chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old received vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 31-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 31-May-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided.  This patient has not reported any symptoms. No additional doses, medications, or treatments have been administered at this time.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In February 2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.    Concomitant medication of the patient was not reported.  Formulation of Humira (adalimumab) was reported as solution for injection in pre-filled pen.  On 11-Nov-2021, the patient received the booster dose (1 in 1 once) of Moderna COVID-19 vaccine via intramuscular route. It was unknown if the patient was enrolled in COVID-19 Vaccine trial. No treatment information was provided by the reporter. Causality for Humira (adalimumab): The reporter's causality for the event(s) of headache was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: When I itch those areas my skin welts/welting of my skin with the lest amount of itching or external pressure that's applied; sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation; sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation), PRURITUS (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation) and URTICARIA (When I itch those areas my skin welts/welting of my skin with the lest amount of itching or external pressure that's applied) 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.   In October 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. In January 2022, the patient experienced BURNING SENSATION (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation) and PRURITUS (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation). On an unknown date, the patient experienced URTICARIA (When I itch those areas my skin welts/welting of my skin with the lest amount of itching or external pressure that's applied). In April 2022, BURNING SENSATION (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation) and PRURITUS (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation) had resolved. At the time of the report, URTICARIA (When I itch those areas my skin welts/welting of my skin with the lest amount of itching or external pressure that's applied) had not resolved.            Concomitant medications was not provided by the reporter.  Patient received two doses of the Moderna vaccine. Patient delaying getting the booster because after patient received second dose in October 2021. About approximately three months later patient started having a sudden reaction of itching or burning sensation to different parts of  the body. When itched those areas had skin welts.   April 2022 was the last time patient  experienced the itching and burning sensation, however patient still experiencing a welting of skin with the lest amount of itching or external pressure that was applied.  Patient was very concerned about getting the booster shot because of side effects.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine to patient but it turned out that they were not stored within CDC guidelines; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine to patient but it turned out that they were not stored within CDC guidelines) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine to patient but it turned out that they were not stored within CDC guidelines). At the time of the report, PRODUCT STORAGE ERROR (Vaccine to patient but it turned out that they were not stored within CDC guidelines) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that, one dose was Moderna vaccine were gave to patient but it turned out that they were not stored within the CDC guidelines reporter stated need to double check.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Myalgia, SARS-CoV-2 test
Clinical narrative: Aches and pain in muscle; Aches and pain in Joint; Received the 1st booster less than 5 months after receiving the 3rd primary dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pain in muscle), ARTHRALGIA (Aches and pain in Joint) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st booster less than 5 months after receiving the 3rd primary dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 004M21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st booster less than 5 months after receiving the 3rd primary dose). On 26-May-2022, the patient experienced MYALGIA (Aches and pain in muscle) and ARTHRALGIA (Aches and pain in Joint). The patient was treated with TRAMADOL at an unspecified dose and frequency. At the time of the report, MYALGIA (Aches and pain in muscle) and ARTHRALGIA (Aches and pain in Joint) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st booster less than 5 months after receiving the 3rd primary dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) tested positive for Covid 19.         On 25-May-2022, patient received first booster of Moderna COVID-19 Vaccine.   This case was linked to MOD-2022-580242 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Headache, Magnetic resonance imaging heart, Pyrexia
