chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Somnolence
Clinical narrative: sore throat; goes to the bathroom more often for bowel movements; felt tired; felt lightheaded; broke out in sweats; rash that was light pink; swollen; urinates less at night; sleeps longer with more "deep sleep" and more "REM"; had "side effects"; "couldn't walk in straight line"; lightheaded, dizzy; Fever 99F; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had "side effects"), GAIT DISTURBANCE ("couldn't walk in straight line"), DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (swollen) and DIZZINESS (felt lightheaded) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (oxycontin).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ADVERSE REACTION (had "side effects"), GAIT DISTURBANCE ("couldn't walk in straight line"), DIZZINESS (lightheaded, dizzy) and PYREXIA (Fever 99F). On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen), OLIGURIA (urinates less at night) and SOMNOLENCE (sleeps longer with more "deep sleep" and more "REM"). On 13-Mar-2021, the patient experienced RASH (rash that was light pink). On 14-Mar-2021, the patient experienced DIZZINESS (felt lightheaded) and HYPERHIDROSIS (broke out in sweats). On 17-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), BOWEL MOVEMENT IRREGULARITY (goes to the bathroom more often for bowel movements) and FATIGUE (felt tired). At the time of the report, ADVERSE REACTION (had "side effects"), GAIT DISTURBANCE ("couldn't walk in straight line"), DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (swollen), DIZZINESS (felt lightheaded), HYPERHIDROSIS (broke out in sweats), OROPHARYNGEAL PAIN (sore throat), BOWEL MOVEMENT IRREGULARITY (goes to the bathroom more often for bowel movements), OLIGURIA (urinates less at night), SOMNOLENCE (sleeps longer with more "deep sleep" and more "REM"), FATIGUE (felt tired), RASH (rash that was light pink) and PYREXIA (Fever 99F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 99F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: shakes; cough; sore throat; arm was sore; diarrhea; fatigue; body aches from head to toe; fever of 101.1 degrees F; severe headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (arm was sore) and DIARRHOEA (diarrhea) in a 68-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (arm was sore), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (body aches from head to toe), PYREXIA (fever of 101.1 degrees F), HEADACHE (severe headache) and CHILLS (chills). On 28-Feb-2021, TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (body aches from head to toe), PYREXIA (fever of 101.1 degrees F), HEADACHE (severe headache) and CHILLS (chills) had resolved. On 06-Mar-2021, PAIN IN EXTREMITY (arm was sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pyrexia: 101.1 (High) fever of 101.1 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment for the events included Tylenol every 4 hours.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: initial additional
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: shakes; cough; sore throat; arm was sore; diarrhea; fatigue; body aches from head to toe; fever of 101.1 degrees F; severe headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (arm was sore) and DIARRHOEA (diarrhea) in a 68-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (arm was sore), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (body aches from head to toe), PYREXIA (fever of 101.1 degrees F), HEADACHE (severe headache) and CHILLS (chills). On 28-Feb-2021, TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (body aches from head to toe), PYREXIA (fever of 101.1 degrees F), HEADACHE (severe headache) and CHILLS (chills) had resolved. On 06-Mar-2021, PAIN IN EXTREMITY (arm was sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pyrexia: 101.1 (High) fever of 101.1 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment for the events included Tylenol every 4 hours.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: initial additional
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Delayed the 2nd dose of the vaccine for 44 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Delayed the 2nd dose of the vaccine for 44 days) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Delayed the 2nd dose of the vaccine for 44 days). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Delayed the 2nd dose of the vaccine for 44 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Burning sensation, Fatigue, Food intolerance, Headache
Clinical narrative: severe pain in her spine; her skin is burning to the touch its on and off; arm is swollen; head really hurts; More fatigue than normal/tired; Nausea; Body aches; Can't eat chicken anymore; Stomach cramps; Seem to not feel well; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off), PERIPHERAL SWELLING (arm is swollen), FOOD INTOLERANCE (Can't eat chicken anymore) and ABDOMINAL PAIN UPPER (Stomach cramps) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046a21a and 027h20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Yellow fever: Yellow fever vaccine (When patient was 21 years old). Past adverse reactions to the above products included No adverse event with Yellow fever vaccine.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off) and PERIPHERAL SWELLING (arm is swollen). 17-Mar-2021, the patient experienced HEADACHE (head really hurts). On an unknown date, the patient experienced FOOD INTOLERANCE (Can't eat chicken anymore), ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (Seem to not feel well), FATIGUE (More fatigue than normal/tired), NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off), PERIPHERAL SWELLING (arm is swollen) and HEADACHE (head really hurts) outcome was unknown and FOOD INTOLERANCE (Can't eat chicken anymore), ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (Seem to not feel well), FATIGUE (More fatigue than normal/tired), NAUSEA (Nausea) and MYALGIA (Body aches) had resolved.            No concomitant medication was reported.  Patient had put ice on her neck, spine and arm as treatment.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-112132 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 contains significant information including updated historic vaccine and added new events myalgia, nausea, fatigue, malaise, abdominal pain upper, foof intolerance.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Peripheral swelling, Spinal pain
