chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injury associated with device, Papule, Pruritus
Clinical narrative: left arm and chin were so itchy; left arm and chin were so itchy and was all red; left arm and chin were so itchy and was all red and bumps; dizzy spells; headache; pharmacist pricked but then had to take it out and do it again so patient was pricked twice; did not feel like herself and had a weird feeling; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INJURY ASSOCIATED WITH DEVICE (pharmacist pricked but then had to take it out and do it again so patient was pricked twice), FEELING ABNORMAL (did not feel like herself and had a weird feeling), DIZZINESS (dizzy spells), PRURITUS (left arm and chin were so itchy) and ERYTHEMA (left arm and chin were so itchy and was all red) in a 73-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 was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROGESTERONE, LORAZEPAM and FISH OIL for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJURY ASSOCIATED WITH DEVICE (pharmacist pricked but then had to take it out and do it again so patient was pricked twice), FEELING ABNORMAL (did not feel like herself and had a weird feeling) and FATIGUE (very fatigued). On 30-Jan-2021, the patient experienced DIZZINESS (dizzy spells) and HEADACHE (headache). On 01-Feb-2021, the patient experienced PRURITUS (left arm and chin were so itchy), ERYTHEMA (left arm and chin were so itchy and was all red) and PAPULE (left arm and chin were so itchy and was all red and bumps). The patient was treated with PARACETAMOL (TYLENOL) on 30-Jan-2021 for Headache, at an unspecified dose and frequency and COCONUT OIL on 01-Feb-2021 for Pruritus, at an unspecified dose and frequency. On 23-Jan-2021, INJURY ASSOCIATED WITH DEVICE (pharmacist pricked but then had to take it out and do it again so patient was pricked twice), FEELING ABNORMAL (did not feel like herself and had a weird feeling) and FATIGUE (very fatigued) had resolved. On 31-Jan-2021, DIZZINESS (dizzy spells) and HEADACHE (headache) had resolved. On 02-Feb-2021, PRURITUS (left arm and chin were so itchy) had resolved. At the time of the report, ERYTHEMA (left arm and chin were so itchy and was all red) and PAPULE (left arm and chin were so itchy and was all red and bumps) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feels like she is on a boat,like she is rocking; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feels like she is on a boat,like she is rocking) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 an unknown date, the patient experienced FEELING ABNORMAL (Feels like she is on a boat,like she is rocking). At the time of the report, FEELING ABNORMAL (Feels like she is on a boat,like she is rocking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) 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 relevant concomitant medications were reported. Treatment details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching; Rash on the injection site, rash has gotten bigger; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Rash on the injection site, rash has gotten bigger) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Rash on the injection site, rash has gotten bigger). At the time of the report, VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Rash on the injection site, rash has gotten bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included unspecified cold medicine.  No concomitant medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance
Clinical narrative: Felt so bad; Coudn't walk; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt so bad) and GAIT DISTURBANCE (Coudn't walk) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (cholesterol). Concomitant products included ALBUTEROL [SALBUTAMOL] for Product used for unknown indication, LEVOTHYROXINE, WARFARIN, LOSARTAN, ALLOPURINOL, ISOSORBIDE, ISOSORBID [ISOSORBIDE], FUROSEMIDE (LASIX [FUROSEMIDE]), METOPROLOL, TRAMADOL, POTASSIUM and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FEELING ABNORMAL (Felt so bad) and GAIT DISTURBANCE (Coudn't walk). On 31-Jan-2021, FEELING ABNORMAL (Felt so bad) and GAIT DISTURBANCE (Coudn't walk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash; Redness; Swelling; Little tenderness in injections site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Little tenderness in injections site), VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little tenderness in injections site). On 26-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). On 20-Jan-2021, VACCINATION SITE PAIN (Little tenderness in injections site) had resolved. At the time of the report, VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) had not resolved.        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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Horrible insomnia; A spontaneous report was received from a Consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On unspecified date the patient experienced horrible insomnia. On Friday night, 29 Jan 2021, the patient slept 2.5 to 3 hours, was in and out of sleep. On saturday night the patient could not sleep had to take naps throughout the day. On sunday the patient slept from 10pm to 2am.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event horrible insomnia, she was in and out of sleep, could not sleep were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further No follow up is possible.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural
Clinical narrative: dizzy spells; really really dizzy for 12 hours; severe dizziness standing or even sitting down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (really really dizzy for 12 hours), DIZZINESS POSTURAL (severe dizziness standing or even sitting down) and DIZZINESS (dizzy spells) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20) for COVID-19 vaccination.     The patient's past medical history included Asthma since an unknown date and Blood pressure high since an unknown date. Concomitant products included EPINEPHRINE BITARTRATE (ASTHMAHALER) for Asthma.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (really really dizzy for 12 hours) and DIZZINESS POSTURAL (severe dizziness standing or even sitting down). On an unknown date, the patient experienced DIZZINESS (dizzy spells). On 08-Jan-2021, DIZZINESS (really really dizzy for 12 hours) and DIZZINESS POSTURAL (severe dizziness standing or even sitting down) had resolved. At the time of the report, DIZZINESS (dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   patient is taking blood pressure medicine unknown drug no treatment information provided
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Peripheral swelling, Pruritus
Clinical narrative: a week later my left arm was swollen, about 2.5 Inches bigger than my other arm; My arm was hot to the touch and the swollen area was 5.5 inches long by 4.5 inches wide.; itchy following the dose; sore following the dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy following the dose), PAIN (sore following the dose), PERIPHERAL SWELLING (a week later my left arm was swollen, about 2.5 Inches bigger than my other arm) and FEELING HOT (My arm was hot to the touch and the swollen area was 5.5 inches long by 4.5 inches wide.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included ZOLPIDEM, COLCHICINE, ASCORBIC ACID, ROSA CANINA (VITAMIN C [ASCORBIC ACID;ROSA CANINA]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM (CALCIUM supplement) for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PRURITUS (itchy following the dose) and PAIN (sore following the dose). On an unknown date, the patient experienced PERIPHERAL SWELLING (a week later my left arm was swollen, about 2.5 Inches bigger than my other arm) and FEELING HOT (My arm was hot to the touch and the swollen area was 5.5 inches long by 4.5 inches wide.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy following the dose), PAIN (sore following the dose), PERIPHERAL SWELLING (a week later my left arm was swollen, about 2.5 Inches bigger than my other arm) and FEELING HOT (My arm was hot to the touch and the swollen area was 5.5 inches long by 4.5 inches wide.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever 101; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101) and PAIN (body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03ZHZUA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (product used for unknown indication).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (fever 101) and PAIN (body aches). At the time of the report, PYREXIA (fever 101) and PAIN (body aches) 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 medication and treatment provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: arm sort of itching; arm kind of red; arm a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (arm sort of itching), INJECTION SITE ERYTHEMA (arm kind of red) and PERIPHERAL SWELLING (arm a little swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced INJECTION SITE PRURITUS (arm sort of itching), INJECTION SITE ERYTHEMA (arm kind of red) and PERIPHERAL SWELLING (arm a little swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (arm sort of itching), INJECTION SITE ERYTHEMA (arm kind of red) and PERIPHERAL SWELLING (arm a little swollen) 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 medication provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Wheezing
Clinical narrative: Wheezing; SOB; Diarrhea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), WHEEZING (Wheezing) and DYSPNOEA (SOB) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (medical history was not provided.). Concomitant products included METOPROLOL TARTRATE (METOPROLOL ACTAVIS [METOPROLOL TARTRATE]), LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 21-Jan-2021, the patient experienced WHEEZING (Wheezing) and DYSPNOEA (SOB). The patient was treated with ALBUTEROL SULFATE (ALBUTEROL SULFATE inhalation) ongoing since an unknown date at an unspecified dose and frequency and CAMPHOR, ESSENTIAL OILS NOS (AEROSOL SPITZNER) ongoing since an unknown date at a dose of 90 microgram every six hours. On 16-Jan-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, WHEEZING (Wheezing) and DYSPNOEA (SOB) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient stated that she has an appointment schedule with Cardiologist and will make an appointment with pulmonologist after seeing Cardiologist. Caller has provided PCP and Cardiologist information.   treatment includes Albuterol Sulfate Inhalation Aerosol 90 MCG: 1-2 puffs by mouth every 4-6 hours
