chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: a shingles outbreak after receiving the vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (a shingles outbreak after receiving the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HERPES ZOSTER (a shingles outbreak after receiving the vaccine). At the time of the report, HERPES ZOSTER (a shingles outbreak after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   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. Further information has been requested.   Reporter did not allow further contact; 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. Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: really sleepy; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (really sleepy) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced SOMNOLENCE (really sleepy) and VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, SOMNOLENCE (really sleepy) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026L20A) for COVID-19 immunization. The patient's past medical history included migraine (prone to migraine). On Jan 28, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine, unknown route; 1 dosage form. On Jan 29, 2021, patient experienced headache. At the time of the report, headache outcome: unknown. No relevant concomitant medications or treatment information reported. Reporter did not allow further contact.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Influenza like illness, Mood altered, Nervousness
Clinical narrative: heavy flu-like symptoms; lousy; shaky disoriented; disoriented; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (heavy flu-like symptoms), MOOD ALTERED (lousy), NERVOUSNESS (shaky disoriented) and DISORIENTATION (disoriented) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (heavy flu-like symptoms), MOOD ALTERED (lousy), NERVOUSNESS (shaky disoriented) and DISORIENTATION (disoriented). On 28-Jan-2021, INFLUENZA LIKE ILLNESS (heavy flu-like symptoms), MOOD ALTERED (lousy), NERVOUSNESS (shaky disoriented) and DISORIENTATION (disoriented) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications reported were medication for prostate, medication for helping him urinate, medication for thyroid. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain, Vaccination site rash
Clinical narrative: (First shot)rush at the injection site; (First shot)sore arm; (First shot)body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH ((First shot)rush at the injection site), VACCINATION SITE PAIN ((First shot)sore arm) and MYALGIA ((First shot)body ache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN ((First shot)sore arm) and MYALGIA ((First shot)body ache). On 18-Jan-2021, the patient experienced VACCINATION SITE RASH ((First shot)rush at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 05-Jan-2021 for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH ((First shot)rush at the injection site), VACCINATION SITE PAIN ((First shot)sore arm) and MYALGIA ((First shot)body ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-043486 (E2B Linked Report). This case was linked to MOD-2021-043486 (Patient Link).; Sender's Comments:  MOD-2021-043486:Second dose Case
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the injection site) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported..   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up was received. Event outcome was updated to recovered/resolved.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Intense , persisting headache; body ache; diarrhea; fever; chills; nausea; swollen arm; Painful arm; A spontaneous report was received from a Consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events intense persisting headache, body ache, diarrhea, fever, chills, nausea, swollen arm and painful arm.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, starting midnight the patient experienced the events intense persisting headache, body ache, diarrhea, fever, chills, nausea, swollen arm  and painful arm.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of events intense, persisting headache, body ache, diarrhea, fever, chills, nausea, swollen arm and painful arm  was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Intense , persisting headache; body ache; diarrhea; fever; chills; nausea; swollen arm; Painful arm; A spontaneous report was received from a Consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events intense persisting headache, body ache, diarrhea, fever, chills, nausea, swollen arm and painful arm.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, starting midnight the patient experienced the events intense persisting headache, body ache, diarrhea, fever, chills, nausea, swollen arm  and painful arm.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of events intense, persisting headache, body ache, diarrhea, fever, chills, nausea, swollen arm and painful arm  was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Peripheral swelling
Clinical narrative: mild pain; fatigue, like "she had had the flu shoot"; swelling of her arm, a small hardness; A spontaneous report was received from a Consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild pain and swelling of her arm and a small hardness(Peripheral swelling ) and fatigue,  like she had had the flu shoot (Influenza).  The patient's medical history was not provided. Concomitant medications reported were Blood pressure medication and Thyroid medication for unknown indication, Iron for her anemia.  On 23 Jan 2021, approximately one day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) unknown route, in the right arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced mild pain and swelling of her arm and a small hardness and Fatigue like she had had the flu shoot. The patient did not receive any treatment medication and drank water and went to sleep and she was better.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the events mild pain and swelling of her arm  and a small hardness and fatigue like she had had the flu shoot" was resolved on 23-JAN-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness on her arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029e028a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (soreness on her arm). At the time of the report, MYALGIA (soreness on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; 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: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness, Raynaud's phenomenon, Skin discolouration
