chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Myalgia, Vaccination site pain
Clinical narrative: dizziness on and off for 2 months; vertigo; Injection site started to hurt really bad; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness on and off for 2 months), VERTIGO (vertigo), VACCINATION SITE PAIN (Injection site started to hurt really bad), MYALGIA (Body aches) and HEADACHE (Headaches) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site started to hurt really bad), MYALGIA (Body aches) and HEADACHE (Headaches). On an unknown date, the patient experienced DIZZINESS (dizziness on and off for 2 months) and VERTIGO (vertigo). At the time of the report, DIZZINESS (dizziness on and off for 2 months) and VERTIGO (vertigo) outcome was unknown and VACCINATION SITE PAIN (Injection site started to hurt really bad), MYALGIA (Body aches) and HEADACHE (Headaches) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) temperature of 100.2 F.         No relevant concomitant medications reported. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information include patient demographic details and events updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: dizziness on and off for 2 months; vertigo; Injection site started to hurt really bad; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness on and off for 2 months), VERTIGO (vertigo), VACCINATION SITE PAIN (Injection site started to hurt really bad), MYALGIA (Body aches) and HEADACHE (Headaches) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site started to hurt really bad), MYALGIA (Body aches) and HEADACHE (Headaches). On an unknown date, the patient experienced DIZZINESS (dizziness on and off for 2 months) and VERTIGO (vertigo). At the time of the report, DIZZINESS (dizziness on and off for 2 months) and VERTIGO (vertigo) outcome was unknown and VACCINATION SITE PAIN (Injection site started to hurt really bad), MYALGIA (Body aches) and HEADACHE (Headaches) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) temperature of 100.2 F.         No relevant concomitant medications reported. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information include patient demographic details and events updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Feeling abnormal
Clinical narrative: Dizziness; Double vision; Foggy head, not feeling herself; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), DIPLOPIA (Double vision) and FEELING ABNORMAL (Foggy head, not feeling herself) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness), DIPLOPIA (Double vision) and FEELING ABNORMAL (Foggy head, not feeling herself). At the time of the report, DIZZINESS (Dizziness), DIPLOPIA (Double vision) and FEELING ABNORMAL (Foggy head, not feeling herself) 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 treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; A spontaneous report was received from a  consumer concerning a unknown  patient, , who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced vertigo.  The patient's medical history and concomitant history was not provided by the reporter , no lab data was reported .   the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  the patient experienced vertigo . the outcome of the events was unknown.   The treatment history was not provided.  The Action taken with the first dose of mRNA-1273 in response to the event was not reported.  The  outcome of the events were considered as unknown.; Sender's Comments:  MOD21-044089:Crosslinked MOD21-044117:Crosslinked
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness for 4 days) and NAUSEA (Nausea for 4 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 DIZZINESS (Dizziness for 4 days) and NAUSEA (Nausea for 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Mar-2021, DIZZINESS (Dizziness for 4 days) and NAUSEA (Nausea for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: significant  follow up received on 21 Jul 2021, Event outcome updated.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Covid arm; Injection site itchy; Injection site is red,Redness spread out 3 inches from injection site; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red,Redness spread out 3 inches from injection site) and VACCINATION SITE SWELLING (Injection site swelling) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jan-2001 to an unknown date and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) from 01-Jan-2001 to an unknown date for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red,Redness spread out 3 inches from injection site) and VACCINATION SITE SWELLING (Injection site swelling). On 18-Feb-2021, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red,Redness spread out 3 inches from injection site) and VACCINATION SITE SWELLING (Injection site swelling) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported. The patient received second dose on 03-Mar-2021, intramuscularly in right arm.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Patient demographics were added, concomitant medications were added , new events; injection site swelling and  vaccination site reaction were added,outcome of events changed from unknown to recovered, event stop date was added and second dose details were added in I narrative.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Malaise, Nausea
