chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Heart rate increased, Rash, Tongue pruritus
Clinical narrative: rash on lower back; heart rate elevated; tongue was itchy; cough; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate elevated), TONGUE PRURITUS (tongue was itchy), COUGH (cough) and RASH (rash on lower back) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.  On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 07-Apr-2021, the patient experienced HEART RATE INCREASED (heart rate elevated), TONGUE PRURITUS (tongue was itchy) and COUGH (cough).   On 08-Apr-2021, the patient experienced RASH (rash on lower back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   On 07-Apr-2021, HEART RATE INCREASED (heart rate elevated) had resolved. On 14-Apr-2021, TONGUE PRURITUS (tongue was itchy) and COUGH (cough) had resolved. At the time of the report, RASH (rash on lower back) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   It is reported that patient's doctor recommended to get the second dose, but patient declines to get second dose due to these side effects experienced. Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Joint stiffness, Myalgia, Pain in extremity, Vaccination site rash
Clinical narrative: splotchy arm rash two days after the first shot; painful leg pain; joint stiffness; muscle ache; 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 PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness), MYALGIA (muscle ache) and VACCINATION SITE RASH (splotchy arm rash two days after the first shot) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 01-Mar-2021, the patient experienced VACCINATION SITE RASH (splotchy arm rash two days after the first shot).   In March 2021, the patient experienced PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness) and MYALGIA (muscle ache).   At the time of the report, PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness), MYALGIA (muscle ache) and VACCINATION SITE RASH (splotchy arm rash two days after the first shot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Excessive cerumen production, Heart rate increased
Clinical narrative: heart beat was faster; accumulation of wax in ear; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart beat was faster) and EXCESSIVE CERUMEN PRODUCTION (accumulation of wax in ear) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007621A and 026C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 20-May-2021, the patient experienced HEART RATE INCREASED (heart beat was faster) and EXCESSIVE CERUMEN PRODUCTION (accumulation of wax in ear). At the time of the report, HEART RATE INCREASED (heart beat was faster) and EXCESSIVE CERUMEN PRODUCTION (accumulation of wax in ear) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-162141 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Herpes zoster, Vaccination site pain
Clinical narrative: itch; Vaccination site pain; Diarrhea; Shingles (Herpes Zoster)/ She said that it was shingles; hives; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), DIARRHOEA (Diarrhea), HERPES ZOSTER (Shingles (Herpes Zoster)/ She said that it was shingles), URTICARIA (hives) and PRURITUS (itch) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Raynaud's syndrome (The patient was diagnosed 10 years ago. The patient is stable and is not on any medication.). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, EZETIMIBE (ZETIA) for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), DIARRHOEA (Diarrhea), HERPES ZOSTER (Shingles (Herpes Zoster)/ She said that it was shingles) and URTICARIA (hives). On 16-Jun-2021, the patient experienced PRURITUS (itch). The patient was treated with VALACYCLOVIR [VALACICLOVIR] from 20-May-2021 to 03-Jun-2021 at a dose of 1 g three times a day. On 21-May-2021, VACCINATION SITE PAIN (Vaccination site pain) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, HERPES ZOSTER (Shingles (Herpes Zoster)/ She said that it was shingles) and PRURITUS (itch) had not resolved and URTICARIA (hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Zyrtec was mentioned as over the counter medication and Patient took aspirin 81 mg as concomitant product  was mentioned as low dose. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-083015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received and contains information about concomitant medication and its indications, treatment medication start date and stop date and new events.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Vaccination site warmth
Clinical narrative: Hotness and stiffness in the arm of the injection; Hotness and stiffness in the arm of the injection; Horrible pain in the arm; Intermittent finger swelling; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE WARMTH (Hotness and stiffness in the arm of the injection), MUSCULOSKELETAL STIFFNESS (Hotness and stiffness in the arm of the injection), PAIN IN EXTREMITY (Horrible pain in the arm) and PERIPHERAL SWELLING (Intermittent finger swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hotness and stiffness in the arm of the injection), MUSCULOSKELETAL STIFFNESS (Hotness and stiffness in the arm of the injection), PAIN IN EXTREMITY (Horrible pain in the arm) and PERIPHERAL SWELLING (Intermittent finger swelling). At the time of the report, VACCINATION SITE WARMTH (Hotness and stiffness in the arm of the injection), MUSCULOSKELETAL STIFFNESS (Hotness and stiffness in the arm of the injection), PAIN IN EXTREMITY (Horrible pain in the arm) and PERIPHERAL SWELLING (Intermittent finger swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; 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 HEADACHE (Headache) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of COUGH (coughing) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing). At the time of the report, COUGH (coughing) outcome was unknown.            