chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling to right side of body; from top of head (scalp) to right thigh area. burning sensation to right ear. extreme headache. have had persisting symptoms since day of vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: I developed a severe cough I was given a covid test still waiting for results. I was given an inhaler and cough medicine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Menstruation irregular
Clinical narrative: My menstrual cycle became irregular after having he COVID-19 Moderna 1st shot. I'm still having irregular periods that are becoming more frequent and painful.
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Death, Dermatitis, Dyspnoea, Hypertransaminasaemia
Clinical narrative: [SARS-COV2 Vaccine (mRNA), Moderna use for COVID-19 under Emergency Use Authorization (EUA)] use for COVID-19 under Emergency Use Authorization (EUA)]: Patient passed away after a long, complicated hospital course that resulted in ARDs and appeared to be precipitated by inflammatory pneumonitis that developed after receipt of the 2nd dose of Moderna vaccine. 38 yo male with select PMH of HIV on antiretroviral therapy, ALK-negative anaplastic large cell lymphoma refractory to first line therapy s/p salvage chemo/radiation in CR1 after primary refractory disease at the time of allogenic peripheral blood stem cell transplant (matched unrelated donor). Post-transplant course complicated by pharyngeal and rectal mucositis, culture negative febrile neutropenia, mild BK virus associated hemorrhagic cystitis, and mild intermittent immune neutropenia. The patient was doing well at home with a good performance status and was exercising regularly. He received his first Moderna SARS-COV2 vaccine on 2/3/21 and developed a mild rash limited to the chest. Ten days after the second Moderna SARS-COV2 vaccine (given 3/12/21), the patient developed sudden onset shortness of breath, was found to have an oxygen saturation of 94% on room air at rest, and was hospitalized for 7 days. Imaging revealed diffuse ground glass opacities. He was also found to have a new transaminitis and worsening dermatitis, still restricted to his chest in discrete patches. Patient had a complicated hospital course and ultimately passed on 5/14/21 after withdrawal of care/comfort measures only on 5/12/21.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Lung opacity, Pneumonitis, Pulmonary imaging procedure abnormal, Rash
Clinical narrative: [SARS-COV2 Vaccine (mRNA), Moderna use for COVID-19 under Emergency Use Authorization (EUA)] use for COVID-19 under Emergency Use Authorization (EUA)]: Patient passed away after a long, complicated hospital course that resulted in ARDs and appeared to be precipitated by inflammatory pneumonitis that developed after receipt of the 2nd dose of Moderna vaccine. 38 yo male with select PMH of HIV on antiretroviral therapy, ALK-negative anaplastic large cell lymphoma refractory to first line therapy s/p salvage chemo/radiation in CR1 after primary refractory disease at the time of allogenic peripheral blood stem cell transplant (matched unrelated donor). Post-transplant course complicated by pharyngeal and rectal mucositis, culture negative febrile neutropenia, mild BK virus associated hemorrhagic cystitis, and mild intermittent immune neutropenia. The patient was doing well at home with a good performance status and was exercising regularly. He received his first Moderna SARS-COV2 vaccine on 2/3/21 and developed a mild rash limited to the chest. Ten days after the second Moderna SARS-COV2 vaccine (given 3/12/21), the patient developed sudden onset shortness of breath, was found to have an oxygen saturation of 94% on room air at rest, and was hospitalized for 7 days. Imaging revealed diffuse ground glass opacities. He was also found to have a new transaminitis and worsening dermatitis, still restricted to his chest in discrete patches. Patient had a complicated hospital course and ultimately passed on 5/14/21 after withdrawal of care/comfort measures only on 5/12/21.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Premature separation of placenta, Stillbirth, Thrombosis
Clinical narrative: 25 year old pregnant female received covid vaccination approximately 2-3 weeks prior to her expected delivery date. Her and her husband lost their baby due to placenta separation caused by a blood clot to the fetus. The root cause of the blood clot was determined to be the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye movement disorder, Feeling hot, Loss of consciousness, Sensory disturbance
