chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Pyrexia
Clinical narrative: Stomach Pain; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Pain), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Pain), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Pain), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dry eye, Eye drop instillation
Clinical narrative: burning sensation in the vaginal area; Eyes dry out; Patient stated she put eye drops in her eyes, used it more times than before; This spontaneous case was reported by a health care professional and describes the occurrence of BURNING SENSATION (burning sensation in the vaginal area), DRY EYE (Eyes dry out) and EYE DROP INSTILLATION (Patient stated she put eye drops in her eyes, used it more times than before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010U20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PRAVASTATIN, SEMAGLUTIDE (OZEMPIC), Tremidon, METHOCARBAMOL (ROBAXIN) and triamrenecholorathiazaide-diuretic for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning sensation in the vaginal area), DRY EYE (Eyes dry out) and EYE DROP INSTILLATION (Patient stated she put eye drops in her eyes, used it more times than before). At the time of the report, BURNING SENSATION (burning sensation in the vaginal area), DRY EYE (Eyes dry out) and EYE DROP INSTILLATION (Patient stated she put eye drops in her eyes, used it more times than before) outcome was unknown.        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 eye drops.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Warm sensation in the chest and the body 10 minutes after the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm sensation in the chest and the body 10 minutes after the vaccine.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING HOT (Warm sensation in the chest and the body 10 minutes after the vaccine.). At the time of the report, FEELING HOT (Warm sensation in the chest and the body 10 minutes after the vaccine.) 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 details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pruritus
Clinical narrative: Itching; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 25-Jan-2021, the patient experienced PRURITUS (Itching). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Warm to the touch; Red itchy, and warm to the touch; Experienced red itchy, and warm to the touch; A spontaneous report was received from a Consumer concerning a 33-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red (Injection site erythema) itchy (Injection site pruritus) and warm to the touch (Injection site warmth).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Jan 2021, approximately 13 days prior to the onset of the events the patient received dose of mRNA-1273 (Batch Number: 026L20A) in the left arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the events red (Injection site erythema) itchy (Injection site pruritus) and warm to the touch (Injection site warmth).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, red (Injection site erythema) itchy (Injection site pruritus) and warm to the touch (Injection site warmth) is considered recovering (symptoms have subsided).; 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. Further information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Headache, Pyrexia
Clinical narrative: fever (101.5); fever; severe lower back pain; dizziness; lower back pain; fever between (99.8-101.8); headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (severe lower back pain), DIZZINESS (dizziness), BACK PAIN (lower back pain), PYREXIA (fever between (99.8-101.8)) and PYREXIA (fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIZZINESS (dizziness), BACK PAIN (lower back pain), PYREXIA (fever between (99.8-101.8)) and HEADACHE (headache). On 29-Jan-2021, the patient experienced BACK PAIN (severe lower back pain) and PYREXIA (fever). On 01-Feb-2021, the patient experienced PYREXIA (fever (101.5)). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (severe lower back pain), DIZZINESS (dizziness), BACK PAIN (lower back pain), PYREXIA (fever between (99.8-101.8)), PYREXIA (fever), PYREXIA (fever (101.5)) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure pill and hydroclorife.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: Felt weak; Was not hungry; Bad chills; Fever; Aching all over; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), DECREASED APPETITE (Was not hungry), CHILLS (Bad chills), PYREXIA (Fever) and MYALGIA (Aching all over) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Prostate adenoma.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ASTHENIA (Felt weak), DECREASED APPETITE (Was not hungry), CHILLS (Bad chills), PYREXIA (Fever) and MYALGIA (Aching all over). At the time of the report, ASTHENIA (Felt weak), DECREASED APPETITE (Was not hungry), CHILLS (Bad chills), PYREXIA (Fever) and MYALGIA (Aching all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure pill, cholesterol pill, prostate pill were reported. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Came down with COVID the night he got his first dose; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Came down with COVID the night he got his first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Came down with COVID the night he got his first dose). At the time of the report, COVID-19 (Came down with COVID the night he got his first dose) outcome was unknown. Not Provided      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.   No concomitant medications were provided.  Treatment medications were not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain in extremity, SARS-CoV-2 test, Swelling face