Concomitant and treatment information does not provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: slept all day; weak; tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), ASTHENIA (weak) and FATIGUE (tired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, LISINOPRIL for Blood pressure high, TAMSULOSIN for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced SOMNOLENCE (slept all day), ASTHENIA (weak) and FATIGUE (tired). At the time of the report, SOMNOLENCE (slept all day), ASTHENIA (weak) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.   This case was linked to MOD-2021-162202 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: Had to reschedule her second dose appointment because she wasn't feeling well; Had to reschedule her second dose appointment because she wasn't feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Had to reschedule her second dose appointment because she wasn't feeling well) and PRODUCT DOSE OMISSION ISSUE (Had to reschedule her second dose appointment because she wasn't feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced MALAISE (Had to reschedule her second dose appointment because she wasn't feeling well). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Had to reschedule her second dose appointment because she wasn't feeling well). At the time of the report, MALAISE (Had to reschedule her second dose appointment because she wasn't feeling well) and PRODUCT DOSE OMISSION ISSUE (Had to reschedule her second dose appointment because she wasn't feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nauseous; threw up several times; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and VOMITING (threw up several times) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE for Pain, MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 22-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced NAUSEA (nauseous) and VOMITING (threw up several times). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, NAUSEA (nauseous) and VOMITING (threw up several times) was resolving.        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.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (Bad headache). At the time of the report, HEADACHE (Bad headache) 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.   This case was linked to MOD-2021-162163 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: i miss my 2nd dose of covid vaccine; 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 PRODUCT DOSE OMISSION ISSUE (i miss my 2nd dose of covid 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 PRODUCT DOSE OMISSION ISSUE (i miss my 2nd dose of covid vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (i miss my 2nd dose of covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Myalgia, Urticaria
Clinical narrative: it is still very sore and those welts are painful; 3 red welts appeared; it burned and stung; 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 BURNING SENSATION (it burned and stung), URTICARIA (3 red welts appeared) and MYALGIA (it is still very sore and those welts are painful) 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 was provided by the reporter .     On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-May-2021, the patient experienced BURNING SENSATION (it burned and stung). On 20-May-2021, the patient experienced URTICARIA (3 red welts appeared). On an unknown date, the patient experienced MYALGIA (it is still very sore and those welts are painful). At the time of the report, BURNING SENSATION (it burned and stung), URTICARIA (3 red welts appeared) and MYALGIA (it is still very sore and those welts are painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: area where I got the shot going red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (area where I got the shot going red) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (area where I got the shot going red). At the time of the report, VACCINATION SITE ERYTHEMA (area where I got the shot going red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Asthenia, Diarrhoea haemorrhagic, Fatigue
Clinical narrative: blood in stool with less amount; diarrhea (7-8 times) with signs of bright red blood; Lower abdominal cramping; extreme pain; severe abdominal pain/cramps; extremely tired/ little exhausted feeling comes and go; body weakness; slept all day; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), HAEMATOCHEZIA (blood in stool with less amount), ASTHENIA (body weakness), SOMNOLENCE (slept all day) and ABDOMINAL PAIN LOWER (Lower abdominal cramping) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Prostatic disorder. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, LISINOPRIL for Blood pressure high, TAMSULOSIN for Prostatic disorder.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ASTHENIA (body weakness), SOMNOLENCE (slept all day) and FATIGUE (extremely tired/ little exhausted feeling comes and go). On 21-May-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), ABDOMINAL PAIN LOWER (Lower abdominal cramping), PAIN (extreme pain) and ABDOMINAL PAIN (severe abdominal pain/cramps). On 22-May-2021, the patient experienced HAEMATOCHEZIA (blood in stool with less amount). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of OTC, 2mg. On 06-May-2021, ASTHENIA (body weakness), SOMNOLENCE (slept all day) and FATIGUE (extremely tired/ little exhausted feeling comes and go) had resolved. On 22-May-2021, PAIN (extreme pain) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), HAEMATOCHEZIA (blood in stool with less amount), ABDOMINAL PAIN LOWER (Lower abdominal cramping) and ABDOMINAL PAIN (severe abdominal pain/cramps) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 06May2021, patient got blood work done. No results was given. Patient was in an extreme pain from 7pm and it last all night This case is linked case to Original Case : MOD-2021-162193 Action taken with mRNA-1273 in response to the event was Not Applicable  Very limited information regarding the events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events have been provided at this time. Further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Pain, Somnolence
