chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Electrocardiogram, Palpitations
Clinical narrative: Heart was racing 2 days after first booster; Could not catch her breath 2 days after first booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PALPITATIONS (Heart was racing 2 days after first booster) and DYSPNOEA (Could not catch her breath 2 days after first booster) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS (Arrhythmias began after Knee Surgery in 1990's) in 1990. Concurrent medical conditions included Arrhythmia (controlled with unknown medication) since 1990.   In 2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced PALPITATIONS (Heart was racing 2 days after first booster) and DYSPNOEA (Could not catch her breath 2 days after first booster). At the time of the report, PALPITATIONS (Heart was racing 2 days after first booster) and DYSPNOEA (Could not catch her breath 2 days after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Scan of the heart was done but they did not find anything. On an unknown date, Electrocardiogram: Did not find anything.         Patient was taking unknown medication for Arrhythmias as concomitant medication.  It was reported that patient never had COVID Disease and never had a positive PCR test.  Treatment information was unknown.
Age: 0.42
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022) and NO ADVERSE EVENT (No adverse event) in a 5-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 vaccination.     No Medical History information was reported.   In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022).    No Concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2022-644904 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Clinic doctor she had spoken too experienced ringing in his ears after the booster shot of Moderna; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Clinic doctor she had spoken too experienced ringing in his ears after the booster shot of Moderna) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Clinic doctor she had spoken too experienced ringing in his ears after the booster shot of Moderna). At the time of the report, TINNITUS (Clinic doctor she had spoken too experienced ringing in his ears after the booster shot of Moderna) outcome was unknown.     The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  Caller stated that when she went to visit her ENT doctor for the tinnitus, she was told by the doctor that this was not the first time he had heard of this reaction after the vaccine and that other people had similar complains as well.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644953, US-MODERNATX, INC.-MOD-2022-644901 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644953:Case for Other People (AC) US-MODERNATX, INC.-MOD-2022-644901:Case for ENT doctor
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient received 0.25ml dose instead of the 0.5ml dose for his bivalent booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Patient received 0.25ml dose instead of the 0.5ml dose for his bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57143C) for COVID-19 prophylaxis.     No medical history was provided by the reporter.     On 13-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 13-Sep-2022, the patient experienced UNDERDOSE (Patient received 0.25ml dose instead of the 0.5ml dose for his bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25ml dose instead of the 0.5ml dose for his bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient's concomitant medications included high blood pressure medication and high cholesterol medication.  On 06-FEB-2021 (Lot:012M20A), the patient received first dose of Moderna vaccine of unknown dose. The patient did not know which arm that he received his vaccine in. Patient had no Adverse reactions or side effects.  On 06-MAR-2021 (Lot: 011A21A), the patient received second dose of Moderna vaccine of unknown dose. The patient does not know which arm that he received his vaccine in. Patient had no Adverse reactions or side effects.  On 25-OCT-2021 (Lot: 014F21A) patient received first booster dose of Moderna vaccine of unknown dose. The patient does not know which arm that he received his vaccine in. Patient had no Adverse reactions or side effects.  On 05-MAY-2022, patient received second booster dose of Moderna vaccine of unknown dose. The patient does not know which arm that he received his vaccine in. Patient had no Adverse reactions or side effects.  No treatment  medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWOLLEN IN ARM; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (SWOLLEN IN ARM) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (SWOLLEN IN ARM). At the time of the report, PERIPHERAL SWELLING (SWOLLEN IN ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported.   This case was linked to MOD-2022-644994, MOD-2022-644996 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment medication were reported.   This case was linked to MOD-2022-644983, MOD-2022-644996 (Patient Link).   Reporter did not allow further contact
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Had normal range reactions with previous doses of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Had normal range reactions with previous doses of the Moderna Covid 19 vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 047A21A and 011M20A) for COVID-19 vaccination.     The patient had not ever tested positive for Covid19.  Concurrent medical conditions included Adhesive tape allergy (Allergy to adhesive in band aids). Concomitant products included ELAGOLIX SODIUM (ORILISSA), ESTROGENS CONJUGATED (PREMARIN) and PROGESTERONE for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had normal range reactions with previous doses of the Moderna Covid 19 vaccine). At the time of the report, IMMUNISATION REACTION (Had normal range reactions with previous doses of the Moderna Covid 19 vaccine) outcome was unknown.            Patient used Hormonal IUD. No treatment medication was reported.   This case was linked to MOD-2022-644939 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Magnetic resonance imaging, Overdose, Tinnitus