Clinical narrative: Raynaud's-like symptoms; left toes started tingling after exercise walk; right toes started tingling and little swollen when taking an exercise walk; Right hand felt cold and was discolored; Middle finger on right hand felt cold and was discolored; Right hand felt cold and was discolored; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Middle finger on right hand felt cold and was discolored), PERIPHERAL COLDNESS (Right hand felt cold and was discolored), SKIN DISCOLOURATION (Right hand felt cold and was discolored), PARAESTHESIA (right toes started tingling and little swollen when taking an exercise walk) and PARAESTHESIA (left toes started tingling after exercise walk) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included MALT lymphoma.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2010, the patient experienced SKIN DISCOLOURATION (Right hand felt cold and was discolored). On 21-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Middle finger on right hand felt cold and was discolored). On 23-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Right hand felt cold and was discolored). On 24-Jan-2021, the patient experienced PARAESTHESIA (right toes started tingling and little swollen when taking an exercise walk). On 26-Jan-2021, the patient experienced PARAESTHESIA (left toes started tingling after exercise walk). On 23-Jan-2010, SKIN DISCOLOURATION (Right hand felt cold and was discolored) had resolved. On 21-Jan-2021, PERIPHERAL COLDNESS (Middle finger on right hand felt cold and was discolored) had resolved. On 23-Jan-2021, PERIPHERAL COLDNESS (Right hand felt cold and was discolored) had resolved. On 25-Jan-2021, PARAESTHESIA (right toes started tingling and little swollen when taking an exercise walk) had resolved. On 27-Jan-2021, PARAESTHESIA (left toes started tingling after exercise walk) 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 reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinitis allergic, SARS-CoV-2 test positive
Clinical narrative: felt an allergy in his nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINITIS ALLERGIC (felt an allergy in his nose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 12-Jan-2021. Concomitant products included ZINC for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced RHINITIS ALLERGIC (felt an allergy in his nose). At the time of the report, RHINITIS ALLERGIC (felt an allergy in his nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 MYALGIA (Body ache) and PYREXIA (Fever). At the time of the report, MYALGIA (Body ache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: nausea; fatigue; headache; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitants were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of Sore arm 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced Sore arm. At the time of the report, Sore arm outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Onycholysis, Pyrexia
Clinical narrative: her large toenail fell off; abdominal pain; back pain; high fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ONYCHOLYSIS (her large toenail fell off), ABDOMINAL PAIN (abdominal pain), BACK PAIN (back pain) and PYREXIA (high fever) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ONYCHOLYSIS (her large toenail fell off), ABDOMINAL PAIN (abdominal pain), BACK PAIN (back pain) and PYREXIA (high fever). At the time of the report, ONYCHOLYSIS (her large toenail fell off), ABDOMINAL PAIN (abdominal pain), BACK PAIN (back pain) and PYREXIA (high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. HCP reported the patient was diagnosed with COVID-19 in the past and recovered. No treatment medications were reported.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: warm to touch; swollen injection site; rash above the injection site; soreness at the site of injection; redness at the site of injection; dizziness; warm to touch; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness), the first episode of VACCINATION SITE WARMTH (warm to touch), the second episode of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PAIN (soreness at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (dizziness), the first episode of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PAIN (soreness at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection). On 25-Jan-2021, the patient experienced the second episode of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE RASH (rash above the injection site). On 14-Jan-2021, DIZZINESS (dizziness) had resolved. On 16-Jan-2021, VACCINATION SITE PAIN (soreness at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection) had resolved. On 28-Jan-2021, last episode of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE RASH (rash above the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: warm to touch; swollen injection site; rash above the injection site; soreness at the site of injection; redness at the site of injection; dizziness; warm to touch; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness), the first episode of VACCINATION SITE WARMTH (warm to touch), the second episode of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PAIN (soreness at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (dizziness), the first episode of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PAIN (soreness at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection). On 25-Jan-2021, the patient experienced the second episode of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE RASH (rash above the injection site). On 14-Jan-2021, DIZZINESS (dizziness) had resolved. On 16-Jan-2021, VACCINATION SITE PAIN (soreness at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection) had resolved. On 28-Jan-2021, last episode of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE RASH (rash above the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy; the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy; the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy; the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE RASH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE WARMTH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) and INJECTION SITE PRURITUS (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) 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 ERYTHEMA (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE RASH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE WARMTH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) and INJECTION SITE PRURITUS (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy). At the time of the report, ERYTHEMA (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE RASH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE WARMTH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) and INJECTION SITE PRURITUS (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Skin swelling