Clinical narrative: blood in stool with less amount; diarrhea (7-8 times) with signs of bright red blood; Lower abdominal cramping; extreme pain; severe abdominal pain/cramps; extremely tired/ little exhausted feeling comes and go; body weakness; slept all day; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), HAEMATOCHEZIA (blood in stool with less amount), ASTHENIA (body weakness), SOMNOLENCE (slept all day) and ABDOMINAL PAIN LOWER (Lower abdominal cramping) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Prostatic disorder. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, LISINOPRIL for Blood pressure high, TAMSULOSIN for Prostatic disorder.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ASTHENIA (body weakness), SOMNOLENCE (slept all day) and FATIGUE (extremely tired/ little exhausted feeling comes and go). On 21-May-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), ABDOMINAL PAIN LOWER (Lower abdominal cramping), PAIN (extreme pain) and ABDOMINAL PAIN (severe abdominal pain/cramps). On 22-May-2021, the patient experienced HAEMATOCHEZIA (blood in stool with less amount). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of OTC, 2mg. On 06-May-2021, ASTHENIA (body weakness), SOMNOLENCE (slept all day) and FATIGUE (extremely tired/ little exhausted feeling comes and go) had resolved. On 22-May-2021, PAIN (extreme pain) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), HAEMATOCHEZIA (blood in stool with less amount), ABDOMINAL PAIN LOWER (Lower abdominal cramping) and ABDOMINAL PAIN (severe abdominal pain/cramps) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 06May2021, patient got blood work done. No results was given. Patient was in an extreme pain from 7pm and it last all night This case is linked case to Original Case : MOD-2021-162193 Action taken with mRNA-1273 in response to the event was Not Applicable  Very limited information regarding the events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events have been provided at this time. Further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Insomnia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (difficulty sleeping.), ILLNESS (ill from hr 4 - 40 hrs), PAIN IN EXTREMITY (sore right arm), PYREXIA (fever) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 021/7A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by reporter. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INSOMNIA (difficulty sleeping.), ILLNESS (ill from hr 4 - 40 hrs), PAIN IN EXTREMITY (sore right arm), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On 07-Apr-2021, INSOMNIA (difficulty sleeping.), ILLNESS (ill from hr 4 - 40 hrs), PAIN IN EXTREMITY (sore right arm), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, HEADACHE (headache) had resolved. No treatment medications provided by the reporter. This case was linked to MOD21-093144 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: significant follow up  received contains, patient demographics, 2nd dose start date, concomitant medication.; Sender's Comments:  MOD21-093144:cross linked id
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (difficulty sleeping.), ILLNESS (ill from hr 4 - 40 hrs), PAIN IN EXTREMITY (sore right arm), PYREXIA (fever) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 021/7A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by reporter. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INSOMNIA (difficulty sleeping.), ILLNESS (ill from hr 4 - 40 hrs), PAIN IN EXTREMITY (sore right arm), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On 07-Apr-2021, INSOMNIA (difficulty sleeping.), ILLNESS (ill from hr 4 - 40 hrs), PAIN IN EXTREMITY (sore right arm), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, HEADACHE (headache) had resolved. No treatment medications provided by the reporter. This case was linked to MOD21-093144 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: significant follow up  received contains, patient demographics, 2nd dose start date, concomitant medication.; Sender's Comments:  MOD21-093144:cross linked id
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hyperhidrosis, Shock symptom, Tremor
Clinical narrative: still feeling body shocks; randomly break out in to sweats just lying here; Shaky; Week; with headaches; 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 SHOCK SYMPTOM (still feeling body shocks), HYPERHIDROSIS (randomly break out in to sweats just lying here), TREMOR (Shaky), ASTHENIA (Week) and HEADACHE (with headaches) 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 SHOCK SYMPTOM (still feeling body shocks), HYPERHIDROSIS (randomly break out in to sweats just lying here), TREMOR (Shaky), ASTHENIA (Week) and HEADACHE (with headaches). At the time of the report, SHOCK SYMPTOM (still feeling body shocks), HYPERHIDROSIS (randomly break out in to sweats just lying here), TREMOR (Shaky), ASTHENIA (Week) and HEADACHE (with headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. SD Text: AE submitted: Its the 2nd day after and Im still feeling body shocks and randomly break out in to sweats just lying here.and Im shaky and week with headaches. Will this hi away soon  Treatment information not reported.  Limited information regarding the events in this unidentified patient has been provided at this time and a causal relationship cannot be excluded.  The reported "body shocks" do not appear to be describing an actual event of "shock", but rather the impact of the other symptoms on the patient, so this event is downgraded via override function.; Sender's Comments: Limited information regarding the events in this unidentified patient has been provided at this time and a causal relationship cannot be excluded.  The reported "body shocks" do not appear to be describing an actual event of "shock", but rather the impact of the other symptoms on the patient, so this event is downgraded via override function.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medication was reported. No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation
Clinical narrative: received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose) in a 39-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 21-May-2021, the patient experienced COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose). At the time of the report, COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-May-2021 and was forwarded to Moderna on 22-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose) in a 39-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 21-May-2021, the patient experienced COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose). At the time of the report, COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: shoulder is swallen after 7 days of receiving the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of SWELLING (shoulder is swallen after 7 days of receiving the shot) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (shoulder is swallen after 7 days of receiving the shot). At the time of the report, SWELLING (shoulder is swallen after 7 days of receiving the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Reporter did not allow further contact This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 22-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of SWELLING (shoulder is swallen after 7 days of receiving the shot) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (shoulder is swallen after 7 days of receiving the shot). At the time of the report, SWELLING (shoulder is swallen after 7 days of receiving the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036D21A and 036D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Mediations were provided by the reporter. No Treatment History was provided by the reporter.   This case was linked to MOD-2021-162243 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received one vaccine 5 months ago; 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 PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago) 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 (received one vaccine 5 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 21-May-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 PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago) 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 (received one vaccine 5 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: right facial numbness for one day; headache for one day; 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 HYPOAESTHESIA (right facial numbness for one day) and HEADACHE (headache for one day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (right facial numbness for one day) and HEADACHE (headache for one day). At the time of the report, HYPOAESTHESIA (right facial numbness for one day) and HEADACHE (headache for one day) had resolved.       No concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: covid arm; COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine; COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine; COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine; COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine), VACCINATION SITE ERYTHEMA (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine), VACCINATION SITE RASH (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine) and VACCINATION SITE PRURITUS (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine), VACCINATION SITE ERYTHEMA (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine), VACCINATION SITE RASH (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine) and VACCINATION SITE PRURITUS (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine). On 30-Apr-2021, VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine), VACCINATION SITE ERYTHEMA (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine), VACCINATION SITE RASH (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the vaccine) and VACCINATION SITE PRURITUS (COVID arm (swelling, itchiness, redness, a bump - small circle) on her left arm - where shereceived the 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.   Concomitant medication and treatment information were not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the left arm), MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area) and HEADACHE (Bad Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness on the left arm). On 26-Mar-2021, the patient experienced MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area), HEADACHE (Bad Headache), FATIGUE (Fatigue), DIZZINESS (Extreme Dizziness) and NAUSEA (Nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 27-Mar-2021, MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area), HEADACHE (Bad Headache), FATIGUE (Fatigue), DIZZINESS (Extreme Dizziness) and NAUSEA (Nausea) had resolved. On 01-Apr-2021, VACCINATION SITE PAIN (Soreness on the left arm) had resolved. No relevant Concomitant medications were reported. This case was linked to MOD-2021-048670. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the left arm), MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area) and HEADACHE (Bad Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. No relevant Concomitant medications were reported. This case was linked to MOD-2021-048670.