEOARTHRITIS (flare up/possible osteoarthritis), FIBROMYALGIA (Fibromyalgia), PRURITUS (Itchiness), PAIN (Pain flare up) and RASH (Rash) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of flare up/possible osteoarthritis, fibromyalgia, sore arm and severe muscle pain with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of itchiness, pain flare up and rash with Humira(adalimumab) was a reasonable possibility.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624197 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: flare up/possible osteoarthritis; Fibromyalgia; Itchiness; Pain flare up; Rash; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (flare up/possible osteoarthritis), FIBROMYALGIA (Fibromyalgia), PRURITUS (Itchiness), PAIN (Pain flare up) and RASH (Rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 20-Mar-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) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced OSTEOARTHRITIS (flare up/possible osteoarthritis), FIBROMYALGIA (Fibromyalgia), PRURITUS (Itchiness), PAIN (Pain flare up) and RASH (Rash). At the time of the report, OSTEOARTHRITIS (flare up/possible osteoarthritis), FIBROMYALGIA (Fibromyalgia), PRURITUS (Itchiness), PAIN (Pain flare up) and RASH (Rash) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of flare up/possible osteoarthritis, fibromyalgia, sore arm and severe muscle pain with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of itchiness, pain flare up and rash with Humira(adalimumab) was a reasonable possibility.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624197 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression
Clinical narrative: Depression aggravated; Exacerbation of anxiety; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depression aggravated) and ANXIETY (Exacerbation of anxiety) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In June 2021, the patient experienced DEPRESSION (Depression aggravated) and ANXIETY (Exacerbation of anxiety). At the time of the report, DEPRESSION (Depression aggravated) and ANXIETY (Exacerbation of anxiety) was resolving.            Patient had an exacerbation of her anxiety and depression over some events at work over the past couple months in Jun-2021 and had begun Electrical stimulation therapy.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624133 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Rash
Clinical narrative: COVID arm; Had diffuse rash after getting the Moderna COVID vaccine / rash all over the body lasting for weeks; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (COVID arm) and RASH (Had diffuse rash after getting the Moderna COVID vaccine / rash all over the body lasting for weeks) 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 IMMUNISATION REACTION (COVID arm) and RASH (Had diffuse rash after getting the Moderna COVID vaccine / rash all over the body lasting for weeks). At the time of the report, IMMUNISATION REACTION (COVID arm) and RASH (Had diffuse rash after getting the Moderna COVID vaccine / rash all over the body lasting for weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2021-624139, US-MODERNATX, INC.-MOD-2021-624209 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-624139:80 year old patient case US-MODERNATX, INC.-MOD-2021-624209:Case for couple of patients
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In April 2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown.            Concomitant Drugs Not Reported.  The reporter's causality for the event of severe muscle pain with Humira(adalimumab) was no reasonable possibility.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624189 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Arm hurt; Low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade temperature) and PAIN IN EXTREMITY (Arm hurt) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 31-Jul-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) Citrate free. In 2021, the patient experienced PYREXIA (Low grade temperature). On 01-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). At the time of the report, PYREXIA (Low grade temperature) had resolved and PAIN IN EXTREMITY (Arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: Low grade temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patient reported events of non-serious Low grade temperature and Arm hurt with HUMIRA (ADALIMUMAB).   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.   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, UNK
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy axillary/Woke up to swollen lymph node in armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymphadenopathy axillary/Woke up to swollen lymph node in armpit) 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 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 On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymphadenopathy axillary/Woke up to swollen lymph node in armpit). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy axillary/Woke up to swollen lymph node in armpit) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient experienced with third COVID Vaccine dosage woke up to swollen lymph node in armpit.  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: M
Vaccine: COVID19
Symptoms: Affect lability, Anxiety
