chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Asthenia, Eating disorder, Hypersomnia, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for two days Straight), EATING DISORDER (not able to eat), ILLNESS (sick for five days), ASTHENIA (no energy) and ADVERSE REACTION (bad reaction "worse than covid") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia on 08-Jan-2021.Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and PROTRIPTYLINE HCL for an unknown indication. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HYPERSOMNIA (Slept for two days Straight), ILLNESS (sick for five days), ASTHENIA (no energy), ADVERSE REACTION (bad reaction "worse than covid"), VACCINATION SITE PAIN (Arm pain) and VOMITING (vomiting ten times). On an unknown date, the patient experienced EATING DISORDER (not able to eat). At the time of the report, HYPERSOMNIA (Slept for two days Straight), EATING DISORDER (not able to eat), ILLNESS (sick for five days), ASTHENIA (no energy), ADVERSE REACTION (bad reaction "worse than covid"), VACCINATION SITE PAIN (Arm pain) and VOMITING (vomiting ten times) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-JUN-2021 contains concomitant medication details. On 22-Jun-2021: Follow up received on 22-JUN-2021 contains No New Information
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for two days Straight), EATING DISORDER (not able to eat), ILLNESS (sick for five days), ASTHENIA (no energy) and ADVERSE REACTION (bad reaction "worse than covid") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia on 08-Jan-2021.Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and PROTRIPTYLINE HCL for an unknown indication. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HYPERSOMNIA (Slept for two days Straight), ILLNESS (sick for five days), ASTHENIA (no energy), ADVERSE REACTION (bad reaction "worse than covid"), VACCINATION SITE PAIN (Arm pain) and VOMITING (vomiting ten times). On an unknown date, the patient experienced EATING DISORDER (not able to eat). At the time of the report, HYPERSOMNIA (Slept for two days Straight), EATING DISORDER (not able to eat), ILLNESS (sick for five days), ASTHENIA (no energy), ADVERSE REACTION (bad reaction "worse than covid"), VACCINATION SITE PAIN (Arm pain) and VOMITING (vomiting ten times) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-JUN-2021 contains concomitant medication details. On 22-Jun-2021: Follow up received on 22-JUN-2021 contains No New Information
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (half tablet) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.No medical history provided by the reporter. Concomitant products included LISINOPRIL, HYDROCODONE, SIMVASTATIN and CYCLOBENZAPRINE for an unknown indication.On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (half tablet). On 06-Jan-2021, PAIN IN EXTREMITY (half tablet) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient  had little soreness of arm.  This case was linked to US-MODERNATX, INC.-MOD-2021-128874 (E2B Linked Report). This case was linked to MOD-2021-128884 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128874:wife 1 st dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Product dose omission issue
Clinical narrative: not received second dose; Felt a little tired; Felt a little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not received second dose), FATIGUE (Felt a little tired) and MYALGIA (Felt a little soreness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (Felt a little tired) and MYALGIA (Felt a little soreness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not received second dose), FATIGUE (Felt a little tired) and MYALGIA (Felt a little soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received Moderna covid 19 vaccine, but has not received second dose. The patient reported felt a little tired and a little sore after receiving first injection.   No concomitant medications and treatment were provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: My Legs became weak; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (My Legs became weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASENAPINE MALEATE (SAPHRIS), ZOLPIDEM TARTRATE (AMBIEN), CARBAMAZEPINE (TEGRETOL), DISULFIRAM (ANTABUSE), VALBENAZINE TOSILATE (INGREZZA), TRAZODONE, CHLORPROMAZINE (THORAZINE [CHLORPROMAZINE]), CLONAZEPAM (KLONOPIN) and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.   On 25-Feb-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) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (My Legs became weak). At the time of the report, MUSCULAR WEAKNESS (My Legs became weak) outcome was unknown.              Treatment medication was not reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Ache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache) and FATIGUE (Tiredness) in a 63-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Ache) and FATIGUE (Tiredness). The patient was treated with ADALIMUMAB (HUMIRA) (subcutaneous) for Rheumatoid arthritis, at an unspecified dose and frequency. At the time of the report, PAIN (Ache) and FATIGUE (Tiredness) outcome was unknown.            Labs data included were: Pain Scale Test - Results not provided.  Concomitant product use was not provided by the reporter.    Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dizziness postural, Pruritus, Rash erythematous
