chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Visual impairment
Clinical narrative: Small bruises on different part of body; There is pain and the experience of being remote from my surroundings-fog lke.; pain; lethargy; graying of vision; I also have had headaches unlike any experienced before.; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain), LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy, Environmental allergy (Numerous Environmental Allergies), Asthma since 15-Dec-1947 and Hypothyroidism. Concomitant products included CALCIUM CITRATE from 15-Jun-2019 to an unknown date for Bone disorder, THYROID (ARMOUR THYROID) for Hypothyroidism, DOCUSATE SODIUM (COLACE) from 30-Nov-2017 to an unknown date for Stools hard, MAGNESIUM CITRATE from 30-Nov-2017 to an unknown date and VITAMIN D NOS from 15-Jun-2019 to an unknown date for Supplementation therapy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (I also have had headaches unlike any experienced before.). On an unknown date, the patient experienced CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain), LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision). At the time of the report, CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain) and HEADACHE (I also have had headaches unlike any experienced before.) had not resolved and LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) Positive for Covid 19.         Patient says she has Headache behind eyes and nose, graying of vision, sensation of being remote from surroundings and lethargy. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Significant FU : Patient details, product details, concomitant medication , event outcome updated
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Greater than 35 days between doses of the Moderna Covid-19 vaccine; Greater than 35 days between doses of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of the Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of the Moderna Covid-19 vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009DZ1A and 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of the Moderna Covid-19 vaccine). On 05-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of the Moderna Covid-19 vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-302041 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow-up received: Patient demoghraphics, medical history and dose two details were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-302041:Same reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, Macule, Pruritus
Clinical narrative: Constant headahe right above her eyebrows; Always tired; Continuous nose bleed every day/runny nose bloody; Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy; Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Continuous nose bleed every day/runny nose bloody), PRURITUS (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy), MACULE (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy), HEADACHE (Constant headahe right above her eyebrows) and FATIGUE (Always tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     Concomitant products included MELOXICAM for Arthritis, LOSARTAN for Blood pressure high, PRAVASTATIN for Cholesterol, DULOXETINE for Fibromyalgia, OXYBUTYNIN for Urinary incontinence, MUPIROCIN, PREDNISONE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced EPISTAXIS (Continuous nose bleed every day/runny nose bloody), PRURITUS (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy) and MACULE (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy). On an unknown date, the patient experienced HEADACHE (Constant headahe right above her eyebrows) and FATIGUE (Always tired). At the time of the report, EPISTAXIS (Continuous nose bleed every day/runny nose bloody), PRURITUS (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy), MACULE (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy), HEADACHE (Constant headahe right above her eyebrows) and FATIGUE (Always tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nose bleed started about 3 weeks after the second shot. Lab details reported include blood work, whose results are not provided. Treatment information reported as, itching stops with medication, came back once she stops taking medication. Patient had three appointments at doctor's office on 28 May 2021, 09 June 2021, 12 July at 3:45 Pm Patient had one appointment at ENT on 14 July at 2:00 Pm   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Added patient demographic details, vaccine facility information, new concomitants, events start date and additional captured I narrative
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Really dry mouth; chills; bodyaches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Really dry mouth), CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (low grade fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 09-Mar-2021. Concurrent medical conditions included Thyroid disorder NOS (1990's) and High cholesterol (1990's). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFEXOR XL) for Anxiety, LOVASTATIN for Cholesterol, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for Routine health maintenance, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021 at 8:00 AM, the patient experienced CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (low grade fever). On an unknown date, the patient experienced DRY MOUTH (Really dry mouth). On 10-Jul-2021, CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (low grade fever) had resolved. At the time of the report, DRY MOUTH (Really dry mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.         Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow-up information included updating patient information, medical history, dose detail, and newevents.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID-19 after getting the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got COVID-19 after getting the vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID-19 after getting the vaccine). At the time of the report, COVID-19 (Got COVID-19 after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2021-253201 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Updated reporter information,  causality for COVID-19 event and added a new event infection.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old received first and second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received first and second dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received first and second dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received first and second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information was provided.  Patient had no problem with both doses   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received on 27-JUL-2021 it contained second dose information, patient demographics were added. On 04-Sep-2021: Non significant follow up-patient initials added
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: started to feel unwell; I also experienced lethargy; I experienced arm soreness that increased throughout the next day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started to feel unwell), LETHARGY (I also experienced lethargy) and MYALGIA (I experienced arm soreness that increased throughout the next day) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Allergy to molds (Mold and mildew) and Dust allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRETIC), SODIUM CHLORIDE (SALINASE [SODIUM CHLORIDE]), EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA), ASCORBIC ACID (VIT C), VIT D [VITAMIN D NOS] and ZINC for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (started to feel unwell), LETHARGY (I also experienced lethargy) and MYALGIA (I experienced arm soreness that increased throughout the next day). At the time of the report, MALAISE (started to feel unwell), LETHARGY (I also experienced lethargy) and MYALGIA (I experienced arm soreness that increased throughout the next day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, SARS-CoV-2 test: positive (Positive) positive for COVID-19.         Other Concomitant medication include Truevita and Barley green for an unknown indication..  No treatment medications were provided.   This case was linked to MOD-2021-253075 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up report contains Patient demographics ,concomitant medication, facility information and new event were added .
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling drunk, Muscle spasms, Speech disorder, Thinking abnormal
Clinical narrative: Felt drunk; Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area; Had problems with talking; Wasn't thinking that well; Felt extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING DRUNK (Felt drunk), MUSCLE SPASMS (Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area), SPEECH DISORDER (Had problems with talking), THINKING ABNORMAL (Wasn't thinking that well) and FATIGUE (Felt extreme tiredness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING DRUNK (Felt drunk), MUSCLE SPASMS (Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area), SPEECH DISORDER (Had problems with talking), THINKING ABNORMAL (Wasn't thinking that well) and FATIGUE (Felt extreme tiredness). The patient was treated with BACLOFEN at a dose of 5 milligram three times a day. At the time of the report, FEELING DRUNK (Felt drunk), MUSCLE SPASMS (Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area), SPEECH DISORDER (Had problems with talking), THINKING ABNORMAL (Wasn't thinking that well) and FATIGUE (Felt extreme tiredness) 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.   No concomitant medications were reported by reporter.   This case was linked to MOD-2021-256655 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Added treatment medication Baclofen, Updated events outcome as Resolved. Rechallenge date and results were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Past Vaccine window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past Vaccine window) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past Vaccine window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past Vaccine window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter.  She has not received her second dose, and it has been five months now. Patient's mother wanted to know whether she can get her second dose now, or if she needs to start the series all over again. (There was no expiration date on the vaccination card).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Patient indentifiers, and event information updated
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Erythema, Hypokinesia, Joint stiffness
Clinical narrative: problems with joints in elbows, knee and ankles they are horribly stiff; can barely move, can't move knees and arm; does not feel active as before; completely knocked off after 2nd dos; Right arm red to the touch; Right arm itches; 102.9 fever; Right arm bruised; Right arm has bumps all over; Right arm completely swollen; She can't work with her arm like this; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this) and JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 17-Jul-2021, the patient experienced CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever). On an unknown date, the patient experienced JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before) and VACCINATION COMPLICATION (completely knocked off after 2nd dos). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before), VACCINATION COMPLICATION (completely knocked off after 2nd dos), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Significant follow-up : New event added
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling, Pruritus, Pyrexia, Skin mass
Clinical narrative: problems with joints in elbows, knee and ankles they are horribly stiff; can barely move, can't move knees and arm; does not feel active as before; completely knocked off after 2nd dos; Right arm red to the touch; Right arm itches; 102.9 fever; Right arm bruised; Right arm has bumps all over; Right arm completely swollen; She can't work with her arm like this; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this) and JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 17-Jul-2021, the patient experienced CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever). On an unknown date, the patient experienced JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before) and VACCINATION COMPLICATION (completely knocked off after 2nd dos). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before), VACCINATION COMPLICATION (completely knocked off after 2nd dos), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Significant follow-up : New event added
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: problems with joints in elbows, knee and ankles they are horribly stiff; can barely move, can't move knees and arm; does not feel active as before; completely knocked off after 2nd dos; Right arm red to the touch; Right arm itches; 102.9 fever; Right arm bruised; Right arm has bumps all over; Right arm completely swollen; She can't work with her arm like this; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this) and JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 17-Jul-2021, the patient experienced CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever). On an unknown date, the patient experienced JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before) and VACCINATION COMPLICATION (completely knocked off after 2nd dos). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before), VACCINATION COMPLICATION (completely knocked off after 2nd dos), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Significant follow-up : New event added
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vertigo
Clinical narrative: vertigo/still has vertigo when  lays down; dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/; felt "wobbly", "like after drinking 3 glasses of champagne"; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/still has vertigo when  lays down), DIZZINESS (dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/) and BALANCE DISORDER (felt "wobbly", "like after drinking 3 glasses of champagne") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo/still has vertigo when  lays down), DIZZINESS (dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/) and BALANCE DISORDER (felt "wobbly", "like after drinking 3 glasses of champagne"). At the time of the report, VERTIGO (vertigo/still has vertigo when  lays down), DIZZINESS (dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/) and BALANCE DISORDER (felt "wobbly", "like after drinking 3 glasses of champagne") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: TCR : e-mail address updated.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No Adverse event; Greater than 35 days since the patient's first Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient's first Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No Adverse event) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient's first Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient's first Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No Adverse event) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow-up received on 03-Sept-2021. 2nd Dose details updated, race and ethinicity also updated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Interchange of vaccine products, Myalgia, Off label use
Clinical narrative: Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country; Interchange of vaccine product; Chills/got some shivering; Body aches; Tiredness; Low grade fever/fever; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches) and FATIGUE (Tiredness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA. Concomitant products included ATENOLOL, GABAPENTIN, CELECOXIB, IBUPROFEN and OXYBUTYNIN for an unknown indication.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever/fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever/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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: New events added (lower grade fever, chills, tiredness, body aches). On 24-Aug-2021: Reporter details and new events shivering and fever were added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country; Interchange of vaccine product; Chills/got some shivering; Body aches; Tiredness; Low grade fever/fever; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches) and FATIGUE (Tiredness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA. Concomitant products included ATENOLOL, GABAPENTIN, CELECOXIB, IBUPROFEN and OXYBUTYNIN for an unknown indication.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever/fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever/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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: New events added (lower grade fever, chills, tiredness, body aches). On 24-Aug-2021: Reporter details and new events shivering and fever were added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus
Clinical narrative: Warmness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmness) and PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-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 FEELING HOT (Warmness) and PRURITUS (Itchiness). At the time of the report, FEELING HOT (Warmness) and PRURITUS (Itchiness) had resolved.            Concomitant medications included: Blood pressure medications  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Includes no new information.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cardiac disorder, Heart rate, Inappropriate schedule of product administration, Stress
Clinical narrative: Stress/anxiety; Stress/anxiety; heart issues; get the 2nd dose so late after the first one,  I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Stress/anxiety), ANXIETY (Stress/anxiety), CARDIAC DISORDER (heart issues) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (get the 2nd dose so late after the first one,  I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STRESS (Stress/anxiety), ANXIETY (Stress/anxiety), CARDIAC DISORDER (heart issues) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (get the 2nd dose so late after the first one,  I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later). At the time of the report, STRESS (Stress/anxiety), ANXIETY (Stress/anxiety) and CARDIAC DISORDER (heart issues) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (get the 2nd dose so late after the first one,  I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient went to the cardiologist for tests. No concomitant medications were reported. No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant follow up appended: event addition On 30-Aug-2021: Non-Significant Follow up document received contains no new information. On 30-Aug-2021: Non-Significant Follow up document received contains no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Palpitations
Clinical narrative: a little puny; heart racing like an adrenaline rush, heart racing; out of breath or become winded, Today she has felt more difficulty with breathing; dizzier; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (a little puny), PALPITATIONS (heart racing like an adrenaline rush, heart racing), DYSPNOEA (out of breath or become winded, Today she has felt more difficulty with breathing) and DIZZINESS (dizzier) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 12-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ASTHENIA (a little puny), PALPITATIONS (heart racing like an adrenaline rush, heart racing), DYSPNOEA (out of breath or become winded, Today she has felt more difficulty with breathing) and DIZZINESS (dizzier). At the time of the report, ASTHENIA (a little puny) and DIZZINESS (dizzier) outcome was unknown, PALPITATIONS (heart racing like an adrenaline rush, heart racing) had not resolved and DYSPNOEA (out of breath or become winded, Today she has felt more difficulty with breathing) was resolving.            No treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Reporter information- Occupation updated and Report Sent to Regulatory Authority by Reporter  from the initial case.Significant Follow-up received on 31-AUG-2021 contains: Updated  Patient demographics, Dose details, Concomitant medications and outcome of the event -'out of breath or become winded, Today she has felt more difficulty with breathing'.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feverish; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (feverish). At the time of the report, PYREXIA (feverish) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided. No treatment details were provided   This case was linked to MOD-2021-275750 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received:  Reporter's additional Contact information updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vacine site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vacine site pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vacine site pain). At the time of the report, VACCINATION SITE PAIN (vacine site pain) outcome was unknown.            No concomitant product information was provided by the reporter.  No treatment information was provided by the reporter.  This case was linked to MOD-2021-085605 (Patient Link). Based on current available information and the temporal association between product sue and the start of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-085605 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received and contains no new information.; Sender's Comments: Based on current available information and the temporal association between product sue and the start of the events a causal relationship cannot be excluded.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (slight fever) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001821A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-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 CHILLS (Chills) and PYREXIA (slight fever). At the time of the report, CHILLS (Chills) and PYREXIA (slight fever) outcome was unknown.            Concomitant medications were not reported. Treatment details not provided. The patient had queried about information about the contamination of Moderna COVID-19 vaccine vials, about the third dose and comparisons with a booster of the Pfizer COVID-19 vaccine and why the Moderna COVID-19 vaccine has not been approved yet in the country.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: significant Follow up: updated narrative
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant patient receiving vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient receiving vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient receiving vaccine). On 06-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient receiving vaccine) had resolved.            Treatment medications information was not provided.   This case was linked to MOD-2021-303333 (Parent-Child Link).   See case MOD-2021-303333 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: follow up received: reporter contact details were updated, coding of event pregnant patient receiving vaccine updated to maternal exposure during pregnancy, outcome of the event maternal exposure during pregnancy updated to recovered and stop date was updated.; Sender's Comments: This is a case of maternal exposure during pregnancy with no associated AEs for this 20-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.