Clinical narrative: Chronic anxiety; Went berserk; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (Chronic anxiety) and AFFECT LABILITY (Went berserk) 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 ANXIETY (Chronic anxiety) and AFFECT LABILITY (Went berserk). At the time of the report, ANXIETY (Chronic anxiety) had not resolved and AFFECT LABILITY (Went berserk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The patient took the Moderna Covid Vaccine and went berserk which started 3 months behind the Moderna Covid Vaccine. The patient was still on medication and that was been since Mar-2021. Now patient was on medications to sleep, on medication for anxiety. The patient had a real chronic anxiety that was ongoing for 3 months. patient was trying best to come off the medications. Patient was employed. Patient never had anything wrong with him, never been on a pill and now patient was on 3 different pills. 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: Immunisation reaction, Product dose omission issue
Clinical narrative: I had a very bad reaction; I never got second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I had a very bad reaction) and PRODUCT DOSE OMISSION ISSUE (I never got second vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   The patient's past medical history included COPD and Chronic heart failure.  On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I had a very bad reaction) and PRODUCT DOSE OMISSION ISSUE (I never got second vaccine). At the time of the report, IMMUNISATION REACTION (I had a very bad reaction) and PRODUCT DOSE OMISSION ISSUE (I never got second vaccine) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Patient mentions as her system is touchy and lots of medicines she cannot tolerate. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Crying, Pain
Clinical narrative: whole body hurt; Uncontrollable crying; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (whole body hurt) and CRYING (Uncontrollable crying) in a 19-year-old male 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (whole body hurt) and CRYING (Uncontrollable crying). At the time of the report, PAIN (whole body hurt) and CRYING (Uncontrollable crying) outcome was unknown. Not Provided          This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. Patient mother was contacted to the hospital and got the number of Pfizer. It was reported that patient received second dose of COVID-19 vaccine, patient mother and sister  had completed the two dose vaccines. Tylenol and Ibuprofen 800 was planning to give because of patient's uncontrollable crying and whole body hurt. It was reported that patient s very active and has no health problems. Caller declined to completed the report at this time because only worry about the patient. No treatment medications were reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt soreness in his arm afterwards; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt soreness in his arm afterwards) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis and Eczema.    The patient's past medical history included Cough in 2020, Productive cough (phlegm) in 2020 and Intentional dose omission (last dupilumab injection was scheduled for 27-Jul-2021, but he was one day late with it) on 27-Jul-2021. Concurrent medical conditions included Smoker, Skin haemorrhage since 2021, Skin infection since 2021, Scratch since 2021 and Skin disorder (scratches so bad that his skin breaks, bleeds and it's caused infection in his arm and hands) since 2021.   In 2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 09-Oct-2020, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On 04-Jun-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced PAIN IN EXTREMITY (felt soreness in his arm afterwards). At the time of the report, PAIN IN EXTREMITY (felt soreness in his arm afterwards) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Since the fourth dose of dupilumab, patient reported that he has a cough and phlegm productive cough. On an unknown date in 2021 the patient reported that he still experiencing bleeding along with an infection on his skin, due to excessive scratching. Patient said that he scratches so bad that his skin breaks and bleeds and it's caused infection in his arm and hands. Patient also stated that he will be taking antibiotics in the near future for relief. Patient reported that he picked up 2 medications that he was going to start from 03-Jun-2021 including hydroxyzine for itching and sulfamethoxazole, an antibiotic because he scratches so bad that his skin breaks, and bleeds and it's caused infection in his arm and hands. It was reported that patient stated that he began therapy with dupilumab in January 2021 using samples from the doctor, and he got three doses using the samples, but then there was an interruption in therapy for about a month and a half before he was able to get on a program that pays for the dupilumab for a year, so then he re-started therapy after that interruption. 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
Symptoms: Skin laceration
Clinical narrative: skin flare up; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LACERATION (skin flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN LACERATION (skin flare up). At the time of the report, SKIN LACERATION (skin flare up) outcome was unknown.            Concomitant medication was not reported.  Skin flare up because she had not been able to get pen replaced it had been two weeks. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Event verbatim updated.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Biopsy breast, Breast cancer in situ, Vaccination site pain
