chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Tachycardia
Clinical narrative: rapid heart beat,rapid heart rate; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat,rapid heart rate) and TACHYCARDIA (tachycardia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart beat,rapid heart rate) and TACHYCARDIA (tachycardia). At the time of the report, HEART RATE INCREASED (rapid heart beat,rapid heart rate) and TACHYCARDIA (tachycardia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid (High) rapid.         Reporter family member is experiencing heart beat, like tachycardia after a month of getting the shot. Reporter does not want to provide further information nor consent for Safety to follow up. No concomitant medications were provided by reporter. No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: caller reports multiple patients received a full dose for the booster.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (caller reports multiple patients received a full dose for the booster.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (caller reports multiple patients received a full dose for the booster.). At the time of the report, ACCIDENTAL OVERDOSE (caller reports multiple patients received a full dose for the booster.) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: received booster 0.25mL instead of third dose 0.5mL; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster 0.25mL instead of third dose 0.5mL) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In August 2021, the patient experienced ACCIDENTAL UNDERDOSE (received booster 0.25mL instead of third dose 0.5mL). In August 2021, ACCIDENTAL UNDERDOSE (received booster 0.25mL instead of third dose 0.5mL) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient was immunocompromised.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Illness, Malaise, Pain
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VERTIGO (Head is still spinning), MALAISE (Not feeling well not at all), PAIN (Ache all over), ILLNESS (Sick) and FEELING ABNORMAL (Feel like crap, Feeling terrible) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Head is still spinning), MALAISE (Not feeling well not at all), PAIN (Ache all over), ILLNESS (Sick), FEELING ABNORMAL (Feel like crap, Feeling terrible), PYREXIA (Fever) and CHILLS (Chills,Shivering from the fever). At the time of the report, VERTIGO (Head is still spinning) had not resolved and MALAISE (Not feeling well not at all), PAIN (Ache all over), ILLNESS (Sick), FEELING ABNORMAL (Feel like crap,Feel like shit,Feeling terrible), PYREXIA (Fever) and CHILLS (Chills,Shivering from the fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment details were reported. It was reported that after second dose patient was not feeling well.It was reported that the patient arm was sore for a month from other shots. This case was linked to MOD-2021-422962 (Patient Link). Reporter did not allow further contact.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VERTIGO (Head is still spinning), MALAISE (Not feeling well not at all), PAIN (Ache all over), ILLNESS (Sick) and FEELING ABNORMAL (Feel like crap, Feeling terrible) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Head is still spinning), MALAISE (Not feeling well not at all), PAIN (Ache all over), ILLNESS (Sick), FEELING ABNORMAL (Feel like crap, Feeling terrible), PYREXIA (Fever) and CHILLS (Chills,Shivering from the fever). At the time of the report, VERTIGO (Head is still spinning) had not resolved and MALAISE (Not feeling well not at all), PAIN (Ache all over), ILLNESS (Sick), FEELING ABNORMAL (Feel like crap,Feel like shit,Feeling terrible), PYREXIA (Fever) and CHILLS (Chills,Shivering from the fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment details were reported. It was reported that after second dose patient was not feeling well.It was reported that the patient arm was sore for a month from other shots. This case was linked to MOD-2021-422962 (Patient Link). Reporter did not allow further contact.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Caller received her booster shot today and the nurse told her she gave her a full dose instead of a half dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Caller received her booster shot today and the nurse told her she gave her a full dose instead of a half dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. (O)02BK21A, 031M20(O)A and 013L20(O)A) 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 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 06-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Caller received her booster shot today and the nurse told her she gave her a full dose instead of a half dose). On 06-Jan-2022, ACCIDENTAL OVERDOSE (Caller received her booster shot today and the nurse told her she gave her a full dose instead of a half dose) 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
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  Reporter states that, vial was initially stored in the refrigerator on the date 4Jan2022 and was first punctured on 5Jan2022 at 8:30am.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Symptoms experienced with vaccination were mials; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms experienced with vaccination were mials) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 VACCINATION COMPLICATION (Symptoms experienced with vaccination were mials). At the time of the report, VACCINATION COMPLICATION (Symptoms experienced with vaccination were mials) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported  It was reported that symptoms experienced with vaccination were mials.   This case was linked to MOD-2022-442120 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fungal infection, Herpes zoster, Immune system disorder, Neuralgia
