chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The lot number Lot# 029K20A it was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The lot number Lot# 029K20A it was expired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The lot number Lot# 029K20A it was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The lot number Lot# 029K20A it was expired) had resolved.            No concomitant medication reported.  No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Acne, Feeling abnormal, Feeling hot, Hot flush
Clinical narrative: Sick to her stomach; Waking up at night; Hot flashes; Sweaty; Cramps like menstrual cramps; Acne; warmth; Heat in vagina; Bleeding from vagina; Felt like ovulation on the right side of body; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to her stomach), MIDDLE INSOMNIA (Waking up at night), HOT FLUSH (Hot flashes), HYPERHIDROSIS (Sweaty) and MUSCLE SPASMS (Cramps like menstrual cramps) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Menopausal in January 2011 and Surgery. Concurrent medical conditions included Bone disorder and Joint disorder.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to her stomach), MIDDLE INSOMNIA (Waking up at night), HOT FLUSH (Hot flashes), HYPERHIDROSIS (Sweaty), MUSCLE SPASMS (Cramps like menstrual cramps), ACNE (Acne), FEELING HOT (warmth), VULVOVAGINAL DISCOMFORT (Heat in vagina), VAGINAL HAEMORRHAGE (Bleeding from vagina) and FEELING ABNORMAL (Felt like ovulation on the right side of body). At the time of the report, ABDOMINAL DISCOMFORT (Sick to her stomach), MIDDLE INSOMNIA (Waking up at night), HOT FLUSH (Hot flashes), HYPERHIDROSIS (Sweaty), MUSCLE SPASMS (Cramps like menstrual cramps), ACNE (Acne), FEELING HOT (warmth), VULVOVAGINAL DISCOMFORT (Heat in vagina), VAGINAL HAEMORRHAGE (Bleeding from vagina) and FEELING ABNORMAL (Felt like ovulation on the right side of body) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided. Patient has comorbidities. Patient is not currently on any medications. Patient did not take any medication to treat the side effects but thought about taking a rapid release Tylenol.   This case was linked to MOD-2022-446890, MOD-2022-446932 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Middle insomnia, Muscle spasms, Vaginal haemorrhage, Vulvovaginal discomfort
Clinical narrative: Sick to her stomach; Waking up at night; Hot flashes; Sweaty; Cramps like menstrual cramps; Acne; warmth; Heat in vagina; Bleeding from vagina; Felt like ovulation on the right side of body; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to her stomach), MIDDLE INSOMNIA (Waking up at night), HOT FLUSH (Hot flashes), HYPERHIDROSIS (Sweaty) and MUSCLE SPASMS (Cramps like menstrual cramps) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Menopausal in January 2011 and Surgery. Concurrent medical conditions included Bone disorder and Joint disorder.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to her stomach), MIDDLE INSOMNIA (Waking up at night), HOT FLUSH (Hot flashes), HYPERHIDROSIS (Sweaty), MUSCLE SPASMS (Cramps like menstrual cramps), ACNE (Acne), FEELING HOT (warmth), VULVOVAGINAL DISCOMFORT (Heat in vagina), VAGINAL HAEMORRHAGE (Bleeding from vagina) and FEELING ABNORMAL (Felt like ovulation on the right side of body). At the time of the report, ABDOMINAL DISCOMFORT (Sick to her stomach), MIDDLE INSOMNIA (Waking up at night), HOT FLUSH (Hot flashes), HYPERHIDROSIS (Sweaty), MUSCLE SPASMS (Cramps like menstrual cramps), ACNE (Acne), FEELING HOT (warmth), VULVOVAGINAL DISCOMFORT (Heat in vagina), VAGINAL HAEMORRHAGE (Bleeding from vagina) and FEELING ABNORMAL (Felt like ovulation on the right side of body) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided. Patient has comorbidities. Patient is not currently on any medications. Patient did not take any medication to treat the side effects but thought about taking a rapid release Tylenol.   This case was linked to MOD-2022-446890, MOD-2022-446932 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: symptom feeling from the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (symptom feeling from the booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptom feeling from the booster). At the time of the report, VACCINATION COMPLICATION (symptom feeling from the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: red bumps two weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot; itchy bumpstwo weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH ERYTHEMATOUS (red bumps two weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) and RASH PRURITIC (itchy bumpstwo weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red bumps two weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) and RASH PRURITIC (itchy bumpstwo weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot). At the time of the report, RASH ERYTHEMATOUS (red bumps two weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) and RASH PRURITIC (itchy bumpstwo weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2022-446893 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: Arm is very sore; redness around injection site i Injection site is veey red and has gotten worse; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore) and VACCINATION SITE ERYTHEMA (redness around injection site i Injection site is veey red and has gotten worse) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is very sore) and VACCINATION SITE ERYTHEMA (redness around injection site i Injection site is veey red and has gotten worse). At the time of the report, PAIN IN EXTREMITY (Arm is very sore) and VACCINATION SITE ERYTHEMA (redness around injection site i Injection site is veey red and has gotten worse) 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.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: red blotchiness; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotchiness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine. Concurrent medical conditions included Shellfish allergy.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red blotchiness). At the time of the report, RASH MACULAR (red blotchiness) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.  Patient asked if there was correlation to shellfish allergy or iodine as ingredient in vaccine that could have caused.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles after getting the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (shingles after getting the booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles after getting the booster). At the time of the report, HERPES ZOSTER (shingles after getting the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Decreased appetite, Pyrexia