Clinical narrative: feeling little dizzy when she stand up fast; felt dizzy and couldn't even stand and could fall; itching in her left arm few days after the 2nd dose; Little red rash in her left arm after the 2nd dose; Little chilling after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (feeling little dizzy when she stand up fast), RASH ERYTHEMATOUS (Little red rash in her left arm after the 2nd dose), DIZZINESS (felt dizzy and couldn't even stand and could fall), PRURITUS (itching in her left arm few days after the 2nd dose) and CHILLS (Little chilling after the 2nd dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025J20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, CLOPIDOGREL, OMEPRAZOLE, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and ATORVASTATIN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced CHILLS (Little chilling after the 2nd dose). On 05-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Little red rash in her left arm after the 2nd dose) and PRURITUS (itching in her left arm few days after the 2nd dose). On 10-May-2021, the patient experienced DIZZINESS (felt dizzy and couldn't even stand and could fall). On 13-May-2021, the patient experienced DIZZINESS POSTURAL (feeling little dizzy when she stand up fast). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 02-Feb-2021, CHILLS (Little chilling after the 2nd dose) had resolved. On 06-Feb-2021, RASH ERYTHEMATOUS (Little red rash in her left arm after the 2nd dose) and PRURITUS (itching in her left arm few days after the 2nd dose) had resolved. On 12-May-2021, DIZZINESS (felt dizzy and couldn't even stand and could fall) had resolved. At the time of the report, DIZZINESS POSTURAL (feeling little dizzy when she stand up fast) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Eye pain, Headache, Neck pain
Clinical narrative: neck pain; pain in eyebrows and around the eyes; backache; everyday has a different part of pain; shoulder pain; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), EYE PAIN (pain in eyebrows and around the eyes), BACK PAIN (backache), PAIN (everyday has a different part of pain) and ARTHRALGIA (shoulder pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (neck pain), EYE PAIN (pain in eyebrows and around the eyes), BACK PAIN (backache), PAIN (everyday has a different part of pain), ARTHRALGIA (shoulder pain) and HEADACHE (severe headache). At the time of the report, NECK PAIN (neck pain), EYE PAIN (pain in eyebrows and around the eyes), BACK PAIN (backache), PAIN (everyday has a different part of pain), ARTHRALGIA (shoulder pain) and HEADACHE (severe headache) outcome was unknown.            No concomitant medications were provided.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: neck pain; pain in eyebrows and around the eyes; backache; everyday has a different part of pain; shoulder pain; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), EYE PAIN (pain in eyebrows and around the eyes), BACK PAIN (backache), PAIN (everyday has a different part of pain) and ARTHRALGIA (shoulder pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (neck pain), EYE PAIN (pain in eyebrows and around the eyes), BACK PAIN (backache), PAIN (everyday has a different part of pain), ARTHRALGIA (shoulder pain) and HEADACHE (severe headache). At the time of the report, NECK PAIN (neck pain), EYE PAIN (pain in eyebrows and around the eyes), BACK PAIN (backache), PAIN (everyday has a different part of pain), ARTHRALGIA (shoulder pain) and HEADACHE (severe headache) outcome was unknown.            No concomitant medications were provided.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Two patients received vaccine that had been punctured 24 hours ago; 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 (Two patients received vaccine that had been punctured 24 hours ago) 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 EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine that had been punctured 24 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine that had been punctured 24 hours ago) 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 relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received a vaccine from a vial punctured 30 hours prior to administration) in a patient, of an unknown age and gender, 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 May 13, 2021, patient administered expired product (patient received a vaccine from a vial punctured 30 hours prior to administration). At the time of the report, administered expired product (patient received a vaccine from a vial punctured 30 hours prior to administration) resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Myalgia, Nausea
Clinical narrative: Fatigue; Nausea; Mild body aches; Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), FATIGUE (Fatigue), NAUSEA (Nausea) and MYALGIA (Mild body aches) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Sep-2021. On 15-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On an unknown date, the patient experienced FATIGUE (Fatigue), NAUSEA (Nausea) and MYALGIA (Mild body aches). On 12-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. At the time of the report, FATIGUE (Fatigue), NAUSEA (Nausea) and MYALGIA (Mild body aches) outcome was unknown.            Treatment medications were not reported.  Concomitant medications were not reported.  Patient mentioned her fetus was healthy at the reporting time.   This case was linked to MOD-2021-073888 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: INFLAMMATION IN JOINTS; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (INFLAMMATION IN JOINTS) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis and Crohn's disease.    No medical history was provided by the reporter.