chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Rash, Skin tightness
Clinical narrative: his left arm is swollen. above elbow to shoulder; tight, hot to touch and red; tight, hot to touch and red; tight, hot to touch and red; big rash above his wrist on left arm next to watch, 2 inch by 3 inch rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (his left arm is swollen. above elbow to shoulder), FEELING HOT (tight, hot to touch and red), ERYTHEMA (tight, hot to touch and red), SKIN TIGHTNESS (tight, hot to touch and red) and RASH (big rash above his wrist on left arm next to watch, 2 inch by 3 inch rash) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No patient medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced RASH (big rash above his wrist on left arm next to watch, 2 inch by 3 inch rash). On an unknown date, the patient experienced PERIPHERAL SWELLING (his left arm is swollen. above elbow to shoulder), FEELING HOT (tight, hot to touch and red), ERYTHEMA (tight, hot to touch and red) and SKIN TIGHTNESS (tight, hot to touch and red). At the time of the report, PERIPHERAL SWELLING (his left arm is swollen. above elbow to shoulder), FEELING HOT (tight, hot to touch and red), ERYTHEMA (tight, hot to touch and red), SKIN TIGHTNESS (tight, hot to touch and red) and RASH (big rash above his wrist on left arm next to watch, 2 inch by 3 inch rash) 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.   The patient notes that they were advised by their health care provider to go to the emergency room and is scheduled to get an ultrasound.  No treatment medication information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041BZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 15-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: vaccine affect vision; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vaccine affect vision) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (vaccine affect vision). At the time of the report, VISUAL IMPAIRMENT (vaccine affect vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Rash, Rash macular
Clinical narrative: Rest of her body looked blotchy everywhere; It was painful.; It was burning/ Stomach rash got worse and felt like chemical burn; some body rash/a rash on chest and stomach. It proceeded to back and then entire body/Underneath her breast and stomach, rash was more solid; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Rest of her body looked blotchy everywhere), PAIN (It was painful.), BURNING SENSATION (It was burning/ Stomach rash got worse and felt like chemical burn) and RASH (some body rash/a rash on chest and stomach. It proceeded to back and then entire body/Underneath her breast and stomach, rash was more solid) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced RASH (some body rash/a rash on chest and stomach. It proceeded to back and then entire body/Underneath her breast and stomach, rash was more solid). On an unknown date, the patient experienced RASH MACULAR (Rest of her body looked blotchy everywhere), PAIN (It was painful.) and BURNING SENSATION (It was burning/ Stomach rash got worse and felt like chemical burn). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Rest of her body looked blotchy everywhere), PAIN (It was painful.), BURNING SENSATION (It was burning/ Stomach rash got worse and felt like chemical burn) and RASH (some body rash/a rash on chest and stomach. It proceeded to back and then entire body/Underneath her breast and stomach, rash was more solid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Skin disorder, Therapeutic response unexpected
Clinical narrative: autoimmune disease has gone; Mild Skin issue; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (autoimmune disease has gone) and SKIN DISORDER (Mild Skin issue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (Recovered after the administration of vaccine), Tiredness (Recovered after the administration  of vaccine) and Lupus syndrome (Patient suffered from lupus 3-4 years ago.). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (autoimmune disease has gone) and SKIN DISORDER (Mild Skin issue). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (autoimmune disease has gone) had resolved and SKIN DISORDER (Mild Skin issue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) autoimmune disease has gone..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included cultural pre and probiotics.   Medical history includes lupus which is recovered after the administration of vaccine. patient tested highly positive for lupus in April 2020. patient lab data included she received the results for blood work that her autoimmune disease has gone. The patient pre-existing medical condition include lupus, 3-4 years ago had really bad sickness and her doctor thought that could have thrown her into autoimmune situation but said she was never diagnosed medically having autoimmune disease. patient had c-difficile about 3 years ago and after the c-difficile was treated she had health issues up until 2 weeks after the 1st moderna coronavirus vaccine.  Treatment information was not provided.   This case was linked to MOD-2021-215828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received on 30-JUL-2021 contain  Patient Demographics added and concomitant medications have been provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report a side effect) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report a side effect). At the time of the report, VACCINATION COMPLICATION (report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Skin burning sensation