Clinical narrative: Patient recived 0.5mL of Booster dose instaed of 0.25 mL; started hearing ringing/buzzing in ear / the ringing is there all the time/ ringing in the ears all the time is an annoyance; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (started hearing ringing/buzzing in ear / the ringing is there all the time/ ringing in the ears all the time is an annoyance) and OVERDOSE (Patient recived 0.5mL of Booster dose instaed of 0.25 mL) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 013M20A and 026L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2021, the patient experienced TINNITUS (started hearing ringing/buzzing in ear / the ringing is there all the time/ ringing in the ears all the time is an annoyance). On 18-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Patient recived 0.5mL of Booster dose instaed of 0.25 mL). At the time of the report, TINNITUS (started hearing ringing/buzzing in ear / the ringing is there all the time/ ringing in the ears all the time is an annoyance) had not resolved and OVERDOSE (Patient recived 0.5mL of Booster dose instaed of 0.25 mL) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: Test results were normal. On an unknown date, Magnetic resonance imaging: Test results were normal.         No concomitant medication was reported. Patient stated After about 2.5 - 3 weeks of receiving the vaccine, she started experiencing buzzing/ringing in her ears. She was not sure what was going on so she decided to see an ENT to get her ears checked out. Her ENT doctor suggested that it could be an inflammatory response to the vaccine which may or may not resolve. She said that the ringing was always there but with the tv on, for example, patient did not noticed it as much. Patient noticed it more when there was silence in the room, like at night, then she can definitely noticed that something was going on. Patient said that she did not get any other side effects from the vaccine, but having that ringing in the ears all the time was an annoyance.   On an unknown date, MRA of the brain done, all test results were normal.  Treatment information provided that, patient also tried to go through acupuncture but it did not resolve the ringing in ears.   This case was linked to MOD-2022-645242 (Patient Link).
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; second dose received was from the presentation for 6m - 5y olds; First dose taken on 4-Aug-2022 and second dose taken on 9-Sep-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (second dose received was from the presentation for 6m - 5y olds), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 4-Aug-2022 and second dose taken on 9-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (second dose received was from the presentation for 6m - 5y olds) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 4-Aug-2022 and second dose taken on 9-Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (second dose received was from the presentation for 6m - 5y olds), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 4-Aug-2022 and second dose taken on 9-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (second dose received was from the presentation for 6m - 5y olds) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 4-Aug-2022 and second dose taken on 9-Sep-2022).    No concomitant medications were provided by the reporter.  Patient did not experienced any symptoms.   No additional doses, medications, or treatments have been administered at this point in time.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Weight decreased
Clinical narrative: Weight loss; Having less appeptite; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (Weight loss) and DECREASED APPETITE (Having less appeptite) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Cervical spondylosis, Chronic lymphocytic leukemia, Allergic reaction to bee sting and Wet macular degeneration. Concomitant products included RANIBIZUMAB (LUCENTIS) and IRON for an unknown indication.    In March 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced WEIGHT DECREASED (Weight loss) and DECREASED APPETITE (Having less appeptite). At the time of the report, WEIGHT DECREASED (Weight loss) and DECREASED APPETITE (Having less appeptite) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2021-029029 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Musculoskeletal stiffness, SARS-CoV-2 test
Clinical narrative: When he received the second dose experienced neck and shoulder stiffness which was more intense; When he received the second dose experienced neck and shoulder stiffness which was more intense; When he received the second dose experienced neck and shoulder stiffness which was more intense; This spontaneous case was reported by a patient and describes the occurrence of the first episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense), the second episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011AC1A and 015MCOA) for COVID-19 vaccination.     Patient has no known allergies. Patient was using spray for insect bite.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced the first episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense), the second episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense). At the time of the report, last episode of MUSCULOSKELETAL STIFFNESS (When he received the last dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) No, the patient has not ever tested positive for covid-19.         Patient had 14 different concomitant medications which didn't specify. Patient received 1st dose of Moderna vaccine and experienced neck and shoulder stiffness. When he received 2nd dose of Moderna vaccine experienced same symptoms with more intensity. Patient wants to know if after the symptoms he experienced he should still get the new bivalent booster. His HCP said it would be okay to get it, but the pharmacist asked to call this number. Treatment medications were not reported.   This case was linked to MOD-2022-645070, MOD-2022-645288 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mass, Pruritus