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In April 2021, the patient experienced ARTHRALGIA (INFLAMMATION IN JOINTS). At the time of the report, ARTHRALGIA (INFLAMMATION IN JOINTS) 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 relevant concomitant medications were provided.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeding disorder, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Enability to eat), PYREXIA (High Fever), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 041L20A) for COVID-19 vaccination. The patient's past medical history included Parvovirus B19 infection, Back surgery and Immunoglobulin therapy (IG treatment) since an unknown date. Concurrent medical conditions included Allergy, Sinusitis NOS, Mastocytosis (Mast cell disease), Hives, Back pain, Nerve pain, Allergy to antibiotic (Levaquin and Ceclor) and Drug allergy (Paxil). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Allergy, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Back pain, DOXEPIN for Hives, GABAPENTIN for Nerve pain. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced FEEDING DISORDER (Enability to eat), PYREXIA (High Fever), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain). On 10-Mar-2021, FEEDING DISORDER (Enability to eat), PYREXIA (High Fever), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain) had resolved.No treatment medication details were provided. This case was linked to MOD-2021-029464 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach pain; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) in an 18-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: shot caused a sort of knot under the skin; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (shot caused a sort of knot under the skin) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sensitivity to sulfa drugs.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and GABAPENTIN for an unknown indication.    On 31-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 VACCINATION SITE MASS (shot caused a sort of knot under the skin). At the time of the report, VACCINATION SITE MASS (shot caused a sort of knot under the skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-129427 (Patient Link).
Sex: U
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal
Clinical narrative: After Moderna Vaccine did not get any noticeable reaction, just attributed feeling like crap to always feeling this way related to Crohn's Disease; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (After Moderna Vaccine did not get any noticeable reaction, just attributed feeling like crap to always feeling this way related to Crohn's Disease) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohns disease aggravated.    No medical history was provided by the reporter.    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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (After Moderna Vaccine did not get any noticeable reaction, just attributed feeling like crap to always feeling this way related to Crohn's Disease). At the time of the report, FEELING ABNORMAL (After Moderna Vaccine did not get any noticeable reaction, just attributed feeling like crap to always feeling this way related to Crohn's Disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.; Sender's Comments: Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of AFTER MODERNA VACCINE DID NOT GET ANY NOTICEABLE REACTIONS, JUST  ATTRIBUTED FEELING LIKE CRAP TO ALWAYS FEELING THIS WAY RELATED TO CROHN'S was not provided
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick; very sick; This spontaneous case was reported by a physician and describes the occurrence of the first episode of ILLNESS (very sick) and the second episode of ILLNESS (very sick) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced the first episode of ILLNESS (very sick) and the second episode of ILLNESS (very sick). At the time of the report, last episode of ILLNESS (very sick) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient was very sick after both the shots, however did not seek medical help. He recovered within a day both times. No information regarding corrective treatment was reported by the patient.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hypoaesthesia
Clinical narrative: Numbness of the arms and went towards her shoulder and to her back/ symptoms have gotten better around the back, chest, and arm but still quite bad; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of the arms and went towards her shoulder and to her back/ symptoms have gotten better around the back, chest, and arm but still quite bad) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Knee operation. Concurrent medical conditions included Allergy to antibiotic (sulfa drug). Concomitant products included GABAPENTIN for Nerve damage, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, unspecified, IBUPROFEN for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness of the arms and went towards her shoulder and to her back/ symptoms have gotten better around the back, chest, and arm but still quite bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness of the arms and went towards her shoulder and to her back/ symptoms have gotten better around the back, chest, and arm but still quite bad) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-129237 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Contusion, Pain, Swelling