Clinical narrative: feeling nausea; kidneys were hurting; Felt awful; had bad diarrhea; stomach hurting; Chills; Wet on herself; All the color of face went away; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidneys were hurting), URINE ABNORMALITY (Wet on herself), PALLOR (All the color of face went away), MALAISE (Felt awful) and DIARRHOEA (had bad diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included PREGABALIN (LYRICA), ATENOLOL, LOSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE, TRAZODONE, CLOPIDOGREL, MONTELUKAST, SERTRALINE and LEVOTHYROXINE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced URINE ABNORMALITY (Wet on herself) and PALLOR (All the color of face went away). On 01-Mar-2021, the patient experienced RENAL PAIN (kidneys were hurting), MALAISE (Felt awful), DIARRHOEA (had bad diarrhea), ABDOMINAL PAIN UPPER (stomach hurting) and CHILLS (Chills). On 03-Mar-2021, the patient experienced NAUSEA (feeling nausea). At the time of the report, RENAL PAIN (kidneys were hurting), URINE ABNORMALITY (Wet on herself), PALLOR (All the color of face went away), MALAISE (Felt awful), DIARRHOEA (had bad diarrhea), ABDOMINAL PAIN UPPER (stomach hurting), CHILLS (Chills) and NAUSEA (feeling nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.  Concomitant products also included Statin for an unknown indication.  Patient had other health problems, not specified.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followup was received on 08-jul-2021: contains no new information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Renal pain, Urine abnormality
Clinical narrative: feeling nausea; kidneys were hurting; Felt awful; had bad diarrhea; stomach hurting; Chills; Wet on herself; All the color of face went away; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidneys were hurting), URINE ABNORMALITY (Wet on herself), PALLOR (All the color of face went away), MALAISE (Felt awful) and DIARRHOEA (had bad diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included PREGABALIN (LYRICA), ATENOLOL, LOSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE, TRAZODONE, CLOPIDOGREL, MONTELUKAST, SERTRALINE and LEVOTHYROXINE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced URINE ABNORMALITY (Wet on herself) and PALLOR (All the color of face went away). On 01-Mar-2021, the patient experienced RENAL PAIN (kidneys were hurting), MALAISE (Felt awful), DIARRHOEA (had bad diarrhea), ABDOMINAL PAIN UPPER (stomach hurting) and CHILLS (Chills). On 03-Mar-2021, the patient experienced NAUSEA (feeling nausea). At the time of the report, RENAL PAIN (kidneys were hurting), URINE ABNORMALITY (Wet on herself), PALLOR (All the color of face went away), MALAISE (Felt awful), DIARRHOEA (had bad diarrhea), ABDOMINAL PAIN UPPER (stomach hurting), CHILLS (Chills) and NAUSEA (feeling nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.  Concomitant products also included Statin for an unknown indication.  Patient had other health problems, not specified.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followup was received on 08-jul-2021: contains no new information
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: A spontaneous report was received from a consumer concerning a 46-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events heart beating and had abnormal palpitations in weird patterns, could feel her heart beating in chest /palpitations; no other side effect except that her heart rate was elevated more so than normal/heart rate increased.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events heart beating, had abnormal palpitations in weird patterns and she could feel her heart beating in her chest. On the same day the patient experienced her heart rate was elevated more so than normal.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 8 Feb 2021 the outcome of events heart beating and had abnormal palpitations in weird pattern, could feel her heart beating in her chest, that her heart rate was elevated more so than normal was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: painful reaction in knees; muscle cramps in her legs; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (painful reaction in knees) and MUSCLE SPASMS (muscle cramps in her legs) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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) dosage form. On 28-Feb-2021, the patient experienced ARTHRALGIA (painful reaction in knees) and MUSCLE SPASMS (muscle cramps in her legs). On 02-Mar-2021, ARTHRALGIA (painful reaction in knees) and MUSCLE SPASMS (muscle cramps in her legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-034300 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant follow up: Called to obtain email address but consumer declined as she said all the events have resolved after 2 days; Sender's Comments:  MOD-2021-034300:same reporter, different patient and events
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 27-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: little achy; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event little achy/pain  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event little achy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable as the patient received both the scheduled doses of the vaccine.  The outcome of event little achy was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: delayed reaction to the vaccine that spread to her neck and face; A spontaneous report was received from a nurse concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event delayed reaction to the vaccine that spread to her neck and face/vaccination complication.  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 first of two planned doses of mRNA-1273 (lot/batch: unknown)  for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event delayed reaction to the vaccine that spread to her neck and face.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event delayed reaction to the vaccine that spread to her neck and face was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush, Injection site inflammation, Lymphadenopathy, Swelling
