chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 69-year-old female patient 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) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, COVID-19: Positive.     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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Body temperature increased, Dizziness, Headache, Nausea
Clinical narrative: heart palpitations; severe vertigo; Headaches; nauseous; dizzy; did not have fever but was a bit more elevated than usual; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), BODY TEMPERATURE INCREASED (did not have fever but was a bit more elevated than usual), VERTIGO (severe vertigo), DIZZINESS (dizzy) and HEADACHE (Headaches) in a 68-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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (did not have fever but was a bit more elevated than usual). On 19-Feb-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On an unknown date, the patient experienced PALPITATIONS (heart palpitations), VERTIGO (severe vertigo) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 18-Feb-2021, BODY TEMPERATURE INCREASED (did not have fever but was a bit more elevated than usual) had resolved. At the time of the report, PALPITATIONS (heart palpitations), VERTIGO (severe vertigo), DIZZINESS (dizzy), HEADACHE (Headaches) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: 12 blood counts (Low) a drop in 12 blood counts.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant FU added as reporter email response : new event updated and event outcome for Body temperature elevated and lab data information also updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vertigo
Clinical narrative: heart palpitations; severe vertigo; Headaches; nauseous; dizzy; did not have fever but was a bit more elevated than usual; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), BODY TEMPERATURE INCREASED (did not have fever but was a bit more elevated than usual), VERTIGO (severe vertigo), DIZZINESS (dizzy) and HEADACHE (Headaches) in a 68-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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (did not have fever but was a bit more elevated than usual). On 19-Feb-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On an unknown date, the patient experienced PALPITATIONS (heart palpitations), VERTIGO (severe vertigo) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 18-Feb-2021, BODY TEMPERATURE INCREASED (did not have fever but was a bit more elevated than usual) had resolved. At the time of the report, PALPITATIONS (heart palpitations), VERTIGO (severe vertigo), DIZZINESS (dizzy), HEADACHE (Headaches) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: 12 blood counts (Low) a drop in 12 blood counts.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant FU added as reporter email response : new event updated and event outcome for Body temperature elevated and lab data information also updated.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Thirst
Clinical narrative: fever 103.6 F; arm soreness; drinking too much water; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 103.6 F), PAIN IN EXTREMITY (arm soreness) and THIRST (drinking too much water) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included GABAPENTIN and ATENOLOL for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (fever 103.6 F), PAIN IN EXTREMITY (arm soreness) and THIRST (drinking too much water). At the time of the report, PYREXIA (fever 103.6 F), PAIN IN EXTREMITY (arm soreness) and THIRST (drinking too much water) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details  were not included .
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pruritus, Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: Arm was sore; Fever; Injection site itchy; Chils in hands and feet/Cold hands and feet; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills), PYREXIA (Fever), INJECTION SITE PRURITUS (Injection site itchy) and PERIPHERAL COLDNESS (Chils in hands and feet/Cold hands and feet) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 CHILLS (Chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore), PYREXIA (Fever), INJECTION SITE PRURITUS (Injection site itchy) and PERIPHERAL COLDNESS (Chils in hands and feet/Cold hands and feet). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and INJECTION SITE PRURITUS (Injection site itchy) was resolving, CHILLS (Chills) and PYREXIA (Fever) had resolved and PERIPHERAL COLDNESS (Chils in hands and feet/Cold hands and feet) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included paracetamol.   This case was linked to MOD21-12837 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: New event added