Clinical narrative: When he received the second dose experienced neck and shoulder stiffness which was more intense; When he received the second dose experienced neck and shoulder stiffness which was more intense; When he received the second dose experienced neck and shoulder stiffness which was more intense; This spontaneous case was reported by a patient and describes the occurrence of the first episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense), the second episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011AC1A and 015MCOA) for COVID-19 vaccination.     Patient has no known allergies. Patient was using spray for insect bite.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced the first episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense), the second episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense). At the time of the report, last episode of MUSCULOSKELETAL STIFFNESS (When he received the last dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) No, the patient has not ever tested positive for covid-19.         Patient had 14 different concomitant medications which didn't specify. Patient received 1st dose of Moderna vaccine and experienced neck and shoulder stiffness. When he received 2nd dose of Moderna vaccine experienced same symptoms with more intensity. Patient wants to know if after the symptoms he experienced he should still get the new bivalent booster. His HCP said it would be okay to get it, but the pharmacist asked to call this number. Treatment medications were not reported.   This case was linked to MOD-2022-645070, MOD-2022-645288 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: When he received the second dose experienced neck and shoulder stiffness which was more intense; When he received the second dose experienced neck and shoulder stiffness which was more intense; When he received the second dose experienced neck and shoulder stiffness which was more intense; This spontaneous case was reported by a patient and describes the occurrence of the first episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense), the second episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011AC1A and 015MCOA) for COVID-19 vaccination.     Patient has no known allergies. Patient was using spray for insect bite.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced the first episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense), the second episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense). At the time of the report, last episode of MUSCULOSKELETAL STIFFNESS (When he received the last dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) No, the patient has not ever tested positive for covid-19.         Patient had 14 different concomitant medications which didn't specify. Patient received 1st dose of Moderna vaccine and experienced neck and shoulder stiffness. When he received 2nd dose of Moderna vaccine experienced same symptoms with more intensity. Patient wants to know if after the symptoms he experienced he should still get the new bivalent booster. His HCP said it would be okay to get it, but the pharmacist asked to call this number. Treatment medications were not reported.   This case was linked to MOD-2022-645070, MOD-2022-645288 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Musculoskeletal stiffness, SARS-CoV-2 test
Clinical narrative: Knot on his shoulder; Arm itched severely; This spontaneous case was reported by a patient and describes the occurrence of MASS (Knot on his shoulder) and PRURITUS (Arm itched severely) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015MCOA, 011AC1A and 015MCOA) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced MASS (Knot on his shoulder) and PRURITUS (Arm itched severely). On 31-Oct-2021, MASS (Knot on his shoulder) and PRURITUS (Arm itched severely) had resolved.     Height:was reported as 5.11 The patient never tested positive for Covid19. Patient received 14 different medications but not specified the names.  It was reported that, With the third dose the first day after receiving it patient felt okay, but then there was a knot on his shoulder and his arm itched severely and this lasted for 5 days. Treatment: Spray for insect bites.   This case was linked to MOD-2022-645070, MOD-2022-645125 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mass, Pruritus