Clinical narrative: It as Hard and inflamed and hot; Redness accomanyed  swelling; injection site; flush like sunborn; It as Hard and inflamed and hot; Swelling; Redness; Lymph node swelling; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling, redness, lymph node swelling.  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 first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On 1 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031M20A) via intramuscular route for prophylaxis of COVID-19 infection.  On 1 Mar 2021, the patient experienced the event(s) swelling, redness, lymph node swelling.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), swelling, redness, lymph node swelling was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: It as Hard and inflamed and hot; Redness accomanyed  swelling; injection site; flush like sunborn; It as Hard and inflamed and hot; Swelling; Redness; Lymph node swelling; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling, redness, lymph node swelling.  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 first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On 1 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031M20A) via intramuscular route for prophylaxis of COVID-19 infection.  On 1 Mar 2021, the patient experienced the event(s) swelling, redness, lymph node swelling.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), swelling, redness, lymph node swelling was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: 1.5 hours after I received the shot, sugar shot to 400.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (1.5 hours after I received the shot, sugar shot to 400.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication.     The patient's past medical history included Stroke and Open heart surgery. Concomitant products included INSULIN and ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (1.5 hours after I received the shot, sugar shot to 400.). At the time of the report, BLOOD GLUCOSE INCREASED (1.5 hours after I received the shot, sugar shot to 400.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Took larger dose of Insulin. Other Concomitant medication include: on a lot of blood pressure medications, has diabetes, urinary bladder problems, and had strokes.; 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Lliquid dripped down the patient arm; Needle detached from barrel while pulling out the syringe; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Lliquid dripped down the patient arm) and DEVICE CONNECTION ISSUE (Needle detached from barrel while pulling out the syringe) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had Covid-19, 90 days prior.). Concurrent medical conditions included Penicillin allergy. Concomitant products included LISINOPRIL and CARVEDILOL for Hypertension, LEVOTHYROXINE for Hypothyroidism.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Lliquid dripped down the patient arm) and DEVICE CONNECTION ISSUE (Needle detached from barrel while pulling out the syringe). On 03-Mar-2021, INCORRECT DOSE ADMINISTERED (Lliquid dripped down the patient arm) and DEVICE CONNECTION ISSUE (Needle detached from barrel while pulling out the syringe) 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2021: No specific follow-up information recorded.; Reporter's Comments: This report refers to a case of a 50-year old female patient who experienced liquid dripping down the patient's arm and that the needle detached from the barrel while pulling out the syringe(syringe connection issue and Incomplete dose administered) for mRNA-1273 (Lot number: 011A21A). There were no reported AEs associated with this case of syringe connection issue and Incomplete dose administered.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; A spontaneous report was received from a consumer concerning a 54-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A) via unknown route for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events, fever, chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fever, chills was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Hypoaesthesia
Clinical narrative: purple-bluish to black blister in the skin of left hand; numb-ish in hand; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blister and numbness in hand. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 03 Mar 2021, the patient experienced purple-bluish to black blister in the skin of left hand and numb-ish in hand. Laboratory details was not provided.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, blister and numbness in hand was considered as unknown at the time of report.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Tenderness at injection site; Bulls eye rash at injection site; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness at injection site/vaccination site pain, bulls eye rash at injection site/vaccination site rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 3 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the events, tenderness at injection site, bulls eye rash at injection site.  No treatment details were reported.  The patient received both the doses of mRNA-1273  prior to the events, therefore action taken against the drug in response to the events was not applicable.  The outcome of events, tenderness at injection site, bulls eye rash at injection site was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RHINORRHOEA (Runny  nose). At the time of the report, RHINORRHOEA (Runny  nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided Treatment information was not provided