Clinical narrative: mild side effects of low grade fever to first Moderna Covid-19 vaccine; headache; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (mild side effects of low grade fever to first Moderna Covid-19 vaccine) and HEADACHE (headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no history of myocarditis/pericarditis and was not diagnosed with myocarditis/pericarditis.  Concurrent medical conditions included Dysautonomia since May 2000, Postural orthostatic tachycardia syndrome (diagnosed in summer of 2021) since May 2000 and Epstein-Barr virus infection (happened years before she received her Moderna COVID-19 vaccine). Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PYREXIA (mild side effects of low grade fever to first Moderna Covid-19 vaccine) and HEADACHE (headache). At the time of the report, PYREXIA (mild side effects of low grade fever to first Moderna Covid-19 vaccine) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Computerised tomogram: results not reported Results not reported. On an unknown date, Magnetic resonance imaging heart: results not reported Results not reported. On an unknown date, Tilt table test: results not reported Results not reported.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications included Beta Blocker and Anti Inflammatory medication. The patient went to the long Covid-19 vaccine clinic in the summer of 2021 because of her history of fainting spells, tachycardia, GI symptoms, nausea, diarrhea, feeling of burning in her body which were first experienced by patient in May 2000. The Doctors were theorizing that the patient has autonomic nerve system damage/ due to Epstein Barre Syndrome and then this evolved into the Dysautonomia and Potts Syndrome. Beta Blocker was taken for Postural Orthostatic Tachycardic syndrome  Patient took the first dose in April or May 2021 and second dose in May or June 2021. No Treatment medication was reported   This case was linked to MOD-2022-580238, MOD-2022-580214 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tilt table test
Clinical narrative: mild side effects of low grade fever to first Moderna Covid-19 vaccine; headache; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (mild side effects of low grade fever to first Moderna Covid-19 vaccine) and HEADACHE (headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no history of myocarditis/pericarditis and was not diagnosed with myocarditis/pericarditis.  Concurrent medical conditions included Dysautonomia since May 2000, Postural orthostatic tachycardia syndrome (diagnosed in summer of 2021) since May 2000 and Epstein-Barr virus infection (happened years before she received her Moderna COVID-19 vaccine). Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PYREXIA (mild side effects of low grade fever to first Moderna Covid-19 vaccine) and HEADACHE (headache). At the time of the report, PYREXIA (mild side effects of low grade fever to first Moderna Covid-19 vaccine) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Computerised tomogram: results not reported Results not reported. On an unknown date, Magnetic resonance imaging heart: results not reported Results not reported. On an unknown date, Tilt table test: results not reported Results not reported.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications included Beta Blocker and Anti Inflammatory medication. The patient went to the long Covid-19 vaccine clinic in the summer of 2021 because of her history of fainting spells, tachycardia, GI symptoms, nausea, diarrhea, feeling of burning in her body which were first experienced by patient in May 2000. The Doctors were theorizing that the patient has autonomic nerve system damage/ due to Epstein Barre Syndrome and then this evolved into the Dysautonomia and Potts Syndrome. Beta Blocker was taken for Postural Orthostatic Tachycardic syndrome  Patient took the first dose in April or May 2021 and second dose in May or June 2021. No Treatment medication was reported   This case was linked to MOD-2022-580238, MOD-2022-580214 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease) and Ulcerative colitis (Moderate to severe ulcerative colitis).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown whether patient was enrolled in clinical trial  Co-suspect Humira solution for injection in prefilled pen was taken on an unknown date.  No concomitant medication was reported by reporter.  On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  No treatment medication was reported by reporter.  Causality for the co-suspect Humira was not related.   This case was linked to MOD-2022-580239 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took dose 1 on 31-Mar-2021 and dose 2 on 10-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took dose 1 on 31-Mar-2021 and dose 2 on 10-Apr-2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food intolerance NOS (Have food in tolerants. Reaction: allergy).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took dose 1 on 31-Mar-2021 and dose 2 on 10-Apr-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took dose 1 on 31-Mar-2021 and dose 2 on 10-Apr-2021) outcome was unknown.            The patient was not taking any other medications within 2 weeks of COVID-19 treatment. No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-580228 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Immunisation reaction, Magnetic resonance imaging heart, Tilt table test