Clinical narrative: COVID-19; Face was swollen, just an arch on either side of my nose down to my lip.; Lump hot and sore; Tired and sleepy; arm sore a little bit; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, arm a little bit sore, lump hot and sore, tired and sleepy , Face was swollen, just an arch on either side of my nose down to my lip and tested positive for covid following the vaccination.    The patient's medical history were unknown.   Relevant concomitant medication included Crestor for cholesterol.   On 02Jan2021 prior to the onset of the events, arm a little bit sore, lump hot and sore, tired and sleepy , Face was swollen, just an arch on either side of my nose down to my lip and tested positive for covid the patient received their mRNA-1273 (lot/batch: not provided) unknown route for prophylaxis of COVID-19 infection.    Laboratory details included covid 19 tested positive on 21JAN2021.     Treatment included Benadryl and nasal corticosteroids for day 13 Ice pack and Advil and for day 2  Action taken with mRNA-1273 in response to the events was not reported.      The outcome of  reported events  like  a little bit sore, lump hot and sore, tired and sleepy  were recovered/resolved. Outcome of , swollen face, just an arch on either side of my nose down to my lip were recovering/resolving, and outcome of covid 19 was not recovered/not resolved.  The reporter assessment for the event(s) arm sore, lump hot and sore, swollen face, nose and lips and covid 19 were not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: COVID-19; Face was swollen, just an arch on either side of my nose down to my lip.; Lump hot and sore; Tired and sleepy; arm sore a little bit; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, arm a little bit sore, lump hot and sore, tired and sleepy , Face was swollen, just an arch on either side of my nose down to my lip and tested positive for covid following the vaccination.    The patient's medical history were unknown.   Relevant concomitant medication included Crestor for cholesterol.   On 02Jan2021 prior to the onset of the events, arm a little bit sore, lump hot and sore, tired and sleepy , Face was swollen, just an arch on either side of my nose down to my lip and tested positive for covid the patient received their mRNA-1273 (lot/batch: not provided) unknown route for prophylaxis of COVID-19 infection.    Laboratory details included covid 19 tested positive on 21JAN2021.     Treatment included Benadryl and nasal corticosteroids for day 13 Ice pack and Advil and for day 2  Action taken with mRNA-1273 in response to the events was not reported.      The outcome of  reported events  like  a little bit sore, lump hot and sore, tired and sleepy  were recovered/resolved. Outcome of , swollen face, just an arch on either side of my nose down to my lip were recovering/resolving, and outcome of covid 19 was not recovered/not resolved.  The reporter assessment for the event(s) arm sore, lump hot and sore, swollen face, nose and lips and covid 19 were not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itches; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches) and RASH (Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (Itches) and RASH (Rash). At the time of the report, PRURITUS (Itches) and RASH (Rash) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not  reported by the reporter. Treatment details was not reported by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Fever (hot) at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Fever (hot) at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Fever (hot) at the injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE WARMTH (Fever (hot) at the injection site) and VACCINATION SITE RASH (Rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe pain from her left leg, hip down to her ankle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain from her left leg, hip down to her ankle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe pain from her left leg, hip down to her ankle). At the time of the report, PAIN IN EXTREMITY (Severe pain from her left leg, hip down to her ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: outer edges become redder; itchiness at the injection site; hump near injection site; stinging at injection site; Large 3 inch rash around injection site, hot to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (outer edges become redder), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (hump near injection site), VACCINATION SITE PAIN (stinging at injection site) and VACCINATION SITE RASH (Large 3 inch rash around injection site, hot to touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 immunisation.     No Medical History information was reported.    On 12-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 VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (hump near injection site), VACCINATION SITE PAIN (stinging at injection site) and VACCINATION SITE RASH (Large 3 inch rash around injection site, hot to touch). On 27-Jan-2021, the patient experienced ERYTHEMA (outer edges become redder). The patient was treated with HYDROCORTISONE (topical) for Antiinflammatory therapy, at a dose of UNK UNK, bid. At the time of the report, ERYTHEMA (outer edges become redder), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (hump near injection site), VACCINATION SITE PAIN (stinging at injection site) and VACCINATION SITE RASH (Large 3 inch rash around injection site, hot to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Hydrocortisone cream twice daily for about a week. Follow up appointment with HCP on 27Jan2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza
Clinical narrative: Mild flu symptoms; Fatigue; A spontaneous report was received from a consumer concerning a 70-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild flu symptoms and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Jan 2021, prior to the onset of the events the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the mild flu symptoms and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events mild flu symptoms and fatigue was not reported.   The events, mild flu symptoms and fatigue was considered resolved (lasted about a day and a half) on an unspecified date.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Fatigue is consistent with the known safety profile of mRNA-1273 vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site and 3 inches around it is red; Swollen; itches; looks like a welt or hive; tender to touch; headache; A spontaneous report was received from a health care professional concerning a 57 year-old patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed injection site and 3 inches around it is red, swollen, itches, looks like a welt or hive, tender to touch, and headache.  The patient's medical history was not provided. Concomitant medications included losartan and hydrochlorothiazide.  On 26-JAN-2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot#: 013L20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient developed redness, swelling, itching, hives, and tenderness at/around the injection site and headache. Treatment included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, injection site and 3 inches around it is red, swollen, itches, looks like a welt or hive, tender to touch, and headache, were 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Injection site and 3 inches around it is red; Swollen; itches; looks like a welt or hive; tender to touch; headache; A spontaneous report was received from a health care professional concerning a 57 year-old patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed injection site and 3 inches around it is red, swollen, itches, looks like a welt or hive, tender to touch, and headache.  The patient's medical history was not provided. Concomitant medications included losartan and hydrochlorothiazide.  On 26-JAN-2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot#: 013L20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient developed redness, swelling, itching, hives, and tenderness at/around the injection site and headache. Treatment included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, injection site and 3 inches around it is red, swollen, itches, looks like a welt or hive, tender to touch, and headache, were 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Injection site became Red again and a little Itchy; Had chills; Injection Site Red again; Rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site became Red again and a little Itchy), INJECTION SITE RASH (Rash on the injection site), CHILLS (Had chills) and INJECTION SITE ERYTHEMA (Injection Site Red again) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-Jan-2021, the patient experienced INJECTION SITE RASH (Rash on the injection site).   On 28-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site became Red again and a little Itchy), CHILLS (Had chills) and INJECTION SITE ERYTHEMA (Injection Site Red again). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   On 22-Jan-2021, INJECTION SITE RASH (Rash on the injection site) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site became Red again and a little Itchy), CHILLS (Had chills) and INJECTION SITE ERYTHEMA (Injection Site Red again) 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.; Sender's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Injection site redness, Injection site rash, injection site pruritus and chills are consistent with the known safety profile of the vaccine
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Swelling of the arm; Red, hot to the touch and itchy arm; Red, hot to the touch and itchy arm; Red, hot to the touch and itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), VACCINATION SITE WARMTH (Red, hot to the touch and itchy arm), PRURITUS (Red, hot to the touch and itchy arm) and VACCINATION SITE ERYTHEMA (Red, hot to the touch and itchy arm) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling of the arm), VACCINATION SITE WARMTH (Red, hot to the touch and itchy arm), PRURITUS (Red, hot to the touch and itchy arm) and VACCINATION SITE ERYTHEMA (Red, hot to the touch and itchy arm). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), VACCINATION SITE WARMTH (Red, hot to the touch and itchy arm) and PRURITUS (Red, hot to the touch and itchy arm) had not resolved and VACCINATION SITE ERYTHEMA (Red, hot to the touch and itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extremely tired; A spontaneous report () was received from a consumer concerning a 18-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extremely tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced the event of extremely tired. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, extremely tired was resolved on 21 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 event, a causal relationship cannot be excluded. Further information has been requested.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site mass, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Hardness at the injection site; Itchiness at the injection site; 2 inch ring around the injection site, red pinkish; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness at the injection site), INJECTION SITE MASS (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (2 inch ring around the injection site, red pinkish) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness at the injection site), INJECTION SITE MASS (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (2 inch ring around the injection site, red pinkish). At the time of the report, PRURITUS (Itchiness at the injection site), INJECTION SITE MASS (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (2 inch ring around the injection site, red pinkish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: NNI FU  - No new information was provided
