chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cold sweat, Dyspnoea, Fatigue, Feeling cold
Clinical narrative: Eyes didn't focus; headache; Extreme fatigue/ very tired/She stays in bed all the time; Achy; Extremely cold; burning up; Sweating; cold sweats; Short of breath; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Eyes didn't focus), VERTIGO (vertigo), FEELING COLD (Extremely cold), BURNING SENSATION (burning up) and HYPERHIDROSIS (Sweating) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme's disease and Fibromyalgia. Concurrent medical conditions included Blood pressure high. Concomitant products included CLONAZEPAM, LISINOPRIL and PAROXETINE for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced FEELING COLD (Extremely cold), BURNING SENSATION (burning up), HYPERHIDROSIS (Sweating), COLD SWEAT (cold sweats), HEADACHE (headache), FATIGUE (Extreme fatigue/ very tired/She stays in bed all the time) and MYALGIA (Achy). In June 2021, the patient experienced VERTIGO (vertigo) and DYSPNOEA (Short of breath). On an unknown date, the patient experienced VISION BLURRED (Eyes didn't focus). The patient was treated with CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) at a dose of 1 dosage form twice a day and VITAMINS NOS at an unspecified dose and frequency. On 21-Jun-2021, FEELING COLD (Extremely cold) and MYALGIA (Achy) had resolved. At the time of the report, VISION BLURRED (Eyes didn't focus) and VERTIGO (vertigo) outcome was unknown, BURNING SENSATION (burning up), HYPERHIDROSIS (Sweating) and COLD SWEAT (cold sweats) was resolving and DYSPNOEA (Short of breath), HEADACHE (headache) and FATIGUE (Extreme fatigue/ very tired/She stays in bed all the time) had not resolved.     The treatment information was patient doctor advised that take fruits and veggies and vitamins in her diet to remove the bad food   This case was linked to MOD-2021-251824 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received and Additional  event (illness) was added.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Vertigo, Vision blurred
Clinical narrative: Eyes didn't focus; headache; Extreme fatigue/ very tired/She stays in bed all the time; Achy; Extremely cold; burning up; Sweating; cold sweats; Short of breath; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Eyes didn't focus), VERTIGO (vertigo), FEELING COLD (Extremely cold), BURNING SENSATION (burning up) and HYPERHIDROSIS (Sweating) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme's disease and Fibromyalgia. Concurrent medical conditions included Blood pressure high. Concomitant products included CLONAZEPAM, LISINOPRIL and PAROXETINE for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced FEELING COLD (Extremely cold), BURNING SENSATION (burning up), HYPERHIDROSIS (Sweating), COLD SWEAT (cold sweats), HEADACHE (headache), FATIGUE (Extreme fatigue/ very tired/She stays in bed all the time) and MYALGIA (Achy). In June 2021, the patient experienced VERTIGO (vertigo) and DYSPNOEA (Short of breath). On an unknown date, the patient experienced VISION BLURRED (Eyes didn't focus). The patient was treated with CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) at a dose of 1 dosage form twice a day and VITAMINS NOS at an unspecified dose and frequency. On 21-Jun-2021, FEELING COLD (Extremely cold) and MYALGIA (Achy) had resolved. At the time of the report, VISION BLURRED (Eyes didn't focus) and VERTIGO (vertigo) outcome was unknown, BURNING SENSATION (burning up), HYPERHIDROSIS (Sweating) and COLD SWEAT (cold sweats) was resolving and DYSPNOEA (Short of breath), HEADACHE (headache) and FATIGUE (Extreme fatigue/ very tired/She stays in bed all the time) had not resolved.     The treatment information was patient doctor advised that take fruits and veggies and vitamins in her diet to remove the bad food   This case was linked to MOD-2021-251824 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received and Additional  event (illness) was added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: Hot arm as site injection 101 temperature; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Sore arm) and INJECTION SITE PAIN (Hot arm as site injection 101 temperature) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Ceftin), Anxiety and Cholesterol. Concomitant products included LORAZEPAM and CITALOPRAM for Anxiety, ATORVASTATIN for Cholesterol, TEMAZEPAM for Sleepy.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2021 at 7:00 AM, the patient experienced MYALGIA (Sore arm). On 31-Jan-2021 at 10:00 AM, the patient experienced INJECTION SITE PAIN (Hot arm as site injection 101 temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Jan-2021, MYALGIA (Sore arm) had resolved. On 01-Feb-2021, INJECTION SITE PAIN (Hot arm as site injection 101 temperature) had resolved. Not Provided          Concomitant medication includes Multivitamin adult 50+ daily. Patient was told take Tylenol and  cold compressors. And the temperature was gone and so the hotness by injection site. next day patient felt tired and relaxed.  Action taken with mRNA-1273 in response to the events were not applicable.