Clinical narrative: burning sensation on skin; red spots; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (burning sensation on skin) and RASH ERYTHEMATOUS (red spots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 SKIN BURNING SENSATION (burning sensation on skin) and RASH ERYTHEMATOUS (red spots). At the time of the report, SKIN BURNING SENSATION (burning sensation on skin) outcome was unknown and RASH ERYTHEMATOUS (red spots) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient took "some unidentified text" and it cleared up.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B821A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus (Tested highly positive for lupus) in April 2020. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood test: normal (normal) Normal.         Concomitant medications also included unspecified cultural pre and probiotic. No treatment medication was reported.   This case was linked to MOD-2021-215806, MOD-2021-215806 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received provided patient details, medical hsitory and concomitant medications.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity
Clinical narrative: feeling dizziness; allergy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizziness) and HYPERSENSITIVITY (allergy) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (feeling dizziness) and HYPERSENSITIVITY (allergy). At the time of the report, DIZZINESS (feeling dizziness) and HYPERSENSITIVITY (allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via eye contact
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPOSURE VIA EYE CONTACT (A vaccine spilled in the eye while taking second dose of Moderna Covid-19 Vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050c21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPOSURE VIA EYE CONTACT (A vaccine spilled in the eye while taking second dose of Moderna Covid-19 Vaccine). At the time of the report, EXPOSURE VIA EYE CONTACT (A vaccine spilled in the eye while taking second dose of Moderna Covid-19 Vaccine) had resolved.        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 reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: can the moderna vaccine effect my heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (can the moderna vaccine effect my heart) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (can the moderna vaccine effect my heart). At the time of the report, CARDIAC DISORDER (can the moderna vaccine effect my heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient receiving a vaccine from a vial that has been punctured for 22 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine from a vial that has been punctured for 22 hours) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 044B21A) 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) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine from a vial that has been punctured for 22 hours). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine from a vial that has been punctured for 22 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Diarrhea after First Vaccine; Stools have changed color after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after First Vaccine) and FAECES DISCOLOURED (Stools have changed color after First Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea after First Vaccine) and FAECES DISCOLOURED (Stools have changed color after First Vaccine). At the time of the report, DIARRHOEA (Diarrhea after First Vaccine) and FAECES DISCOLOURED (Stools have changed color after First Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: forgot about the scheduled second dose appointment on 25May2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (forgot about the scheduled second dose appointment on 25May2021) 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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (forgot about the scheduled second dose appointment on 25May2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (forgot about the scheduled second dose appointment on 25May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Still has headache 15 days later; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Still has headache 15 days later) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Still has headache 15 days later). At the time of the report, HEADACHE (Still has headache 15 days later) outcome was unknown.            No Concomitant and  treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine dose was administered from the vial punctured for > 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported.  HCP stated that Moderna COVID-19 vaccine was given to 4 patients yesterday (9Jun2021) from the vial which was punctured for more than 12 hours  Treatment information were not reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Malaise, Myalgia, Nausea
Clinical narrative: slept all day and night; was feeling pretty bad/still don't feel good; bodyaches /  feels like he got punched in the arm; nausea / still have nausea; headache / still have headache; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), SOMNOLENCE (slept all day and night), MALAISE (was feeling pretty bad/still don't feel good), MYALGIA (bodyaches /  feels like he got punched in the arm) and NAUSEA (nausea / still have nausea) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced ILLNESS (sick), MYALGIA (bodyaches /  feels like he got punched in the arm), NAUSEA (nausea / still have nausea) and HEADACHE (headache / still have headache). On an unknown date, the patient experienced SOMNOLENCE (slept all day and night) and MALAISE (was feeling pretty bad/still don't feel good). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) ongoing since an unknown date for Headache, at a dose of 1 dosage form and NAPROXEN ongoing since an unknown date for Headache, at a dose of 1 dosage form. At the time of the report, ILLNESS (sick), SOMNOLENCE (slept all day and night), MALAISE (was feeling pretty bad/still don't feel good), MYALGIA (bodyaches /  feels like he got punched in the arm), NAUSEA (nausea / still have nausea) and HEADACHE (headache / still have headache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medicines were not reported   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Updated Reporter details, Patient demographics, Added vaccination details , Treatment medications, Added new event Somnolence