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (mild side effects after her second dose of the Moderna Covid-19 vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Postural orthostatic tachycardia syndrome (evolved from Dysautonomia in the Summer of 2021.) since 2021, Epstein-Barr virus infection (happened years before she received her Moderna Covid-19 vaccine) and Dysautonomia. Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (mild side effects after her second dose of the Moderna Covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (mild side effects after her second dose of the Moderna Covid-19 vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Computerized tomogram: results not reported Results not reported. On an unknown date, Magnetic resonance imaging heart: results not reported Results not reported. On an unknown date, Tilt table test: results not reported Results not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were reported as Beta Blocker and Anti Inflammatory.   Patient had a symptoms like fainting spells, tachycardia, GI symptoms, nausea, diarrhea, feeling of burning in her body in May 2000 . The patient went to long Covid-19 vaccine clinic in the summer of 2021.The symptoms were diagnosed as autonomic nerve system damage/ due to Epstein Barre Syndrome. and then into the Dysautonomia and Potts Syndrome.    Patient received second dose of the Moderna Covid-19 vaccine in May or June of 2021 and was not sure about the lot number, expiration date and also the arm where vaccination was administered.  No treatment medication was reported.   This case was linked to MOD-2022-580233, MOD-2022-580214 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose of vaccine received on 10-FEB-2021 and second on 20-MAR-2021, 38 days apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine received on 10-FEB-2021 and second on 20-MAR-2021, 38 days apart) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis (Moderate to severe ulcerative colitis) and Crohn's disease (Moderate to severe adult Crohn's disease).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine received on 10-FEB-2021 and second on 20-MAR-2021, 38 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine received on 10-FEB-2021 and second on 20-MAR-2021, 38 days apart) outcome was unknown.            No concomitant medication was reported by reporter.  On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. It was unknown if the patient was enrolled in COVID-19 vaccine trial.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-580234 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Inappropriate schedule of product administration, Pain in extremity, Peripheral swelling
Clinical narrative: Finger swollen all time; Finger swollen all time and hurts/finger stays swollen all the time and hurts, some redness and swelling not lot of pain; Finger swollen all time and hurts/redness; Patient received second dose on 10-Feb-2021 and first booster on 30-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Finger swollen all time), PAIN IN EXTREMITY (Finger swollen all time and hurts/finger stays swollen all the time and hurts, some redness and swelling not lot of pain), ERYTHEMA (Finger swollen all time and hurts/redness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 10-Feb-2021 and first booster on 30-Mar-2021) in an 80-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.    The patient's past medical history included Swelling of fingers and Localized erythema. Concurrent medical conditions included Arthritis rheumatoid.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 10-Feb-2021 and first booster on 30-Mar-2021). On an unknown date, the patient experienced PERIPHERAL SWELLING (Finger swollen all time), PAIN IN EXTREMITY (Finger swollen all time and hurts/finger stays swollen all the time and hurts, some redness and swelling not lot of pain) and ERYTHEMA (Finger swollen all time and hurts/redness). At the time of the report, PERIPHERAL SWELLING (Finger swollen all time), PAIN IN EXTREMITY (Finger swollen all time and hurts/finger stays swollen all the time and hurts, some redness and swelling not lot of pain), ERYTHEMA (Finger swollen all time and hurts/redness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 10-Feb-2021 and first booster on 30-Mar-2021) outcome was unknown.            It was unknown if patient was enrolled in COVID-19 vaccine trial.  No concomitant medications were provided.  The causality relationship between co-suspect Rinvoq and event swelling of finger was reported as not related.  The causality relationship between co-suspect Rinvoq and events pain in finger, localized erythema was reported as not reported.  No treatment medications were provided.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: huge red bump that came up on her arm; huge red bump that came up on her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (huge red bump that came up on her arm) and VACCINATION SITE SWELLING (huge red bump that came up on her arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (huge red bump that came up on her arm) and VACCINATION SITE SWELLING (huge red bump that came up on her arm). At the time of the report, VACCINATION SITE ERYTHEMA (huge red bump that came up on her arm) and VACCINATION SITE SWELLING (huge red bump that came up on her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-580246, MOD-2022-580248 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: huge red bump that came up on her arm; huge red bump that came up on her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (huge red bump that came up on her arm) and VACCINATION SITE SWELLING (huge red bump that came up on her arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (huge red bump that came up on her arm) and VACCINATION SITE SWELLING (huge red bump that came up on her arm). At the time of the report, VACCINATION SITE ERYTHEMA (huge red bump that came up on her arm) and VACCINATION SITE SWELLING (huge red bump that came up on her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-580246, MOD-2022-580248 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Patient had received 1st dose on 05 march 2021 and 2nd dose on 4th april 2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 05 march 2021 and 2nd dose on 4th april 2022) in a 76-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 011A21A and 004M21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Penicillin allergy. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 05 march 2021 and 2nd dose on 4th april 2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 05 march 2021 and 2nd dose on 4th april 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         No treatment medication were reported.   This case was linked to MOD-2022-580229 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood test, Chills, General physical health deterioration, Pain, Pain in extremity
