chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: had long term super hypersensitive skin; flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal; Her psoriasis had bigger breakouts than ever before; had poison ivy that was worse than ever; got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed; 1st dose 9Mar2021; 2nd dose 21Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (had long term super hypersensitive skin), ARTHROPOD BITE (flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal), PSORIASIS (Her psoriasis had bigger breakouts than ever before), DERMATITIS CONTACT (had poison ivy that was worse than ever) and HERPES ZOSTER (got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 9Mar2021; 2nd dose 21Apr2021). On 27-Aug-2021, the patient experienced HERPES ZOSTER (got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed). On an unknown date, the patient experienced SENSITIVE SKIN (had long term super hypersensitive skin), ARTHROPOD BITE (flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal), PSORIASIS (Her psoriasis had bigger breakouts than ever before) and DERMATITIS CONTACT (had poison ivy that was worse than ever). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 9Mar2021; 2nd dose 21Apr2021) had resolved. At the time of the report, SENSITIVE SKIN (had long term super hypersensitive skin), ARTHROPOD BITE (flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal), PSORIASIS (Her psoriasis had bigger breakouts than ever before), DERMATITIS CONTACT (had poison ivy that was worse than ever) and HERPES ZOSTER (got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed) outcome was unknown.            No Concomitant medication was reported.  No treatment medication was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction
Clinical narrative: COVID arm; Rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE RASH (Rash in the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE RASH (Rash in the injection site). At the time of the report, VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE RASH (Rash in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-349571 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Stomatitis
Clinical narrative: just a little bit irritated my mouth; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (just a little bit irritated my mouth), HEADACHE (headache) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypothyroidism, Diabetes and Immunocompromised. Concomitant products included LISINOPRIL for Blood pressure, EZETIMIBE (ZETIA) for Cholesterol, METFORMIN for Diabetes, ALPRAZOLAM for Panic attack, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Thyroid disorder NOS, OMEGA-3-ACID ETHYL ESTER (OMEGA 3 ACID ETHYL ESTERS) for Triglycerides, CHLORTALIDONE (HIPREX [CHLORTALIDONE]) for Urinary tract infection, PREDNISONE, PROBIOTICS NOS, SERTRALINE, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), VITAMIN D NOS, VITAMIN A [RETINOL] and CALCIUM for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, 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 STOMATITIS (just a little bit irritated my mouth), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, STOMATITIS (just a little bit irritated my mouth), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has been taking all the conmeds since she was 30.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: he got shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (he got shingles) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HERPES ZOSTER (he got shingles). At the time of the report, HERPES ZOSTER (he got shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Urgent care doctor  prescribed an antiviral for treatment of shingles.  No concomitant medications was reported   This case was linked to MOD-2021-350352 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Potential allergic reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of ALLERGY TO VACCINE (Potential allergic reaction) 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 ALLERGY TO VACCINE (Potential allergic reaction). At the time of the report, ALLERGY TO VACCINE (Potential allergic reaction) 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 were reported. The treatment information were unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue, Pyrexia
Clinical narrative: Patient missed the 2nd dose window; Sick for a day; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Sick for a day), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose window) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose window). On an unknown date, the patient experienced ILLNESS (Sick for a day) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose window) had resolved. At the time of the report, ILLNESS (Sick for a day) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: report a possible side effect; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (report a possible side effect) 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 VACCINATION COMPLICATION (report a possible side effect). At the time of the report, VACCINATION COMPLICATION (report a possible side effect) 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 were provided by the reporter  No treatment medications were provided by the reporter    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph node under his left armpit after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses). In 2021, LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter. In 20Sep2021 patient got a booster of the Moderna COVID-19 vaccine Lot no 046C21A, patient had CAT scan done and next to the sternum,on the right side had an enlarged lymph node. patient had few side effects after third dose as well.   