Clinical narrative: severe pain in her spine; her skin is burning to the touch its on and off; arm is swollen; head really hurts; More fatigue than normal/tired; Nausea; Body aches; Can't eat chicken anymore; Stomach cramps; Seem to not feel well; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off), PERIPHERAL SWELLING (arm is swollen), FOOD INTOLERANCE (Can't eat chicken anymore) and ABDOMINAL PAIN UPPER (Stomach cramps) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046a21a and 027h20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Yellow fever: Yellow fever vaccine (When patient was 21 years old). Past adverse reactions to the above products included No adverse event with Yellow fever vaccine.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off) and PERIPHERAL SWELLING (arm is swollen). 17-Mar-2021, the patient experienced HEADACHE (head really hurts). On an unknown date, the patient experienced FOOD INTOLERANCE (Can't eat chicken anymore), ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (Seem to not feel well), FATIGUE (More fatigue than normal/tired), NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off), PERIPHERAL SWELLING (arm is swollen) and HEADACHE (head really hurts) outcome was unknown and FOOD INTOLERANCE (Can't eat chicken anymore), ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (Seem to not feel well), FATIGUE (More fatigue than normal/tired), NAUSEA (Nausea) and MYALGIA (Body aches) had resolved.            No concomitant medication was reported.  Patient had put ice on her neck, spine and arm as treatment.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-112132 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 contains significant information including updated historic vaccine and added new events myalgia, nausea, fatigue, malaise, abdominal pain upper, foof intolerance.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: Tingling in left arm; Numbness in left arm; Enough to wake her up from sleep; Hurting left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in left arm), HYPOAESTHESIA (Numbness in left arm), SLEEP DISORDER (Enough to wake her up from sleep) and PAIN IN EXTREMITY (Hurting left arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 040A21A) for COVID-19 vaccination.     The patient's past medical history included Postmenopausal symptoms. Concurrent medical conditions included Hypertension (Under control), Latex allergy, Allergy to chemicals and Soap allergy. Concomitant products included OLMESARTAN, ESTRADIOL, MULTIPLUS, EPINEPHRINE (EPIPEN) and VITAMINS NOS (VIT B COMPLEXE [VITAMINS NOS]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, the patient experienced PARAESTHESIA (Tingling in left arm), HYPOAESTHESIA (Numbness in left arm), SLEEP DISORDER (Enough to wake her up from sleep) and PAIN IN EXTREMITY (Hurting left arm). At the time of the report, PARAESTHESIA (Tingling in left arm), HYPOAESTHESIA (Numbness in left arm), SLEEP DISORDER (Enough to wake her up from sleep) and PAIN IN EXTREMITY (Hurting left arm) outcome was unknown.      No treatment related information has been reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: My arm has been extremely sore; Didn't have a taste/I could barely taste it; Loss of smell for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm has been extremely sore), AGEUSIA (Didn't have a taste/I could barely taste it) and ANOSMIA (Loss of smell for 48 hours) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced ANOSMIA (Loss of smell for 48 hours). On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm has been extremely sore) and AGEUSIA (Didn't have a taste/I could barely taste it). On 16-Apr-2021, ANOSMIA (Loss of smell for 48 hours) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm has been extremely sore) and AGEUSIA (Didn't have a taste/I could barely taste it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received and added reporter details, patient demographics, lab data, suspect drug details and new event.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Feels a little bit sore today; A spontaneous report was received from a consumer concerning himself a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feels a little bit sore today/pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Mar 2021, 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 18 Mar 2021, the patient felt a little bit sore. Treatment details included none.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event feels a little bit sore today was considered not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Headache, Nasal congestion
Clinical narrative: Hoarseness; Congestion; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarseness), NASAL CONGESTION (Congestion) and HEADACHE (headache) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included PREGABALIN (LYRICA) and ATENOLOL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPHONIA (Hoarseness), NASAL CONGESTION (Congestion) and HEADACHE (headache). At the time of the report, DYSPHONIA (Hoarseness) and NASAL CONGESTION (Congestion) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The treatment information was unknown. Patient decline follow up with safety.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Inappropriate schedule of product administration, Peripheral swelling
Clinical narrative: Memory loss; Arm swollen; Inappropriate schedule of product administration; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration), AMNESIA (Memory loss) and PERIPHERAL SWELLING (Arm swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 001Z1Z) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On an unknown date, the patient experienced AMNESIA (Memory loss) and PERIPHERAL SWELLING (Arm swollen). On 03-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. At the time of the report, AMNESIA (Memory loss) and PERIPHERAL SWELLING (Arm swollen) outcome was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Mouth swelling, Swelling face