Clinical narrative: Stage 0 after having breast biopsy; Vaccination site pain/left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER IN SITU (Stage 0 after having breast biopsy) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Psoriasis.   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 BREAST CANCER IN SITU (Stage 0 after having breast biopsy) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Vaccination site pain/left arm soreness). At the time of the report, BREAST CANCER IN SITU (Stage 0 after having breast biopsy) had not resolved and VACCINATION SITE PAIN (Vaccination site pain/left arm soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy breast: stage 0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs were not Reported. On unknown dates, the patient experienced Stage 0 after having breast biopsy and left arm soreness after Moderna vaccination.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 concerns an elderly female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of Breast cancer in situ on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and event onset date were not disclosed. Patient underwent breast biopsy with result reported as stage 0.  No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of Breast cancer in situ on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and event onset date were not disclosed. Patient underwent breast biopsy with result reported as stage 0.  No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: Stomach pain; Painful L arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and PAIN IN EXTREMITY (Painful L arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and PAIN IN EXTREMITY (Painful L arm). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and PAIN IN EXTREMITY (Painful L arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient experienced stomach pain and pain in left arm.  Reporters causality of events with Rinvoq 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: Fatigue, Immunisation reaction, Influenza like illness, Injection site papule, Injection site pruritus
Clinical narrative: feels sore; injection site itchy; injection site raised; vaccine caused flu like symptoms; vaccine made sick; very fatigued; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (vaccine caused flu like symptoms), IMMUNISATION REACTION (vaccine made sick), FATIGUE (very fatigued), VOMITING (Vomiting) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 01-Oct-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) Solution for injection in pre-filled pen. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (vaccine caused flu like symptoms), IMMUNISATION REACTION (vaccine made sick), FATIGUE (very fatigued), VOMITING (Vomiting) and PYREXIA (Fever). On an unknown date, the patient experienced PAIN (feels sore), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE PAPULE (injection site raised). At the time of the report, INFLUENZA LIKE ILLNESS (vaccine caused flu like symptoms), IMMUNISATION REACTION (vaccine made sick), FATIGUE (very fatigued), VOMITING (Vomiting) and PYREXIA (Fever) had resolved, PAIN (feels sore) had not resolved and INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE PAPULE (injection site raised) was resolving.            Concomitant product use was not provided by the reporter.  Action taken was reported as unknown for the co-suspect ADALIMUMAB (HUMIRA) with respect to all the events.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of vaccine made sick, feels sore, injection site raised, injection site itchy, vaccine caused flu like symptoms, very fatigued, vomiting and fever 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Live follow-up received additional event injection site raised, injection site itchy, vaccine caused flu like symptoms and fever were added. the event of sick was updated to vaccine made sick. As reported term of event fatigue were updated. causality of events were updated. start date of suspect vaccine were updated.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: feels sore; injection site itchy; injection site raised; vaccine caused flu like symptoms; vaccine made sick; very fatigued; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (vaccine caused flu like symptoms), IMMUNISATION REACTION (vaccine made sick), FATIGUE (very fatigued), VOMITING (Vomiting) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 01-Oct-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) Solution for injection in pre-filled pen. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (vaccine caused flu like symptoms), IMMUNISATION REACTION (vaccine made sick), FATIGUE (very fatigued), VOMITING (Vomiting) and PYREXIA (Fever). On an unknown date, the patient experienced PAIN (feels sore), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE PAPULE (injection site raised). At the time of the report, INFLUENZA LIKE ILLNESS (vaccine caused flu like symptoms), IMMUNISATION REACTION (vaccine made sick), FATIGUE (very fatigued), VOMITING (Vomiting) and PYREXIA (Fever) had resolved, PAIN (feels sore) had not resolved and INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE PAPULE (injection site raised) was resolving.            Concomitant product use was not provided by the reporter.  Action taken was reported as unknown for the co-suspect ADALIMUMAB (HUMIRA) with respect to all the events.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of vaccine made sick, feels sore, injection site raised, injection site itchy, vaccine caused flu like symptoms, very fatigued, vomiting and fever 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Live follow-up received additional event injection site raised, injection site itchy, vaccine caused flu like symptoms and fever were added. the event of sick was updated to vaccine made sick. As reported term of event fatigue were updated. causality of events were updated. start date of suspect vaccine were updated.