Clinical narrative: No Appetite; was in bed for three days; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No Appetite), BEDRIDDEN (was in bed for three days), PYREXIA (Fever) and CHILLS (chills) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 021M020A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse event with Flu shot. Concurrent medical conditions included Heart disorder (Heart condition) since 1997. Concomitant products included ATORVASTATIN from 1997 to an unknown date for Heart disorder, LOSARTAN, CARVEDILOL, VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (D) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 18-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (No Appetite), BEDRIDDEN (was in bed for three days), PYREXIA (Fever) and CHILLS (chills). At the time of the report, DECREASED APPETITE (No Appetite), BEDRIDDEN (was in bed for three days), PYREXIA (Fever) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. Patient did not experience any adverse events for dose 1 of Moderna COVID-19 vaccine.   This case was linked to MOD-2021-403386 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2022: Follow yp received: Added secondary reporter.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest X-ray
Clinical narrative: Enlarged heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (Enlarged heart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Hip surgery (Had few weeks ago.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIOMEGALY (Enlarged heart). At the time of the report, CARDIOMEGALY (Enlarged heart) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: abnormal (abnormal) ENLARGED HEART.   No concomitant medication was reported. No treatment medication was reported.  Stress test and Chest X-ray done before the hip surgery.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Ears ringing; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ears ringing) and DIZZINESS (Light headedness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2022, the patient experienced TINNITUS (Ears ringing) and DIZZINESS (Light headedness). At the time of the report, TINNITUS (Ears ringing) and DIZZINESS (Light headedness) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: I have golf ball size lump at my injection site; hurts really bad; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MASS (I have golf ball size lump at my injection site) and VACCINATION SITE PAIN (hurts really bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (I have golf ball size lump at my injection site) and VACCINATION SITE PAIN (hurts really bad). At the time of the report, VACCINATION SITE MASS (I have golf ball size lump at my injection site) and VACCINATION SITE PAIN (hurts really bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Some side effects; This spontaneous case was reported by another health care professional and describes the occurrence of VACCINATION COMPLICATION (Some side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects). At the time of the report, VACCINATION COMPLICATION (Some side effects) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Extreme aching body, body aches; No energy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme aching body, body aches), ASTHENIA (No energy) and PYREXIA (Fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced PAIN (Extreme aching body, body aches), ASTHENIA (No energy) and PYREXIA (Fever). At the time of the report, PAIN (Extreme aching body, body aches), ASTHENIA (No energy) and PYREXIA (Fever) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided. The patient height was 175.26 cm.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: sore throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced HEADACHE (headache). On 10-Jan-2022, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) outcome was unknown.            Patient took first dose on 01-April-2021 and Second dose 21 day after first dose.Patient said he's not going to see a doctor unless the events get worse. No treatment information was provided by the reporter. No Concomitant medicines were reported.   This case was linked to MOD-2022-448146 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling). At the time of the report, PARAESTHESIA (tingling) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient had side effect of tingling after booster.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: The patient was boosted with Moderna, but later found out that she qualified for the 3rd full dose d/t a health condition.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient was boosted with Moderna, but later found out that she qualified for the 3rd full dose d/t a health condition.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (The patient was boosted with Moderna, but later found out that she qualified for the 3rd full dose d/t a health condition.). At the time of the report, ACCIDENTAL UNDERDOSE (The patient was boosted with Moderna, but later found out that she qualified for the 3rd full dose d/t a health condition.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the patient was boosted with Moderna, but later found out that the patient qualified for the 3rd full dose due to a health condition. The patient wanted to know if they could return for another half dose of the vaccine.  No treatment information was provided   Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Very Itchy all over her body after booster; Rash all over body after booster; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very Itchy all over her body after booster) and RASH (Rash all over body after booster) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced PRURITUS (Very Itchy all over her body after booster) and RASH (Rash all over body after booster). At the time of the report, PRURITUS (Very Itchy all over her body after booster) and RASH (Rash all over body after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2022-448167 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Developed cold symptoms a few days ago. Should I get the booster if I have cold symptoms; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (Developed cold symptoms a few days ago. Should I get the booster if I have cold symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Developed cold symptoms a few days ago. Should I get the booster if I have cold symptoms). At the time of the report, NASOPHARYNGITIS (Developed cold symptoms a few days ago. Should I get the booster if I have cold symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever 104 for 3 days after initial vaccinations; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever 104 for 3 days after initial vaccinations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever 104 for 3 days after initial vaccinations). At the time of the report, PYREXIA (High fever 104 for 3 days after initial vaccinations) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 104 (High) 104.