Clinical narrative: a little puffy in the beginning and its fading now; a little on the warm side; a big round red rash (4 inch red rash) at the injection site, the rash was very dark; itches; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (a little puffy in the beginning and its fading now), INJECTION SITE WARMTH (a little on the warm side), INJECTION SITE RASH (a big round red rash (4 inch red rash) at the injection site, the rash was very dark) and INJECTION SITE PRURITUS (itches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included CHLORTHALIDONE and ROSUVASTATIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced SKIN SWELLING (a little puffy in the beginning and its fading now), INJECTION SITE WARMTH (a little on the warm side), INJECTION SITE RASH (a big round red rash (4 inch red rash) at the injection site, the rash was very dark) and INJECTION SITE PRURITUS (itches). At the time of the report, SKIN SWELLING (a little puffy in the beginning and its fading now), INJECTION SITE WARMTH (a little on the warm side), INJECTION SITE RASH (a big round red rash (4 inch red rash) at the injection site, the rash was very dark) and INJECTION SITE PRURITUS (itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included antibiotics and steroids for drug use for unknown indication. Treatment details included Steroids, Antibiotics   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Vaccination site pain
Clinical narrative: Acute joint pain; Chills; Headache; Soreness that went down into the opposite arm and radiated into her hand; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Acute joint pain), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness that went down into the opposite arm and radiated into her hand) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and BUDESONIDE for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ARTHRALGIA (Acute joint pain), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness that went down into the opposite arm and radiated into her hand). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. On 26-Jan-2021, ARTHRALGIA (Acute joint pain), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness that went down into the opposite arm and radiated into her hand) 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A spontaneous report was received from a consumer concerning a adult female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unspecified date, the patient received their first of two planned doses of mRNA-1273 (unknown batch number) for prophylaxis of COVID-19 infection.  On 25 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (unknown batch number) in intramuscular, for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event headache was unknown.; Reporter's Comments: Based on the information provided and the established safety profile of mRNA-1273 vaccine, a causal association between the event of headache and the product use cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: developed a little fever of 100.7; slight diarrhea; arm was sore; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PYREXIA (developed a little fever of 100.7) and DIARRHOEA (slight diarrhea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included MULTIVITAMINS [VITAMINS NOS], LISINOPRIL, EZETIMIBE, SIMVASTATIN (VYTORIN) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 23-Jan-2021, the patient experienced PYREXIA (developed a little fever of 100.7) and DIARRHOEA (slight diarrhea). On 22-Jan-2021, PAIN IN EXTREMITY (arm was sore) had resolved. On 23-Jan-2021, PYREXIA (developed a little fever of 100.7) and DIARRHOEA (slight diarrhea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: (High) 100.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Osteitis
Clinical narrative: Puffy Lower Jaw; This spontaneous case was reported by a consumer and describes the occurrence of OSTEITIS (Puffy Lower Jaw) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced OSTEITIS (Puffy Lower Jaw). At the time of the report, OSTEITIS (Puffy Lower Jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported. Treatment was taken with cetirizine and loratadine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Fatigue, Injection site pain, Rash pruritic
Clinical narrative: Bruise at left elbow; Itchy Rash; Redness; Tiered; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy Rash), ERYTHEMA (Redness), FATIGUE (Tiered), INJECTION SITE PAIN (Pain at injection site) and CONTUSION (Bruise at left elbow) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced FATIGUE (Tiered) and INJECTION SITE PAIN (Pain at injection site). On 26-Jan-2021, the patient experienced RASH PRURITIC (Itchy Rash) and ERYTHEMA (Redness). On an unknown date, the patient experienced CONTUSION (Bruise at left elbow). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Injection site reaction, at a dose of 1 dosage form and CORTISONE ACETATE for Injection site reaction, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy Rash), ERYTHEMA (Redness), FATIGUE (Tiered), INJECTION SITE PAIN (Pain at injection site) and CONTUSION (Bruise at left elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Injection site swelling, Injection site warmth, Muscle tightness, Pruritus