Clinical narrative: sore; swelling; marks on leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), SWELLING (swelling) and CONTUSION (marks on leg) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PREGABALIN (LYRICA) for an unknown indication.    Concurrent medical conditions included Thrombosis leg (Blood clots in legs) since July 2020.   In July 2020, the patient started PREGABALIN (LYRICA) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (sore), SWELLING (swelling) and CONTUSION (marks on leg). At the time of the report, PAIN (sore), SWELLING (swelling) and CONTUSION (marks on leg) outcome was unknown.            Treatment information not reported.  No concomitant medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Pain in extremity, Somnolence
Clinical narrative: Pain that went down my leg to my foot, feeling it going down my thighs and knees; Pain started with one side of the hip then both; Tired; Sleepy; I have lack of appetite; lost 17 pounds; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain started with one side of the hip then both), FATIGUE (Tired), SOMNOLENCE (Sleepy) and DECREASED APPETITE (I have lack of appetite) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain started with one side of the hip then both), FATIGUE (Tired), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite) and WEIGHT DECREASED (lost 17 pounds). At the time of the report, PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain started with one side of the hip then both), FATIGUE (Tired), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite) and WEIGHT DECREASED (lost 17 pounds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Pain that went down my leg to my foot, feeling it going down my thighs and knees; Pain started with one side of the hip then both; Tired; Sleepy; I have lack of appetite; lost 17 pounds; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain started with one side of the hip then both), FATIGUE (Tired), SOMNOLENCE (Sleepy) and DECREASED APPETITE (I have lack of appetite) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain started with one side of the hip then both), FATIGUE (Tired), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite) and WEIGHT DECREASED (lost 17 pounds). At the time of the report, PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain started with one side of the hip then both), FATIGUE (Tired), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite) and WEIGHT DECREASED (lost 17 pounds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.            No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-029852 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up document not received . No new information provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: generalized aching; pain in arm; fever; This spontaneous case was reported by an other and describes the occurrence of PAIN (generalized aching), PAIN IN EXTREMITY (pain in arm) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (generalized aching), PAIN IN EXTREMITY (pain in arm) and PYREXIA (fever). At the time of the report, PAIN (generalized aching), PAIN IN EXTREMITY (pain in arm) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100.4 (High) fever of 100.4 for about 24 hours and 99 (High) few days later had a fever of 99.         Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Generalized aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04GA21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Tobacco user (six to seven sticks per day), Abstains from alcohol, Diabetes and Hypercholesterolemia. Concomitant products included METHOTREXATE, METFORMIN, ATORVASTATIN, BENAZEPRIL and RISPERIDONE (RISPERDAL) for an unknown indication.   In 2011, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 28-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 PAIN (Generalized aching). At the time of the report, PAIN (Generalized aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-129574 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Influenza like illness, Somnolence
Clinical narrative: drowsiness; flu like symptoms; confusion; This spontaneous case was reported by an other and describes the occurrence of SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    No Medical History information was reported.   On 28-Apr-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 50 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion). At the time of the report, SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Generalized aching; Joint ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching) and ARTHRALGIA (Joint ache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 04GA21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Tobacco user (TOBACCO USE: SIX TO SEVEN STICKS PER DAY), Abstains from alcohol, Diabetes and Hypercholesterolemia. Concomitant products included METFORMIN, ATORVASTATIN, BENAZEPRIL, RISPERIDONE (RISPERDAL) and METHOTREXATE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40mg/0.4ml. On 17-Apr-2021, the patient experienced PAIN (Generalized aching) and ARTHRALGIA (Joint ache). At the time of the report, PAIN (Generalized aching) outcome was unknown and ARTHRALGIA (Joint ache) was resolving.            No treatment information was provided.    This case was linked to MOD-2021-129496 (Patient Link).   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Limb injury