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: slept all day and night; was feeling pretty bad/still don't feel good; bodyaches /  feels like he got punched in the arm; nausea / still have nausea; headache / still have headache; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), SOMNOLENCE (slept all day and night), MALAISE (was feeling pretty bad/still don't feel good), MYALGIA (bodyaches /  feels like he got punched in the arm) and NAUSEA (nausea / still have nausea) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced ILLNESS (sick), MYALGIA (bodyaches /  feels like he got punched in the arm), NAUSEA (nausea / still have nausea) and HEADACHE (headache / still have headache). On an unknown date, the patient experienced SOMNOLENCE (slept all day and night) and MALAISE (was feeling pretty bad/still don't feel good). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) ongoing since an unknown date for Headache, at a dose of 1 dosage form and NAPROXEN ongoing since an unknown date for Headache, at a dose of 1 dosage form. At the time of the report, ILLNESS (sick), SOMNOLENCE (slept all day and night), MALAISE (was feeling pretty bad/still don't feel good), MYALGIA (bodyaches /  feels like he got punched in the arm), NAUSEA (nausea / still have nausea) and HEADACHE (headache / still have headache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medicines were not reported   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Updated Reporter details, Patient demographics, Added vaccination details , Treatment medications, Added new event Somnolence
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain; my shoulder has been killing me,My shoulder aches to touch it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain) and ARTHRALGIA (my shoulder has been killing me,My shoulder aches to touch it) 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 PAIN (couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain) and ARTHRALGIA (my shoulder has been killing me,My shoulder aches to touch it). At the time of the report, PAIN (couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain) and ARTHRALGIA (my shoulder has been killing me,My shoulder aches to touch it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vaccination site pain
Clinical narrative: sore arm; my energy is low; feeling dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jun-2021 and was forwarded to Moderna on 10-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), ASTHENIA (my energy is low) and DIZZINESS (feeling dizzy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     N Medical History was reported.  Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced VACCINATION SITE PAIN (sore arm), ASTHENIA (my energy is low) and DIZZINESS (feeling dizzy). At the time of the report, VACCINATION SITE PAIN (sore arm), ASTHENIA (my energy is low) and DIZZINESS (feeling dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment Medicines were reported
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Paraesthesia oral, Pharyngeal swelling, Pyrexia, Rash pruritic
Clinical narrative: Throat is swollen, seemed to partially block her throat; Tongue felt bigger and seemed to partially block throat; Ulcer in mouth between her teeth and gums; Little rashes on chin and arms that were very itchy,itchy rash; Horrible sinus; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums), RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) and SINUS DISORDER (Horrible sinus) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PYREXIA (Fever). On 17-May-2021, the patient experienced PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums), RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) and SINUS DISORDER (Horrible sinus). The patient was treated with PARACETAMOL (TYLENOL) in May 2021 for Fever, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) in May 2021 for Sinus disorder, at an unspecified dose and frequency. On 17-May-2021, PYREXIA (Fever) had resolved. On 29-May-2021, SINUS DISORDER (Horrible sinus) had resolved. At the time of the report, PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums) and RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.   The treatment information was reported as some unknown antibiotic cream.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: Throat is swollen, seemed to partially block her throat; Tongue felt bigger and seemed to partially block throat; Ulcer in mouth between her teeth and gums; Little rashes on chin and arms that were very itchy,itchy rash; Horrible sinus; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums), RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) and SINUS DISORDER (Horrible sinus) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PYREXIA (Fever). On 17-May-2021, the patient experienced PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums), RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) and SINUS DISORDER (Horrible sinus). The patient was treated with PARACETAMOL (TYLENOL) in May 2021 for Fever, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) in May 2021 for Sinus disorder, at an unspecified dose and frequency. On 17-May-2021, PYREXIA (Fever) had resolved. On 29-May-2021, SINUS DISORDER (Horrible sinus) had resolved. At the time of the report, PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums) and RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.   The treatment information was reported as some unknown antibiotic cream.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 disease after 1st vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid-19 disease after 1st vaccine) in a 66-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 disease after 1st vaccine). At the time of the report, COVID-19 (covid-19 disease after 1st vaccine) 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.   No concomitant medications were provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Headache, Nausea, Swelling face, Vaccination site rash