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Rash
Clinical narrative: Neck pain; Rash all over the body; This spontaneous case was reported by a physician and describes the occurrence of NECK PAIN (Neck pain) and RASH (Rash all over the body) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Blood pressure and Thyroid disorder NOS.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced NECK PAIN (Neck pain) and RASH (Rash all over the body).   At the time of the report, NECK PAIN (Neck pain) outcome was unknown and RASH (Rash all over the body) 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 is currently taking Blood pressure and Thyroid medications. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm; Chills; A spontaneous report was received from a consumer concerning a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm and chills.  The patient's medical history was not provided. Concomitant medications reported were cholesterol medication and Hypertension medication for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 3 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events sore arm and chills. Consumer reported that she and her husband took second vaccine on same day but, her husband experienced the symptoms. Patient gave consent to be contacted by safety team.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable   The outcome of events, sore arm and chills were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 1ml instead of 0.5ml; A spontaneous report (United States) was received from a pharmacist concerning a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administered 1ml instead of 0.5ml of the vaccine.  The patient's medical history was not provided. Concomitant medications were not mentioned.   On 01 Mar 2021, approximately 1 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 014M20A) in the left arm for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the pharmacist reported that one of the pharmacists at the store incorrectly administered 1ml instead of 0.5ml of the vaccine to the patient. The patient has been notified of the incorrect administration as per pharmacist. No treatment information was provided. No lab tests and results were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event administered 1ml instead of 0.5ml, was considered recovered/resolved on 01 Mar 2021.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033777:Crosslinked case
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 14-Oct-2020 and the estimated date of delivery was 21-Jul-2021. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 03-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Restless legs syndrome, Thirst, Vision blurred
Clinical narrative: Restless leg syndrome; Blurred vision; Burning sensation accompanied the muscle spasms; Excessive thirst; Real dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESTLESS LEGS SYNDROME (Restless leg syndrome), VISION BLURRED (Blurred vision), BURNING SENSATION (Burning sensation accompanied the muscle spasms), THIRST (Excessive thirst) and DIZZINESS (Real dizzy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 immunization.     The patient's past medical history included Neuropathy. Previously administered products included for an unreported indication: GABAPENTIN. Concurrent medical conditions included Obesity.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 26-Feb-2021, the patient experienced VISION BLURRED (Blurred vision), BURNING SENSATION (Burning sensation accompanied the muscle spasms), THIRST (Excessive thirst) and DIZZINESS (Real dizzy). On an unknown date, the patient experienced RESTLESS LEGS SYNDROME (Restless leg syndrome). At the time of the report, RESTLESS LEGS SYNDROME (Restless leg syndrome), VISION BLURRED (Blurred vision), BURNING SENSATION (Burning sensation accompanied the muscle spasms), THIRST (Excessive thirst) and DIZZINESS (Real dizzy) outcome was unknown.            Treatment for the events include ice, heat, pregabalin and pramipexole.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Pain in extremity, Vaccination site lymphadenopathy
Clinical narrative: quite suddenly and all at once her left arm hurt"; lymph nodes swelled under her (left) arm; left side of her face went numb- from eyes to lips"; a very deep pain inside her chest; arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (quite suddenly and all at once her left arm hurt"), VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelled under her (left) arm), HYPOAESTHESIA (left side of her face went numb- from eyes to lips"), CHEST PAIN (a very deep pain inside her chest) and PAIN IN EXTREMITY (arm pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for an unknown indication.     The patient's past medical history included Malignant ventricular arrhythmias.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (quite suddenly and all at once her left arm hurt"), VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelled under her (left) arm), HYPOAESTHESIA (left side of her face went numb- from eyes to lips"), CHEST PAIN (a very deep pain inside her chest) and PAIN IN EXTREMITY (arm pain). The patient was treated with ice at an unspecified dose and frequency. On 12-Feb-2021, HYPOAESTHESIA (left side of her face went numb- from eyes to lips") had resolved. On 14-Feb-2021, PAIN IN EXTREMITY (quite suddenly and all at once her left arm hurt"), VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelled under her (left) arm), CHEST PAIN (a very deep pain inside her chest) and PAIN IN EXTREMITY (arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-034292 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: had to get steroid shot on the knee for a pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (had to get steroid shot on the knee for a pain) 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 medical history was reported.).    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (had to get steroid shot on the knee for a pain). At the time of the report, ARTHRALGIA (had to get steroid shot on the knee for a pain) outcome was unknown.            Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Unevaluable event