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site swelling; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; Hot at the injection site; Red at the injection site; Swollen at the injection site; Chills; Was not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Hot at the injection site), INJECTION SITE ERYTHEMA (Red at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), CHILLS (Chills) and MALAISE (Was not feeling well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    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 INJECTION SITE WARMTH (Hot at the injection site), INJECTION SITE ERYTHEMA (Red at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), CHILLS (Chills) and MALAISE (Was not feeling well). On 23-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 23-Jan-2021, CHILLS (Chills) and MALAISE (Was not feeling well) had resolved. On 28-Jan-2021, INJECTION SITE WARMTH (Hot at the injection site), INJECTION SITE ERYTHEMA (Red at the injection site) and INJECTION SITE SWELLING (Swollen at the injection site) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Swollen lymph nodes; Hot at the injection site; Red at the injection site; Swollen at the injection site; Chills; Was not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Hot at the injection site), INJECTION SITE ERYTHEMA (Red at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), CHILLS (Chills) and MALAISE (Was not feeling well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    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 INJECTION SITE WARMTH (Hot at the injection site), INJECTION SITE ERYTHEMA (Red at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), CHILLS (Chills) and MALAISE (Was not feeling well). On 23-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 23-Jan-2021, CHILLS (Chills) and MALAISE (Was not feeling well) had resolved. On 28-Jan-2021, INJECTION SITE WARMTH (Hot at the injection site), INJECTION SITE ERYTHEMA (Red at the injection site) and INJECTION SITE SWELLING (Swollen at the injection site) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment provided
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID-19 positive after receiving the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Diagnosed with COVID-19 positive after receiving the vaccine) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Diagnosed with COVID-19 positive after receiving the vaccine). At the time of the report, COVID-19 (Diagnosed with COVID-19 positive after receiving the vaccine) 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.   Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non-significant follow-up appended: no new info, added hx; Sender's Comments: Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 positive is assessed as unlikely related to mRNA-1273.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: rash and a sinus infection; rash and a sinus infection; stomach stress, like in the intestine; the shoulder aches there and there is the red rash; rash on the arm and a bump red, very red; It was hot; there was just pain; appeared a red bubble, or red bump, and it was hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine), INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot) and RASH ERYTHEMATOUS (rash on the arm and a bump red, very red) 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.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), RIVAROXABAN (XARELTO), BUPROPION, TOPIRAMATE (TOPAMAX) and FUROSEMIDE for an unknown indication.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot), INJECTION SITE WARMTH (It was hot) and INJECTION SITE PAIN (there was just pain). On 02-Feb-2021, the patient experienced RASH ERYTHEMATOUS (rash on the arm and a bump red, very red). On an unknown date, the patient experienced RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine) and ARTHRALGIA (the shoulder aches there and there is the red rash). The patient was treated with AZITHROMYCIN for Sinus infection, at an unspecified dose and frequency. On 29-Jan-2021, INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot) and INJECTION SITE WARMTH (It was hot) had resolved. At the time of the report, RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine), RASH ERYTHEMATOUS (rash on the arm and a bump red, very red), ARTHRALGIA (the shoulder aches there and there is the red rash) and INJECTION SITE PAIN (there was just pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Sinusitis
Clinical narrative: rash and a sinus infection; rash and a sinus infection; stomach stress, like in the intestine; the shoulder aches there and there is the red rash; rash on the arm and a bump red, very red; It was hot; there was just pain; appeared a red bubble, or red bump, and it was hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine), INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot) and RASH ERYTHEMATOUS (rash on the arm and a bump red, very red) 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.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), RIVAROXABAN (XARELTO), BUPROPION, TOPIRAMATE (TOPAMAX) and FUROSEMIDE for an unknown indication.