This case was linked to MOD-2021-350370 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose/The pharmacist confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose/The pharmacist confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A, 044A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose/The pharmacist confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose/The pharmacist confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, The pharmacist updated the details to previous case, and had confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021. Pharmacist was willing to know whether the patients had to be revaccinated and also whether the patients were going to be fine. She had confirmed that the patients had received all their doses from her facility. Consent given for safety to contact the pharmacist. The pharmacist confirmed that the patient was immunocompromised.  Concomitant product use was not provided.  Treatment product information was not provided.   This case was linked to MOD-2021-350559 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered an expired vaccine to 1 patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to 1 patient.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to 1 patient.). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to 1 patient.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Extra dose administered, Feeling abnormal, Headache, Malaise
Clinical narrative: malaise; dizziness; "I am not myself"; dull headaches; received 3 dose accidental of Moderna instead of Flu shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), DIZZINESS (dizziness), FEELING ABNORMAL ("I am not myself"), HEADACHE (dull headaches) and EXTRA DOSE ADMINISTERED (received 3 dose accidental of Moderna instead of Flu shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (received 3 dose accidental of Moderna instead of Flu shot). On an unknown date, the patient experienced MALAISE (malaise), DIZZINESS (dizziness), FEELING ABNORMAL ("I am not myself") and HEADACHE (dull headaches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (malaise), DIZZINESS (dizziness), FEELING ABNORMAL ("I am not myself") and HEADACHE (dull headaches) outcome was unknown and EXTRA DOSE ADMINISTERED (received 3 dose accidental of Moderna instead of Flu shot) had resolved.            No concomitant drug details were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Body aches - 2nd dose; Fever for less than 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches - 2nd dose) and PYREXIA (Fever for less than 24 hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoedema.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches - 2nd dose) and PYREXIA (Fever for less than 24 hours). At the time of the report, MYALGIA (Body aches - 2nd dose) and PYREXIA (Fever for less than 24 hours) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-350318, MOD-2021-350366 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and HERPES ZOSTER (shingles) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (pain). On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, PAIN (pain) had not resolved and HERPES ZOSTER (shingles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   after receiving the 1st dose on 9Feb2021 patient got shingles and  He was prescribed an antiviral by an urgent care doctor at that time. no concomitant medications were reported.   This case was linked to MOD-2021-349818 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Unsure whether a patient received a dose from a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unsure whether a patient received a dose from a vial that was punctured more than 12 hours ago) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No medical history was provided by the repor.    On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, 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 EXPIRED PRODUCT ADMINISTERED (Unsure whether a patient received a dose from a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Unsure whether a patient received a dose from a vial that was punctured more than 12 hours ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: more severe side effects than the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (more severe side effects than the second shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    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 VACCINATION COMPLICATION (more severe side effects than the second shot). At the time of the report, VACCINATION COMPLICATION (more severe side effects than the second shot) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-350337 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph node under his left armpit after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer survivor).    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses). At the time of the report, LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-350286 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness on her left arm at injection site down to her below that lasted 12 days; Severe itching on her left arm at injection site down to her elbow that last 12 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her below that lasted 12 days) and VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow that last 12 days) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her below that lasted 12 days) and VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow that last 12 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at a dose of Cortisone 10. On 30-Jan-2021, VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her below that lasted 12 days) and VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow that last 12 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details also included Icepacks.   This case was linked to MOD-2021-350425, MOD-2021-350426.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm after second dose; extremely tired after second dose/was tired for 2 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm after second dose) and FATIGUE (extremely tired after second dose/was tired for 2 days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M2DA) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm after second dose) and FATIGUE (extremely tired after second dose/was tired for 2 days). The patient was treated with Manual therapy (good sleep and hot water bottle to sore arm) for Pain in extremity. On 04-Mar-2021, PAIN IN EXTREMITY (sore arm after second dose) and FATIGUE (extremely tired after second dose/was tired for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-350343, MOD-2021-350398 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: No new information