Clinical narrative: About 12-14 hours after my second dose of the Pfizer Covid-19 vaccine, I had symptoms consistent with passing out. I was in bed trying to get warm from the intense chills I was feeling. My eyes felt like they rolled up to the back of my head, I felt a sinking feeling, and I snapped out of it with a warm feeling all over and my chills were gone.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: patient reported submandibular lymphadenopathy as possible side effect o f cosentyx. he reported that he had moderna covid-19 vaccination on 3/18 and on 3/11 he developed right sided submandibular lymphadenopathy, then it happened again after his 2nd dose. he spoke to an internist that felt it may be due to vaccination and gave him an antibiotic. however he ha d a third case 3 days after cosentyx injection so he is not sure that is if from the vaccination. pt is a retired physician. he will speak to his rheumatologist again to see if he should keep using or if he needs to consider another treatment.no additional information or dates  provided.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bed rest, Headache, Immobile, Impaired work ability, Migraine
Clinical narrative: progressively worse heacache that become a Migraine; patient was incapicitated and unable to work; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MIGRAINE (progressively worse heacache that become a Migraine) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was incapicitated and unable to work) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced MIGRAINE (progressively worse heacache that become a Migraine) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was incapicitated and unable to work). The patient was treated with Bed rest for Migraine. At the time of the report, MIGRAINE (progressively worse heacache that become a Migraine) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was incapicitated and unable to work) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.   This case was linked to MOD-2021-028469 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Migraine
Clinical narrative: progressively worse heacache that become a Migraine; patient was incapicitated and unable to work; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MIGRAINE (progressively worse heacache that become a Migraine) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was incapicitated and unable to work) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced MIGRAINE (progressively worse heacache that become a Migraine) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was incapicitated and unable to work). The patient was treated with Bed rest for Migraine. At the time of the report, MIGRAINE (progressively worse heacache that become a Migraine) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was incapicitated and unable to work) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.   This case was linked to MOD-2021-028469 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (vaccination site rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (vaccination site rash). At the time of the report, VACCINATION SITE RASH (vaccination site rash) had resolved.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site rash
Clinical narrative: vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (vaccination site rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (vaccination site rash). At the time of the report, VACCINATION SITE RASH (vaccination site rash) had resolved.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red rash; Soreness; A spontaneous report  was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red rash(rash erythematous), soreness(pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, approximately 8 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the event(s) red rash and soreness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), red rash and soreness was unknown..
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash erythematous
Clinical narrative: Red rash; Soreness; A spontaneous report  was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red rash(rash erythematous), soreness(pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, approximately 8 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the event(s) red rash and soreness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), red rash and soreness was unknown..
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis, Erythema, Pruritus