Clinical narrative: Swollen face; Swollen mouth; Diarrhea; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA, SWELLING FACE, and MOUTH SWELLING in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced DIARRHOEA. On 14-Jan-2021, the patient experienced SWELLING FACE and MOUTH SWELLING. On 15-Jan-2021, SWELLING FACE and MOUTH SWELLING had resolved. At the time of the report, DIARRHOEA 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. 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: F
Vaccine: COVID19
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Local injection reaction (not systematic); Not feeling well; Pain on injection site; Redness; Itching with significant induration at the site; Iching with significant induration at the site; Swelling around 8cm at the site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION, MALAISE, INJECTION SITE PAIN, ERYTHEMA, and INJECTION SITE PRURITUS in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION, MALAISE, INJECTION SITE PAIN, ERYTHEMA, INJECTION SITE PRURITUS, INJECTION SITE INDURATION, and INJECTION SITE SWELLING. At the time of the report, INJECTION SITE REACTION, MALAISE, INJECTION SITE PAIN, ERYTHEMA, INJECTION SITE PRURITUS, INJECTION SITE INDURATION, and INJECTION SITE SWELLING 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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Malaise
Clinical narrative: Local injection reaction (not systematic); Not feeling well; Pain on injection site; Redness; Itching with significant induration at the site; Iching with significant induration at the site; Swelling around 8cm at the site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION, MALAISE, INJECTION SITE PAIN, ERYTHEMA, and INJECTION SITE PRURITUS in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION, MALAISE, INJECTION SITE PAIN, ERYTHEMA, INJECTION SITE PRURITUS, INJECTION SITE INDURATION, and INJECTION SITE SWELLING. At the time of the report, INJECTION SITE REACTION, MALAISE, INJECTION SITE PAIN, ERYTHEMA, INJECTION SITE PRURITUS, INJECTION SITE INDURATION, and INJECTION SITE SWELLING 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.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Sore arm; Little heavy arm; Redness in the injection site; Swollen in the injection site; Little itch; A Spontaneous report was received from consumer concerning 84-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore and little heavy arm, redness, and swollen in the injection site, little itch.  The patient's medical history, and concomitant medications are unknown.  On 12 Jan 2021, the patient received her first dose of two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly for prophylaxis of COVID-19 infection On 20 Jan 2021 patient started experiencing sore arm, as reported redness and swollen in the injection site.  No laboratory tests were provided.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event is unknown.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: swelling,//left arm, around the site of injection; darkened, oval ring around the site of injection; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2021, the patient received the 1st dose of Shingrix. On 29th June 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On 30th June 2021, the patient experienced injection site coloration. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site coloration were not recovered/not resolved and the outcome of the injection site swelling was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site coloration to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The pain at injection site begin immediately and reoccurs whenever she have to lift or carry something heavy, such as groceries. The swelling began a few days after receiving the injection and was still present. The oval ring around the site of injection appeared a day or so after the injection. The oval ring appeared to be approximately two to two and half inches wide and was still present. The patient received 1st dose of Shingrix and experienced pain, swelling and oval ring. Till the time of reporting the patient did not receive 2nd dose. The reporter did not consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus disorder, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; SINUS ISSUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: nonsmoker, and non alcohol user. The patient had no medical conditions, no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) 0.5 ml, 1 total administered to right arm on 01-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 07-AUG-2021 Saturday, the patient stated that he felt like he got a sinus issue and a little bit of fatigue.  On 10-AUG-2021,the patient tested positive and he stated that he gets tested everyday at work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus issue, and suspected covid-19 infection. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189168. The suspected product quality complaint has been confirmed to be void: Y (does not meet product quality complaint criteria). Based on the time elapsed between administration of the vaccine and the positive covid-19 test, there was insufficient time for the consumer to achieve immunity. This report does not meet the criteria for lack of effect, therefore this record is approved for void based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip dry, Lip erythema, Lip swelling, Rash