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Tachycardia
Clinical narrative: Tachycardia; chest swelling; This spontaneous case was reported by a pharmacist and describes the occurrence of TACHYCARDIA (Tachycardia) and SWELLING (chest swelling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia) and SWELLING (chest swelling). At the time of the report, TACHYCARDIA (Tachycardia) and SWELLING (chest swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication 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
Symptoms: Fear of injection, Vaccination site eczema
Clinical narrative: eczema flare at modenra vaccine injection site; Fear of needles; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ECZEMA (eczema flare at modenra vaccine injection site) and FEAR OF INJECTION (Fear of needles) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.     Previously administered products included for Atopic dermatitis: DUPIXENT (Solution for injection, 150 mg/mL Dose: 300 mg Frequency: QOW Route: Subcutaneous Exp. date: 30Apr2022) on 24-Oct-2019, DUPIXENT on 24-Oct-2019 and DUPIXENT on 24-Oct-2019. Past adverse reactions to the above products included Intentionally missed dose with DUPIXENT; Therapy interrupted with DUPIXENT; and Treatment nonadherence with DUPIXENT.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ECZEMA (eczema flare at modenra vaccine injection site) and FEAR OF INJECTION (Fear of needles). At the time of the report, VACCINATION SITE ECZEMA (eczema flare at modenra vaccine injection site) and FEAR OF INJECTION (Fear of needles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was off dupixent for more than 4 weeks and poor adherence to dupixent while being treated with dupilumab [Dupixent] with the use of dupilumab pre filled syringe and COVID-19 vaccine MRNA (MRNA 1273) [moderna COVID-19 vaccine].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medications were reported.  It was not reported if the patient received a corrective treatment for the events.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated/Small Flair Up) and VACCINATION SITE PAIN (Vaccination site pain/Achy after the Moderna shot) in a 63-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 and Rheumatoid arthritis. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Second dose, lot number and expiration date unknown) and COVID-19 Vaccine (First dose lot number and expiration date unknown). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine. Concurrent medical conditions included Psoriatic arthritis and Rheumatoid arthritis. On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/Achy after the moderna shot). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated/Small Flair Up). At the time of the report, CONDITION AGGRAVATED (Condition aggravated/Small Flair Up) had not resolved and VACCINATION SITE PAIN (Vaccination site pain/Achy after the moderna shot) outcome was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was provided. The reporter's causality for the event(s) of ACHY AFTER THE MODERNA SHOT with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of FLARE UP with HUMIRA(ADALIMUMAB) was a reasonable possibility. No treatment medication 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 03-Dec-2021: Live follow up, Medical history was updated. Reporter causality was updated. i-narrative supplement was updated.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pruritus
Clinical narrative: Vaccination site pruritus/covid-19 vaccines felt itchy after first one; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Vaccination site pruritus/covid-19 vaccines felt itchy after first one) 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 Rheumatoid arthritis.    There was no reported medical history.    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 VACCINATION SITE PRURITUS (Vaccination site pruritus/covid-19 vaccines felt itchy after first one). At the time of the report, VACCINATION SITE PRURITUS (Vaccination site pruritus/covid-19 vaccines felt itchy after first one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication details were provided. No treatment medication details were 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
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: COVID VACCINE CAUSED ARM TO HURT; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID VACCINE CAUSED ARM TO HURT) 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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-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 VACCINATION SITE PAIN (COVID VACCINE CAUSED ARM TO HURT). In 2021, VACCINATION SITE PAIN (COVID VACCINE CAUSED ARM TO HURT) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.