Clinical narrative: Knot on his shoulder; Arm itched severely; This spontaneous case was reported by a patient and describes the occurrence of MASS (Knot on his shoulder) and PRURITUS (Arm itched severely) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015MCOA, 011AC1A and 015MCOA) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced MASS (Knot on his shoulder) and PRURITUS (Arm itched severely). On 31-Oct-2021, MASS (Knot on his shoulder) and PRURITUS (Arm itched severely) had resolved.     Height:was reported as 5.11 The patient never tested positive for Covid19. Patient received 14 different medications but not specified the names.  It was reported that, With the third dose the first day after receiving it patient felt okay, but then there was a knot on his shoulder and his arm itched severely and this lasted for 5 days. Treatment: Spray for insect bites.   This case was linked to MOD-2022-645070, MOD-2022-645125 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Knot on his shoulder; Arm itched severely; This spontaneous case was reported by a patient and describes the occurrence of MASS (Knot on his shoulder) and PRURITUS (Arm itched severely) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015MCOA, 011AC1A and 015MCOA) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced MASS (Knot on his shoulder) and PRURITUS (Arm itched severely). On 31-Oct-2021, MASS (Knot on his shoulder) and PRURITUS (Arm itched severely) had resolved.     Height:was reported as 5.11 The patient never tested positive for Covid19. Patient received 14 different medications but not specified the names.  It was reported that, With the third dose the first day after receiving it patient felt okay, but then there was a knot on his shoulder and his arm itched severely and this lasted for 5 days. Treatment: Spray for insect bites.   This case was linked to MOD-2022-645070, MOD-2022-645125 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Dry mouth, Lymphadenopathy
Clinical narrative: Dry mouth; occasionally experienced interesting vivid dreams; Swollen glands after first moderna covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), ABNORMAL DREAMS (occasionally experienced interesting vivid dreams) and LYMPHADENOPATHY (Swollen glands after first moderna covid vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TASIMELTEON (HETLIOZ) capsule for Non-24-hour sleep-wake disorder.    Concurrent medical conditions included Food allergy (Fish containing products), Allergy to plants (Poison oak), Allergy to antibiotic (Bactrim DS), Blindness (Blindness Right category 5, Left category 5) and Panniculitis (Panniculitis affecting regions of neck and back). Concomitant products included HYDROCHLOROTHIAZIDE, SIMVASTATIN, ENALAPRIL MALEATE, CENTRUM SILVER WOMEN 50+ and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN ES) for an unknown indication.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TASIMELTEON (HETLIOZ) (Oral) 20 milligram once an hour. On an unknown date, the patient experienced DRY MOUTH (Dry mouth), ABNORMAL DREAMS (occasionally experienced interesting vivid dreams) and LYMPHADENOPATHY (Swollen glands after first moderna covid vaccine). At the time of the report, DRY MOUTH (Dry mouth), ABNORMAL DREAMS (occasionally experienced interesting vivid dreams) and LYMPHADENOPATHY (Swollen glands after first moderna covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's age was late 60s when at the time of report.  It was reported that patient might accidentally ingest the Hetlioz packets or may thought someone had tampered with the medication.  It was reported that the event dry mouth was result of Hetlioz. The reporter did not provide causality between events of swollen glands and vivid dreams.  Information regarding the patient's dry mouth or dietary intake was not provided. However, in agreement with the reporter, until additional information was obtained, the causal relationship between Hetlioz and Dry mouth was assessed as possible. Due to the knowledge of the product the causal relationship between Hetlioz and Abnormal dreams was assessed as possible. The patient's Lymphadenopathy per the report, was fater COVID vaccine, therefore the causal relationship between Hetlioz and Lymphadenopathy was assessed as not related.  No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1: 01 Mar 2021, Dose 2: 6 Apr 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01 Mar 2021, Dose 2: 6 Apr 2021) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Adverse drug reaction (Arava reaction) in 2015 and Spinal stenosis (left L4-5 Spinal stenosis secondary to L4-5 facet cyst) on 08-May-2018. Concurrent medical conditions included Rheumatoid arthritis since 2005, Hypertension, Psoriasis, Depression since 2015 and Osteoporosis. Concomitant products included ABATACEPT (ORENCIA) from September 2015 to an unknown date for Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01 Mar 2021, Dose 2: 6 Apr 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01 Mar 2021, Dose 2: 6 Apr 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant products included intravenous bisphosphonate from Jul-2016 to an unknown date for osteoporosis.  Reported that patient received METHOTREXATE orally from December 2021 to an unknown date for Rheumatoid arthritis.  The patient had received an unspecified Pfizer product in Jun-21 and was stopped in Jan-22, 2000 mg which was used for an unknown indication. An unspecified Pfizer product was stopped due to inadequate initial response.  No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product monitoring error
Clinical narrative: Refrigerator temperature logs were not recorded; No adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT MONITORING ERROR (Refrigerator temperature logs were not recorded) and NO ADVERSE EVENT (No adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT MONITORING ERROR (Refrigerator temperature logs were not recorded). an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, PRODUCT MONITORING ERROR (Refrigerator temperature logs were not recorded) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for PRODUCT MONITORING ERROR (Refrigerator temperature logs were not recorded).    No concomitant medications were reported.   It was reported that the patient was given a Moderna vaccine as first-time vaccination two weeks prior to this report. Also, the refrigerator temperature logs were not recorded and the COVID vaccinators had advised to throw all the vaccine.  The reporter had reported that the refrigerator was working and was never down.  No treatment details was reported.
