chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative, SARS-CoV-2 antibody test, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Vaccination did not work / Doesn't have antibodies for Covid-19; Swollen arm with a big red dot the size of a tennis ball; Swollen arm with a big red dot the size of a tennis ball; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Vaccination did not work / Doesn't have antibodies for Covid-19), VACCINATION SITE SWELLING (Swollen arm with a big red dot the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Swollen arm with a big red dot the size of a tennis ball) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm with a big red dot the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Swollen arm with a big red dot the size of a tennis ball). On 24-Mar-2021, the patient experienced ANTIBODY TEST NEGATIVE (Vaccination did not work / Doesn't have antibodies for Covid-19). On 12-Feb-2021, VACCINATION SITE SWELLING (Swollen arm with a big red dot the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Swollen arm with a big red dot the size of a tennis ball) had resolved. At the time of the report, ANTIBODY TEST NEGATIVE (Vaccination did not work / Doesn't have antibodies for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.         No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.  Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site swelling, vaccination site erythema) a causal relationship cannot be excluded. Very limited information has been provided for the event (antibody test negative) at this time.; 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 (vaccination site swelling, vaccination site erythema) a causal relationship cannot be excluded. Very limited information has been provided for the event (antibody test negative) at this time.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypersensitivity, Lymphadenopathy, Pruritus
Clinical narrative: allergic reaction; lightheadedness; Breathing difficult; Lymph nodes, enlarged; Swollen lymph nodes; Painful lymphadenopathy; itchy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), DIZZINESS (lightheadedness), DYSPNOEA (Breathing difficult), LYMPHADENOPATHY (Lymph nodes, enlarged ) and LYMPHADENOPATHY (Swollen lymph nodes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Diabetes and Diabetic neuropathy.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), DIZZINESS (lightheadedness), DYSPNOEA (Breathing difficult), LYMPHADENOPATHY (Lymph nodes, enlarged ), LYMPHADENOPATHY (Swollen lymph nodes), LYMPHADENOPATHY (Painful lymphadenopathy) and PRURITUS (itchy). At the time of the report, HYPERSENSITIVITY (allergic reaction), DIZZINESS (lightheadedness), DYSPNOEA (Breathing difficult), LYMPHADENOPATHY (Lymph nodes, enlarged ), LYMPHADENOPATHY (Swollen lymph nodes), LYMPHADENOPATHY (Painful lymphadenopathy) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. Patient had an allergic reaction: light-headedness,little trouble breathing, lymph nodes down in her  groin area in left side have grown, painful, itchy. Neck and throat lymph nodes were swollen as well. Patient was taking high blood pressure, diabetes,diabetic neuropathy, micro colitis medication as concomitant medication.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body was sore; little chills; low fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body was sore), CHILLS (little chills) and PYREXIA (low fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-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 PAIN (body was sore), CHILLS (little chills) and PYREXIA (low fever). At the time of the report, PAIN (body was sore), CHILLS (little chills) and PYREXIA (low fever) outcome was unknown.            Patient took Tylenol to treat symptoms. No concomitant medication was reported   Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Chills and pyrexia are consistent with the known safety profile of the vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Premature ventricular contractions; This spontaneous case was reported by a physician and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) in a 42-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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions). At the time of the report, VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant details were provided No treatment details were provided; Sender's Comments: There is limited information provide to assess the causal association between the reported event and the administration of mRNA-1273 as the date of treatment  and onset dates of the event were not specified.  Additional information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Nasopharyngitis
Clinical narrative: chills; cough; cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASOPHARYNGITIS (cold) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced COUGH (cough) and NASOPHARYNGITIS (cold). On an unknown date, the patient experienced CHILLS (chills). At the time of the report, COUGH (cough), NASOPHARYNGITIS (cold) and CHILLS (chills) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Chills is consistent with the known safety profile of the vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Restlessness
Clinical narrative: lightheadedness; diarrhea; restlessness,; confusion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), DIARRHOEA (diarrhea), RESTLESSNESS (restlessness,) and CONFUSIONAL STATE (confusion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 040A21A) for COVID-19 vaccination.     Concomitant products included MEMANTINE HYDROCHLORIDE (NAMENDA), ASA, AMLODIPINE, ESCITALOPRAM, ATORVASTATIN, DONEPEZIL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D NOS) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (lightheadedness), DIARRHOEA (diarrhea), RESTLESSNESS (restlessness,) and CONFUSIONAL STATE (confusion). At the time of the report, DIZZINESS (lightheadedness), DIARRHOEA (diarrhea), RESTLESSNESS (restlessness,) and CONFUSIONAL STATE (confusion) outcome was unknown. Not Provided          Treatment information was not provided. /unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in his ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Ringing in ears.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TINNITUS (ringing in his ears). At the time of the report, TINNITUS (ringing in his ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Face injury, Skin exfoliation