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Following the first dose she had a sore arm started later that night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Following the first dose she had a sore arm started later that night) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Dec-2021, the patient experienced PAIN IN EXTREMITY (Following the first dose she had a sore arm started later that night). On 14-Dec-2021, PAIN IN EXTREMITY (Following the first dose she had a sore arm started later that night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-448040 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: given a 2nd booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (given a 2nd booster dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 051C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 11-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 11-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (given a 2nd booster dose). On 11-Jan-2022, EXTRA DOSE ADMINISTERED (given a 2nd booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient may have some dementia. .No concomitant drug details were reported. No treatment details were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pruritus, Rash
Clinical narrative: Itchy skin; Rashes all over the skin and appear specially at night; Patient is 32 weeks pregnant and received Moderna booster dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin), RASH (Rashes all over the skin and appear specially at night) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is 32 weeks pregnant and received Moderna booster dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 040B21A and 044A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and LEVOTHYROXINE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is 32 weeks pregnant and received Moderna booster dose). On 31-Dec-2021, the patient experienced PRURITUS (Itchy skin) and RASH (Rashes all over the skin and appear specially at night). On 18-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is 32 weeks pregnant and received Moderna booster dose) had resolved. At the time of the report, PRURITUS (Itchy skin) and RASH (Rashes all over the skin and appear specially at night) had not resolved.            No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold symptoms; This spontaneous case was reported by another health care professional and describes the occurrence of NASOPHARYNGITIS (Cold symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold symptoms). At the time of the report, NASOPHARYNGITIS (Cold symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. The patient had concerned that if could get a booster vaccine if they had cold symptoms. No Treatment medication reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Pain, Pain in extremity
Clinical narrative: Felt very hot; Fever of 101.6; Chills; Shaking; Really achy; Arm was sore; Did not sleep; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), PAIN (Really achy), PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (Did not sleep) and FEELING HOT (Felt very hot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040H21A and 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced TREMOR (Shaking), PAIN (Really achy), PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (Did not sleep) and CHILLS (Chills). On 11-Jan-2022, the patient experienced FEELING HOT (Felt very hot) and PYREXIA (Fever of 101.6). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), PAIN (Really achy), PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (Did not sleep), FEELING HOT (Felt very hot), CHILLS (Chills) and PYREXIA (Fever of 101.6) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, Body temperature: 101.6 (High) High.         No concomitant medications was provided by the reporter.   This case was linked to MOD-2022-447941 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Tremor
Clinical narrative: Felt very hot; Fever of 101.6; Chills; Shaking; Really achy; Arm was sore; Did not sleep; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), PAIN (Really achy), PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (Did not sleep) and FEELING HOT (Felt very hot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040H21A and 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced TREMOR (Shaking), PAIN (Really achy), PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (Did not sleep) and CHILLS (Chills). On 11-Jan-2022, the patient experienced FEELING HOT (Felt very hot) and PYREXIA (Fever of 101.6). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), PAIN (Really achy), PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (Did not sleep), FEELING HOT (Felt very hot), CHILLS (Chills) and PYREXIA (Fever of 101.6) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, Body temperature: 101.6 (High) High.         No concomitant medications was provided by the reporter.   This case was linked to MOD-2022-447941 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Aphonia, Cough
Clinical narrative: I can't stop coughing; loose my voice; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (I can't stop coughing) and APHONIA (loose my voice) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (I can't stop coughing) and APHONIA (loose my voice). At the time of the report, COUGH (I can't stop coughing) and APHONIA (loose my voice) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Loss of personal independence in daily activities, Rash, Urticaria
