chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Very bad rash from booster; Warm at injection site; Very swollen, arm all red; Itching near injection site/Itchy; Red at injection site; Swelling near injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Very bad rash from booster), VACCINATION SITE WARMTH (Warm at injection site), PERIPHERAL SWELLING (Very swollen, arm all red), VACCINATION SITE PRURITUS (Itching near injection site/Itchy) and VACCINATION SITE ERYTHEMA (Red at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (Allergic to latex).   On 10-Nov-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced RASH (Very bad rash from booster), VACCINATION SITE WARMTH (Warm at injection site), PERIPHERAL SWELLING (Very swollen, arm all red), VACCINATION SITE PRURITUS (Itching near injection site/Itchy), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling near injection site). In November 2021, PERIPHERAL SWELLING (Very swollen, arm all red) had resolved. At the time of the report, RASH (Very bad rash from booster), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE PRURITUS (Itching near injection site/Itchy), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling near injection site) was resolving.            No concomitant medications were reported. The patient states the tape that was used to put over injection site may be the cause or contained latex, the itching had got better after removing the tape but still ongoing. Patient taken some medication for allergies (Pills) and the itching subsidized for a little while. It was very swollen before, and arm was all red. Patient said It was horrible itching. At the time of report,she said that it is itching a little, but not too much Patient mentioned that she had the previous 2 doses of the vaccines, and did not feel anything   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Patient demographics and new events were added
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Rash, Vaccination complication
Clinical narrative: adverse effects; developed a bad rash gets warmer at night and seems to be spreading to her arms, ankles, a little on feet and on chest; fever; tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (adverse effects), RASH (developed a bad rash gets warmer at night and seems to be spreading to her arms, ankles, a little on feet and on chest), PYREXIA (fever) and FATIGUE (tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson on 16-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concomitant products included OXCARBAZEPINE, MONTELUKAST, QUETIAPINE, PANTOPRAZOLE, CILNIDIPINE, AMLODIPINE, PAROXETINE ACETATE, CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), SALBUTAMOL (ALBUTEROL HFA) and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Nov-2021, the patient experienced PYREXIA (fever) and FATIGUE (tired). On 11-Nov-2021, the patient experienced RASH (developed a bad rash gets warmer at night and seems to be spreading to her arms, ankles, a little on feet and on chest). On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse effects). The patient was treated with PREDNISONE ongoing from 15-Nov-2021 for Rash, at a dose of 6-Pack (methylprednisolone). At the time of the report, VACCINATION COMPLICATION (adverse effects), PYREXIA (fever) and FATIGUE (tired) outcome was unknown and RASH (developed a bad rash gets warmer at night and seems to be spreading to her arms, ankles, a little on feet and on chest) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 11Nov2021, the patient developed a bad rash. She reported the rash got warmer at night and seemed to be spreading to ankles, a little on feet and on chest. Caller reported that she had it for a week and went to doctor and got prednisone on 15Nov2021. She states she didn't get a rash from the Johnson & Johnson COVID-19 vaccine first.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Followup received with significant information where new events are added (Rash, pyrexia, fatigue). Reporter was added, Primary reporter type was changed. patient gender, treatment and concomitant drugs were added.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Urticaria
Clinical narrative: Had the booster and they got a bunch of/ welts rae red, itchy bumps, itchy bloches/Hives; Itching; Tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Had the booster and they got a bunch of/ welts rae red, itchy bumps, itchy bloches/Hives), PRURITUS (Itching) and FATIGUE (Tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Developed allergies this year). Concomitant products included ATORVASTATIN and LISINOPRIL 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 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PRURITUS (Itching). In 2021, the patient experienced FATIGUE (Tired). On 10-Nov-2021, the patient experienced URTICARIA (Had the booster and they got a bunch of/ welts rae red, itchy bumps, itchy bloches/Hives). At the time of the report, URTICARIA (Had the booster and they got a bunch of/ welts rae red, itchy bumps, itchy bloches/Hives) and FATIGUE (Tired) had not resolved and PRURITUS (Itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  treatment  medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up documents contains additional new events and reporter details. On 17-Nov-2021: Follow up received and Secondary reporter information was added. On 17-Nov-2021: Follow-up received and Patient details and events added.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Illness, Product administered to patient of inappropriate age
Clinical narrative: 5 y/o are now sick in the ER.; giving doses of the vaccine to 5 y/o; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (5 y/o are now sick in the ER.) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (giving doses of the vaccine to 5 y/o) in a 5-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (5 y/o are now sick in the ER.) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (giving doses of the vaccine to 5 y/o). At the time of the report, ILLNESS (5 y/o are now sick in the ER.) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (giving doses of the vaccine to 5 y/o) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non-Significant follow up appended-Contact info updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Pyrexia