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid) 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.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, COVID-19: (Positive) positive. On 16-Feb-2021, COVID-19: (Negative) negative. On an unknown date, COVID-19:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Macule, Pain, Skin disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness), SKIN DISORDER (a bump on her left arm red and hot, with a red circle on it), MACULE (a bump on her left arm red and hot, with a red circle on it), SKIN WARM (a bump on her left arm red and hot, with a red circle on it) and PAIN (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced BLISTER (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness), PAIN (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) and FATIGUE (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness). On 18-Feb-2021, the patient experienced SKIN DISORDER (a bump on her left arm red and hot, with a red circle on it), MACULE (a bump on her left arm red and hot, with a red circle on it) and SKIN WARM (a bump on her left arm red and hot, with a red circle on it). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Feb-2021, BLISTER (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) and FATIGUE (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) had resolved, PAIN (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) outcome was unknown. At the time of the report, SKIN DISORDER (a bump on her left arm red and hot, with a red circle on it), MACULE (a bump on her left arm red and hot, with a red circle on it) and SKIN WARM (a bump on her left arm red and hot, with a red circle on it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included Tylenol(paracetamol).  Concomitant medications were not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness), SKIN DISORDER (a bump on her left arm red and hot, with a red circle on it), MACULE (a bump on her left arm red and hot, with a red circle on it), SKIN WARM (a bump on her left arm red and hot, with a red circle on it) and PAIN (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced BLISTER (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness), PAIN (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) and FATIGUE (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness). On 18-Feb-2021, the patient experienced SKIN DISORDER (a bump on her left arm red and hot, with a red circle on it), MACULE (a bump on her left arm red and hot, with a red circle on it) and SKIN WARM (a bump on her left arm red and hot, with a red circle on it). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Feb-2021, BLISTER (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) and FATIGUE (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) had resolved, PAIN (a little blister appeared on her arm that lasted 24hs, aches that lasted 72hs tiredness) outcome was unknown. At the time of the report, SKIN DISORDER (a bump on her left arm red and hot, with a red circle on it), MACULE (a bump on her left arm red and hot, with a red circle on it) and SKIN WARM (a bump on her left arm red and hot, with a red circle on it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included Tylenol(paracetamol).  Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to touch; Hard; Received second dose, has a large amount of swelling at the site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Some of the swelling is expanding), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE SWELLING (Received second dose, has a large amount of swelling at the site) 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 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Some of the swelling is expanding), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE SWELLING (Received second dose, has a large amount of swelling at the site). At the time of the report, SWELLING (Some of the swelling is expanding), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE SWELLING (Received second dose, has a large amount of swelling at the site) outcome was unknown.            Concomitant product use and treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Headache
Clinical narrative: Headache; Breastfeeding; A spontaneous report was received from a consumer concerning herself, a 35-year-old breastfeeding mother, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events; breastfeeding/exposure via breastmilk and headache.  The patient's medical history was not provided. Concomitant medication list was not provided by the reporter.  On 24 Feb 2021 the patient received their first of two planned doses of mRNA-1273 (Batch number: 013A21A) via an unknown route in an unspecified arm for the prophylaxis of COVID-19 infection.  On 24 Feb 2021, after receiving mRNA-1273 the patient experienced vaccine exposure while breastfeeding. On 25 Feb 2021, one day after receiving mRNA-1273 the patient experienced headache. Treatment information was not provided.  Action taken with the drug in response to the event; breastfeeding is not applicable. Action taken with the drug in response to the event; headache is unknown.  The outcome of the event; breastfeeding was considered to be recovered/resolved on 24 Feb2021. The outcome of the event; headache was considered to be recovered/resolved on 26 Feb 2021.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: some tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (some tenderness at injection site) 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. Concomitant products included CEFALEXIN (CEPHALEXIN AMEL) for UTI.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (some tenderness at injection site). At the time of the report, INJECTION SITE PAIN (some tenderness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.   