chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Golf ball size Lump on arm; Soreness of the Arm; Hot to Touch; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Golf ball size Lump on arm), PAIN IN EXTREMITY (Soreness of the Arm), INJECTION SITE WARMTH (Hot to Touch) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (Golf ball size Lump on arm), PAIN IN EXTREMITY (Soreness of the Arm), INJECTION SITE WARMTH (Hot to Touch) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, PERIPHERAL SWELLING (Golf ball size Lump on arm), PAIN IN EXTREMITY (Soreness of the Arm), INJECTION SITE WARMTH (Hot to Touch) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.       Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non-significant Follow-up appended
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed rash over neck chest back and stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed rash over neck chest back and stomach) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Developed rash over neck chest back and stomach). At the time of the report, RASH (Developed rash over neck chest back and stomach) outcome was unknown.            No concomitant medications were reported by the reporter.  The patient had the event a month after second dose.  Treatment medication was not provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain in extremity
Clinical narrative: Mild Dizziness; General feeling of mild energy; Heavy legs when walking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Mild Dizziness), ASTHENIA (General feeling of mild energy) and PAIN IN EXTREMITY (Heavy legs when walking) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced DIZZINESS (Mild Dizziness), ASTHENIA (General feeling of mild energy) and PAIN IN EXTREMITY (Heavy legs when walking). The patient was treated with PERMETHRIN (PERMETHRIN lotion) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Mild Dizziness), ASTHENIA (General feeling of mild energy) and PAIN IN EXTREMITY (Heavy legs when walking) outcome was unknown.            This case was linked to MOD-2021-047874 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   Company Comment: This case concerns a 84-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 84-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   Company Comment: This case concerns a 76-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 76-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   Company Comment: This case concerns a 94-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 94-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   Company Comment: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   Company Comment: This case concerns a 80-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 80-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: got vaccinated in Feb and until now haven't suffered from any headaches or earaches of any kind since then; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (got vaccinated in Feb and until now haven't suffered from any headaches or earaches of any kind since then) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache, Earache and Sinus disorder NOS (Sinus) since an unknown date.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (got vaccinated in Feb and until now haven't suffered from any headaches or earaches of any kind since then). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (got vaccinated in Feb and until now haven't suffered from any headaches or earaches of any kind since then) outcome was unknown. Headaches      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included unknown pain pills for the treatment of headache and earache, nose sprays for the treatment of sinus.  On a social media platform the patient stated that after vaccination the patient's headaches, earaches and pain pills were "put away". No other treatment information was provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Inflamed; Has a lump on it, the size of a small egg; Very itchy; Real red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE MASS (Has a lump on it, the size of a small egg), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Real red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Heart rate irregular. Concomitant products included ATENOLOL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE MASS (Has a lump on it, the size of a small egg), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Real red). On 06-Feb-2021, VACCINATION SITE MASS (Has a lump on it, the size of a small egg) and VACCINATION SITE ERYTHEMA (Real red) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PRURITUS (Very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Vaccination error, Vaccination site discolouration, Vaccination site inflammation