Clinical narrative: Affecting his life; Pretty bad,Not comfortable at all; Rash; Hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Affecting his life), FEELING ABNORMAL (Pretty bad,Not comfortable at all) and RASH (Rash) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21A, 004C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (Hives all over the body) and RASH (Rash). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Affecting his life) and FEELING ABNORMAL (Pretty bad,Not comfortable at all). At the time of the report, URTICARIA (Hives all over the body) and RASH (Rash) had not resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Affecting his life) and FEELING ABNORMAL (Pretty bad,Not comfortable at all) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) blood work came out good.         No concomitant medications were reported. The patient was a cyclist and works out on regular basis. The patient stated that he has rash, hives all over the body and stated that the doctors are still checking and symptoms started within 11 days after the booster dose and treatment received included antihistamines.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Neck pain, Pain, Rash, Vaccination site pain
Clinical narrative: The pain is worse with movement and when lifting heavy objects; a little rash like little white dots over this area; chest pain; chest pain is localized to the breast bone, and in his neck area.; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), NECK PAIN (chest pain is localized to the breast bone, and in his neck area.), PAIN (The pain is worse with movement and when lifting heavy objects), RASH (a little rash like little white dots over this area) and VACCINATION SITE PAIN (Sore left arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (He stayed overnight in a hospital with that diagnosis, but does not recall receiving any treatments) on 10-Dec-2020, Cough (since before taking the vaccine) and Cold (since before taking the vaccine).    On 31-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2022, the patient experienced VACCINATION SITE PAIN (Sore left arm). On 02-Jan-2022, the patient experienced CHEST PAIN (chest pain), NECK PAIN (chest pain is localized to the breast bone, and in his neck area.) and RASH (a little rash like little white dots over this area). On an unknown date, the patient experienced PAIN (The pain is worse with movement and when lifting heavy objects). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and ALCOHOL at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain) and NECK PAIN (chest pain is localized to the breast bone, and in his neck area.) had not resolved, PAIN (The pain is worse with movement and when lifting heavy objects) and RASH (a little rash like little white dots over this area) outcome was unknown and VACCINATION SITE PAIN (Sore left arm) had resolved.            No prior history of myocarditis or pericarditis.  No Concomitant medication was reported.  Patient had chest pain on 2 JAN 2022 which had continued up until that day. This chest pain was localized to the breast bone, and in his neck area. These was also a little rash like little white dots over this area. The pain was worse with movement and when lifting heavy objects.   This case was linked to MOD-2022-448106 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed the 42 day window to get 2nd shot/Came back for a second vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the 42 day window to get 2nd shot/Came back for a second vaccine) 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 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the 42 day window to get 2nd shot/Came back for a second vaccine). On 01-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the 42 day window to get 2nd shot/Came back for a second vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  No treatment details were reported.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 13 year-old-patient received moderna vaccine booster dose/Patient under the age of 18 received moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 13 year-old-patient received moderna vaccine booster dose/Patient under the age of 18 received moderna vaccine) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pfizer (1st dose) on 13-May-2021 and pfizer (2nd dose) on 03-Jun-2021. Past adverse reactions to the above products included No adverse event with pfizer and pfizer.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 13 year-old-patient received moderna vaccine booster dose/Patient under the age of 18 received moderna vaccine). On 11-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 13 year-old-patient received moderna vaccine booster dose/Patient under the age of 18 received moderna vaccine) had resolved.            Patient of age 13 years old received primary series of Pfizer vaccine and then received Moderna booster dose.  No concomitant treatment was provided.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Pain in extremity
Clinical narrative: Sore arm; Patient received the first Moderna Covid vaccine and a week later found out she was pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MATERNAL EXPOSURE BEFORE PREGNANCY (Patient received the first Moderna Covid vaccine and a week later found out she was pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Jan-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 12-Jan-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Patient received the first Moderna Covid vaccine and a week later found out she was pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. On 12-Jan-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Patient received the first Moderna Covid vaccine and a week later found out she was pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications list was not provided.  Treatment information was not provided.   Patient decided at the time they were not going to get the second dose of the vaccine. Patient did not get the second dose of the Moderna vaccine. Patient reported  that since then she had her child and had spoken to some doctors about what she should do to become fully vaccinated. Patient would like to knowwhether she should start over or just get the booster shot.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had my moderna booster Sunday and still have side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (had my moderna booster Sunday and still have side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had my moderna booster Sunday and still have side effects). At the time of the report, VACCINATION COMPLICATION (had my moderna booster Sunday and still have side effects) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient had moderna booster on Sunday.