Clinical narrative: upper arm where she got vaccinated is red; upper arm where she got vaccinated started itching; upper arm where she got vaccinated is swollen; A spontaneous report (United States) was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events upper arm where she got vaccinated started itching, upper arm where she got vaccinated is red, upper arm where she got vaccinated is swollen, upper arm where she got vaccinated is very itch, upper arm where she got vaccinated is a large oval at about 2 inch wide and 3 inch long,  The patient's medical history was not provided. Concomitant medications reported were Losartan, Lipitor, Vitamin D, Omeprazole, Turmeric, Movfree, Ginko Billoba, preservision, Anti-histamine for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) upper arm where she got vaccinated started itching. upper arm where she got vaccinated is red, upper arm where she got vaccinated is swollen, upper arm where she got vaccinated is very itch, upper arm where she got vaccinated is a large oval at about 2 inch wide and 3 inch long.  Treatment details included Said that she is still able to tolerate it that is why she haven't took any medication to treat it..  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), upper arm where she got vaccinated started itching, upper arm where she got vaccinated is red,upper arm where she got vaccinated is swollen,upper arm where she got vaccinated is very itch,upper arm where she got vaccinated is a large oval at about 2 inch wide and 3 inch long,  was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: upper arm where she got vaccinated is red; upper arm where she got vaccinated started itching; upper arm where she got vaccinated is swollen; A spontaneous report (United States) was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events upper arm where she got vaccinated started itching, upper arm where she got vaccinated is red, upper arm where she got vaccinated is swollen, upper arm where she got vaccinated is very itch, upper arm where she got vaccinated is a large oval at about 2 inch wide and 3 inch long,  The patient's medical history was not provided. Concomitant medications reported were Losartan, Lipitor, Vitamin D, Omeprazole, Turmeric, Movfree, Ginko Billoba, preservision, Anti-histamine for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) upper arm where she got vaccinated started itching. upper arm where she got vaccinated is red, upper arm where she got vaccinated is swollen, upper arm where she got vaccinated is very itch, upper arm where she got vaccinated is a large oval at about 2 inch wide and 3 inch long.  Treatment details included Said that she is still able to tolerate it that is why she haven't took any medication to treat it..  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), upper arm where she got vaccinated started itching, upper arm where she got vaccinated is red,upper arm where she got vaccinated is swollen,upper arm where she got vaccinated is very itch,upper arm where she got vaccinated is a large oval at about 2 inch wide and 3 inch long,  was unknown.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Speech disorder, Swollen tongue
Clinical narrative: Shortness of breath( breathing difficulty); fogginess; Headache; fatigue; Soreness of arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), DYSPNOEA (Shortness of breath( breathing difficulty)), FEELING ABNORMAL (fogginess), HEADACHE (Headache) and FATIGUE (fatigue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). On 21-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath( breathing difficulty)), FEELING ABNORMAL (fogginess), HEADACHE (Headache) and FATIGUE (fatigue). The patient was treated with PREDNISONE at an unspecified dose and frequency; AZITHROMYCIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of arm), DYSPNOEA (Shortness of breath( breathing difficulty)), FEELING ABNORMAL (fogginess), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of Prednisone 20mg, Azithromycin 500mg, Tylenol reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-070096 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070096:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Headache, Vision blurred
Clinical narrative: Shortness of breath( breathing difficulty); fogginess; Headache; fatigue; Soreness of arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), DYSPNOEA (Shortness of breath( breathing difficulty)), FEELING ABNORMAL (fogginess), HEADACHE (Headache) and FATIGUE (fatigue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). On 21-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath( breathing difficulty)), FEELING ABNORMAL (fogginess), HEADACHE (Headache) and FATIGUE (fatigue). The patient was treated with PREDNISONE at an unspecified dose and frequency; AZITHROMYCIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of arm), DYSPNOEA (Shortness of breath( breathing difficulty)), FEELING ABNORMAL (fogginess), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of Prednisone 20mg, Azithromycin 500mg, Tylenol reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-070096 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070096:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Shortness of breath( breathing difficulty); fogginess; Headache; fatigue; Soreness of arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), DYSPNOEA (Shortness of breath( breathing difficulty)), FEELING ABNORMAL (fogginess), HEADACHE (Headache) and FATIGUE (fatigue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). On 21-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath( breathing