Age: 83.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Angiogram, Headache, Photopsia, SARS-CoV-2 test, Vascular imaging
Clinical narrative: Flashes of light in the eyes; Continuous headache; This spontaneous case was reported by a patient and describes the occurrence of PHOTOPSIA (Flashes of light in the eyes) and HEADACHE (Continuous headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A, 015M20A and 062G20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included COVID-19 (The patient was not hospitalized due to COVID-19. No treatment received.) on 01-Aug-2021 and Stent placement (has 3 stints). Concurrent medical conditions included Diabetes, Sleep apnea, Blood pressure high, Leukemia, Immunocompromised and House dust mite allergy (postnasal drip). Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN ASPART (NOVOLOG), EMPAGLIFLOZIN (JARDIANCE), PANTOPRAZOLE, MONTELUKAST, SITAGLIPTIN PHOSPHATE (JANUVIA), AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), EZETIMIBE, FENOFIBRATE and POTASSIUM for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Oct-2021, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced PHOTOPSIA (Flashes of light in the eyes) and HEADACHE (Continuous headache). At the time of the report, PHOTOPSIA (Flashes of light in the eyes) outcome was unknown and HEADACHE (Continuous headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: (Positive) COVID-19 test positive. On an unknown date, Angiogram: found nothing. On an unknown date, Vascular imaging: found nothing.         It was reported that the patient's physician did an MRI. He went to a cardiologist. It has been a year and the patient was still having a headache. He suffered headache anywhere in the head. He never had headache before now he was having them 2/3 times a day.  The patient tried 3 different medications to help with the headache, but it was not stopping the headache.   This case was linked to MOD-2022-645273.
Age: 83.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Flashes of light in the eyes; Continuous headache; This spontaneous case was reported by a patient and describes the occurrence of PHOTOPSIA (Flashes of light in the eyes) and HEADACHE (Continuous headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A, 015M20A and 062G20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included COVID-19 (The patient was not hospitalized due to COVID-19. No treatment received.) on 01-Aug-2021 and Stent placement (has 3 stints). Concurrent medical conditions included Diabetes, Sleep apnea, Blood pressure high, Leukemia, Immunocompromised and House dust mite allergy (postnasal drip). Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN ASPART (NOVOLOG), EMPAGLIFLOZIN (JARDIANCE), PANTOPRAZOLE, MONTELUKAST, SITAGLIPTIN PHOSPHATE (JANUVIA), AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), EZETIMIBE, FENOFIBRATE and POTASSIUM for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Oct-2021, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced PHOTOPSIA (Flashes of light in the eyes) and HEADACHE (Continuous headache). At the time of the report, PHOTOPSIA (Flashes of light in the eyes) outcome was unknown and HEADACHE (Continuous headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: (Positive) COVID-19 test positive. On an unknown date, Angiogram: found nothing. On an unknown date, Vascular imaging: found nothing.         It was reported that the patient's physician did an MRI. He went to a cardiologist. It has been a year and the patient was still having a headache. He suffered headache anywhere in the head. He never had headache before now he was having them 2/3 times a day.  The patient tried 3 different medications to help with the headache, but it was not stopping the headache.   This case was linked to MOD-2022-645273.
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Hypersensitivity, Rash
Clinical narrative: After COVID shots hands broke out; Eczema; Allergies; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After COVID shots hands broke out), ECZEMA (Eczema) and HYPERSENSITIVITY (Allergies) in an elderly 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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic).   On 04-Jan-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) in pre filled pen. On an unknown date, the patient experienced RASH (After COVID shots hands broke out), ECZEMA (Eczema) and HYPERSENSITIVITY (Allergies). The patient was treated with DUPILUMAB (DUPIXENT) at an unspecified dose and frequency. At the time of the report, RASH (After COVID shots hands broke out), ECZEMA (Eczema) and HYPERSENSITIVITY (Allergies) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for Humira with respect to the events, eczema, rash and allergies were not provided.   This case was linked to MOD-2022-645284 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eczema, Hypersensitivity, Inappropriate schedule of product administration, Rash
Clinical narrative: After COVID shots hands broke out; Eczema; Allergies; Dose 1, 04-Jan-2021 and Dose 2, 28-Jan-2021/ Dose 2, 28-Jan-2021 and booster 28-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After COVID shots hands broke out), ECZEMA (Eczema), HYPERSENSITIVITY (Allergies) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1, 04-Jan-2021 and Dose 2, 28-Jan-2021/ Dose 2, 28-Jan-2021 and booster 28-Feb-2021) in an elderly 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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RASH (After COVID shots hands broke out), ECZEMA (Eczema), HYPERSENSITIVITY (Allergies) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1, 04-Jan-2021 and Dose 2, 28-Jan-2021/ Dose 2, 28-Jan-2021 and booster 28-Feb-2021). The patient was treated with DUPILUMAB (DUPIXENT) at an unspecified dose and frequency. At the time of the report, RASH (After COVID shots hands broke out), ECZEMA (Eczema) and HYPERSENSITIVITY (Allergies) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1, 04-Jan-2021 and Dose 2, 28-Jan-2021/ Dose 2, 28-Jan-2021 and booster 28-Feb-2021) outcome was unknown.            Concomitant medication list was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for Humira with respect to events, eczema, rash and allergy was not provided.   This case was linked to MOD-2022-645270 (Patient Link).