Clinical narrative: whole face blew up; face became red; face became scaly; This spontaneous case was reported by a consumer and describes the occurrence of FACE INJURY (whole face blew up), ERYTHEMA (face became red) and SKIN EXFOLIATION (face became scaly) 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).    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 FACE INJURY (whole face blew up), ERYTHEMA (face became red) and SKIN EXFOLIATION (face became scaly). At the time of the report, FACE INJURY (whole face blew up), ERYTHEMA (face became red) and SKIN EXFOLIATION (face became scaly) outcome was unknown.            No concomitant medication was reported.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Suspected COVID-19
Clinical narrative: household had someone who is positive for covid and he is now symptomatic for covid; coughing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (coughing) and SUSPECTED COVID-19 (household had someone who is positive for covid and he is now symptomatic for covid) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Mar-2021, the patient experienced COUGH (coughing). On an unknown date, the patient experienced SUSPECTED COVID-19 (household had someone who is positive for covid and he is now symptomatic for covid). At the time of the report, COUGH (coughing) and SUSPECTED COVID-19 (household had someone who is positive for covid and he is now symptomatic for covid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Event coding correction and narrative update. On 07-Jul-2021: Outcome updated to recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Rash
Clinical narrative: high blood pressure; Rash happened a week or so after the vaccine; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure) and RASH (Rash happened a week or so after the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection (Prior to getting the vaccine.).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure) and RASH (Rash happened a week or so after the vaccine). At the time of the report, HYPERTENSION (high blood pressure) outcome was unknown and RASH (Rash happened a week or so after the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERTENSION (high blood pressure) to be possibly related. No further causality assessment was provided for RASH (Rash happened a week or so after the vaccine).    Concomitant medications were not provided.  The patient was prescribed unspecified antibiotics for the rash, but did not take the antibiotics because the rash went away. Action taken with mRNA-1273 in response to the event was unknown.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) 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 HEADACHE (slight headache). At the time of the report, HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm itchy red at site of injection over next 2-3 days warm red swollen itchy; itching at the injection site; golf ball bump at the injection site; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (body aches), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (golf ball bump at the injection site) and VACCINATION SITE ERYTHEMA (arm itchy red at site of injection over next 2-3 days warm red swollen itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension (controlled) since 2017, Macular degeneration since 2020 and Penicillin allergy. Concomitant products included METOPROLOL, METFORMIN and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced MYALGIA (body aches). On 25-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (golf ball bump at the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm itchy red at site of injection over next 2-3 days warm red swollen itchy). On 26-Mar-2021, VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (golf ball bump at the injection site) had resolved. At the time of the report, MYALGIA (body aches) and VACCINATION SITE ERYTHEMA (arm itchy red at site of injection over next 2-3 days warm red swollen itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 100.7 degree Celsius (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is allergy to IVP dye No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: No specific follow-up information recorded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea, Peripheral swelling, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick in stomach), DIARRHOEA (severe diarrhea and vomiting), PERIPHERAL SWELLING (arm swelled up real bad with knots on it), VOMITING (severe diarrhea and vomiting) and NAUSEA (nauseous) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination. The patient's past medical history included Surgery. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, HYDROXYCHLOROQUINE for Autoimmune disorder, OMEPRAZOLE for Barrett's oesophagus, ISOSORBIDE, ATENOLOL, LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3, BENAZEPRIL, HCTZ, PRAVASTATIN and LORAZEPAM for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (sick in stomach), PERIPHERAL SWELLING (arm swelled up real bad with knots on it) and VOMITING (severe diarrhea and vomiting). 19-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea and vomiting) and NAUSEA (nauseous). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (sick in stomach), DIARRHOEA (severe diarrhea and vomiting), PERIPHERAL SWELLING (arm swelled up real bad with knots on it), VOMITING (severe diarrhea and vomiting) and NAUSEA (nauseous) outcome was unknown. Patient took lot of medications for heart and blood pressure. Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Nausea and vomiting are consistent with the known safety profile of the vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm to the touch around injection site; Itchy around injection site; Red around injection site; Fatigue; Little soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness on arm), VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site), VACCINATION SITE ERYTHEMA (Red around injection site) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Breast operation (Breast surgery last year to take out a sentinel node on her left side) in 2020.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little soreness on arm) and FATIGUE (Fatigue). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Little soreness on arm), VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site), VACCINATION SITE ERYTHEMA (Red around injection site) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. No concomitant medications were reported.