Clinical narrative: Reduced general condition; Chills; Generalized aching; Fever; Unevaluable event; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition), CHILLS (Chills), PAIN (Generalized aching), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm) in a 56-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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In April 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in pre-filled pen. On 25-Mar-2022, the patient experienced PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition), CHILLS (Chills), PAIN (Generalized aching), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) was resolving, CHILLS (Chills), PAIN (Generalized aching), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event) outcome was unknown and PAIN IN EXTREMITY (Pain in arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high (High) Markers were really high..         No Concomitant medication reported. No Treatment medication reported. It had been reported that Blood work showed that markers were really high.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2022: Live follow up contain Significant information Patient demographics, event information updated.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Pyrexia, Unevaluable event
Clinical narrative: Reduced general condition; Chills; Generalized aching; Fever; Unevaluable event; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition), CHILLS (Chills), PAIN (Generalized aching), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm) in a 56-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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In April 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in pre-filled pen. On 25-Mar-2022, the patient experienced PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition), CHILLS (Chills), PAIN (Generalized aching), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) was resolving, CHILLS (Chills), PAIN (Generalized aching), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event) outcome was unknown and PAIN IN EXTREMITY (Pain in arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high (High) Markers were really high..         No Concomitant medication reported. No Treatment medication reported. It had been reported that Blood work showed that markers were really high.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2022: Live follow up contain Significant information Patient demographics, event information updated.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash around the injection site; Rash all over back, legs, arms and stomach; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site) and RASH (Rash all over back, legs, arms and stomach) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Patient has no known allergies and no relevant medical history.    On 07-Jan-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) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash around the injection site) and RASH (Rash all over back, legs, arms and stomach). At the time of the report, VACCINATION SITE RASH (Rash around the injection site) and RASH (Rash all over back, legs, arms and stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient not taken concomitant drugs .  It was unknown if patient was enrolled in covid-19 vaccine trail.  No treatment medication were provided.   This case was linked to MOD-2022-580251 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: It was reported that patient experienced weakness; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (It was reported that patient experienced weakness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Hypertension, Depression, Multiple sclerosis and Multiple sclerosis aggravated. Concomitant products included METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL), TAMSULOSIN, PHENAZOPYRIDINE HCL, BIOTIN, KERATIN, FLUOXETINE HYDROCHLORIDE (FLUXETINE), VITAMIN D3, METHENAMINE HIPPURATE, IBUPROFEN (ADVIL [IBUPROFEN]), ZOLPIDEM TARTRATE (AMBIEN), FAMPRIDINE (AMPYRA), CALCIUM, ALPRAZOLAM (XANAX) and RITUXIMAB (RITUXAN) for an unknown indication.   On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (It was reported that patient experienced weakness). At the time of the report, ASTHENIA (It was reported that patient experienced weakness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product included MCG-Keretin. No treatment medication reported by reporter.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vacciane received on Dose 1 07-Jan-2021 and Dose 2 02-Apr-2021 85 days apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vacciane received on Dose 1 07-Jan-2021 and Dose 2 02-Apr-2021 85 days apart) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 07-Jan-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) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vacciane received on Dose 1 07-Jan-2021 and Dose 2 02-Apr-2021 85 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vacciane received on Dose 1 07-Jan-2021 and Dose 2 02-Apr-2021 85 days apart) outcome was unknown.            