Clinical narrative: facial swelling; redness; hot red rash at injection site spreading around top part of arm; headache; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), ERYTHEMA (redness), VACCINATION SITE RASH (hot red rash at injection site spreading around top part of arm), HEADACHE (headache) and NAUSEA (nausea) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (facial swelling), ERYTHEMA (redness), VACCINATION SITE RASH (hot red rash at injection site spreading around top part of arm), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, SWELLING FACE (facial swelling), ERYTHEMA (redness), VACCINATION SITE RASH (hot red rash at injection site spreading around top part of arm), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Mobility decreased, Neck pain
Clinical narrative: she can't even move; neck pain is unbearable; has diarrhea  since January started as every 10 to 15 minutes but now happen occasionally; shoulder pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (she can't even move), NECK PAIN (neck pain is unbearable), DIARRHOEA (has diarrhea  since January started as every 10 to 15 minutes but now happen occasionally) and ARTHRALGIA (shoulder pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced NECK PAIN (neck pain is unbearable), DIARRHOEA (has diarrhea  since January started as every 10 to 15 minutes but now happen occasionally) and ARTHRALGIA (shoulder pain). On 10-Jun-2021, the patient experienced MOBILITY DECREASED (she can't even move). The patient was treated with OMEPRAZOLE ongoing since an unknown date at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (she can't even move), NECK PAIN (neck pain is unbearable), DIARRHOEA (has diarrhea  since January started as every 10 to 15 minutes but now happen occasionally) and ARTHRALGIA (shoulder pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up information received on 10-JUN-2021 contains Significant information: Events, Concomitant and Treatment medications and Vaccine Doses updated
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Insomnia, Myalgia, Nausea
Clinical narrative: diarrhea; chest pain; nightmares; Difficulty sleeping; body pain; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping) and PAIN (body pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (cardiac stents), Pacemaker insertion (cardiac) (pacemaker) and Defibrillator/pacemaker insertion. Concurrent medical conditions included Diabetes.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping), PAIN (body pain), MYALGIA (body ache) and NAUSEA (nausea). The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) ongoing since an unknown date for Chest pain, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping), PAIN (body pain), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment was reported.  Patient has 8 cardiac stents and a pacemaker.  Patient reported allergic to about a dozen prescription drugs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Pain
Clinical narrative: diarrhea; chest pain; nightmares; Difficulty sleeping; body pain; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping) and PAIN (body pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (cardiac stents), Pacemaker insertion (cardiac) (pacemaker) and Defibrillator/pacemaker insertion. Concurrent medical conditions included Diabetes.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping), PAIN (body pain), MYALGIA (body ache) and NAUSEA (nausea). The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) ongoing since an unknown date for Chest pain, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping), PAIN (body pain), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment was reported.  Patient has 8 cardiac stents and a pacemaker.  Patient reported allergic to about a dozen prescription drugs.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (vaccination adverse reaction) in a patient, of an unknown age and gender, 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), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (vaccination adverse reaction). At the time of the report, vaccination complication (vaccination adverse reaction) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine): unknown. Concomitant product use and treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling on left side of face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling on left side of face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PARAESTHESIA (tingling on left side of face). At the time of the report, PARAESTHESIA (tingling on left side of face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications was  provided by the reporter. No concomitant medications was reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue and pyrexia (fever) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On May 19, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced fatigue and pyrexia (fever). At the time of the report, fatigue and pyrexia (fever) outcome: unknown. Diagnostic results: On an unknown date, SARS-CoV-2 test: Negative. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use and treatment information not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Increased appetite
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of increased appetite (strong appetite the next day after second Moderna shot) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced increased appetite (strong appetite the next day after second Moderna shot). At the time of the report, increased appetite (strong appetite the next day after second Moderna shot) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048c21a) 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 PRODUCT STORAGE ERROR (Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion) 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.   No Concomitant medications were provided No Treatment information provided
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.