This case was linked to MOD-2021-015479 (E2B Linked Report).; Sender's Comments:  MOD-2021-015479:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some arm pain that lasted for a few days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Some arm pain that lasted for a few days). At the time of the report, PAIN IN EXTREMITY (Some arm pain that lasted for a few days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-091438.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: very itchy around her eyes; red and rashy; red and rashy; 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 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (very itchy around her eyes), INJECTION SITE RASH (red and rashy) and INJECTION SITE ERYTHEMA (red and rashy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE RASH (red and rashy) and INJECTION SITE ERYTHEMA (red and rashy). On 19-Feb-2021, the patient experienced RASH (very itchy around her eyes). At the time of the report, RASH (very itchy around her eyes), INJECTION SITE RASH (red and rashy) and INJECTION SITE ERYTHEMA (red and rashy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment products were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: not significant
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Flatulence, Joint swelling
Clinical narrative: having migraine every couple of days; Inflammation in knew and elbows; Gastro (stomach) issues; Extremely Gassy; Wet stool; Chronic fatigue; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (having migraine every couple of days), JOINT SWELLING (Inflammation in knew and elbows), ABDOMINAL PAIN UPPER (Gastro (stomach) issues), FLATULENCE (Extremely Gassy) and DIARRHOEA (Wet stool) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-Jan-2021, the patient experienced MIGRAINE (having migraine every couple of days), JOINT SWELLING (Inflammation in knew and elbows), ABDOMINAL PAIN UPPER (Gastro (stomach) issues), FLATULENCE (Extremely Gassy), DIARRHOEA (Wet stool), FATIGUE (Chronic fatigue) and NAUSEA (Nauseous). At the time of the report, MIGRAINE (having migraine every couple of days), JOINT SWELLING (Inflammation in knew and elbows), ABDOMINAL PAIN UPPER (Gastro (stomach) issues), FLATULENCE (Extremely Gassy), DIARRHOEA (Wet stool), FATIGUE (Chronic fatigue) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included Tylenol(paracetamol), Ibuprofen, Advil and Motrin.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: having migraine every couple of days; Inflammation in knew and elbows; Gastro (stomach) issues; Extremely Gassy; Wet stool; Chronic fatigue; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (having migraine every couple of days), JOINT SWELLING (Inflammation in knew and elbows), ABDOMINAL PAIN UPPER (Gastro (stomach) issues), FLATULENCE (Extremely Gassy) and DIARRHOEA (Wet stool) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-Jan-2021, the patient experienced MIGRAINE (having migraine every couple of days), JOINT SWELLING (Inflammation in knew and elbows), ABDOMINAL PAIN UPPER (Gastro (stomach) issues), FLATULENCE (Extremely Gassy), DIARRHOEA (Wet stool), FATIGUE (Chronic fatigue) and NAUSEA (Nauseous). At the time of the report, MIGRAINE (having migraine every couple of days), JOINT SWELLING (Inflammation in knew and elbows), ABDOMINAL PAIN UPPER (Gastro (stomach) issues), FLATULENCE (Extremely Gassy), DIARRHOEA (Wet stool), FATIGUE (Chronic fatigue) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included Tylenol(paracetamol), Ibuprofen, Advil and Motrin.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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 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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information received on 27-APR-2021 contains non-significant information: Corrected first name of reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: huge red rash; rash: a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (huge red rash) and VACCINATION SITE PRURITUS (rash: a little itchy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (huge red rash) and VACCINATION SITE PRURITUS (rash: a little itchy). At the time of the report, VACCINATION SITE RASH (huge red rash) and VACCINATION SITE PRURITUS (rash: a little itchy) 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Low platelet count of 11000; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Low platelet count of 11000) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PLATELET COUNT DECREASED (Low platelet count of 11000). At the time of the report, PLATELET COUNT DECREASED (Low platelet count of 11000) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Platelet count: 11000 Inconclusive. On 17-Feb-2021, Platelet count: 59000 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.. Treatment information include steroids.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Nausea; Headache; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea) and HEADACHE (Headache) in a 76-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) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: red raised hives like symptoms in middle flexion, front, back, and forearm, ones on the waist are bigger compared to others, ones on arm are little itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red raised hives like symptoms in middle flexion, front, back, and forearm, ones on the waist are bigger compared to others, ones on arm are little itchy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LISINOPRIL and DOXYCYCLINE (ORACEA [DOXYCYCLINE]) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced URTICARIA (red raised hives like symptoms in middle flexion, front, back, and forearm, ones on the waist are bigger compared to others, ones on arm are little itchy). At the time of the report, URTICARIA (red raised hives like symptoms in middle flexion, front, back, and forearm, ones on the waist are bigger compared to others, ones on arm are little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Vomiting