difficulty)), FEELING ABNORMAL (fogginess), HEADACHE (Headache) and FATIGUE (fatigue). The patient was treated with PREDNISONE at an unspecified dose and frequency; AZITHROMYCIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of arm), DYSPNOEA (Shortness of breath( breathing difficulty)), FEELING ABNORMAL (fogginess), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of Prednisone 20mg, Azithromycin 500mg, Tylenol reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-070096 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070096:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: ecchymosis type bruising; upper left arm covered in purpura; spot high on th eupper right arm that is scabbed over approximately 4 mm in size; little redness; slight soreness on the left arm; bruising noted on the lower half of both arms as well; This spontaneous case was reported by a nurse and describes the occurrence of ECCHYMOSIS (ecchymosis type bruising), PURPURA (upper left arm covered in purpura), SCAB (spot high on th eupper right arm that is scabbed over approximately 4 mm in size), ERYTHEMA (little redness) and PAIN IN EXTREMITY (slight soreness on the left arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal fusion. Concurrent medical conditions included Leg infection and Hearing loss. Concomitant products included ACETYLSALICYLIC ACID for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ECCHYMOSIS (ecchymosis type bruising), PURPURA (upper left arm covered in purpura), SCAB (spot high on th eupper right arm that is scabbed over approximately 4 mm in size), ERYTHEMA (little redness), PAIN IN EXTREMITY (slight soreness on the left arm) and CONTUSION (bruising noted on the lower half of both arms as well). At the time of the report, ECCHYMOSIS (ecchymosis type bruising), PURPURA (upper left arm covered in purpura), SCAB (spot high on th eupper right arm that is scabbed over approximately 4 mm in size), ERYTHEMA (little redness), PAIN IN EXTREMITY (slight soreness on the left arm) and CONTUSION (bruising noted on the lower half of both arms as well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medications included blood pressure medications, cholesterol medications, blood thinner.  The patient has not and does not plan to seek medical attention for this local reaction.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Ecchymosis, Erythema, Pain in extremity, Purpura
Clinical narrative: ecchymosis type bruising; upper left arm covered in purpura; spot high on th eupper right arm that is scabbed over approximately 4 mm in size; little redness; slight soreness on the left arm; bruising noted on the lower half of both arms as well; This spontaneous case was reported by a nurse and describes the occurrence of ECCHYMOSIS (ecchymosis type bruising), PURPURA (upper left arm covered in purpura), SCAB (spot high on th eupper right arm that is scabbed over approximately 4 mm in size), ERYTHEMA (little redness) and PAIN IN EXTREMITY (slight soreness on the left arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal fusion. Concurrent medical conditions included Leg infection and Hearing loss. Concomitant products included ACETYLSALICYLIC ACID for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ECCHYMOSIS (ecchymosis type bruising), PURPURA (upper left arm covered in purpura), SCAB (spot high on th eupper right arm that is scabbed over approximately 4 mm in size), ERYTHEMA (little redness), PAIN IN EXTREMITY (slight soreness on the left arm) and CONTUSION (bruising noted on the lower half of both arms as well). At the time of the report, ECCHYMOSIS (ecchymosis type bruising), PURPURA (upper left arm covered in purpura), SCAB (spot high on th eupper right arm that is scabbed over approximately 4 mm in size), ERYTHEMA (little redness), PAIN IN EXTREMITY (slight soreness on the left arm) and CONTUSION (bruising noted on the lower half of both arms as well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medications included blood pressure medications, cholesterol medications, blood thinner.  The patient has not and does not plan to seek medical attention for this local reaction.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scab