Clinical narrative: weakened immune system; Shingles; Nerve pain; yeast infection; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain), FUNGAL INFECTION (yeast infection), IMMUNE SYSTEM DISORDER (weakened immune system) and HERPES ZOSTER (Shingles) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Accident automobile (on muscle relaxer). Concurrent medical conditions included Back muscle spasms (Car injury caused back spasm (prior to vaccine)) and Back pain (Car injury caused Back pain (prior to vaccine)). Concomitant products included VITAMINS NOS for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FUNGAL INFECTION (yeast infection). In September 2021, the patient experienced NEURALGIA (Nerve pain) and HERPES ZOSTER (Shingles). On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (weakened immune system). The patient was treated with GABAPENTIN for Nerve pain, at a dose of rarely takes. At the time of the report, NEURALGIA (Nerve pain) had not resolved, FUNGAL INFECTION (yeast infection) and IMMUNE SYSTEM DISORDER (weakened immune system) outcome was unknown and HERPES ZOSTER (Shingles) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Hashimoto's bloodwork-normal. On an unknown date, Thyroid function test: normal (normal) normal.         Concomitant medications include: Muscle relaxer for back spasm and back pain, and Supplements Treatment medications include: OTC medication & One dose antibiotic for Yeast Infection, Antiviral Pill for Shingles.  The patient experienced yeast infection about  5-6 occurring almost monthly.On 6jan2022, the shingles have gotten better and almost gone but the nerve pain remains. Patient's doctor thinks the vaccine weakened the immune system. Patient planned for rheumatologist in feb2022.   This case was linked to MOD-2022-441583 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test
Clinical narrative: weakened immune system; Shingles; Nerve pain; yeast infection; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain), FUNGAL INFECTION (yeast infection), IMMUNE SYSTEM DISORDER (weakened immune system) and HERPES ZOSTER (Shingles) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Accident automobile (on muscle relaxer). Concurrent medical conditions included Back muscle spasms (Car injury caused back spasm (prior to vaccine)) and Back pain (Car injury caused Back pain (prior to vaccine)). Concomitant products included VITAMINS NOS for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FUNGAL INFECTION (yeast infection). In September 2021, the patient experienced NEURALGIA (Nerve pain) and HERPES ZOSTER (Shingles). On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (weakened immune system). The patient was treated with GABAPENTIN for Nerve pain, at a dose of rarely takes. At the time of the report, NEURALGIA (Nerve pain) had not resolved, FUNGAL INFECTION (yeast infection) and IMMUNE SYSTEM DISORDER (weakened immune system) outcome was unknown and HERPES ZOSTER (Shingles) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Hashimoto's bloodwork-normal. On an unknown date, Thyroid function test: normal (normal) normal.         Concomitant medications include: Muscle relaxer for back spasm and back pain, and Supplements Treatment medications include: OTC medication & One dose antibiotic for Yeast Infection, Antiviral Pill for Shingles.  The patient experienced yeast infection about  5-6 occurring almost monthly.On 6jan2022, the shingles have gotten better and almost gone but the nerve pain remains. Patient's doctor thinks the vaccine weakened the immune system. Patient planned for rheumatologist in feb2022.   This case was linked to MOD-2022-441583 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm is swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen) and ERYTHEMA (red) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 33H21A, 044A21A and 013?20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), AMITRIPTYLINE, ATORVASTATIN, VITAMIN D NOS, LISINOPRIL, METOPROLOL and UBIDECARENONE (COQ-10) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, 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 PERIPHERAL SWELLING (arm is swollen) and ERYTHEMA (red). At the time of the report, PERIPHERAL SWELLING (arm is swollen) and ERYTHEMA (red) outcome was unknown.            No treatment medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site (left arm)) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J21-2A, 050C21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain at the injection site (left arm)). At the time of the report, VACCINATION SITE PAIN (pain at the injection site (left arm)) had not resolved.            No concomitant drug details were reported. No treatment details were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Sensitive skin
Clinical narrative: skin feels sensitive on his forearm on both sides, it does not appear to be a rash but is sensitive to the touch.; feeling of nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (skin feels sensitive on his forearm on both sides, it does not appear to be a rash but is sensitive to the touch.) and NAUSEA (feeling of nauseous) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 017A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SENSITIVE SKIN (skin feels sensitive on his forearm on both sides, it does not appear to be a rash but is sensitive to the touch.) and NAUSEA (feeling of nauseous). At the time of the report, SENSITIVE SKIN (skin feels sensitive on his forearm on both sides, it does not appear to be a rash but is sensitive to the touch.) and NAUSEA (feeling of nauseous) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The patient stated that feeling of nauseous was not a major concern as the sensitive skin. Patient stated, it was unfolding and changes every day and stated that he meant it was folding in front of eyes every day.  No treatment medication information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity
Clinical narrative: Muscle aches in patients back; Muscle aches in patients legs; tired for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Muscle aches in patients back), PAIN IN EXTREMITY (Muscle aches in patients legs) and FATIGUE (tired for 24 hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced BACK PAIN (Muscle aches in patients back), PAIN IN EXTREMITY (Muscle aches in patients legs) and FATIGUE (tired for 24 hours). In January 2021, FATIGUE (tired for 24 hours) had resolved. At the time of the report, BACK PAIN (Muscle aches in patients back) and PAIN IN EXTREMITY (Muscle aches in patients legs) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2022-441948, MOD-2022-441953 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Non Significant Follow Up