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: take his second vaccine of moderna on may 3rd but he couldnt take it; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (take his second vaccine of moderna on may 3rd but he couldnt take it) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 PRODUCT DOSE OMISSION ISSUE (take his second vaccine of moderna on may 3rd but he couldnt take it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (take his second vaccine of moderna on may 3rd but he couldnt take it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: rash came back; fever after second dose; tiredness came back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash came back), PYREXIA (fever after second dose) and FATIGUE (tiredness came back) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Typically gets a rash with the flu shot - but small and goes away in two or three days). Past adverse reactions to the above products included Rash with Flu shot. Concurrent medical conditions included Arthritis, Drug allergy (Allergic to anti-inflammatory drug used for arthritis - Clinoril), Psoriatic arthritis, Psoriasis, Blood pressure and Thyroid disorder NOS. Concomitant products included BETAMETHASONE for Psoriasis, LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMINS NOS and FLUOCINONIDE for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced RASH (rash came back), PYREXIA (fever after second dose) and FATIGUE (tiredness came back). On 07-Mar-2021, RASH (rash came back), PYREXIA (fever after second dose) and FATIGUE (tiredness came back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient put ice on her rash.   This case was linked to MOD-2021-027848 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients received a Moderna COVID-19 vaccine came from 2 days expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received a Moderna COVID-19 vaccine came from 2 days expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received a Moderna COVID-19 vaccine came from 2 days expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received a Moderna COVID-19 vaccine came from 2 days expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  medications were provided. No Treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received on 31 Aug 2021,contains No New Information and event date updated from initial
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Myalgia, Mydriasis
Clinical narrative: not feeling well; weakness; tiredness; Achy; Dilation of eyes; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), ASTHENIA (weakness), MYDRIASIS (Dilation of eyes), FATIGUE (tiredness) and MYALGIA (Achy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced MYDRIASIS (Dilation of eyes). On 18-Jun-2021, the patient experienced ASTHENIA (weakness), FATIGUE (tiredness) and MYALGIA (Achy). On an unknown date, the patient experienced MALAISE (not feeling well). In June 2021, ASTHENIA (weakness), MYDRIASIS (Dilation of eyes), FATIGUE (tiredness) and MYALGIA (Achy) had resolved. At the time of the report, MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications include Thyroid medications. Treatment information was not provided.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: could not move in bed for a whole day; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not move in bed for a whole day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (could not move in bed for a whole day). At the time of the report, MOBILITY DECREASED (could not move in bed for a whole day) had resolved.            No relevant concomitant medication was reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Injection site pain
Clinical narrative: Blisters on Hand and fingers; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters on Hand and fingers) and INJECTION SITE PAIN (Sore injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 22-Apr-2021, the patient experienced BLISTER (Blisters on Hand and fingers) and INJECTION SITE PAIN (Sore injection site). At the time of the report, BLISTER (Blisters on Hand and fingers) and INJECTION SITE PAIN (Sore injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment medications were not reported.   This case was linked to MOD-2021-122486, MOD-2021-122486 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: serious reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (serious reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (serious reaction). At the time of the report, VACCINATION COMPLICATION (serious reaction) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Patient had a history of blood infection. No concomitant drugs were reported. No treatment information was reported.   This case was linked to MOD-2021-232889 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Issues with leg; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LIMB DISCOMFORT (Issues with leg) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced LIMB DISCOMFORT (Issues with leg). At the time of the report, LIMB DISCOMFORT (Issues with leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of two 325 milligram tablets. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chills) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 96.5 (normal) 96.5 degrees F, 101.5 (High) at 6 pm and 100 (High) Temperature regressed to 100 F; fever (>98.6).         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant medications was reported. Patient took one and only dose of Tylenol tablets of two 325 milligram at 6 pm. Patient had stated that she did not experienced any dermatological reaction with the second dose and also stated that she felt Upper and especially lower extremities like they weighed 50 pounds each.   