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness on her left arm at injection site down to her elbow for 9 days; Severe itching on her left arm at injection site down to her elbow for 9 days; Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her elbow for 9 days), VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow for 9 days) and PYREXIA (Had a fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her elbow for 9 days), VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow for 9 days) and PYREXIA (Had a fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her elbow for 9 days) and VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow for 9 days) had resolved. At the time of the report, PYREXIA (Had a fever) outcome was unknown.            Treatment information includes icepacks.  No concomitant medications were reported.   This case was linked to MOD-2021-350376, MOD-2021-350426 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Hypoaesthesia, Hypoaesthesia oral, Oral discomfort
Clinical narrative: Numbness in face; Doesn't have a lot of movement in the right eye; Cannot move upper lip; Numbness in the lip; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in face), EYE MOVEMENT DISORDER (Doesn't have a lot of movement in the right eye), ORAL DISCOMFORT (Cannot move upper lip) and HYPOAESTHESIA ORAL (Numbness in the lip) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Oct-2021, the patient experienced HYPOAESTHESIA (Numbness in face), EYE MOVEMENT DISORDER (Doesn't have a lot of movement in the right eye), ORAL DISCOMFORT (Cannot move upper lip) and HYPOAESTHESIA ORAL (Numbness in the lip). At the time of the report, HYPOAESTHESIA (Numbness in face), EYE MOVEMENT DISORDER (Doesn't have a lot of movement in the right eye), ORAL DISCOMFORT (Cannot move upper lip) and HYPOAESTHESIA ORAL (Numbness in the lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided.  Patient reported that the right part of face was mainly affected.  Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Extra dose administered, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: "on and off dizziness"; Has a dull headache that throbs constantly at back of head; Experienced tiredness; Inappropriate schedule of vaccine administered; 3rd dose of Moderna vaccine administered by accident instead of flu vaccine was on 14Aug2021; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS ("on and off dizziness"), HEADACHE (Has a dull headache that throbs constantly at back of head), FATIGUE (Experienced tiredness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXTRA DOSE ADMINISTERED (3rd dose of Moderna vaccine administered by accident instead of flu vaccine was on 14Aug2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer on 26-Feb-2021 and Pfizer on 26-Mar-2021.    On 14-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXTRA DOSE ADMINISTERED (3rd dose of Moderna vaccine administered by accident instead of flu vaccine was on 14Aug2021). On an unknown date, the patient experienced DIZZINESS ("on and off dizziness"), HEADACHE (Has a dull headache that throbs constantly at back of head) and FATIGUE (Experienced tiredness). On 14-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXTRA DOSE ADMINISTERED (3rd dose of Moderna vaccine administered by accident instead of flu vaccine was on 14Aug2021) had resolved. At the time of the report, DIZZINESS ("on and off dizziness"), HEADACHE (Has a dull headache that throbs constantly at back of head) and FATIGUE (Experienced tiredness) outcome was unknown.            Concomitant medication were not given.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: Kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Kidney problems) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced RENAL DISORDER (Kidney problems). At the time of the report, RENAL DISORDER (Kidney problems) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. Reporter reports that the patient had to go to the hospital Reporter reports that she was just running a farm stand she happened to stop
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 24 patients who received a vaccine past the 30-day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (24 patients who received a vaccine past the 30-day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (24 patients who received a vaccine past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (24 patients who received a vaccine past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 01-SEP-2021 vial was initially stored in the refrigerator. Vaccine was administered on 06-OCT-2021, 07-OCT-2021, 08-OCT-2021, 09-OCT-2021, 10-OCT-2021, 11-OCT-2021. Vials were kept between 40 F and 42 F No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Palpitations, Product dose omission issue