Clinical narrative: A little bit of a sore arm; Fever; received expired Moderna booster; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (A little bit of a sore arm), PYREXIA (Fever) and EXPIRED PRODUCT ADMINISTERED (received expired Moderna booster) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Atrophic vaginitis, Allergy to antibiotic (Bactrim allergy) and Allergy to antibiotic (Bactrim allergy). Concomitant products included ESTRADIOL (VAGIFEM) for Atrophic vaginitis.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna booster). On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received expired Moderna booster) had resolved. At the time of the report, PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) to be related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received expired Moderna booster).    Concomitantly, the patient also took Carem/D orally for osteoporosis and Miltrret orally for health.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-387101 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Suspect drug information, patient information, new event, medical history and concomitant medication were added; outcome was updated. On 16-Nov-2021: Consent for follow up was denied.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headaches; aching all over body; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and MYALGIA (aching all over body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included NAPROXEN SODIUM (ALEVE ARTHRITIS) and IBUPROFEN for Arthritis.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) and MYALGIA (aching all over body). At the time of the report, HEADACHE (headaches) and MYALGIA (aching all over body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-387079 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: No erection; This spontaneous case was reported by a pharmacist and describes the occurrence of ERECTILE DYSFUNCTION (No erection) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced ERECTILE DYSFUNCTION (No erection) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (No erection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. The husband had no erection. The husband was born in 1972.  Company comment: This spontaneous  case concerns a male patient born in 1972 with no relevant medical history who experienced serious unexpected event of erectile dysfunction. The event occurred after the first dose of the Moderna COVID-19 vaccine .Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous  case concerns a male patient born in 1972 with no relevant medical history who experienced serious unexpected event of erectile dysfunction. The event occurred after the first dose of the Moderna COVID-19 vaccine .Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Neuralgia, Vaccination complication
Clinical narrative: a bad reaction to the booster; couldn't get out of bed; had neuropathy pain in places she has never had neuropathy pain before/She still has mild pain today but not like it was; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (had neuropathy pain in places she has never had neuropathy pain before/She still has mild pain today but not like it was), VACCINATION COMPLICATION (a bad reaction to the booster) and MOBILITY DECREASED (couldn't get out of bed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 016B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-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 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEURALGIA (had neuropathy pain in places she has never had neuropathy pain before/She still has mild pain today but not like it was). On an unknown date, the patient experienced VACCINATION COMPLICATION (a bad reaction to the booster) and MOBILITY DECREASED (couldn't get out of bed). At the time of the report, NEURALGIA (had neuropathy pain in places she has never had neuropathy pain before/She still has mild pain today but not like it was) was resolving and VACCINATION COMPLICATION (a bad reaction to the booster) and MOBILITY DECREASED (couldn't get out of bed) outcome was unknown.            No relevant concomitant medications were reported. Patient used a compounded cream that she normally uses for neuropathy pain and it did not help at all.  She said that her rheumatologist said that the cream would not  have helped since it was a side effect of the vaccine.  She still has mild pain today but not like it was. She mentioned she did not have anything like this with the 1st two doses.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Rheumatoid arthritis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (feels like Rheumatoid Arthritis) and NECK PAIN (my neck is sore) in a 6-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (feels like Rheumatoid Arthritis) and NECK PAIN (my neck is sore). At the time of the report, RHEUMATOID ARTHRITIS (feels like Rheumatoid Arthritis) and NECK PAIN (my neck is sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported only reason that patient was taking the Covid-19 vaccine was that being forced to by the company. Patient had seen several Doctors. Patient said that was in the late fifties. No treatment medication details were provided. Patient experienced swollen joints in my hands and thumbs. Both of my knees are painful. My neck is sore. Feels like Rheumatoid Arthritis. Patient had Rheumatoid Arthritis RA. No concomitant medication details were provided. Company's comment: This case concerns a female patient of unknown age, with a history of Rheumatoid arthritis, who experienced the unexpected AESI of Rheumatoid arthritis. The event occurred at an unknown date after the first dose of mRNA-1273 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The medical history, of Rheumatoid arthritis remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Non-Significant Follow up. On 16-Nov-2021: Non Significant Follow up. On 16-Nov-2021: Non Significant follow-up appended, snapshot document was attached; Sender's Comments: This case concerns a female patient of unknown age, with a history of Rheumatoid arthritis, who experienced the unexpected AESI of Rheumatoid arthritis. The event occurred at an unknown date after the first dose of mRNA-1273 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The medical history, of Rheumatoid arthritis remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: negative (Negative) done 3 times COVID-19 test, but all turned out to be negative.         