Clinical narrative: Vaccinated too low on her arm; Her skin became purple and green; Arm of the injection inflamed; Pain in also on the left side of her neck and goes down her chest; It is pain with burning sensation; Injection arm hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION ERROR (Vaccinated too low on her arm), VACCINATION SITE DISCOLOURATION (Her skin became purple and green), VACCINATION SITE INFLAMMATION (Arm of the injection inflamed), NECK PAIN (Pain in also on the left side of her neck and goes down her chest) and PAIN (It is pain with burning sensation) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION ERROR (Vaccinated too low on her arm), VACCINATION SITE DISCOLOURATION (Her skin became purple and green), VACCINATION SITE INFLAMMATION (Arm of the injection inflamed), NECK PAIN (Pain in also on the left side of her neck and goes down her chest), PAIN (It is pain with burning sensation) and VACCINATION SITE PAIN (Injection arm hurts a lot). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 27-Feb-2021, VACCINATION ERROR (Vaccinated too low on her arm) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Her skin became purple and green) and NECK PAIN (Pain in also on the left side of her neck and goes down her chest) outcome was unknown and VACCINATION SITE INFLAMMATION (Arm of the injection inflamed), PAIN (It is pain with burning sensation) and VACCINATION SITE PAIN (Injection arm hurts a lot) had not resolved.            The patient post receiving their second dose of vaccine complains of having vaccinated too low on their arm and not as high as the patient supposed it should be. The patient also reported that around the injection site and close to a vein that passes there, their skin became purple and green and was inflamed and was hurting a lot.   Reportedly, the pain was also there on the left side of their neck and it went down their chest. The patient's arm was hurting a lot whenever they wanted to exercise, and it was inflamed. The patient took ibuprofen, but the pain continued, and it was pain with burning sensation.  No Concomitant product use was reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-031334 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccinated too low on her arm; Her skin became purple and green; Arm of the injection inflamed; Pain in also on the left side of her neck and goes down her chest; It is pain with burning sensation; Injection arm hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION ERROR (Vaccinated too low on her arm), VACCINATION SITE DISCOLOURATION (Her skin became purple and green), VACCINATION SITE INFLAMMATION (Arm of the injection inflamed), NECK PAIN (Pain in also on the left side of her neck and goes down her chest) and PAIN (It is pain with burning sensation) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION ERROR (Vaccinated too low on her arm), VACCINATION SITE DISCOLOURATION (Her skin became purple and green), VACCINATION SITE INFLAMMATION (Arm of the injection inflamed), NECK PAIN (Pain in also on the left side of her neck and goes down her chest), PAIN (It is pain with burning sensation) and VACCINATION SITE PAIN (Injection arm hurts a lot). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 27-Feb-2021, VACCINATION ERROR (Vaccinated too low on her arm) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Her skin became purple and green) and NECK PAIN (Pain in also on the left side of her neck and goes down her chest) outcome was unknown and VACCINATION SITE INFLAMMATION (Arm of the injection inflamed), PAIN (It is pain with burning sensation) and VACCINATION SITE PAIN (Injection arm hurts a lot) had not resolved.            The patient post receiving their second dose of vaccine complains of having vaccinated too low on their arm and not as high as the patient supposed it should be. The patient also reported that around the injection site and close to a vein that passes there, their skin became purple and green and was inflamed and was hurting a lot.   Reportedly, the pain was also there on the left side of their neck and it went down their chest. The patient's arm was hurting a lot whenever they wanted to exercise, and it was inflamed. The patient took ibuprofen, but the pain continued, and it was pain with burning sensation.  No Concomitant product use was reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-031334 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza, Limb discomfort, Pyrexia
Clinical narrative: flu; sore arm; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), LIMB DISCOMFORT (sore arm), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis and Dermatitis (The current event is unspecified dermatitis). Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced INFLUENZA (flu), LIMB DISCOMFORT (sore arm), PYREXIA (fever) and CHILLS (chills). At the time of the report, INFLUENZA (flu), LIMB DISCOMFORT (sore arm), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided by the reporter.  The case is an medication error spontaneous case.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (body aches) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (body aches) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (body aches) and CHILLS (chills) had resolved.          Concomitant medications were not provided.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-025737 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: TCR of Both Doses . patient state that she  had the reported symptoms for about 1.5-2days after each shot, then the symptoms resolved.and she didn't have email for follow up