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site erythema, vaccination site pruritus and fatigue are consistent with the known safety profile of the vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rashes; really itchy; scalp and private area have been itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes), PRURITUS (really itchy) and PRURITUS (scalp and private area have been itchy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes), PRURITUS (really itchy) and PRURITUS (scalp and private area have been itchy). At the time of the report, RASH (Rashes), PRURITUS (really itchy) and PRURITUS (scalp and private area have been itchy) 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.   Patient reports taking Benadryl two weeks after her first dose and last night 25Mar2021. Patient started taking prednisone 50mg (daily for 5 days) on 25Mar2021, and she noticed improvement   Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Rash is consistent with the known safety profile of the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: She still feels bad, but eventually she's feeling a little better everyday; feeling sick; Loss of appetite; lost of taste; she's not getting the second dose/ will not receive second vaccine; felt like throwing up; headache; muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She still feels bad, but eventually she's feeling a little better everyday), MALAISE (feeling sick), DECREASED APPETITE (Loss of appetite), AGEUSIA (lost of taste) and PRODUCT DOSE OMISSION ISSUE (she's not getting the second dose/ will not receive second vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-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 (She still feels bad, but eventually she's feeling a little better everyday), MALAISE (feeling sick), DECREASED APPETITE (Loss of appetite), AGEUSIA (lost of taste), PRODUCT DOSE OMISSION ISSUE (she's not getting the second dose/ will not receive second vaccine), NAUSEA (felt like throwing up), HEADACHE (headache), MYALGIA (muscle pain) and CHILLS (chills). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (She still feels bad, but eventually she's feeling a little better everyday) was resolving, MALAISE (feeling sick), DECREASED APPETITE (Loss of appetite), AGEUSIA (lost of taste), NAUSEA (felt like throwing up), HEADACHE (headache), MYALGIA (muscle pain) and CHILLS (chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she's not getting the second dose/ will not receive second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included blood pressure and diabetes medications. Treatment information included an antibiotic.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Updated the event(will not receive the second vaccine).; Sender's Comments: This case concerns a 73-year-old female patient who received the first dose of mRNA-1273 vaccine and will not receive second vaccine (product dose omission issue).  The other events are temporarily associated with the administration of the product and causal association cannot be excluded.  Product dose omission is assessed as not applicable
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Product dose omission issue
Clinical narrative: She still feels bad, but eventually she's feeling a little better everyday; feeling sick; Loss of appetite; lost of taste; she's not getting the second dose/ will not receive second vaccine; felt like throwing up; headache; muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She still feels bad, but eventually she's feeling a little better everyday), MALAISE (feeling sick), DECREASED APPETITE (Loss of appetite), AGEUSIA (lost of taste) and PRODUCT DOSE OMISSION ISSUE (she's not getting the second dose/ will not receive second vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-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 (She still feels bad, but eventually she's feeling a little better everyday), MALAISE (feeling sick), DECREASED APPETITE (Loss of appetite), AGEUSIA (lost of taste), PRODUCT DOSE OMISSION ISSUE (she's not getting the second dose/ will not receive second vaccine), NAUSEA (felt like throwing up), HEADACHE (headache), MYALGIA (muscle pain) and CHILLS (chills). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (She still feels bad, but eventually she's feeling a little better everyday) was resolving, MALAISE (feeling sick), DECREASED APPETITE (Loss of appetite), AGEUSIA (lost of taste), NAUSEA (felt like throwing up), HEADACHE (headache), MYALGIA (muscle pain) and CHILLS (chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she's not getting the second dose/ will not receive second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included blood pressure and diabetes medications. Treatment information included an antibiotic.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Updated the event(will not receive the second vaccine).; Sender's Comments: This case concerns a 73-year-old female patient who received the first dose of mRNA-1273 vaccine and will not receive second vaccine (product dose omission issue).  The other events are temporarily associated with the administration of the product and causal association cannot be excluded.  Product dose omission is assessed as not applicable
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: has a cold sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (has a cold sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ORAL HERPES (has a cold sore). At the time of the report, ORAL HERPES (has a cold sore) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Reporter did not allow further contact; Sender's Comments: Although a temporal association exist, based on the information provided, it cannot be determined if the event was pre-existing or started after vaccination  Event was reported one day after vaccine administration. Additional information has been requested