No concomitant medications were reported.  Treatment information was not provided. Patient was very sick in December 2020 and had COVID-19 test 3 times which all turned out to be negative but she thinks she had the COVID-19. Patient was given experimental flu drug at that time.   This case was linked to MOD-2021-388542, MOD-2021-388559 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Laid-up on Saturday and Sunday after booster; he received twice the dose of the booster vaccine instead of a half dose; Loss of appetite; Body aches; Fatigue; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), MALAISE (Laid-up on Saturday and Sunday after booster), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 023M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced MALAISE (Laid-up on Saturday and Sunday after booster) and ACCIDENTAL OVERDOSE (he received twice the dose of the booster vaccine instead of a half dose). In November 2021, the patient experienced DECREASED APPETITE (Loss of appetite), MYALGIA (Body aches), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills). On 06-Nov-2021, ACCIDENTAL OVERDOSE (he received twice the dose of the booster vaccine instead of a half dose) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite), MALAISE (Laid-up on Saturday and Sunday after booster), MYALGIA (Body aches), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported. Patient reported that he called his manager at vaccine facility job and they set up a meeting for next week. They have not told him as to what happened.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Laid-up on Saturday and Sunday after booster; he received twice the dose of the booster vaccine instead of a half dose; Loss of appetite; Body aches; Fatigue; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), MALAISE (Laid-up on Saturday and Sunday after booster), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 023M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced MALAISE (Laid-up on Saturday and Sunday after booster) and ACCIDENTAL OVERDOSE (he received twice the dose of the booster vaccine instead of a half dose). In November 2021, the patient experienced DECREASED APPETITE (Loss of appetite), MYALGIA (Body aches), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills). On 06-Nov-2021, ACCIDENTAL OVERDOSE (he received twice the dose of the booster vaccine instead of a half dose) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite), MALAISE (Laid-up on Saturday and Sunday after booster), MYALGIA (Body aches), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported. Patient reported that he called his manager at vaccine facility job and they set up a meeting for next week. They have not told him as to what happened.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided          Concomitant information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (At the age of 10) and Nervous system neoplasm surgery (Had two months ago). Concurrent medical conditions included Osteoarthritis, Arthritis and Disability (Since 33 years old).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            It was reported that the patient had their vocal cord snip during spine cord surgery performed according to the MRI (Magnetic Resonance Imaging).  No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-389026 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate increased, Hyperhidrosis, Pain
Clinical narrative: Felt like she was going to pass out, but didn't; Broke out in a sweat; Feels kind of weird/Feels a little off; Achy; Tired/Still felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like she was going to pass out, but didn't), HYPERHIDROSIS (Broke out in a sweat), FEELING ABNORMAL (Feels kind of weird/Feels a little off), PAIN (Achy) and FATIGUE (Tired/Still felt tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077CZ1B) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN (Achy) and FATIGUE (Tired/Still felt tired). On 17-Nov-2021, the patient experienced PRESYNCOPE (Felt like she was going to pass out, but didn't), HYPERHIDROSIS (Broke out in a sweat) and FEELING ABNORMAL (Feels kind of weird/Feels a little off). At the time of the report, PRESYNCOPE (Felt like she was going to pass out, but didn't), HYPERHIDROSIS (Broke out in a sweat), FEELING ABNORMAL (Feels kind of weird/Feels a little off) and PAIN (Achy) outcome was unknown and FATIGUE (Tired/Still felt tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, Heart rate increased: high (High) Rapid heart beat for about 10 minutes.    Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-389175 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Felt like she was going to pass out, but didn't; Broke out in a sweat; Feels kind of weird/Feels a little off; Achy; Tired/Still felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like she was going to pass out, but didn't), HYPERHIDROSIS (Broke out in a sweat), FEELING ABNORMAL (Feels kind of weird/Feels a little off), PAIN (Achy) and FATIGUE (Tired/Still felt tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077CZ1B) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN (Achy) and FATIGUE (Tired/Still felt tired). On 17-Nov-2021, the patient experienced PRESYNCOPE (Felt like she was going to pass out, but didn't), HYPERHIDROSIS (Broke out in a sweat) and FEELING ABNORMAL (Feels kind of weird/Feels a little off). At the time of the report, PRESYNCOPE (Felt like she was going to pass out, but didn't), HYPERHIDROSIS (Broke out in a sweat), FEELING ABNORMAL (Feels kind of weird/Feels a little off) and PAIN (Achy) outcome was unknown and FATIGUE (Tired/Still felt tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, Heart rate increased: high (High) Rapid heart beat for about 10 minutes.    Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-389175 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (the event she had symptoms after booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (the event she had symptoms after booster dose). At the time of the report, VACCINATION COMPLICATION (the event she had symptoms after booster dose) outcome was unknown. No concomitant medication information was provided. No treatment medication information was given. This case was linked to MOD-2021-389233 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: a lot of fever in the injection site/very very hot; real bad bump/swollen about 3 inches across; a lot of redness/very very red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a lot of fever in the injection site/very very hot), VACCINATION SITE SWELLING (real bad bump/swollen about 3 inches across) and VACCINATION SITE ERYTHEMA (a lot of redness/very very red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (a lot of fever in the injection site/very very hot), VACCINATION SITE SWELLING (real bad bump/swollen about 3 inches across) and VACCINATION SITE ERYTHEMA (a lot of redness/very very red). At the time of the report, VACCINATION SITE WARMTH (a lot of fever in the injection site/very very hot), VACCINATION SITE SWELLING (real bad bump/swollen about 3 inches across) and VACCINATION SITE ERYTHEMA (a lot of redness/very very red) outcome was unknown.            Patient stated that She didn't have any reaction to the first two shots at all, Concomitant information was not reported. Treatment information was not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Joint swelling, Vaccination site pain
Clinical narrative: Large swelling on left ankle; Exhaustion; Headache; Pain in left arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Large swelling on left ankle), FATIGUE (Exhaustion), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in left arm after second dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Thyroiditis and Anxiety.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced JOINT SWELLING (Large swelling on left ankle). On an unknown date, the patient experienced FATIGUE (Exhaustion), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in left arm after second dose). The patient was treated with Surgery (Surgical removal of large swelling on left ankle) for Joint swelling. At the time of the report, JOINT SWELLING (Large swelling on left ankle) was resolving and FATIGUE (Exhaustion), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in left arm after second dose) had resolved.            Concomitant medications included blood pressure, thyroid, anxiety medication and took muscle relaxant when needed. No treatment medications were reported. Within 5 to 7 days she developed large swelling on the left ankle which was surgically removed by a podiatrist on 14Oct2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Pain in extremity
Clinical narrative: Very achy, would not want no one to touch her; Sore arm after every shot; body was hurting; light chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Nov-2021 and was forwarded to Moderna on 17-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Very achy, would not want no one to touch her), PAIN IN EXTREMITY (Sore arm after every shot), MYALGIA (body was hurting) and CHILLS (light chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN, PARACETAMOL (TYLENOL [PARACETAMOL]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Very achy, would not want no one to touch her), PAIN IN EXTREMITY (Sore arm after every shot), MYALGIA (body was hurting) and CHILLS (light chills). At the time of the report, PAIN (Very achy, would not want no one to touch her), PAIN IN EXTREMITY (Sore arm after every shot), MYALGIA (body was hurting) and CHILLS (light chills) had resolved.        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.   Treatment medication was not provided.  Patient forgot the concomitant medication Flonase sometimes and had regular pain, so she takes a combination of pain killers. She was dosage sensitive.  Patient sometimes replaces Ibuprofen with aspirin, does not take aspirin everyday.   This case was linked to MOD-2021-390091, MOD-2021-390090 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Pain, Pyrexia
Clinical narrative: Aches /all night I had aches; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches /all night I had aches), PYREXIA (Fever) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS (Cardiac problems and irritability, arrhythmia-type.).   On 09-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. In April 2021, the patient experienced PAIN (Aches /all night I had aches), PYREXIA (Fever) and CHILLS (chills). In April 2021, PAIN (Aches /all night I had aches), PYREXIA (Fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 104 (High) 104. In April 2021, Heart rate: irregular (abnormal) Some kind of irritability that was irregular beating of the heart. Did not continue the next day..         Concomitant medications were  not provided.  It was reported that the patient had bad reaction after the second dose. She experienced aches, fever and chills. All night she had aches. She experienced some kind of irritability that was irregular beating of heart , arrhythmia type at that night and she could only lie there and sleep because the fever and chills were so bad. The cardiac stuff did not continue the next day. Within a couple of days, she was fine.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Caller presented information that she was potentially given only half of a booster dose by a pharmacy; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Caller presented information that she was potentially given only half of a booster dose by a pharmacy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Caller presented information that she was potentially given only half of a booster dose by a pharmacy). On 09-Nov-2021, ACCIDENTAL UNDERDOSE (Caller presented information that she was potentially given only half of a booster dose by a pharmacy) had resolved.            No concomitant medications were provided.  No treatment medications were provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash pruritic