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Pain, Tinnitus
Clinical narrative: Vaccination site swelling; Vaccination site erythema; Vaccination site pruritus; Vaccination site warmth; Body aches; joint pain; muscle pain; Nausea; Ringing in the ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear), PAIN (Body aches), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and NAUSEA (Nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced TINNITUS (Ringing in the ear). On 12-Jan-2021, the patient experienced PAIN (Body aches), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and NAUSEA (Nausea). On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE WARMTH (Vaccination site warmth). At the time of the report, TINNITUS (Ringing in the ear), PAIN (Body aches), ARTHRALGIA (joint pain), MYALGIA (muscle pain), NAUSEA (Nausea), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE WARMTH (Vaccination site warmth) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site swelling; Vaccination site erythema; Vaccination site pruritus; Vaccination site warmth; Body aches; joint pain; muscle pain; Nausea; Ringing in the ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear), PAIN (Body aches), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and NAUSEA (Nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced TINNITUS (Ringing in the ear). On 12-Jan-2021, the patient experienced PAIN (Body aches), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and NAUSEA (Nausea). On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE WARMTH (Vaccination site warmth). At the time of the report, TINNITUS (Ringing in the ear), PAIN (Body aches), ARTHRALGIA (joint pain), MYALGIA (muscle pain), NAUSEA (Nausea), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE WARMTH (Vaccination site warmth) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia
Clinical narrative: body aches; temperature; Nausea; joint pain; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (body aches), PYREXIA (temperature), NAUSEA (Nausea) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (body aches), PYREXIA (temperature), NAUSEA (Nausea) and ARTHRALGIA (joint pain). At the time of the report, MYALGIA (body aches), PYREXIA (temperature), NAUSEA (Nausea) and ARTHRALGIA (joint pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site oedema, Vaccination site swelling
Clinical narrative: Stiif arm; Little Edema around injection site; Little Swelling around injection site; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiif arm), VACCINATION SITE OEDEMA (Little Edema around injection site) and VACCINATION SITE SWELLING (Little Swelling around injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Stroke. Concomitant products included INSULIN, ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID] and CLOPIDOGREL for an unknown indication.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiif arm), VACCINATION SITE OEDEMA (Little Edema around injection site) and VACCINATION SITE SWELLING (Little Swelling around injection site). On 02-Feb-2021, MUSCULOSKELETAL STIFFNESS (Stiif arm) had resolved. At the time of the report, VACCINATION SITE OEDEMA (Little Edema around injection site) and VACCINATION SITE SWELLING (Little Swelling around injection site) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   o No treatment medications provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site swelling, redness and soreness; injection site swelling, redness and soreness; injection site swelling, redness and soreness; itchiness and hot to touch at the injection site; itchiness and hot to touch at the injection site; Redness gradually started spreding and has spread down her arm to her elbow and inside the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling, redness and soreness), VACCINATION SITE ERYTHEMA (injection site swelling, redness and soreness), VACCINATION SITE PAIN (injection site swelling, redness and soreness), VACCINATION SITE PRURITUS (itchiness and hot to touch at the injection site) and VACCINATION SITE WARMTH (itchiness and hot to touch at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site swelling, redness and soreness), VACCINATION SITE ERYTHEMA (injection site swelling, redness and soreness), VACCINATION SITE PAIN (injection site swelling, redness and soreness), VACCINATION SITE PRURITUS (itchiness and hot to touch at the injection site), VACCINATION SITE WARMTH (itchiness and hot to touch at the injection site) and ERYTHEMA (Redness gradually started spreding and has spread down her arm to her elbow and inside the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Allergy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (injection site swelling, redness and soreness), VACCINATION SITE ERYTHEMA (injection site swelling, redness and soreness), VACCINATION SITE PAIN (injection site swelling, redness and soreness), VACCINATION SITE PRURITUS (itchiness and hot to touch at the