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot), INJECTION SITE WARMTH (It was hot) and INJECTION SITE PAIN (there was just pain). On 02-Feb-2021, the patient experienced RASH ERYTHEMATOUS (rash on the arm and a bump red, very red). On an unknown date, the patient experienced RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine) and ARTHRALGIA (the shoulder aches there and there is the red rash). The patient was treated with AZITHROMYCIN for Sinus infection, at an unspecified dose and frequency. On 29-Jan-2021, INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot) and INJECTION SITE WARMTH (It was hot) had resolved. At the time of the report, RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine), RASH ERYTHEMATOUS (rash on the arm and a bump red, very red), ARTHRALGIA (the shoulder aches there and there is the red rash) and INJECTION SITE PAIN (there was just pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included ZINC, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID (VITAMIN C FORMULA) for an unknown indication.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pruritus, Rash, Vaccination site erythema, Vaccination site warmth
Clinical narrative: felt Fluey; a red, warmish circle under the injection site; Larger than silver dollar circular rash, about the size of a small can; a red, warmish circle under the injection site; Intense itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Intense itchiness), INFLUENZA (felt Fluey), VACCINATION SITE WARMTH (a red, warmish circle under the injection site), RASH (Larger than silver dollar circular rash, about the size of a small can) and VACCINATION SITE ERYTHEMA (a red, warmish circle under the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Intense itchiness). On 30-Jan-2021, the patient experienced INFLUENZA (felt Fluey), VACCINATION SITE WARMTH (a red, warmish circle under the injection site), RASH (Larger than silver dollar circular rash, about the size of a small can) and VACCINATION SITE ERYTHEMA (a red, warmish circle under the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (Intense itchiness), INFLUENZA (felt Fluey), VACCINATION SITE WARMTH (a red, warmish circle under the injection site), RASH (Larger than silver dollar circular rash, about the size of a small can) and VACCINATION SITE ERYTHEMA (a red, warmish circle under the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: Arm warm; Arm sore; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING HOT (Arm warm) and PAIN IN EXTREMITY (Arm sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Arm warm) and PAIN IN EXTREMITY (Arm sore). At the time of the report, FEELING HOT (Arm warm) and PAIN IN EXTREMITY (Arm sore) outcome 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 medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-019502 (Patient Link).
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Chills, Dizziness, Fatigue
Clinical narrative: pulse racing; increase blood pressure; Dizzy; Weakness; Nausea; Fatigue; Headache; Chills; Fever; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse racing), BLOOD PRESSURE INCREASED (increase blood pressure), PAIN IN EXTREMITY (Arm pain), DIZZINESS (Dizzy) and ASTHENIA (Weakness) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills). On 31-Jan-2021, the patient experienced HEART RATE INCREASED (pulse racing), BLOOD PRESSURE INCREASED (increase blood pressure), DIZZINESS (Dizzy), ASTHENIA (Weakness), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (pulse racing), BLOOD PRESSURE INCREASED (increase blood pressure), PAIN IN EXTREMITY (Arm pain), DIZZINESS (Dizzy), ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Blood pressure medication. Treatment details included blood pressure medicine off and on normally.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: pulse racing; increase blood pressure; Dizzy; Weakness; Nausea; Fatigue; Headache; Chills; Fever; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse racing), BLOOD PRESSURE INCREASED (increase blood pressure), PAIN IN EXTREMITY (Arm pain), DIZZINESS (Dizzy) and ASTHENIA (Weakness) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills). On 31-Jan-2021, the patient experienced HEART RATE INCREASED (pulse racing), BLOOD PRESSURE INCREASED (increase blood pressure), DIZZINESS (Dizzy), ASTHENIA (Weakness), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (pulse racing), BLOOD PRESSURE INCREASED (increase blood pressure), PAIN IN EXTREMITY (Arm pain), DIZZINESS (Dizzy), ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Blood pressure medication. Treatment details included blood pressure medicine off and on normally.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Vaccination site kind of hard like a lump; The arm at the vaccination site turn all red about 2 inches long and 1 inch across; Vaccination site kind of hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Vaccination site kind of hard like a lump), VACCINATION SITE ERYTHEMA (The arm at the vaccination site turn all red about 2 inches long and 1 inch across) and VACCINATION SITE PAIN (Vaccination site kind of hurt) 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 18-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 VACCINATION SITE INDURATION (Vaccination site kind of hard like a lump), VACCINATION SITE ERYTHEMA (The arm at the vaccination site turn all red about 2 inches long and 1 inch across) and VACCINATION SITE PAIN (Vaccination site kind of hurt). At the time of the report, VACCINATION SITE INDURATION (Vaccination site kind of hard like a lump), VACCINATION SITE ERYTHEMA (The arm at the vaccination site turn all red about 2 inches long and 1 inch across) and VACCINATION SITE PAIN (Vaccination site kind of hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm was red; Arm swelling; Arm felt warm; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm swelling, arm felt warm, and arm was red.