No concomitant medications were reported. No Known allergy. There was no reported medical history.  It was unknown if patient was enrolled in covid-19 vaccine trail.   This case was linked to MOD-2022-580249 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Pains; Muscle aches; Fever/elevated temperature; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Sensitivity to penicillin).  On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue). At the time of the report, PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated temperature (High) Elevated temperature.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  Concomitant product use was not provided by the reporter.  Patient had no COVID-19 in past or diagnosed with COVID-19.  Treatment information was not provided.   This case was linked to MOD-2022-580194, MOD-2022-580257, MOD-2022-580258 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Feeling hot, Immunisation reaction, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pains; Muscle aches; Fever/elevated temperature; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Sensitivity to penicillin).  On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue). At the time of the report, PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated temperature (High) Elevated temperature.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  Concomitant product use was not provided by the reporter.  Patient had no COVID-19 in past or diagnosed with COVID-19.  Treatment information was not provided.   This case was linked to MOD-2022-580194, MOD-2022-580257, MOD-2022-580258 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Pains; Muscle aches; Fever/elevated temperature; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Sensitivity to penicillin).  On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue). At the time of the report, PAIN (Pains), MYALGIA (Muscle aches), PYREXIA (Fever/elevated temperature) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated temperature (High) Elevated temperature.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  Concomitant product use was not provided by the reporter.  Patient had no COVID-19 in past or diagnosed with COVID-19.  Treatment information was not provided.   This case was linked to MOD-2022-580194, MOD-2022-580257, MOD-2022-580258 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Neck pain, Pain in extremity, Vaccination site reaction
Clinical narrative: Neck pain; Pain in extremity/ Pain with right arm left foot; Shoulder pain; Vaccination site reaction; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), VACCINATION SITE REACTION (Vaccination site reaction), PAIN IN EXTREMITY (Pain in extremity/ Pain with right arm left foot) and ARTHRALGIA (Shoulder pain) in an 89-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In March 2022, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction). On an unknown date, the patient experienced NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity/ Pain with right arm left foot) and ARTHRALGIA (Shoulder pain). At the time of the report, NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain) outcome was unknown, VACCINATION SITE REACTION (Vaccination site reaction) had resolved and PAIN IN EXTREMITY (Pain in extremity/ Pain with right arm left foot) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was unknown if the patient was enrolled in clinical trail.  Concomitant medications were not reported.  The daily dose of Humira was reported as Citrate free.   The stop date for event vaccination adverse reaction was reported as 2022.  Treatment information was not reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: couldn't do much of anything; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MOBILITY DECREASED (couldn't do much of anything) and PYREXIA (fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nasal allergy and Skin cancer. Concomitant products included METOPROLOL, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS and CREATININE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (couldn't do much of anything) and PYREXIA (fever). At the time of the report, MOBILITY DECREASED (couldn't do much of anything) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications also included Create (D).  No treatment medications were reported.   This case was linked to MOD-2022-580265, MOD-2022-580266, MOD-2022-580267 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site reaction
Clinical narrative: Felt Stiffness was coming back when over did yard work; Vaccination site reaction was larger and lasted longer; soreness at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Felt Stiffness was coming back when over did yard work), VACCINATION SITE REACTION (Vaccination site reaction was larger and lasted longer) and VACCINATION SITE PAIN (soreness at vaccine site) in an elderly 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 12-Apr-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Felt Stiffness was coming back when over did yard work), VACCINATION SITE REACTION (Vaccination site reaction was larger and lasted longer) and VACCINATION SITE PAIN (soreness at vaccine site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Felt Stiffness was coming back when over did yard work) was resolving and VACCINATION SITE REACTION (Vaccination site reaction was larger and lasted longer) and VACCINATION SITE PAIN (soreness at vaccine site) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter  It was unknown if patient was enrolled in a trail..   This case was linked to MOD-2022-580297 (Patient Link).