Clinical narrative: Shortness of breath; Skin pain; Calf pain; Itchy skin; Chills; Headache; Fever; LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN; Arm injury; Sexual problem; Open wound; Sweating; This spontaneous case was reported by a physician and describes the occurrence of SKIN LESION (LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN), LIMB INJURY (Arm injury), SEXUAL DYSFUNCTION (Sexual problem), WOUND (Open wound) and HYPERHIDROSIS (Sweating) in a 40-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) solution for Hidradenitis suppurativa.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (unknown route) 80 milligram. In April 2021, the patient experienced SKIN LESION (LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN), LIMB INJURY (Arm injury), SEXUAL DYSFUNCTION (Sexual problem), WOUND (Open wound), HYPERHIDROSIS (Sweating), PAIN OF SKIN (Skin pain), PAIN IN EXTREMITY (Calf pain), PRURITUS (Itchy skin), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, SKIN LESION (LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN), LIMB INJURY (Arm injury) and WOUND (Open wound) had not resolved and SEXUAL DYSFUNCTION (Sexual problem), HYPERHIDROSIS (Sweating), DYSPNOEA (Shortness of breath), PAIN OF SKIN (Skin pain), PAIN IN EXTREMITY (Calf pain), PRURITUS (Itchy skin), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) 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.   Medical history included lesion under right arm that was scratched open (started March 2021) No concomitant product use was reported No treatment information was provided   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin, Pruritus, Pyrexia, Sexual dysfunction
Clinical narrative: Shortness of breath; Skin pain; Calf pain; Itchy skin; Chills; Headache; Fever; LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN; Arm injury; Sexual problem; Open wound; Sweating; This spontaneous case was reported by a physician and describes the occurrence of SKIN LESION (LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN), LIMB INJURY (Arm injury), SEXUAL DYSFUNCTION (Sexual problem), WOUND (Open wound) and HYPERHIDROSIS (Sweating) in a 40-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) solution for Hidradenitis suppurativa.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (unknown route) 80 milligram. In April 2021, the patient experienced SKIN LESION (LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN), LIMB INJURY (Arm injury), SEXUAL DYSFUNCTION (Sexual problem), WOUND (Open wound), HYPERHIDROSIS (Sweating), PAIN OF SKIN (Skin pain), PAIN IN EXTREMITY (Calf pain), PRURITUS (Itchy skin), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, SKIN LESION (LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN), LIMB INJURY (Arm injury) and WOUND (Open wound) had not resolved and SEXUAL DYSFUNCTION (Sexual problem), HYPERHIDROSIS (Sweating), DYSPNOEA (Shortness of breath), PAIN OF SKIN (Skin pain), PAIN IN EXTREMITY (Calf pain), PRURITUS (Itchy skin), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) 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.   Medical history included lesion under right arm that was scratched open (started March 2021) No concomitant product use was reported No treatment information was provided   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Wound
Clinical narrative: Shortness of breath; Skin pain; Calf pain; Itchy skin; Chills; Headache; Fever; LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN; Arm injury; Sexual problem; Open wound; Sweating; This spontaneous case was reported by a physician and describes the occurrence of SKIN LESION (LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN), LIMB INJURY (Arm injury), SEXUAL DYSFUNCTION (Sexual problem), WOUND (Open wound) and HYPERHIDROSIS (Sweating) in a 40-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) solution for Hidradenitis suppurativa.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (unknown route) 80 milligram. In April 2021, the patient experienced SKIN LESION (LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN), LIMB INJURY (Arm injury), SEXUAL DYSFUNCTION (Sexual problem), WOUND (Open wound), HYPERHIDROSIS (Sweating), PAIN OF SKIN (Skin pain), PAIN IN EXTREMITY (Calf pain), PRURITUS (Itchy skin), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, SKIN LESION (LESION UNDER RIGHT ARM THAT WAS SCRATCHED OPEN), LIMB INJURY (Arm injury) and WOUND (Open wound) had not resolved and SEXUAL DYSFUNCTION (Sexual problem), HYPERHIDROSIS (Sweating), DYSPNOEA (Shortness of breath), PAIN OF SKIN (Skin pain), PAIN IN EXTREMITY (Calf pain), PRURITUS (Itchy skin), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) 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.   Medical history included lesion under right arm that was scratched open (started March 2021) No concomitant product use was reported No treatment information was provided   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Limb discomfort, Nausea, Pyrexia
Clinical narrative: Arm was sore; Headache; Nausea; Fever; Felt like she had been hit by truck 24 hours later.; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Felt like she had been hit by truck 24 hours later.), LIMB DISCOMFORT (Arm was sore), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis, ADALIMUMAB (HUMIRA) for an unknown indication.   On 13-Apr-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) 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like she had been hit by truck 24 hours later.). On an unknown date, the patient experienced LIMB DISCOMFORT (Arm was sore), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Felt like she had been hit by truck 24 hours later.) outcome was unknown and LIMB DISCOMFORT (Arm was sore), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided.   Reporter did not allow further contact