Clinical narrative: Extremely tired/ Weary; Raging rash all over his body, shoulder, back, elbow, knees, groin, butt, Itching his body when sitting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH PRURITIC (Raging rash all over his body, shoulder, back, elbow, knees, groin, butt, Itching his body when sitting) and FATIGUE (Extremely tired/ Weary) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included DOFETILIDE, METOPROLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), SITAGLIPTIN PHOSPHATE (JANUVIA), CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]), FINASTERIDE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), WARFARIN, GUAIFENESIN (MUCINEX), HYDROCODONE, LORATADINE and INSULIN GLARGINE (LANTUS) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Raging rash all over his body, shoulder, back, elbow, knees, groin, butt, Itching his body when sitting). On an unknown date, the patient experienced FATIGUE (Extremely tired/ Weary). At the time of the report, RASH PRURITIC (Raging rash all over his body, shoulder, back, elbow, knees, groin, butt, Itching his body when sitting) had not resolved and FATIGUE (Extremely tired/ Weary) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 10-Feb-2021 patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) (batch no.  013M20A) for COVID-19 vaccination. On 02-Nov-2021 patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) on left nondominant deltoid (batch no. 039F21A) for COVID-19 vaccination.  A week after the first shot, the patient got a raging rash all over his body, rash was on the shoulders, back, elbow, knees, groin, and butt and went to several dermatologist and gave him shots of steroids and put him on more steroids (unspecified) and more itch cream (unspecified). It never went away, and the rash was still there. The steroid shot helped it a bit but as soon as he got off of the steroid shots, the rash came back. He sits and itches his body and he was extremely tired and it is wearing him out. He was able to sleep but then wakes up in the middle of the night, it drives him crazy. An allergist was going to do a skin prick test on him, and already gave him another large injection of steroids.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Lymphadenopathy, Myalgia, Oral herpes
Clinical narrative: minor soreness; lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow; cold sores; muscle soreness; joint pain; fever, 101.5°F, very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor soreness), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), ORAL HERPES (cold sores), MYALGIA (muscle soreness) and ARTHRALGIA (joint pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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 experienced PAIN (minor soreness), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), ORAL HERPES (cold sores), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (minor soreness) had not resolved and LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), ORAL HERPES (cold sores), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5°f (High) 101.5°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Rheumatologist recommended to stop taking biologicals when getting the vaccine.   This case was linked to MOD-2021-390480, MOD-2021-390502 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: minor soreness; lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow; cold sores; muscle soreness; joint pain; fever, 101.5°F, very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor soreness), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), ORAL HERPES (cold sores), MYALGIA (muscle soreness) and ARTHRALGIA (joint pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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 experienced PAIN (minor soreness), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), ORAL HERPES (cold sores), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (minor soreness) had not resolved and LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), ORAL HERPES (cold sores), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5°f (High) 101.5°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Rheumatologist recommended to stop taking biologicals when getting the vaccine.   This case was linked to MOD-2021-390480, MOD-2021-390502 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection in October; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 infection in October) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COVID-19 (COVID-19 infection in October). At the time of the report, COVID-19 (COVID-19 infection in October) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter. Company comment includes: This is a spontaneous case concerning a elderly female patient with no relevant medical history, who experienced the unexpected, non serious, ADR event of Covid-19. The event Covid-19 exact occurrence unknown but stated that the event occurred after the unknown date of primary doses of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a elderly female patient with no relevant medical history, who experienced the unexpected, non serious, ADR event of Covid-19. The event Covid-19 exact occurrence unknown but stated that the event occurred after the unknown date of primary doses of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.