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Rash on the injection site; Injection hurt a lot / hurt like a regular flu shot; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PAIN (Injection hurt a lot / hurt like a regular flu shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included DIAZEPAM for Anxiety, CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection hurt a lot / hurt like a regular flu shot). On 26-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on the injection site). On 20-Mar-2021, VACCINATION SITE PAIN (Injection hurt a lot / hurt like a regular flu shot) had resolved. At the time of the report, VACCINATION SITE RASH (Rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: Felt like being hit by a brick; Exhausted; Fever of 100.6; Fever of 100.9; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt like being hit by a brick), PYREXIA (Fever of 100.9), PYREXIA (Fever of 100.6) and FATIGUE (Exhausted) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever of 100.9). On 05-Mar-2021, the patient experienced PYREXIA (Fever of 100.6). On 07-Mar-2021, the patient experienced PAIN (Felt like being hit by a brick) and FATIGUE (Exhausted). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 03-Mar-2021, PYREXIA (Fever of 100.9) had resolved. On 05-Mar-2021, PYREXIA (Fever of 100.6) had resolved. On 07-Mar-2021, PAIN (Felt like being hit by a brick) had resolved. At the time of the report, FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100.9 High. On 05-Mar-2021, Body temperature: 100.6 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.    This case was linked to MOD-2021-036736 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 03/May/2021 and updated reporter contact details. On 11-Jul-2021: Follow up document received on 11/Jul/2021 and contains no new information.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) 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 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) outcome was unknown. Not Provided          Treatment information not provided. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced TACHYCARDIA (Tachycardia). At the time of the report, TACHYCARDIA (Tachycardia) outcome was unknown. Not Provided          Concomitant medication use was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch Injection Site; Red Rash ( Size 1" to 2"); Injection site pain/Tender Injection Site; Swollen Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site), RASH ERYTHEMATOUS (Red Rash ( Size 1" to 2")), VACCINATION SITE PAIN (Injection site pain/Tender Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRON for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch Injection Site), RASH ERYTHEMATOUS (Red Rash ( Size 1" to 2")), VACCINATION SITE PAIN (Injection site pain/Tender Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site), RASH ERYTHEMATOUS (Red Rash ( Size 1" to 2")), VACCINATION SITE PAIN (Injection site pain/Tender Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment also included iron.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site pain, vaccination site swelling and rash  are consistent with the known safety profile of the vaccine,
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (While the patient was at hospital patient) in December 2020 and Platelet rich plasma therapy in December 2020.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong technique in device usage process
Clinical narrative: Sore arm; Vaccine given after being dropped and patient is not sure if it was shaken while dropped; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Vaccine given after being dropped and patient is not sure if it was shaken while dropped) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Vaccine given after being dropped and patient is not sure if it was shaken while dropped). On 17-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Vaccine given after being dropped and patient is not sure if it was shaken while dropped) had resolved. On 18-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up information was received and  contained no new information. On 12-May-2021: Follow up information was received and contained non significant information. The reporter information was updated. On 13-May-2021: Non-significant Follow up information was received and contained non significant  information, contact information was updated.; Sender's Comments: This case concerns a 64-year-old female patient who experienced vaccine given after being dropped and patient is not sure if it was shaken while dropped (wrong technique in device usage process).  Patient experienced the event of sore arm  which was temporarily associated with product use.  Hence, causal relationship cannot be excluded. event of wrong technique in device usage process is assessed as not applicable.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis, Lymphadenopathy, Myalgia
Clinical narrative: Sweating; Swollen lymph node in neck; Short of breath; Chest pressure; Classified by HCP as "severe" reactions; Body aches; Fevers; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph node in neck), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest pressure) and VACCINATION COMPLICATION (Classified by HCP as "severe" reactions) in a 66-year-old male 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph node in neck), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest pressure), VACCINATION COMPLICATION (Classified by HCP as "severe" reactions), MYALGIA (Body aches) and PYREXIA (Fevers). At the time of the report, HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph node in neck), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest pressure), VACCINATION COMPLICATION (Classified by HCP as "severe" reactions), MYALGIA (Body aches) and PYREXIA (Fevers) 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.   relevant concomitant products usage were not reported by the reporter. Treatment details not included.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Fever and myalgia are consistent with the known safety profile of the vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Sweating; Swollen lymph node in neck; Short of breath; Chest pressure; Classified by HCP as "severe" reactions; Body aches; Fevers; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph node in neck), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest pressure) and VACCINATION COMPLICATION (Classified by HCP as "severe" reactions) in a 66-year-old male 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph node in neck), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest pressure), VACCINATION COMPLICATION (Classified by HCP as "severe" reactions), MYALGIA (Body aches) and PYREXIA (Fevers). At the time of the report, HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph node in neck), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest pressure), VACCINATION COMPLICATION (Classified by HCP as "severe" reactions), MYALGIA (Body aches) and PYREXIA (Fevers) 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.   relevant concomitant products usage were not reported by the reporter. Treatment details not included.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Fever and myalgia are consistent with the known safety profile of the vaccine.