This case was linked to MOD-2021-029240 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: tangling in arms and face; blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tangling in arms and face) and VISION BLURRED (blurry vision) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 2. On 24-Feb-2021, the patient experienced PARAESTHESIA (tangling in arms and face) and VISION BLURRED (blurry vision). At the time of the report, PARAESTHESIA (tangling in arms and face) and VISION BLURRED (blurry vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment was provided by the reporter. No concomitant medications was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: suffocated his chest, his chest would feel like really pressured, discomfort and annoying; a lot of pain; shortness of breath; This spontaneous case was reported by an other and describes the occurrence of CHEST DISCOMFORT (suffocated his chest, his chest would feel like really pressured, discomfort and annoying), CHEST PAIN (a lot of pain) and DYSPNOEA (shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced CHEST DISCOMFORT (suffocated his chest, his chest would feel like really pressured, discomfort and annoying), CHEST PAIN (a lot of pain) and DYSPNOEA (shortness of breath). At the time of the report, CHEST DISCOMFORT (suffocated his chest, his chest would feel like really pressured, discomfort and annoying), CHEST PAIN (a lot of pain) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder
Clinical narrative: Deathly Ill; This spontaneous case was reported by a consumer and describes the occurrence of ILL-DEFINED DISORDER (Deathly Ill) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication.    No Medical History information was reported.   On 06-Jan-2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced ILL-DEFINED DISORDER (Deathly Ill). At the time of the report, ILL-DEFINED DISORDER (Deathly Ill) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Granuloma, Papule
Clinical narrative: Granuloma; Two rim circle bumps on my chin and one underneath my eye; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA (Granuloma) and PAPULE (Two rim circle bumps on my chin and one underneath my eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HYALURONIC ACID (RESTYLANE) for an unknown indication.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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 HYALURONIC ACID (RESTYLANE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced GRANULOMA (Granuloma) and PAPULE (Two rim circle bumps on my chin and one underneath my eye). At the time of the report, GRANULOMA (Granuloma) and PAPULE (Two rim circle bumps on my chin and one underneath my eye) outcome was unknown.            No concomitant medication reported. No treatment medication or therapy reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Intentional product misuse, Pyrexia
Clinical narrative: DID NOT FEEL RIGHT; PATIENT WAS OFF HUMIRA FOR TWO MONTHS; SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS; SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (DID NOT FEEL RIGHT), INTENTIONAL PRODUCT MISUSE (PATIENT WAS OFF HUMIRA FOR TWO MONTHS), CHILLS (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) and PYREXIA (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Herpes zoster immunization: Shingles Vaccine (Side effects were fever and chills). Past adverse reactions to the above products included Fever with Shingles Vaccine. Concomitant products included ADALIMUMAB (HUMIRA) for Plaque psoriasis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (DID NOT FEEL RIGHT), INTENTIONAL PRODUCT MISUSE (PATIENT WAS OFF HUMIRA FOR TWO MONTHS), CHILLS (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) and PYREXIA (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS). At the time of the report, FEELING ABNORMAL (DID NOT FEEL RIGHT), CHILLS (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) and PYREXIA (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) outcome was unknown and INTENTIONAL PRODUCT MISUSE (PATIENT WAS OFF HUMIRA FOR TWO MONTHS) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported stopping Humira (ADALIMUMAB) for two months because she received the Shingles Vaccine but it was not reported if she stopped Humira before or after receiving the shingles vaccine.  No treatment information was provided by the reporter.  RA Report: 21K-163-3972737-00
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with ADALIMUMAB (HUMIRA) (subcutaneous) on 01-Apr-2021 at a dose of 40 mg once a day. At the time of the report, HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: Plaque psoriasis; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (Plaque psoriasis) in a 66-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) injection for Plaque psoriasis.    No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis). At the time of the report, PSORIASIS (Plaque psoriasis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No treatment information provided. Concomitant drugs are not reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: COVID-19 antibody test negative; This spontaneous case was reported by an other and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 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 SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided by the reporter.  Concomitant medications were not reported by the reporter.  Medical history were not provided by the reporter.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine after allowed expiry at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine after allowed expiry at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.  It was reported that four doses of the Moderna vaccine were given to three patients after being at room temperature for 12 hours. The vials were removed from the fridge at approximately 08:30 on 07-JUL-2021 and administered at 13:00 on 08-JUL-2021.  Treatment information, if any, was not provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine after allowed expiry at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications was reported.  Treatment information was not provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort