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received her 1st dose of mRNA-1273 (lot/batch: 029L20A) in the right arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the events- Arm swelling, Arm felt warm, and Arm was red.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, swelling and Arm felt warm was considered  resolved. .; 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
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Urticaria, Vaccination site erythema, Vaccination site pain
Clinical narrative: really didn't feel good at all; developed welts; big red patch that was hot and very tender, sore at the site; a big red patch that was hot and very tender, sore at the site; big red patch that was hot and very tender, sore at the site; exhausted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (really didn't feel good at all), URTICARIA (developed welts), VACCINATION SITE WARMTH (big red patch that was hot and very tender, sore at the site), VACCINATION SITE ERYTHEMA (a big red patch that was hot and very tender, sore at the site) and VACCINATION SITE PAIN (big red patch that was hot and very tender, sore at the site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic fatigue (took 2 years to recover from.). Concurrent medical conditions included Immune system disorder (about 20 years ago, her immune system went hay wire, she had a high T-cell count). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and THYROID (ARMOUR THYROID) for an unknown indication.    On 13-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 MALAISE (really didn't feel good at all), URTICARIA (developed welts), VACCINATION SITE WARMTH (big red patch that was hot and very tender, sore at the site), VACCINATION SITE ERYTHEMA (a big red patch that was hot and very tender, sore at the site), VACCINATION SITE PAIN (big red patch that was hot and very tender, sore at the site) and FATIGUE (exhausted). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Vaccination site erythema, Vaccination site warmth and Vaccination site pain, at an unspecified dose and frequency and DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, MALAISE (really didn't feel good at all), URTICARIA (developed welts), VACCINATION SITE WARMTH (big red patch that was hot and very tender, sore at the site), VACCINATION SITE ERYTHEMA (a big red patch that was hot and very tender, sore at the site), VACCINATION SITE PAIN (big red patch that was hot and very tender, sore at the site) and FATIGUE (exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient used ice pack on a big red patch that was hot and very tender, sore at the site.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: really didn't feel good at all; developed welts; big red patch that was hot and very tender, sore at the site; a big red patch that was hot and very tender, sore at the site; big red patch that was hot and very tender, sore at the site; exhausted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (really didn't feel good at all), URTICARIA (developed welts), VACCINATION SITE WARMTH (big red patch that was hot and very tender, sore at the site), VACCINATION SITE ERYTHEMA (a big red patch that was hot and very tender, sore at the site) and VACCINATION SITE PAIN (big red patch that was hot and very tender, sore at the site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic fatigue (took 2 years to recover from.). Concurrent medical conditions included Immune system disorder (about 20 years ago, her immune system went hay wire, she had a high T-cell count). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and THYROID (ARMOUR THYROID) for an unknown indication.    On 13-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 MALAISE (really didn't feel good at all), URTICARIA (developed welts), VACCINATION SITE WARMTH (big red patch that was hot and very tender, sore at the site), VACCINATION SITE ERYTHEMA (a big red patch that was hot and very tender, sore at the site), VACCINATION SITE PAIN (big red patch that was hot and very tender, sore at the site) and FATIGUE (exhausted). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Vaccination site erythema, Vaccination site warmth and Vaccination site pain, at an unspecified dose and frequency and DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, MALAISE (really didn't feel good at all), URTICARIA (developed welts), VACCINATION SITE WARMTH (big red patch that was hot and very tender, sore at the site), VACCINATION SITE ERYTHEMA (a big red patch that was hot and very tender, sore at the site), VACCINATION SITE PAIN (big red patch that was hot and very tender, sore at the site) and FATIGUE (exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient used ice pack on a big red patch that was hot and very tender, sore at the site.