injection site), VACCINATION SITE WARMTH (itchiness and hot to touch at the injection site) and ERYTHEMA (Redness gradually started spreding and has spread down her arm to her elbow and inside the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site swelling, redness and soreness; injection site swelling, redness and soreness; injection site swelling, redness and soreness; itchiness and hot to touch at the injection site; itchiness and hot to touch at the injection site; Redness gradually started spreding and has spread down her arm to her elbow and inside the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling, redness and soreness), VACCINATION SITE ERYTHEMA (injection site swelling, redness and soreness), VACCINATION SITE PAIN (injection site swelling, redness and soreness), VACCINATION SITE PRURITUS (itchiness and hot to touch at the injection site) and VACCINATION SITE WARMTH (itchiness and hot to touch at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site swelling, redness and soreness), VACCINATION SITE ERYTHEMA (injection site swelling, redness and soreness), VACCINATION SITE PAIN (injection site swelling, redness and soreness), VACCINATION SITE PRURITUS (itchiness and hot to touch at the injection site), VACCINATION SITE WARMTH (itchiness and hot to touch at the injection site) and ERYTHEMA (Redness gradually started spreding and has spread down her arm to her elbow and inside the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Allergy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (injection site swelling, redness and soreness), VACCINATION SITE ERYTHEMA (injection site swelling, redness and soreness), VACCINATION SITE PAIN (injection site swelling, redness and soreness), VACCINATION SITE PRURITUS (itchiness and hot to touch at the injection site), VACCINATION SITE WARMTH (itchiness and hot to touch at the injection site) and ERYTHEMA (Redness gradually started spreding and has spread down her arm to her elbow and inside the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Computerised tomogram, Headache, Myalgia, Pain in extremity
Clinical narrative: sore arm; muscle aches and pain; Slight headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches and pain) and HEADACHE (Slight headaches) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperthyroidism. Concomitant products included LEVOTHYROXINE, PREDNISONE, TIZANIDINE and APIXABAN (ELIQUIS) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches and pain) and HEADACHE (Slight headaches). At the time of the report, PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches and pain) and HEADACHE (Slight headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Thyroid function test: (High) thyroid levels had doubled from her previously good thyroid levels checked in Oct2020. On 07-Feb-2021, Body temperature: 101.8 (High) 7Feb2021 had a temperature of 101.8. On 07-Feb-2021, SARS-CoV-2 test: (Negative) COVID test  came back negative.. On 09-Feb-2021, Computerised tomogram: They found two new pulmonary embolisms in the right lung and an old PE in the left lung. On 09-Feb-2021, X-ray: They found two new pulmonary embolisms in the right lung and an old PE in the left lung.         Treatment information was not provided.  Event outcome was not reported.   This case was linked to MOD-2021-018427 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non-significant information was updated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thyroid function test, X-ray
Clinical narrative: sore arm; muscle aches and pain; Slight headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches and pain) and HEADACHE (Slight headaches) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperthyroidism. Concomitant products included LEVOTHYROXINE, PREDNISONE, TIZANIDINE and APIXABAN (ELIQUIS) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches and pain) and HEADACHE (Slight headaches). At the time of the report, PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches and pain) and HEADACHE (Slight headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Thyroid function test: (High) thyroid levels had doubled from her previously good thyroid levels checked in Oct2020. On 07-Feb-2021, Body temperature: 101.8 (High) 7Feb2021 had a temperature of 101.8. On 07-Feb-2021, SARS-CoV-2 test: (Negative) COVID test  came back negative.. On 09-Feb-2021, Computerised tomogram: They found two new pulmonary embolisms in the right lung and an old PE in the left lung. On 09-Feb-2021, X-ray: They found two new pulmonary embolisms in the right lung and an old PE in the left lung.         Treatment information was not provided.  Event outcome was not reported.   This case was linked to MOD-2021-018427 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non-significant information was updated.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Heart rate abnormal
Clinical narrative: Feeling weak; Real bad headache; Terrible chills; Felt heart skip a beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (Felt heart skip a beat), ASTHENIA (Feeling weak), HEADACHE (Real bad headache) and CHILLS (Terrible chills) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE ABNORMAL (Felt heart skip a beat), HEADACHE (Real bad headache) and CHILLS (Terrible chills). On 02-Feb-2021, the patient experienced ASTHENIA (Feeling weak). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 02-Feb-2021, HEART RATE ABNORMAL (Felt heart skip a beat), HEADACHE (Real bad headache) and CHILLS (Terrible chills) had resolved. At the time of the report, ASTHENIA (Feeling weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included beta blockers.