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID positive; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID positive). At the time of the report, COVID-19 (COVID positive) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Vomiting for 3 days; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting for 3 days) and HEADACHE (Headache) 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 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting for 3 days) and HEADACHE (Headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at an unspecified dose and frequency. At the time of the report, VOMITING (Vomiting for 3 days) and HEADACHE (Headache) outcome was unknown.            No concomitant medication were reported .  Pharmacist gave her Zofran as a treatment medication for vomiting , Patient refused to take Zofran because it messes with her brain.   This case was linked to MOD-2021-221341 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache and vomiting in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 24, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 24, 2021, patient experienced headache and vomiting. Patient treated with Zofran (ondansetron hydrochloride dihydrate) ongoing since an unknown date; at an unspecified dose and frequency. At the time of the report, headache and vomiting outcome: unknown/not provided. Action taken with mRNA-1273 in response to the events: not applicable. Concomitant product use not provided. This case linked to MOD-2021-221339 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Intentional product use issue
Clinical narrative: Back pain; Delayed her 2nd dose due to back pain after first dose; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and INTENTIONAL PRODUCT USE ISSUE (Delayed her 2nd dose due to back pain after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Delayed her 2nd dose due to back pain after first dose). On an unknown date, the patient experienced BACK PAIN (Back pain). On 09-Mar-2021, INTENTIONAL PRODUCT USE ISSUE (Delayed her 2nd dose due to back pain after first dose) had resolved. At the time of the report, BACK PAIN (Back pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.  Patient back pain resolved after ten days of the first dose of Moderna vaccine.    This case was linked to MOD-2021-043188 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Loss of appetite; Forceful Vomitting; Diarrhea; Nausea; very tired; fever; headache/headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), SELF-INDUCED VOMITING (Forceful Vomitting), DIARRHOEA (Diarrhea), PYREXIA (fever) and HEADACHE (headache/headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache/headache). On 06-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), SELF-INDUCED VOMITING (Forceful Vomitting), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and FATIGUE (very tired). On 03-Feb-2021, PYREXIA (fever) had resolved. On 06-Feb-2021, SELF-INDUCED VOMITING (Forceful Vomitting) and DIARRHOEA (Diarrhea) had resolved. On 07-Feb-2021, DECREASED APPETITE (Loss of appetite), HEADACHE (headache/headache) and NAUSEA (Nausea) had resolved. At the time of the report, FATIGUE (very tired) had not resolved.            No concomitant and treatment drugs were reported. The action taken with the drug was Not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Self-induced vomiting
Clinical narrative: Loss of appetite; Forceful Vomitting; Diarrhea; Nausea; very tired; fever; headache/headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), SELF-INDUCED VOMITING (Forceful Vomitting), DIARRHOEA (Diarrhea), PYREXIA (fever) and HEADACHE (headache/headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache/headache). On 06-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), SELF-INDUCED VOMITING (Forceful Vomitting), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and FATIGUE (very tired). On 03-Feb-2021, PYREXIA (fever) had resolved. On 06-Feb-2021, SELF-INDUCED VOMITING (Forceful Vomitting) and DIARRHOEA (Diarrhea) had resolved. On 07-Feb-2021, DECREASED APPETITE (Loss of appetite), HEADACHE (headache/headache) and NAUSEA (Nausea) had resolved. At the time of the report, FATIGUE (very tired) had not resolved.            No concomitant and treatment drugs were reported. The action taken with the drug was Not applicable.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: moderna for his first vaccine, pfizer for his second vaccine; Received doses more than 21 and 28 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (moderna for his first vaccine, pfizer for his second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received doses more than 21 and 28 days apart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02YC21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (moderna for his first vaccine, pfizer for his second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received doses more than 21 and 28 days apart). On 14-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (moderna for his first vaccine, pfizer for his second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received doses more than 21 and 28 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Received doses more than 21 and 28 days apart.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspnoea, Malaise, Night sweats, Pain in extremity