Clinical narrative: 42 days post first shot & has not received the 2nd shot; A little worst "hard time breathing" after first shot; Increased palpitation after first shot/Heart racing; Condition aggravated; This case was received via an unknown source (no reference has been entered for a regulatory authority or license partner) on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (A little worst "hard time breathing" after first shot), PALPITATIONS (Increased palpitation after first shot/Heart racing), CONDITION AGGRAVATED (Condition aggravated) and PRODUCT DOSE OMISSION ISSUE (42 days post first shot & has not received the 2nd shot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disorder (Heart problem), Palpitation (Heart Palpitation) and Dyspnea.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced DYSPNOEA (A little worst "hard time breathing" after first shot), PALPITATIONS (Increased palpitation after first shot/Heart racing) and CONDITION AGGRAVATED (Condition aggravated). On 12-Oct-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (42 days post first shot & has not received the 2nd shot). On 12-Oct-2021, PRODUCT DOSE OMISSION ISSUE (42 days post first shot & has not received the 2nd shot) had resolved. At the time of the report, DYSPNOEA (A little worst "hard time breathing" after first shot), PALPITATIONS (Increased palpitation after first shot/Heart racing) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Patient's regular cardiologist looked at her old records and recommended to get the second dose. EKG or any new tests were not performed.  Treatment information was not provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching was incredible; Had a full body rash, rash didn't clear on the first regimen, covered in the rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Had a full body rash,rash didn't clear on the first regimen,covered in the rash) and PRURITUS (itching was incredible) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH (Had a full body rash,rash didn't clear on the first regimen,covered in the rash). On an unknown date, the patient experienced PRURITUS (itching was incredible). The patient was treated with PREDNISONE for Rash, at a dose of 10 day rounds of prednisone each. At the time of the report, RASH (Had a full body rash,rash didn't clear on the first regimen,covered in the rash) and PRURITUS (itching was incredible) 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 medications provided. No treatment medications provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Fatigue
Clinical narrative: Sporadic for a couple of hours and really goofy; Sweating like a stuffed pig; Shakes; Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever; Chills; Sudden headache; Nausea; Could not lift the arm; Diarrhea; Destruction in head; Swelling; Tenderness; Fatigue; Joint pain; Somewhat muscle pain; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea) and HEAD DISCOMFORT (Destruction in head) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced MYALGIA (Somewhat muscle pain). On 09-Oct-2021, the patient experienced LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-Oct-2021, the patient experienced FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig) and TREMOR (Shakes). The patient was treated with NAPROXEN SODIUM (ALEVE) on 12-Oct-2021 for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), TREMOR (Shakes), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache) and NAUSEA (Nausea) had not resolved, LIMB DISCOMFORT (Could not lift the arm) was resolving and DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), MYALGIA (Somewhat muscle pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, Body temperature: 101 (High) mild fever, highest was 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported.  Additional treatment medication was pain pills.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Headache, Hyperhidrosis, Limb discomfort
Clinical narrative: Sporadic for a couple of hours and really goofy; Sweating like a stuffed pig; Shakes; Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever; Chills; Sudden headache; Nausea; Could not lift the arm; Diarrhea; Destruction in head; Swelling; Tenderness; Fatigue; Joint pain; Somewhat muscle pain; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea) and HEAD DISCOMFORT (Destruction in head) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced MYALGIA (Somewhat muscle pain). On 09-Oct-2021, the patient experienced LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-Oct-2021, the patient experienced FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig) and TREMOR (Shakes). The patient was treated with NAPROXEN SODIUM (ALEVE) on 12-Oct-2021 for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), TREMOR (Shakes), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache) and NAUSEA (Nausea) had not resolved, LIMB DISCOMFORT (Could not lift the arm) was resolving and DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), MYALGIA (Somewhat muscle pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, Body temperature: 101 (High) mild fever, highest was 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported.  Additional treatment medication was pain pills.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Swelling, Tenderness
Clinical narrative: Sporadic for a couple of hours and really goofy; Sweating like a stuffed pig; Shakes; Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever; Chills; Sudden headache; Nausea; Could not lift the arm; Diarrhea; Destruction in head; Swelling; Tenderness; Fatigue; Joint pain; Somewhat muscle pain; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea) and HEAD DISCOMFORT (Destruction in head) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced MYALGIA (Somewhat muscle pain). On 09-Oct-2021, the patient experienced LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-Oct-2021, the patient experienced FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig) and TREMOR (Shakes). The patient was treated with NAPROXEN SODIUM (ALEVE) on 12-Oct-2021 for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), TREMOR (Shakes), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache) and NAUSEA (Nausea) had not resolved, LIMB DISCOMFORT (Could not lift the arm) was resolving and DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), MYALGIA (Somewhat muscle pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, Body temperature: 101 (High) mild fever, highest was 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported.  Additional treatment medication was pain pills.