Clinical narrative: soreness on his right arm which progressed to his shoulder and collar bone; something in his blood; A spontaneous report was received from a healthcare professional concerning a 72-years-old Male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events something in his blood, soreness on his right arm which progressed to his shoulder and collar bone.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021,patient received first of two planned doses of mRNA-1273 (lot/batch: 037K20A) via unknown route in the right arm. On 19-fe-2021 prior to the onset patient received second of two planned of mRNA-1273(Batch:037K20A) via unknown route in the right arm for prophylaxis of covid-19 infection.  On 22 Feb 2021, the patient experienced the events something in his blood. On 24 Feb 2021, the patient experienced the event soreness on his right arm which progressed to his shoulder and collar bone.  Treatment details included Metronidazole, Oxacillin, Famotidine.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, something in his blood, soreness on his right arm which progressed to his shoulder and collar bone was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warmness at the injection site; Itchiness at the injection site; Redness at the injection site; Soreness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Nasal congestion, Nasopharyngitis, Pain in extremity
Clinical narrative: little bit of a cold; congestion; headache that is above and behind her head that comes and goes; arm hurt so bad she could not lift her coffee; possibly allergies; Sharp pains in her hand; Arm pain; A spontaneous report was received from a consumer concerning a 59 year old  female patient, who  received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in extremity cold , congestion nasal, headache and allergy  The patient's medical history, as provided by the reporter included unknown. Concomitant medications as provided by reporter included unknown  On 3 mar 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) in right arm  for prophylaxis of COVID-19 infection.  On 4 mar 2021, prior to receiving mRNA-1273, the patient experienced arm pain and her arm hurt so bad she could not lift coffee. On 4 mar 2021, The patient had little bit of cold or possible allergies with congestion. On 4 mar 2021, the patient  started sharp pains in her hand and headache that is above and behind her head that comes and goes. Treatment for the events was included unknown  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events pain in extremity, cold, congestion nasal, headache and allergy were considered unknown
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: nausea; fever; dizziness; weakness; fatigue; muscle pain; joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event since an unknown date.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness) and ASTHENIA (weakness). On an unknown date, the patient experienced NAUSEA (nausea). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness) and ASTHENIA (weakness) had not resolved.            Tylenol is the treatment received by the patient
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: nausea; fever; dizziness; weakness; fatigue; muscle pain; joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event since an unknown date.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness) and ASTHENIA (weakness). On an unknown date, the patient experienced NAUSEA (nausea). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness) and ASTHENIA (weakness) had not resolved.            Tylenol is the treatment received by the patient
Age: 80.0
Sex: M
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 an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), PYREXIA (fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 73-year-old male 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 COVID-19 (Had antibiotics later) in December 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID), ROSUVASTATIN and TESTOSTERONE (TESTOSTERON [TESTOSTERONE]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 25-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 26-Feb-2021, the patient experienced MYALGIA (myalgia) and PYREXIA (fever). On 26-Feb-2021, HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. On 27-Feb-2021, MYALGIA (myalgia) and PYREXIA (fever) had resolved.            Concomitant medications was not provided by the reporter.  Treatment information  was not provided .   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Attached Additional info-1 : VAERS, Patient initials, age, AE's, concomitant medications,second dose detailswere added
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness) and SWELLING (swelling) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness) and SWELLING (swelling). At the time of the report, ERYTHEMA (redness) and SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided