chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Condition aggravated, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Adverse reaction; arm is swollen/from the top of my shoulder down to my elbow; My arm is swollen from the top of my shoulder down to my elbow. It's painful; itches; got worse by Friday; tight; really red; hot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction), PERIPHERAL SWELLING (arm is swollen/from the top of my shoulder down to my elbow), PAIN IN EXTREMITY (My arm is swollen from the top of my shoulder down to my elbow. It's painful), PRURITUS (itches) and FEELING HOT (hot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.  Concomitant products included ANASTROZOLE (ANASTRAZOLE DENK), SULFASALAZINE, CELECOXIB (CELEBREX), OMEPRAZOLE, METFORMIN, ZIPRASIDONE HYDROCHLORIDE (GEODON [ZIPRASIDONE HYDROCHLORIDE]), BACLOFEN, BENZTROPINE [BENZATROPINE], PREGABALIN (LYRICA), ROSUVASTATIN CALCIUM (CRESTOR), LOSARTAN POTASSIUM (COZAAR), CLONAZEPAM, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), ETANERCEPT (ENBREL), LORATADINE (CLARITIN [LORATADINE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced FEELING HOT (hot), VACCINATION SITE INDURATION (tight) and VACCINATION SITE ERYTHEMA (really red). On 12-Nov-2021, the patient experienced CONDITION AGGRAVATED (got worse by Friday). On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction), PERIPHERAL SWELLING (arm is swollen/from the top of my shoulder down to my elbow), PAIN IN EXTREMITY (My arm is swollen from the top of my shoulder down to my elbow. It's painful) and PRURITUS (itches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (Adverse reaction), PERIPHERAL SWELLING (arm is swollen/from the top of my shoulder down to my elbow), PAIN IN EXTREMITY (My arm is swollen from the top of my shoulder down to my elbow. It's painful), PRURITUS (itches), FEELING HOT (hot), CONDITION AGGRAVATED (got worse by Friday), VACCINATION SITE INDURATION (tight) and VACCINATION SITE ERYTHEMA (really red) outcome was unknown.            Narrative states that patient received 2 doses of Pfizer vaccine & also patient  was told to do cold compresses for the itching.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Significant follow-up : Events Added & Email added
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site induration
Clinical narrative: Adverse reaction; arm is swollen/from the top of my shoulder down to my elbow; My arm is swollen from the top of my shoulder down to my elbow. It's painful; itches; got worse by Friday; tight; really red; hot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction), PERIPHERAL SWELLING (arm is swollen/from the top of my shoulder down to my elbow), PAIN IN EXTREMITY (My arm is swollen from the top of my shoulder down to my elbow. It's painful), PRURITUS (itches) and FEELING HOT (hot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.  Concomitant products included ANASTROZOLE (ANASTRAZOLE DENK), SULFASALAZINE, CELECOXIB (CELEBREX), OMEPRAZOLE, METFORMIN, ZIPRASIDONE HYDROCHLORIDE (GEODON [ZIPRASIDONE HYDROCHLORIDE]), BACLOFEN, BENZTROPINE [BENZATROPINE], PREGABALIN (LYRICA), ROSUVASTATIN CALCIUM (CRESTOR), LOSARTAN POTASSIUM (COZAAR), CLONAZEPAM, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), ETANERCEPT (ENBREL), LORATADINE (CLARITIN [LORATADINE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced FEELING HOT (hot), VACCINATION SITE INDURATION (tight) and VACCINATION SITE ERYTHEMA (really red). On 12-Nov-2021, the patient experienced CONDITION AGGRAVATED (got worse by Friday). On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction), PERIPHERAL SWELLING (arm is swollen/from the top of my shoulder down to my elbow), PAIN IN EXTREMITY (My arm is swollen from the top of my shoulder down to my elbow. It's painful) and PRURITUS (itches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (Adverse reaction), PERIPHERAL SWELLING (arm is swollen/from the top of my shoulder down to my elbow), PAIN IN EXTREMITY (My arm is swollen from the top of my shoulder down to my elbow. It's painful), PRURITUS (itches), FEELING HOT (hot), CONDITION AGGRAVATED (got worse by Friday), VACCINATION SITE INDURATION (tight) and VACCINATION SITE ERYTHEMA (really red) outcome was unknown.            Narrative states that patient received 2 doses of Pfizer vaccine & also patient  was told to do cold compresses for the itching.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Significant follow-up : Events Added & Email added
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Very very sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very very sick) 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 ILLNESS (Very very sick). At the time of the report, ILLNESS (Very very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The reporter called to inform that their relative was very very sick.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up was received and contains contact information. Updated the contact information. On 12-Nov-2021: Follow-up information included No new information.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Influenza like illness, Muscle twitching
Clinical narrative: Flu-like symptoms; Twitching on the ground; Over dosage given 5ml; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MUSCLE TWITCHING (Twitching on the ground) and ACCIDENTAL OVERDOSE (Over dosage given 5ml) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 5 ml. On 13-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MUSCLE TWITCHING (Twitching on the ground) and ACCIDENTAL OVERDOSE (Over dosage given 5ml). On 13-Nov-2021, ACCIDENTAL OVERDOSE (Over dosage given 5ml) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MUSCLE TWITCHING (Twitching on the ground) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain
Clinical narrative: heart issues/experiencing some irregular; Chest pain, Heart pain; felling a quarter size discomfort on the left side of the chet and had the felling of it "jumping out of his chest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart issues/experiencing some irregular), CHEST PAIN (Chest pain, Heart pain) and CHEST DISCOMFORT (felling a quarter size discomfort on the left side of the chet and had the felling of it "jumping out of his chest) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced CHEST DISCOMFORT (felling a quarter size discomfort on the left side of the chet and had the felling of it "jumping out of his chest). On an unknown date, the patient experienced CARDIAC DISORDER (heart issues/experiencing some irregular) and CHEST PAIN (Chest pain, Heart pain). At the time of the report, CARDIAC DISORDER (heart issues/experiencing some irregular), CHEST PAIN (Chest pain, Heart pain) and CHEST DISCOMFORT (felling a quarter size discomfort on the left side of the chet and had the felling of it "jumping out of his chest) outcome was unknown.            Patient stated  had a CAT scan for blockages and heart attack (this diagnose is was discarded) and was concerned about the myocarditis and decided to go to the emergency room  11Nov2021. He was administered no treatment. Concomitant medications was not reported.  Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received event added. On 17-Nov-2021: Nonsignificant follow up append and contact information added
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: extreme fatigue; high fever 39 degrees; nausea; fatigue; severe headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Nov-2021 and was forwarded to Moderna on 12-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue), PYREXIA (high fever 39 degrees), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (severe headache) 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 FATIGUE (extreme fatigue). an unknown date, the patient experienced PYREXIA (high fever 39 degrees), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (severe headache). At the time of the report, FATIGUE (extreme fatigue) had not resolved and PYREXIA (high fever 39 degrees), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (severe headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever 39 degrees (High) Fever 39 degrees.         No concomitant information was reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Translation received on 17-NOV-2021 included: given  information was translated from native language to English.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna booster dose given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna booster dose given) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna booster dose given). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna booster dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Significant follow-up appended _ Reported & patient details added, event information updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pruritus, Rash pruritic, Vaccination site induration, Vaccination site rash
Clinical narrative: a rash of the form of an egg bomb; itchy rash; itchy; hot; hard; sore on the armpit too; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (a rash of the form of an egg bomb), RASH PRURITIC (itchy rash), PRURITUS (itchy), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (a rash of the form of an egg bomb), RASH PRURITIC (itchy rash), PRURITUS (itchy), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard) and AXILLARY PAIN (sore on the armpit too). At the time of the report, VACCINATION SITE RASH (a rash of the form of an egg bomb), RASH PRURITIC (itchy rash), PRURITUS (itchy), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard) and AXILLARY PAIN (sore on the armpit too) 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: a rash of the form of an egg bomb; itchy rash; itchy; hot; hard; sore on the armpit too; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (a rash of the form of an egg bomb), RASH PRURITIC (itchy rash), PRURITUS (itchy), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (a rash of the form of an egg bomb), RASH PRURITIC (itchy rash), PRURITUS (itchy), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard) and AXILLARY PAIN (sore on the armpit too). At the time of the report, VACCINATION SITE RASH (a rash of the form of an egg bomb), RASH PRURITIC (itchy rash), PRURITUS (itchy), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard) and AXILLARY PAIN (sore on the armpit too) 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: F
Vaccine: COVID19
Symptoms: Accidental underdose, Wrong technique in device usage process
Clinical narrative: received booster instead of 3rd dose, vanishing point syringe used, does not think patient got the full booster dose due to improper syringe administration; improper syringe administration; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose, vanishing point syringe used, does not think patient got the full booster dose due to improper syringe administration) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (improper syringe administration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose, vanishing point syringe used, does not think patient got the full booster dose due to improper syringe administration) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (improper syringe administration). On 15-Nov-2021, ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose, vanishing point syringe used, does not think patient got the full booster dose due to improper syringe administration) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (improper syringe administration) had resolved.        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 were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Significant follow-up appended(event and gender updated)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered booster shot, for more than 12hrs out of refrigerator for 5 patients; 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 (Administered booster shot, for more than 12hrs out of refrigerator for 5 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered booster shot, for more than 12hrs out of refrigerator for 5 patients). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered booster shot, for more than 12hrs out of refrigerator for 5 patients) had 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. Reporter stated that date the vial was initially stored in the refrigerator on 5-Nov-2021,Date and time vial was first punctured on 11Nov2021- 11:25 am date of administration of vaccine on12-Nov-2021 and the vails stored post puncture in RT over 25 hours for the first dose up to 29 hours for the last dose.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non significant follow up  received on 15-Nov-2021
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection area is still hot to touch; injection area is still very red; injection area is still very swollen; This spontaneous case was reported by another health care professional and describes the occurrence of INJECTION SITE WARMTH (injection area is still hot to touch), INJECTION SITE ERYTHEMA (injection area is still very red) and INJECTION SITE SWELLING (injection area is still very swollen) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced INJECTION SITE WARMTH (injection area is still hot to touch), INJECTION SITE ERYTHEMA (injection area is still very red) and INJECTION SITE SWELLING (injection area is still very swollen). At the time of the report, INJECTION SITE WARMTH (injection area is still hot to touch), INJECTION SITE ERYTHEMA (injection area is still very red) and INJECTION SITE SWELLING (injection area is still very swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported.  Treatment information was not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Aches; Pain in the arm; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), PAIN IN EXTREMITY (Pain in the arm) and HEADACHE (Headaches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 13F21A, 007B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), PAIN IN EXTREMITY (Pain in the arm) and HEADACHE (Headaches). At the time of the report, PAIN (Aches), PAIN IN EXTREMITY (Pain in the arm) and HEADACHE (Headaches) outcome was unknown.            Concomitant and treatment medications were not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Headache
Clinical narrative: Legs hurting, couldn't move legs; I am having bad cramping, never have cramping like this usually; Armpit hurting along with cramps that she has not experienced before; Nausea; Vomiting; Chills; 100.08F Fever; Fatigue; Headache/Felt like a weight on my head; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea) and VOMITING (Vomiting) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (100.08F Fever), FATIGUE (Fatigue), HEADACHE (Headache/Felt like a weight on my head), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (100.08F Fever), FATIGUE (Fatigue), HEADACHE (Headache/Felt like a weight on my head), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: 100.08 (High) 100.08F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Legs hurting, couldn't move legs; I am having bad cramping, never have cramping like this usually; Armpit hurting along with cramps that she has not experienced before; Nausea; Vomiting; Chills; 100.08F Fever; Fatigue; Headache/Felt like a weight on my head; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea) and VOMITING (Vomiting) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (100.08F Fever), FATIGUE (Fatigue), HEADACHE (Headache/Felt like a weight on my head), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (100.08F Fever), FATIGUE (Fatigue), HEADACHE (Headache/Felt like a weight on my head), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: 100.08 (High) 100.08F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Legs hurting, couldn't move legs; I am having bad cramping, never have cramping like this usually; Armpit hurting along with cramps that she has not experienced before; Nausea; Vomiting; Chills; 100.08F Fever; Fatigue; Headache/Felt like a weight on my head; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea) and VOMITING (Vomiting) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (100.08F Fever), FATIGUE (Fatigue), HEADACHE (Headache/Felt like