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: muscle twitching and fasciculations; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE TWITCHING (muscle twitching and fasciculations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (muscle twitching and fasciculations). At the time of the report, MUSCLE TWITCHING (muscle twitching and fasciculations) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold
Clinical narrative: feeling cold; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold) and FATIGUE (tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced FEELING COLD (feeling cold) and FATIGUE (tired). At the time of the report, FEELING COLD (feeling cold) and FATIGUE (tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided It was reported that patient was a participant for the Novovaxclinical trial and had the 2nd dose of its vaccine on 12May2021 .He had cold and tired afterward.He waited for the booster dose of the company and it has not become available yet.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Followup information received include suspect product Moderna details and newevents were added.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: right arm  hurting continuously/can't lay down on his arm; right arm hurts where the shot went in/hurts down in his arm/right arm is hurting continuously; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (right arm  hurting continuously/can't lay down on his arm) and VACCINATION SITE PAIN (right arm hurts where the shot went in/hurts down in his arm/right arm is hurting continuously) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced VACCINATION SITE DISCOMFORT (right arm  hurting continuously/can't lay down on his arm) and VACCINATION SITE PAIN (right arm hurts where the shot went in/hurts down in his arm/right arm is hurting continuously). At the time of the report, VACCINATION SITE DISCOMFORT (right arm  hurting continuously/can't lay down on his arm) and VACCINATION SITE PAIN (right arm hurts where the shot went in/hurts down in his arm/right arm is hurting continuously) had not resolved.            Patient had no known drug or food allergies. No Treatment information was reported. No medical history was provided by the reporter. Patient had a flu shot on the same day of booster in the left arm, whereas booster shot was into the right arm. Reporter stated that his right arm was not hurting until 3 days after receiving the booster dose. The patient stated that his right arm was hurting where the Moderna shot went in his arm. He stated it hurts down in his arm and he was not able to lay down on his arm due to the arm pain. The patient mentioned his right arm was hurting continuously. Patient had done some work overhead reaching his right arm up in the air and he wonders if this was also a cause of his hurting arm.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. No treatment medication were reported.  It was reported that the Patient had no adverse reaction other than a sore arm for Dose 1.   This case was linked to MOD-2022-439259, MOD-2022-439515 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna booster, after 30 day Use By Date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day Use By Date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day Use By Date). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day Use By Date) had resolved.            No concomitant medications were reported.  No treatment information was provided. It was reported that the pharmacy, they said it may be a typo or someone put the manufacturing date instead.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: aches; chills; High fever (103 plus) for two consecutive days; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (aches), CHILLS (chills) and PYREXIA (High fever (103 plus) for two consecutive days) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), CHILLS (chills) and PYREXIA (High fever (103 plus) for two consecutive days). At the time of the report, PAIN (aches) and CHILLS (chills) outcome was unknown and PYREXIA (High fever (103 plus) for two consecutive days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) High fever (103 plus).     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2022-442218 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-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 PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient relaxed all day and took it easy and drunk plenty of water. No relevant concomitant product were reported No treatment medication was provided   This case was linked to MOD-2022-442240, MOD-2022-442243 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No concomitant and medication information provided. No treatment information provided
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient is given an expired Moderna Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient is given an expired Moderna Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient is given an expired Moderna Vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (patient is given an expired Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Number of doses/vials: 19 doses: 1 dose was a 2nd primary series dose, and 18 doses were booster doses. Date the vial was initially stored in the refrigerator: 14-Dec-2021. As per HCP, the vial did not undergo any temperature excursions.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Booster dose instead of 3rd dose administered to an immunocompromised  Patient argued that is; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Booster dose instead of 3rd dose administered to an immunocompromised  Patient argued that is) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced OFF LABEL USE (Booster dose instead of 3rd dose administered to an immunocompromised  Patient argued that is). In December 2021, OFF LABEL USE (Booster dose instead of 3rd dose administered to an immunocompromised  Patient argued that is) had resolved.            No Concomitant medication information were reported. No Treatment medications were provided   This case was linked to MOD-2022-441639 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeds) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy (Helibut) and Hay fever.