Clinical narrative: ecchymosis type bruising; upper left arm covered in purpura; spot high on th eupper right arm that is scabbed over approximately 4 mm in size; little redness; slight soreness on the left arm; bruising noted on the lower half of both arms as well; This spontaneous case was reported by a nurse and describes the occurrence of ECCHYMOSIS (ecchymosis type bruising), PURPURA (upper left arm covered in purpura), SCAB (spot high on th eupper right arm that is scabbed over approximately 4 mm in size), ERYTHEMA (little redness) and PAIN IN EXTREMITY (slight soreness on the left arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal fusion. Concurrent medical conditions included Leg infection and Hearing loss. Concomitant products included ACETYLSALICYLIC ACID for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ECCHYMOSIS (ecchymosis type bruising), PURPURA (upper left arm covered in purpura), SCAB (spot high on th eupper right arm that is scabbed over approximately 4 mm in size), ERYTHEMA (little redness), PAIN IN EXTREMITY (slight soreness on the left arm) and CONTUSION (bruising noted on the lower half of both arms as well). At the time of the report, ECCHYMOSIS (ecchymosis type bruising), PURPURA (upper left arm covered in purpura), SCAB (spot high on th eupper right arm that is scabbed over approximately 4 mm in size), ERYTHEMA (little redness), PAIN IN EXTREMITY (slight soreness on the left arm) and CONTUSION (bruising noted on the lower half of both arms as well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medications included blood pressure medications, cholesterol medications, blood thinner.  The patient has not and does not plan to seek medical attention for this local reaction.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Swelling
Clinical narrative: EYES FEEL AS IF THEY ARE BULGING; DIFFICULTY BREATHING; EYES SECRETING WHITE RESIDUE; FEELS BLOATED; FEELING OF LUNGS BEING COMPRESSED/SWALLON; FEELS EXHAUSTED; SWELLING OF LIMBS / SWELLING  IN HER HANDS; GAINED 20LBS OVERNIGHT; BODY ACHES; RASH ON HER LEFT LOWER LEG; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced body aches. On 22-MAR-2021, the patient experienced rash on her left lower leg. On 22-MAR-2021, the patient experienced headache. On 23-MAR-2021, the patient experienced swelling of limbs / swelling in her hands. On 23-MAR-2021, the patient experienced gained 20lbs overnight. On 12-JUL-2021, Laboratory data included: Vascular test (NR: not provided) veins felt like they were going to pop. On 28-JUL-2021, Laboratory data included: Pulmonary function test (NR: not provided) not reported. On an unspecified date, the patient experienced eyes feel as if they are bulging, difficulty breathing, eyes secreting white residue, feels bloated, feeling of lungs being compressed/swallon, and feels exhausted. Laboratory data (dates unspecified) included: Blood test (NR: not provided) negative for blood clots, and EKG (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body aches, rash on her left lower leg, swelling of limbs / swelling in her hands, gained 20lbs overnight, eyes feel as if they are bulging, difficulty breathing, eyes secreting white residue, feels exhausted, feels bloated and feeling of lungs being compressed/swallon was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abnormal sensation in eye, Blood test, Chest discomfort, Dyspnoea
Clinical narrative: EYES FEEL AS IF THEY ARE BULGING; DIFFICULTY BREATHING; EYES SECRETING WHITE RESIDUE; FEELS BLOATED; FEELING OF LUNGS BEING COMPRESSED/SWALLON; FEELS EXHAUSTED; SWELLING OF LIMBS / SWELLING  IN HER HANDS; GAINED 20LBS OVERNIGHT; BODY ACHES; RASH ON HER LEFT LOWER LEG; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced body aches. On 22-MAR-2021, the patient experienced rash on her left lower leg. On 22-MAR-2021, the patient experienced headache. On 23-MAR-2021, the patient experienced swelling of limbs / swelling in her hands. On 23-MAR-2021, the patient experienced gained 20lbs overnight. On 12-JUL-2021, Laboratory data included: Vascular test (NR: not provided) veins felt like they were going to pop. On 28-JUL-2021, Laboratory data included: Pulmonary function test (NR: not provided) not reported. On an unspecified date, the patient experienced eyes feel as if they are bulging, difficulty breathing, eyes secreting white residue, feels bloated, feeling of lungs being compressed/swallon, and feels exhausted. Laboratory data (dates unspecified) included: Blood test (NR: not provided) negative for blood clots, and EKG (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body aches, rash on her left lower leg, swelling of limbs / swelling in her hands, gained 20lbs overnight, eyes feel as if they are bulging, difficulty breathing, eyes secreting white residue, feels exhausted, feels bloated and feeling of lungs being compressed/swallon was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Ocular discomfort, Pain