Clinical narrative: burning; itching; tight sensation; eczema; rash; big goose egg; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), INJECTION SITE SWELLING (big goose egg), INJECTION SITE WARMTH (hot to the touch), SKIN BURNING SENSATION (burning) and PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided by reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LOSARTAN, PRIMIDONE and ROSUVASTATIN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced RASH (rash), INJECTION SITE SWELLING (big goose egg) and INJECTION SITE WARMTH (hot to the touch). On 13-Jan-2021, the patient experienced SKIN BURNING SENSATION (burning), PRURITUS (itching), MUSCLE TIGHTNESS (tight sensation) and ECZEMA (eczema). On 10-Jan-2021, RASH (rash), INJECTION SITE SWELLING (big goose egg) and INJECTION SITE WARMTH (hot to the touch) had resolved. On 20-Jan-2021, SKIN BURNING SENSATION (burning), PRURITUS (itching), MUSCLE TIGHTNESS (tight sensation) and ECZEMA (eczema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included ketoconazole shampoo and Clobetasol propionate.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation
Clinical narrative: burning; itching; tight sensation; eczema; rash; big goose egg; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), INJECTION SITE SWELLING (big goose egg), INJECTION SITE WARMTH (hot to the touch), SKIN BURNING SENSATION (burning) and PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided by reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LOSARTAN, PRIMIDONE and ROSUVASTATIN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced RASH (rash), INJECTION SITE SWELLING (big goose egg) and INJECTION SITE WARMTH (hot to the touch). On 13-Jan-2021, the patient experienced SKIN BURNING SENSATION (burning), PRURITUS (itching), MUSCLE TIGHTNESS (tight sensation) and ECZEMA (eczema). On 10-Jan-2021, RASH (rash), INJECTION SITE SWELLING (big goose egg) and INJECTION SITE WARMTH (hot to the touch) had resolved. On 20-Jan-2021, SKIN BURNING SENSATION (burning), PRURITUS (itching), MUSCLE TIGHTNESS (tight sensation) and ECZEMA (eczema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included ketoconazole shampoo and Clobetasol propionate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Influenza
Clinical narrative: This spontaneous report received from a healthcare professional, concerns a 71-year-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced adverse events: really bad gastrointestinal symptoms, diarrhea and bad flu. The patient's medical history reported as had flu shot last year. No concomitant medications reported. On Jan 5, 2021, prior to the onset of the events, patient received the first of two planned doses of mRNA-1273 (batch/lot# 011J20A), intramuscularly, for prophylaxis of COVID-19 infection. On Jan 26, 2021, patient experienced really bad gastrointestinal symptoms (abdominal discomfort), diarrhea and really bad flu (influenza). On an unknown date the outcome of events: really bad gastrointestinal symptoms, diarrhea and really bad flu: not reported. No treatment information provided. Action taken with mRNA-1273 in response to the events: not reported. Sender's comments: Very limited information regarding this events has been provided at this time. Further information requested. Events assessed to be unlikely related to the product.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (tested positive for COVID-19 3 to 4 days after receiving 1st 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 reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced COVID-19 (tested positive for COVID-19 3 to 4 days after receiving 1st vaccine). At the time of the report, COVID-19 (tested positive for COVID-19 3 to 4 days after receiving 1st vaccine) outcome: unknown. Diagnostic results: On an unknown date, SARS-CoV-2 test: Tested positive for COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rash (a week later) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013L20A) for COVID-19 immunization. No medical history reported. On Jan 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 26, 2021, patient experienced rash (a week later). At the time of the report, rash (a week later) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. Reporter did not allow further contact.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site urticaria (red bumps that looks like hives at the site of injection) and injection site pruritus (slight itchiness at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013L20A) for COVID-19 immunization. No medical history reported. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 27, 2021, patient experienced injection site urticaria (red bumps that looks like hives at the site of injection) and injection site pruritus (slight itchiness at injection site). At the time of the report, injection site urticaria (red bumps that looks like hives at the site of injection) and injection site pruritus (slight itchiness at injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dyspnea (labored breathing) and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dyspnea (labored breathing) and nausea. At the time of the report, dyspnea (labored breathing) and nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported. Reporter did not allow further contact.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Lip pain, Mass excision, Pain in extremity
Clinical narrative: lip sore; knot; itchy; red; felt warm on the Left arm,just below the injection site; rash; soreness of the Left arm the day of injection; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (lip sore), MASS EXCISION (knot), PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (felt warm on the Left arm,just below the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness of the Left arm the day of injection). On 26-Jan-2021, the patient experienced LIP PAIN (lip sore), MASS EXCISION (knot), PRURITUS (itchy), ERYTHEMA (red), FEELING HOT (felt warm on the Left arm,just below the injection site) and RASH (rash). At the time of the report, LIP PAIN (lip sore), MASS EXCISION (knot), PRURITUS (itchy), ERYTHEMA (red), FEELING HOT (felt warm on the Left arm,just below the injection site) and RASH (rash) outcome was unknown and PAIN IN EXTREMITY (soreness of the Left arm the day of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not provided. No relevant concomitant medications were reported.