Clinical narrative: feeling no good, no energy; Night sweat; taste of salt in mouth; trouble breathing; pain in arms; lost weight; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (feeling no good, no energy), NIGHT SWEATS (Night sweat), DYSGEUSIA (taste of salt in mouth), DYSPNOEA (trouble breathing) and PAIN IN EXTREMITY (pain in arms) in a male 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.    Co-suspect product included non-company product INFLIXIMAB (INFLECTRA [INFLIXIMAB]) for Crohn's disease.    The patient's past medical history included Infection NOS. Concurrent medical conditions included Chronic disease and Inflammation (related to Crohn's ). Concomitant products included METRONIDAZOLE and CIPROFLOXACIN for Infection NOS.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient started INFLIXIMAB (INFLECTRA [INFLIXIMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (feeling no good, no energy), NIGHT SWEATS (Night sweat), DYSGEUSIA (taste of salt in mouth), DYSPNOEA (trouble breathing), PAIN IN EXTREMITY (pain in arms) and WEIGHT DECREASED (lost weight). At the time of the report, MALAISE (feeling no good, no energy), NIGHT SWEATS (Night sweat), DYSGEUSIA (taste of salt in mouth), DYSPNOEA (trouble breathing), PAIN IN EXTREMITY (pain in arms) and WEIGHT DECREASED (lost weight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for these events were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: feeling no good, no energy; Night sweat; taste of salt in mouth; trouble breathing; pain in arms; lost weight; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (feeling no good, no energy), NIGHT SWEATS (Night sweat), DYSGEUSIA (taste of salt in mouth), DYSPNOEA (trouble breathing) and PAIN IN EXTREMITY (pain in arms) in a male 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.    Co-suspect product included non-company product INFLIXIMAB (INFLECTRA [INFLIXIMAB]) for Crohn's disease.    The patient's past medical history included Infection NOS. Concurrent medical conditions included Chronic disease and Inflammation (related to Crohn's ). Concomitant products included METRONIDAZOLE and CIPROFLOXACIN for Infection NOS.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient started INFLIXIMAB (INFLECTRA [INFLIXIMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (feeling no good, no energy), NIGHT SWEATS (Night sweat), DYSGEUSIA (taste of salt in mouth), DYSPNOEA (trouble breathing), PAIN IN EXTREMITY (pain in arms) and WEIGHT DECREASED (lost weight). At the time of the report, MALAISE (feeling no good, no energy), NIGHT SWEATS (Night sweat), DYSGEUSIA (taste of salt in mouth), DYSPNOEA (trouble breathing), PAIN IN EXTREMITY (pain in arms) and WEIGHT DECREASED (lost weight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for these events were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rash (incredible rash for the past 10 days) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced rash (incredible rash for the past 10 days). At the time of the report, rash (incredible rash for the past 10 days) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. Most recent follow-up information incorporated: On Jul 2, 2021: Follow-up received on Jul 2, 2021, event outcome updated from not recovered to recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0178) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Jun-2021 at 4:20 PM, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine administered). On 15-Jun-2021, WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not listed.  Treatment Information was not provided by the Reporter .   Reporter did not allow further contact
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of diarrhea in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 3, 2021, patient experienced diarrhea. The patient treated with Imodium (loperamide hydrochloride); 1 dosage form. At the time of the report, diarrhea outcome: unknown. The reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event: not applicable. Reporter stated the patient is on many medications but did not give additional information. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: Itchiness; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itchiness) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness) and HEADACHE (Headache). At the time of the report, PRURITUS (Itchiness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.No concomitant medications are provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: inappropriate schedule of vaccine; She had 103F fever for 3 days after 2nd shot.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine) and PYREXIA (She had 103F fever for 3 days after 2nd shot.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine). On an unknown date, the patient experienced PYREXIA (She had 103F fever for 3 days after 2nd shot.). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine) had resolved. At the time of the report, PYREXIA (She had 103F fever for 3 days after 2nd shot.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 103 (High) 103 degrees Fahrenheit.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: OB stated she should hold off on getting the second dose; first vaccine back in March; found out she was pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (OB stated she should hold off on getting the second dose) and EXPOSURE DURING PREGNANCY (first vaccine back in March; found out she was pregnant) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (first vaccine back in March; found out she was pregnant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (OB stated she should hold off on getting the second dose). On 06-Mar-2021, EXPOSURE DURING PREGNANCY (first vaccine back in March; found out she was pregnant) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (OB stated she should hold off on getting the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported  Treatment medication were not reported Additional information: Second dose was scheduled on April 2nd and the patient wanted to knew whether she can administer the 2nd dose of vaccine   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Significant Follow up information includes:Reporter details, patient details and new event was added