Clinical narrative: EYES FEEL AS IF THEY ARE BULGING; DIFFICULTY BREATHING; EYES SECRETING WHITE RESIDUE; FEELS BLOATED; FEELING OF LUNGS BEING COMPRESSED/SWALLON; FEELS EXHAUSTED; SWELLING OF LIMBS / SWELLING  IN HER HANDS; GAINED 20LBS OVERNIGHT; BODY ACHES; RASH ON HER LEFT LOWER LEG; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced body aches. On 22-MAR-2021, the patient experienced rash on her left lower leg. On 22-MAR-2021, the patient experienced headache. On 23-MAR-2021, the patient experienced swelling of limbs / swelling in her hands. On 23-MAR-2021, the patient experienced gained 20lbs overnight. On 12-JUL-2021, Laboratory data included: Vascular test (NR: not provided) veins felt like they were going to pop. On 28-JUL-2021, Laboratory data included: Pulmonary function test (NR: not provided) not reported. On an unspecified date, the patient experienced eyes feel as if they are bulging, difficulty breathing, eyes secreting white residue, feels bloated, feeling of lungs being compressed/swallon, and feels exhausted. Laboratory data (dates unspecified) included: Blood test (NR: not provided) negative for blood clots, and EKG (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body aches, rash on her left lower leg, swelling of limbs / swelling in her hands, gained 20lbs overnight, eyes feel as if they are bulging, difficulty breathing, eyes secreting white residue, feels exhausted, feels bloated and feeling of lungs being compressed/swallon was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pulmonary function test, Rash, Vascular test, Weight increased
Clinical narrative: EYES FEEL AS IF THEY ARE BULGING; DIFFICULTY BREATHING; EYES SECRETING WHITE RESIDUE; FEELS BLOATED; FEELING OF LUNGS BEING COMPRESSED/SWALLON; FEELS EXHAUSTED; SWELLING OF LIMBS / SWELLING  IN HER HANDS; GAINED 20LBS OVERNIGHT; BODY ACHES; RASH ON HER LEFT LOWER LEG; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced body aches. On 22-MAR-2021, the patient experienced rash on her left lower leg. On 22-MAR-2021, the patient experienced headache. On 23-MAR-2021, the patient experienced swelling of limbs / swelling in her hands. On 23-MAR-2021, the patient experienced gained 20lbs overnight. On 12-JUL-2021, Laboratory data included: Vascular test (NR: not provided) veins felt like they were going to pop. On 28-JUL-2021, Laboratory data included: Pulmonary function test (NR: not provided) not reported. On an unspecified date, the patient experienced eyes feel as if they are bulging, difficulty breathing, eyes secreting white residue, feels bloated, feeling of lungs being compressed/swallon, and feels exhausted. Laboratory data (dates unspecified) included: Blood test (NR: not provided) negative for blood clots, and EKG (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body aches, rash on her left lower leg, swelling of limbs / swelling in her hands, gained 20lbs overnight, eyes feel as if they are bulging, difficulty breathing, eyes secreting white residue, feels exhausted, feels bloated and feeling of lungs being compressed/swallon was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: rash on the left leg; diarhea; rash on the stomach; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the left leg), DIARRHOEA (diarhea), RASH (rash on the stomach) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included Blood pressure medication and Diabetes medication for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (rash on the left leg), DIARRHOEA (diarhea), RASH (rash on the stomach) and FATIGUE (fatigue). At the time of the report, RASH (rash on the left leg), DIARRHOEA (diarhea), RASH (rash on the stomach) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non significant follow up on 12-MAY-2021, Email, Address Updated
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Rash
Clinical narrative: rash on the left leg; diarhea; rash on the stomach; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the left leg), DIARRHOEA (diarhea), RASH (rash on the stomach) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included Blood pressure medication and Diabetes medication for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (rash on the left leg), DIARRHOEA (diarhea), RASH (rash on the stomach) and FATIGUE (fatigue). At the time of the report, RASH (rash on the left leg), DIARRHOEA (diarhea), RASH (rash on the stomach) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non significant follow up on 12-MAY-2021, Email, Address Updated
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Pneumonia,  death
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Pneumonia
Clinical narrative: Pneumonia,  death
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dizziness, Trismus
Clinical narrative: Initially mildly dizzy at about 20 minutes post vaccine Significant difficulty breathing at about 35 minutes post vaccine Extremely ill 2-3 days post vaccine. Fever, massive headache, chills, bone pain, shortness of breath.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Chills, Dizziness, Dyspnoea, Dystonia
Clinical narrative: Initially mildly dizzy at about 20 minutes post vaccine Significant difficulty breathing at about 35 minutes post vaccine Extremely ill 2-3 days post vaccine. Fever, massive headache, chills, bone pain, shortness of breath.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypersensitivity, Malaise, Pyrexia