Clinical narrative: Left arm felt limp; She felt tired all over; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left arm felt limp) and FATIGUE (She felt tired all over) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Left arm felt limp) and FATIGUE (She felt tired all over). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Left arm felt limp) and FATIGUE (She felt tired all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that within 24 hours her left arm felt limp and she felt tired all over.  No relevant concomitant medications were reported   This case was linked to MOD-2021-252756 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Formication, Paraesthesia, Tachycardia, Urticaria
Clinical narrative: Hives; Tachycardia; Felt needle pricking stuff; Felt like her skin was crawling on back, chest and neck; Arthritis in both hands; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), TACHYCARDIA (Tachycardia), PARAESTHESIA (Felt needle pricking stuff), FORMICATION (Felt like her skin was crawling on back, chest and neck) and ARTHRITIS (Arthritis in both hands) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-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 experienced URTICARIA (Hives), TACHYCARDIA (Tachycardia), PARAESTHESIA (Felt needle pricking stuff), FORMICATION (Felt like her skin was crawling on back, chest and neck) and ARTHRITIS (Arthritis in both hands). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives), TACHYCARDIA (Tachycardia), PARAESTHESIA (Felt needle pricking stuff), FORMICATION (Felt like her skin was crawling on back, chest and neck) and ARTHRITIS (Arthritis in both hands) outcome was unknown.            Concomitant medication information  was not provided  by the reporter.  The treatment history was not provided.   This case was linked to MOD-2021-252746 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose less than 25 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days apart) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days apart) outcome 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.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: Problem with the thyroids after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THYROID DISORDER (Problem with the thyroids after receiving the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 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. On an unknown date, the patient experienced THYROID DISORDER (Problem with the thyroids after receiving the vaccine). At the time of the report, THYROID DISORDER (Problem with the thyroids after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up received and contains No new Information.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swollen tongue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced SWOLLEN TONGUE (Swollen tongue). At the time of the report, SWOLLEN TONGUE (Swollen tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  No relevant Lab Data was provided.  No relevant medical history was provided.   This case was linked to MOD-2021-252824 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Swelling face
Clinical narrative: Face is swollen; Voice is scratchy; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen), DYSPHONIA (Voice is scratchy) and DIZZINESS (Dizzy) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face is swollen), DYSPHONIA (Voice is scratchy) and DIZZINESS (Dizzy). At the time of the report, SWELLING FACE (Face is swollen), DYSPHONIA (Voice is scratchy) and DIZZINESS (Dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lip swelling, Pyrexia, Swollen tongue
Clinical narrative: Swollen tongue; Swollen lip like an allergic reaction; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip like an allergic reaction), CHILLS (Chills) and PYREXIA (Fever) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip like an allergic reaction), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip like an allergic reaction), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            Concomitant medications were not provided.   Treatment information was not provided.   This case was linked to MOD-2021-252814 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: pain; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, the patient experienced PAIN (pain) and FATIGUE (fatigue). At the time of the report, PAIN (pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Untoward effects from COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (Untoward effects from COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Untoward effects from COVID). At the time of the report, ADVERSE EVENT (Untoward effects from COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. No relevant Lab Data was provided.   This case was linked to MOD-2021-250591 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (her husband was also sick after receiving Moderna vaccine) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced vaccination complication (her husband was also sick after receiving Moderna vaccine). At the time of the report, vaccination complication (her husband was also sick after receiving Moderna vaccine) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.