Clinical narrative: Pain in back; he threw up; Arm  was sore; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in back), PAIN IN EXTREMITY (Arm  was sore) and VOMITING (he threw up) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 PAIN IN EXTREMITY (Arm  was sore). On 23-Jan-2021, the patient experienced BACK PAIN (Pain in back) and VOMITING (he threw up). At the time of the report, BACK PAIN (Pain in back), PAIN IN EXTREMITY (Arm  was sore) and VOMITING (he threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site papule, Vaccination site pruritus
Clinical narrative: Bump that has come back but is not pinkish; bump has come back but not pinkish but is itching; very pinkish-red raised bump/red arm; lump within arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (lump within arm), VACCINATION SITE PAPULE (Bump that has come back but is not pinkish), VACCINATION SITE PRURITUS (bump has come back but not pinkish but is itching) and VACCINATION SITE ERYTHEMA (very pinkish-red raised bump/red arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE MASS (lump within arm) and VACCINATION SITE ERYTHEMA (very pinkish-red raised bump/red arm). On 19-Feb-2021, the patient experienced VACCINATION SITE PAPULE (Bump that has come back but is not pinkish) and VACCINATION SITE PRURITUS (bump has come back but not pinkish but is itching). At the time of the report, VACCINATION SITE MASS (lump within arm), VACCINATION SITE PAPULE (Bump that has come back but is not pinkish), VACCINATION SITE PRURITUS (bump has come back but not pinkish but is itching) and VACCINATION SITE ERYTHEMA (very pinkish-red raised bump/red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient got red arm and lump within arm after receiving the first dose of the vaccine and was disappeared but came back after 9 days. Concomitant medications were not provided. The patient did not receive any treatment medications.   This case was linked to MOD-2021-169362 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Contact information and additional event updated. On 25-May-2021: No new information reported
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Feeling jittery, Headache, Nervousness
Clinical narrative: feeling weak; feeling jittery; shaking; nervous; coughing; headache; fever; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (feeling weak), FEELING JITTERY (feeling jittery), TREMOR (shaking), NERVOUSNESS (nervous) and COUGH (coughing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). On 16-Feb-2021, the patient experienced ASTHENIA (feeling weak), FEELING JITTERY (feeling jittery), TREMOR (shaking), NERVOUSNESS (nervous) and COUGH (coughing). At the time of the report, ASTHENIA (feeling weak), FEELING JITTERY (feeling jittery), TREMOR (shaking), NERVOUSNESS (nervous), COUGH (coughing), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment was taken by patient for events.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: feeling weak; feeling jittery; shaking; nervous; coughing; headache; fever; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (feeling weak), FEELING JITTERY (feeling jittery), TREMOR (shaking), NERVOUSNESS (nervous) and COUGH (coughing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). On 16-Feb-2021, the patient experienced ASTHENIA (feeling weak), FEELING JITTERY (feeling jittery), TREMOR (shaking), NERVOUSNESS (nervous) and COUGH (coughing). At the time of the report, ASTHENIA (feeling weak), FEELING JITTERY (feeling jittery), TREMOR (shaking), NERVOUSNESS (nervous), COUGH (coughing), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment was taken by patient for events.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: arm  was swollen; arm  was sore; arm  was blotchy; arm  was a little bit itchy again; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  was swollen), PAIN IN EXTREMITY (arm  was sore), RASH MACULAR (arm  was blotchy) and PRURITUS (arm  was a little bit itchy again) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm  was swollen), PAIN IN EXTREMITY (arm  was sore), RASH MACULAR (arm  was blotchy) and PRURITUS (arm  was a little bit itchy again). At the time of the report, PERIPHERAL SWELLING (arm  was swollen), PAIN IN EXTREMITY (arm  was sore), RASH MACULAR (arm  was blotchy) and PRURITUS (arm  was a little bit itchy again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Head discomfort, Headache, Herpes zoster