Clinical narrative: Initially mildly dizzy at about 20 minutes post vaccine Significant difficulty breathing at about 35 minutes post vaccine Extremely ill 2-3 days post vaccine. Fever, massive headache, chills, bone pain, shortness of breath.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: BLOOD CLOTS ON LUNGS; PAIN IN BACK; PAIN IN SHOULDERS; WASN'T FEELING WELL; This spontaneous report received from a parent concerned a 27 year old, male. The patient's weight was 200 pounds, and height was 70.5 inches. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, one total administered on right arm on 30-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 04-AUG-2021, the patient wasn't feeling well and had pain in shoulders and pain in back.  On 05-AUG-2021, the patient experienced chest pain that got worse with deep breath, and went to urgent care and was later on that day, the patient was sent to emergency room and ran a bunch of tests including a CT scan and found blood clots on his lungs. The patient was hospitalized on the same day and was kept on Heparin until 08-AUG-2021 On an unspecified date, laboratory test of hereditary disease was performed whose results were negative. On 08-AUG-2021, the patient was discharged with a prescription for a blood thinner, Eliquis, for an unknown amount of time.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wasn't feeling well, pain in shoulders, pain in back and blood clots on lungs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210832359-covid-19 vaccine ad26.cov2.s-blood clots on lungs; pain in back. This case concerned to a concerned a 27 year old, male patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210832359-covid-19 vaccine ad26.cov2.s-pain in shoulders; wasn't feeling well. This event(s) is labeled and is therefore considered potentially related.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Computerised tomogram, Laboratory test, Malaise
Clinical narrative: BLOOD CLOTS ON LUNGS; PAIN IN BACK; PAIN IN SHOULDERS; WASN'T FEELING WELL; This spontaneous report received from a parent concerned a 27 year old, male. The patient's weight was 200 pounds, and height was 70.5 inches. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, one total administered on right arm on 30-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 04-AUG-2021, the patient wasn't feeling well and had pain in shoulders and pain in back.  On 05-AUG-2021, the patient experienced chest pain that got worse with deep breath, and went to urgent care and was later on that day, the patient was sent to emergency room and ran a bunch of tests including a CT scan and found blood clots on his lungs. The patient was hospitalized on the same day and was kept on Heparin until 08-AUG-2021 On an unspecified date, laboratory test of hereditary disease was performed whose results were negative. On 08-AUG-2021, the patient was discharged with a prescription for a blood thinner, Eliquis, for an unknown amount of time.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wasn't feeling well, pain in shoulders, pain in back and blood clots on lungs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210832359-covid-19 vaccine ad26.cov2.s-blood clots on lungs; pain in back. This case concerned to a concerned a 27 year old, male patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210832359-covid-19 vaccine ad26.cov2.s-pain in shoulders; wasn't feeling well. This event(s) is labeled and is therefore considered potentially related.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS ON LUNGS; PAIN IN BACK; PAIN IN SHOULDERS; WASN'T FEELING WELL; This spontaneous report received from a parent concerned a 27 year old, male. The patient's weight was 200 pounds, and height was 70.5 inches. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, one total administered on right arm on 30-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 04-AUG-2021, the patient wasn't feeling well and had pain in shoulders and pain in back.  On 05-AUG-2021, the patient experienced chest pain that got worse with deep breath, and went to urgent care and was later on that day, the patient was sent to emergency room and ran a bunch of tests including a CT scan and found blood clots on his lungs. The patient was hospitalized on the same day and was kept on Heparin until 08-AUG-2021 On an unspecified date, laboratory test of hereditary disease was performed whose results were negative. On 08-AUG-2021, the patient was discharged with a prescription for a blood thinner, Eliquis, for an unknown amount of time.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wasn't feeling well, pain in shoulders, pain in back and blood clots on lungs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210832359-covid-19 vaccine ad26.cov2.s-blood clots on lungs; pain in back. This case concerned to a concerned a 27 year old, male patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210832359-covid-19 vaccine ad26.cov2.s-pain in shoulders; wasn't feeling well. This event(s) is labeled and is therefore considered potentially related.