Clinical narrative: Lips feeling numb; both lips started to swell and got red; red upper lip; Upper lip dry; Rash; A spontaneous report was received from physician a concerning a 44-year-old, female patient who received Moderna's COVID-19 vaccine and developed a rash, numb, swollen, red, and dry lips.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included women's multi-vitamins.  On 30 Dec 2020, approximately 12:30pm prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.     On 30 Dec 2020, after receiving the vaccine, the patient developed a rash. The next day on 01 Jan 2021, her upper lip was dry and both lips started to swell. On 02 Jan 2021, the patient started to feel better, however, her lips were still swollen. The patient stated her upper lip was red and has not improved. As of 04 Jan 2020, the patient's upper lip felt numb. Treatment for the event included diphenhydramine and lip balm.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event, of a rash, was considered recovered on 30 Dec 2020. The event, of the dry upper lip, was considered resolved on 01 Jan 2021. The outcome of the events swollen, red and numb lips, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Body ache; Headache; Fatigue; A spontaneous report was received from a nurse who was an 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, headache and fatigue.  The patient's medical history included history of autoimmune disorder. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same night, the patient experienced body aches, headache and fatigue.  On 06 Jan 2021, it was reported that the symptoms became severe. Treatment for the events included Tylenol.  She was due for the second shot of the vaccine in the first week of February.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, body aches, headache and fatigue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Started itching around the injection site; Hot to the touch; Injection site area became a little swollen/more swelling around the injection site; injection site area beacme red; A spontaneous report was received from a consumer concerning a 32-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced injection site area became a little swollen and red, itching, more swelling and hot to touch.  The patient's medical history was not provided. The concomitant medication included included vitamins.  On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020 after administration of vaccine patient experienced, injection site became a little swollen and red, but went away.   On 06 Jan 2021, it started itching and more swelling (size of a biscuit) at the injection site. That night, it was not as red but swollen and hot to touch.  Treatment included diphenhydramine and fexofenadine.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of injection site area became a little swollen, itching, more swelling and hot to touch, were considered unknown and recovered for redness.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Peripheral coldness, Tremor
Clinical narrative: Shaking hand; Cold and crummy hand; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011C20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: pain in shoulder; pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in shoulder) and MYALGIA (pain all over body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No reported medical history.     On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2020, the patient experienced MYALGIA (pain all over body). On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (pain in shoulder). On 01-Jan-2021, VACCINATION SITE PAIN (pain in shoulder) was resolving and MYALGIA (pain all over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  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.   This case was linked to; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very little pain at the injection site; A spontaneous report was received from a physician concerning a 60 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced very little pain at the injection site (Vaccination site pain).   The patient's medical history was not provided. Relevant concomitant medications included propranolol, adderall, atorvastatin, alprazolam, lisinopril, ticagrelor, vitamin d2, aspirin, pork thyroid, paroxetine, bupropion, zolpidem: and testosterone injections used for unknown indication and Torsemaid used as blood pressure medication.  On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) via intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient stated that he had no side effects, only very little pain at the injection site (Vaccination site pain). No treatment information.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, little pain at the injection site, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Shortness of breath; Stomach ache; Fever; Chills; Nausea; Tiredness; Headache; Vomiting; A spontaneous report was received from a consumer who was a 46 year female patient, who received Moderna's COVID-19 Vaccine and experienced fever, chills, nausea, tiredness, headache, vomiting, stomachache and shortness of breath.  The patient's medical history was not reported. Concomitant medication included Ropinirole.  On an unreported date, the patient received the first of two planned doses of mRNA-1273 (batch number: 039J20A) intramuscularly in her left deltoid for prophylaxis of COVID-19 infection.  On 07 JAN 2021, the patient experienced fever, chills, nausea, tiredness, headache, vomiting, stomachache and shortness of breath.  Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events fever, chills, nausea, tiredness, headache, vomiting, stomachache and shortness of breath were not reported.; Reporter's Comments: This case concerns a 46 year old female who experienced nonserious unexpected events of stomachache and shortness of breath and nonserious expected events of fever, chills, nausea, tiredness, headache, and vomiting. The events occurred an unknown time after first dose of mRNA-1273 administration.  Treatment for the events was not reported.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Shortness of breath; Stomach ache; Fever; Chills; Nausea; Tiredness; Headache; Vomiting; A spontaneous report was received from a consumer who was a 46 year female patient, who received Moderna's COVID-19 Vaccine and experienced fever, chills, nausea, tiredness, headache, vomiting, stomachache and shortness of breath.  