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EPISTAXIS (Nose bleeds). At the time of the report, EPISTAXIS (Nose bleeds) had not resolved. Not Provided          No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-333301 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: aches; chills; High fever (103+) for two consecutive days; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (aches), CHILLS (chills) and PYREXIA (High fever (103+) for two consecutive days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), CHILLS (chills) and PYREXIA (High fever (103+) for two consecutive days). At the time of the report, PAIN (aches) and CHILLS (chills) outcome was unknown and PYREXIA (High fever (103+) for two consecutive days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103+ (High) High fever (103+).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-441955 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: fatigue; being tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), FATIGUE (being tired) and MYALGIA (sore arm) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 (fatigue), FATIGUE (being tired) and MYALGIA (sore arm). At the time of the report, FATIGUE (fatigue), FATIGUE (being tired) and MYALGIA (sore arm) outcome was unknown.            No concomitant medications were reported. The patient stated that they relaxed all day and took it easy and drunk plenty of water.   This case was linked to MOD-2022-441979, MOD-2022-442243, MOD-2022-442243 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Their body broke up in hives and this has being everyday for 5 days already, that they broke up in crazy hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Their body broke up in hives and this has being everyday for 5 days already, that they broke up in crazy hives) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 038A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (Their body broke up in hives and this has being everyday for 5 days already, that they broke up in crazy hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of At night time and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at a dose of At day time,the non drowsy kind. At the time of the report, URTICARIA (Their body broke up in hives and this has being everyday for 5 days already, that they broke up in crazy hives) had not resolved.            Patient stated they do not have any allergies. Patient stated they do not take any medication regularly.   Concomitant medications was not reported.   This case was linked to MOD-2022-442240, MOD-2022-441979 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Parosmia, Pyrexia
Clinical narrative: foggy head; Chills; Metal smell.; Feeling bad today; Had 031F; This spontaneous case was reported by a pharmacist and describes the occurrence of PAROSMIA (Metal smell.), FEELING ABNORMAL (Feeling bad today), FEELING ABNORMAL (foggy head), PYREXIA (Had 031F) and CHILLS (Chills) 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 04-Jan-2022, the patient experienced PYREXIA (Had 031F). On 05-Jan-2022, the patient experienced PAROSMIA (Metal smell.) and FEELING ABNORMAL (Feeling bad today). On an unknown date, the patient experienced FEELING ABNORMAL (foggy head) and CHILLS (Chills). At the time of the report, PAROSMIA (Metal smell.), FEELING ABNORMAL (Feeling bad today), FEELING ABNORMAL (foggy head), PYREXIA (Had 031F) and CHILLS (Chills) 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.   It was reported the patient had 031F yesterday (04-Jan-2022).The patient was feeling bad today (05-Jan-2022) metal smell. The patient had chills and foggy head. No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Urticaria
Clinical narrative: She has developed Tinnitus; She has developed debilitating hives; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (She has developed Tinnitus) and URTICARIA (She has developed debilitating hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (She has developed Tinnitus) and URTICARIA (She has developed debilitating hives). On 05-Jan-2022, TINNITUS (She has developed Tinnitus) and URTICARIA (She has developed debilitating hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. Treatment information reported as Unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered greater than 35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered greater than 35 days after the first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered greater than 35 days after the first dose). In December 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered greater than 35 days after the first dose) had resolved.            No concomitant medications were reported.  Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccination was expired beyond the 12 hour BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccination was expired beyond the 12 hour BUD) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2022 at 1:32 PM, 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 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccination was expired beyond the 12 hour BUD). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (vaccination was expired beyond the 12 hour BUD) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. The vial was initially stored in the refrigerator on 22-Dec-2021. The vial was first punctured on 04-Jan-2022 at 17:30 PM EST. The vial Refrigerated post puncture. Less than one hour  the vial was exposed to room temperature.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: was at room temperature for 48 hours was administered; administration from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration from expired vial) and PRODUCT STORAGE ERROR (was at room temperature for 48 hours was administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration from expired vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (was at room temperature for 48 hours was administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administration from expired vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (was at room temperature for 48 hours was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose). On 19-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose) had resolved.            Concomitant medication include  regular medications and did not provide names of the medications. No treatment information was provided   This case was linked to MOD-2022-442530 (Patient Link).