a weight on my head), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (100.08F Fever), FATIGUE (Fatigue), HEADACHE (Headache/Felt like a weight on my head), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: 100.08 (High) 100.08F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Dizziness; Cold sweat; Fatigue and feeling exhausted; But has some sweatiness; "face was damp-ish".; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweat), HYPERHIDROSIS (But has some sweatiness; "face was damp-ish".), DIZZINESS (Dizziness) and FATIGUE (Fatigue and feeling exhausted) 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 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 12-Nov-2021, the patient experienced FATIGUE (Fatigue and feeling exhausted). On 14-Nov-2021, the patient experienced COLD SWEAT (Cold sweat). On 14-Nov-2021 at 3:00 PM, the patient experienced DIZZINESS (Dizziness). In November 2021, the patient experienced HYPERHIDROSIS (But has some sweatiness; "face was damp-ish".). On 13-Nov-2021, FATIGUE (Fatigue and feeling exhausted) had resolved. On 14-Nov-2021 at 4:00 PM, DIZZINESS (Dizziness) had resolved. At the time of the report, COLD SWEAT (Cold sweat) and HYPERHIDROSIS (But has some sweatiness; "face was damp-ish".) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus tripled in severity/ Loud noise is uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus tripled in severity/ Loud noise is uncomfortable) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046821A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus (10 years history of mild tinnitus) and Enlarged prostate. Concomitant products included TAMSULOSIN for Enlarged prostate.   On 24-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. In April 2021, the patient experienced TINNITUS (Tinnitus tripled in severity/ Loud noise is uncomfortable). At the time of the report, TINNITUS (Tinnitus tripled in severity/ Loud noise is uncomfortable) had not resolved.            Immediately after second dose, patient's tinnitus tripled in severity and had not gone down at all. It made patient's hearing very sensitive, loud noise was uncomfortable. Patient had not sought any treatment.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dysstasia, Headache, Impaired work ability
Clinical narrative: no appetite; feeling achy; continued having a headache; did not sleep well; unable to do anything for 2 days; she is unable to get up; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep well), DECREASED APPETITE (no appetite), IMPAIRED WORK ABILITY (unable to do anything for 2 days), DYSSTASIA (she is unable to get up) and PAIN (feeling achy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Psoriatic arthritis (she takes methotrexate once weekly on Friday and folic acid). Concomitant products included METHOTREXATE for Psoriatic arthritis, FOLIC ACID for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced INSOMNIA (did not sleep well). On 13-Nov-2021, the patient experienced HEADACHE (continued having a headache). On 15-Nov-2021, the patient experienced DECREASED APPETITE (no appetite) and PAIN (feeling achy). In November 2021, the patient experienced IMPAIRED WORK ABILITY (unable to do anything for 2 days) and DYSSTASIA (she is unable to get up). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (did not sleep well), DECREASED APPETITE (no appetite), IMPAIRED WORK ABILITY (unable to do anything for 2 days), DYSSTASIA (she is unable to get up), PAIN (feeling achy) and HEADACHE (continued having a headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, Body temperature: 99.5 f (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated she felt like she had low-grade migraine pre-vaccination.She stated that she got the 100% of booster dose because she is immunocompromised. also stated symptoms are persisting.She was told not to take methotrexate on the vaccination date 12Nov2021 by her rheumatologist. Reporter states that the patient received 1st dose on 25Jan2021 and 2nd dose on 28Feb2021 (date not exact, per patient). Vaccine was administered on her left arm except for one dose that patient does not remember
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain
Clinical narrative: no appetite; feeling achy; continued having a headache; did not sleep well; unable to do anything for 2 days; she is unable to get up; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep well), DECREASED APPETITE (no appetite), IMPAIRED WORK ABILITY (unable to do anything for 2 days), DYSSTASIA (she is unable to get up) and PAIN (feeling achy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Psoriatic arthritis (she takes methotrexate once weekly on Friday and folic acid). Concomitant products included METHOTREXATE for Psoriatic arthritis, FOLIC ACID for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced INSOMNIA (did not sleep well). On 13-Nov-2021, the patient experienced HEADACHE (continued having a headache). On 15-Nov-2021, the patient experienced DECREASED APPETITE (no appetite) and PAIN (feeling achy). In November 2021, the patient experienced IMPAIRED WORK ABILITY (unable to do anything for 2 days) and DYSSTASIA (she is unable to get up). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (did not sleep well), DECREASED APPETITE (no appetite), IMPAIRED WORK ABILITY (unable to do anything for 2 days), DYSSTASIA (she is unable to get up), PAIN (feeling achy) and HEADACHE (continued having a headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, Body temperature: 99.5 f (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated she felt like she had low-grade migraine pre-vaccination.She stated that she got the 100% of booster dose because she is immunocompromised. also stated symptoms are persisting.She was told not to take methotrexate on the vaccination date 12Nov2021 by her rheumatologist. Reporter states that the patient received 1st dose on 25Jan2021 and 2nd dose on 28Feb2021 (date not exact, per patient). Vaccine was administered on her left arm except for one dose that patient does not remember
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site irritation
Clinical narrative: Skin irritation and redness at the site of the vaccination just  like psoriasis; Skin irritation and redness at the site of the vaccination just  like psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Skin irritation and redness at the site of the vaccination just  like psoriasis) and VACCINATION SITE ERYTHEMA (Skin irritation and redness at the site of the vaccination just  like psoriasis) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Psoriasis (Had an psoriasis injection 7Nov2021.). Concomitant products included LOSARTAN for Blood pressure.    On 10-Nov-2021, 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 IRRITATION (Skin irritation and redness at the site of the vaccination just  like psoriasis) and VACCINATION SITE ERYTHEMA (Skin irritation and redness at the site of the vaccination just  like psoriasis). At the time of the report, VACCINATION SITE IRRITATION (Skin irritation and redness at the site of the vaccination just  like psoriasis) and VACCINATION SITE ERYTHEMA (Skin irritation and redness at the site of the vaccination just  like psoriasis) outcome was unknown.            No treatment information was provided.  Patient was taking sleeping pills.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2021: Nonsignificant followup appended.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration of booster shot which was more than 18 hr in fridge/ gave a patient a booster does from a vile that had been started The previous day, it had been refrigerated the whole time; Administration of booster shot which was more than 18 hr in fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge/ gave a patient a booster does from a vile that had been started The previous day, it had been refrigerated the whole time) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge/ gave a patient a booster does from a vile that had been started The previous day, it had been refrigerated the whole time) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge/ gave a patient a booster does from a vile that had been started The previous day, it had been refrigerated the whole time) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge) had resolved.        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.   This case was linked to MOD-2021-388723, MOD-2021-388696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up appended on 12-nov-2021 contains Event related information. On 16-Nov-2021: Follow up received contains Patient demographics and Vaccine information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects/symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by another health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects/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 VACCINATION COMPLICATION (side effects/symptoms). At the time of the report, VACCINATION COMPLICATION (side effects/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.   Concomitant drugs were not reported. Treatment medications were not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: experienced fatigue after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (experienced fatigue after the 2nd dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), CLONIDINE and AMLODIPINE for an unknown indication.   On 12-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. On an unknown date, the patient experienced FATIGUE (experienced fatigue after the 2nd dose). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Adverse event, at a dose of 1 tab twice daily from the emergency room. At the time of the report, FATIGUE (experienced fatigue after the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-385894 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Epistaxis, Pyrexia, Vaccination site pain
Clinical narrative: Little bleeding in the nose; Chest pains on both sides, right side more than the left side of the chest; Arm soreness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Little bleeding in the nose), CHEST PAIN (Chest pains on both sides, right side more than the left side of the chest), VACCINATION SITE PAIN (Arm soreness) and PYREXIA (Fever) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EPISTAXIS (Little bleeding in the nose). In November 2021, the patient experienced CHEST PAIN (Chest pains on both sides, right side more than the left side of the chest), VACCINATION SITE PAIN (Arm soreness) and PYREXIA (Fever). At the time of the report, EPISTAXIS (Little bleeding in the nose), CHEST PAIN (Chest pains on both sides, right side more than the left side of the chest), VACCINATION SITE PAIN (Arm soreness) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up received and contains Non significant information.