The patient's medical history was not reported. Concomitant medication included Ropinirole.  On an unreported date, the patient received the first of two planned doses of mRNA-1273 (batch number: 039J20A) intramuscularly in her left deltoid for prophylaxis of COVID-19 infection.  On 07 JAN 2021, the patient experienced fever, chills, nausea, tiredness, headache, vomiting, stomachache and shortness of breath.  Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events fever, chills, nausea, tiredness, headache, vomiting, stomachache and shortness of breath were not reported.; Reporter's Comments: This case concerns a 46 year old female who experienced nonserious unexpected events of stomachache and shortness of breath and nonserious expected events of fever, chills, nausea, tiredness, headache, and vomiting. The events occurred an unknown time after first dose of mRNA-1273 administration.  Treatment for the events was not reported.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Taste disorder, Tension
Clinical narrative: Body aches; Mouth is tasteless; Tension inside body; Body was shaking; Shivering; Pain in the left arm; A spontaneous report was received from a 42-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, pain in the left arm, shivering, body was shaking, mouth tasteless and tension inside body.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, at 2:30pm, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced body aches, pain in the left arm and shivering and body was shaking when he woke up. He stated that his mouth was tasteless and tension inside body. The patient took two (unknown dosage) Tylenol as treatment.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, body aches, pain in the left arm, shivering, body was shaking, mouth tasteless and tension inside body, were unknown.; Reporter's Comments: This case concerns a 42-year-old male who experienced NS unexpected events of pain, pain in extremity, tremor, tensions and taste disorder and NS expected event of chills.  Event onset occurred on Day 1 after the first dose of mRNA-1273. Treatment included Tylenol. Event outcomes unknown. Based on 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Body aches; Mouth is tasteless; Tension inside body; Body was shaking; Shivering; Pain in the left arm; A spontaneous report was received from a 42-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, pain in the left arm, shivering, body was shaking, mouth tasteless and tension inside body.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, at 2:30pm, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced body aches, pain in the left arm and shivering and body was shaking when he woke up. He stated that his mouth was tasteless and tension inside body. The patient took two (unknown dosage) Tylenol as treatment.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, body aches, pain in the left arm, shivering, body was shaking, mouth tasteless and tension inside body, were unknown.; Reporter's Comments: This case concerns a 42-year-old male who experienced NS unexpected events of pain, pain in extremity, tremor, tensions and taste disorder and NS expected event of chills.  Event onset occurred on Day 1 after the first dose of mRNA-1273. Treatment included Tylenol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Nausea
Clinical narrative: Pain in arm; Body aches; Very ill; Severe headache; Nausea; Chills; Joint pain; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MALAISE (Very ill), HEADACHE (Severe headache) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included ATORVASTATIN for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MALAISE (Very ill), HEADACHE (Severe headache), NAUSEA (Nausea), CHILLS (Chills) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MALAISE (Very ill), HEADACHE (Severe headache), NAUSEA (Nausea), CHILLS (Chills) and ARTHRALGIA (Joint pain) was resolving.        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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in arm; Body aches; Very ill; Severe headache; Nausea; Chills; Joint pain; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MALAISE (Very ill), HEADACHE (Severe headache) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included ATORVASTATIN for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MALAISE (Very ill), HEADACHE (Severe headache), NAUSEA (Nausea), CHILLS (Chills) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MALAISE (Very ill), HEADACHE (Severe headache), NAUSEA (Nausea), CHILLS (Chills) and ARTHRALGIA (Joint pain) was resolving.        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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: temperature this morning of right under 100 degrees; A spontaneous report was received from a consumer concerning a 79 year old male patient. Call was made by patient's wife. Concern was that the patient was having a raised temperature of just under 100 degrees but had since went away.   The patient's medical history includes Covid-19 infection in November 2020. No other medical history was provided. Concomitant product use was not provided.   Patient's wife reports that both she and her husband who tested positive for Covid-19 on 22 Nov 2020. Reporter stated they managed the symptoms at home for two weeks with the help of their health care provider. Reporter stated that they both received negative tests two weeks after convalescing.  Two to three days prior to the patient receiving the vaccine, he tested negative again.. Patient received one of two planned doses of mRNA1273 on 6Jan2021, for prophylaxis of Covid-19 infection, and the next morning had a body temperature of just under 100 degrees, which had since gone away. Called to inquire if he should have waited 90 days past infection to receive vaccine.   Action taken for mRNA-1273 in response to the events was not reported.   The outcome of this event was not provided.  The reporter did not provide causality for the event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of pyrexia, a causal relationship cannot be excluded. Pyrexia is a listed event in all including CCDS.