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Looks like shingles on her hairline and partially on scalp), VISION BLURRED (Unable to focus in one eye), DECREASED APPETITE (Loss of appetite), SWELLING (Head feels swollen) and ASTHENIA (weak) in a 74-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Looks like shingles on her hairline and partially on scalp), VISION BLURRED (Unable to focus in one eye), DECREASED APPETITE (Loss of appetite), SWELLING (Head feels swollen), ASTHENIA (weak), HEAD DISCOMFORT (Head feels filled with Cement) and HEADACHE (occasional pains running up the back of her head). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Looks like shingles on her hairline and partially on scalp), VISION BLURRED (Unable to focus in one eye), DECREASED APPETITE (Loss of appetite), SWELLING (Head feels swollen), ASTHENIA (weak), HEAD DISCOMFORT (Head feels filled with Cement) and HEADACHE (occasional pains running up the back of her head) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The treatment reported was eye drops.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vision blurred
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Looks like shingles on her hairline and partially on scalp), VISION BLURRED (Unable to focus in one eye), DECREASED APPETITE (Loss of appetite), SWELLING (Head feels swollen) and ASTHENIA (weak) in a 74-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Looks like shingles on her hairline and partially on scalp), VISION BLURRED (Unable to focus in one eye), DECREASED APPETITE (Loss of appetite), SWELLING (Head feels swollen), ASTHENIA (weak), HEAD DISCOMFORT (Head feels filled with Cement) and HEADACHE (occasional pains running up the back of her head). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Looks like shingles on her hairline and partially on scalp), VISION BLURRED (Unable to focus in one eye), DECREASED APPETITE (Loss of appetite), SWELLING (Head feels swollen), ASTHENIA (weak), HEAD DISCOMFORT (Head feels filled with Cement) and HEADACHE (occasional pains running up the back of her head) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The treatment reported was eye drops.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE at a dose of 50 milligram. At the time of the report, URTICARIA (Hives) was resolving.            Concomitantly, patient was taking blood thinner and antidepressant medications.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood Sugar elevated; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood Sugar elevated) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood Sugar elevated). The patient was treated with INSULIN at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (Blood Sugar elevated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood glucose: 150 (150) and 250 to 350 (250 to 350).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking an unspecified medication.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Arm  is sore; Arm  is red; Arm  is hot to touch; arm  is rash; Arm  i s itchy; Arm  is hard; Arm  is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  is sore), ERYTHEMA (Arm  is red), FEELING HOT (Arm  is hot to touch), RASH (arm  is rash) and PRURITUS (Arm  i s itchy) in a 71-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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm  is sore), ERYTHEMA (Arm  is red), FEELING HOT (Arm  is hot to touch), RASH (arm  is rash), PRURITUS (Arm  i s itchy), INDURATION (Arm  is hard) and PERIPHERAL SWELLING (Arm  is swollen). At the time of the report, PAIN IN EXTREMITY (Arm  is sore), ERYTHEMA (Arm  is red), FEELING HOT (Arm  is hot to touch), RASH (arm  is rash), PRURITUS (Arm  i s itchy), INDURATION (Arm  is hard) and PERIPHERAL SWELLING (Arm  is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Email address provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Arm  is sore; Arm  is red; Arm  is hot to touch; arm  is rash; Arm  i s itchy; Arm  is hard; Arm  is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  is sore), ERYTHEMA (Arm  is red), FEELING HOT (Arm  is hot to touch), RASH (arm  is rash) and PRURITUS (Arm  i s itchy) in a 71-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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm  is sore), ERYTHEMA (Arm  is red), FEELING HOT (Arm  is hot to touch), RASH (arm  is rash), PRURITUS (Arm  i s itchy), INDURATION (Arm  is hard) and PERIPHERAL SWELLING (Arm  is swollen). At the time of the report, PAIN IN EXTREMITY (Arm  is sore), ERYTHEMA (Arm  is red), FEELING HOT (Arm  is hot to touch), RASH (arm  is rash), PRURITUS (Arm  i s itchy), INDURATION (Arm  is hard) and PERIPHERAL SWELLING (Arm  is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Email address provided
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Paraesthesia
Clinical narrative: migraine; hands tingling; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine) and PARAESTHESIA (hands tingling) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039KZOA) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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 05-Feb-2021, the patient experienced MIGRAINE (migraine) and PARAESTHESIA (hands tingling). At the time of the report, MIGRAINE (migraine) and PARAESTHESIA (hands tingling) outcome was unknown. Patient received the second dose of Moderna COVID-19 vaccine yesterday and started experiencing migraine and hands tingling. Inquires if hands tingling is a common adverse event regarding the vaccine.          Concomitant product use was not provided by the reporter. No treatment information was provided.