chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: arm got so swollen went to ER twice; broke out in rash in both arms and front of chest; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm got so swollen went to ER twice) and RASH (broke out in rash in both arms and front of chest) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma and Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced RASH (broke out in rash in both arms and front of chest). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm got so swollen went to ER twice). The patient was treated with MUPIROCIN at an unspecified dose and frequency. In 2021, RASH (broke out in rash in both arms and front of chest) had resolved. At the time of the report, PERIPHERAL SWELLING (arm got so swollen went to ER twice) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included pill for cholesterol.  Patient never had any problem with the first dose. After 2nd moderna dose patient had broke out in rash in both arms and front of chest and arm got so swollen went to emergency room twice. Given with steroid and it was a small dose for 6 days and went back (to emergency room) and got another dose for 12 days because rash did not get better. Patient noticed rash about 2 weeks after second dose lasted for 3 months. Patient stated she really should not be on steroid cause as she has glaucoma (previously diagnosed). It was stated that they told patient at the eye place she should not be on any steroid but without them her could not get rid of rash, it was horrible.  Treatment information reported as went to a dermatologist gave her all kinds of stuff and mupirocin mixed with lotion cetaphil on arms
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: She felt nauseous/She continued to feel nauseous for months and then it dissipated; She vomited.  She sat with a basin in case she vomited again; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (She felt nauseous/She continued to feel nauseous for months and then it dissipated) and VOMITING (She vomited.  She sat with a basin in case she vomited again) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced NAUSEA (She felt nauseous/She continued to feel nauseous for months and then it dissipated) and VOMITING (She vomited.  She sat with a basin in case she vomited again). At the time of the report, NAUSEA (She felt nauseous/She continued to feel nauseous for months and then it dissipated) and VOMITING (She vomited.  She sat with a basin in case she vomited again) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report extreme reactions to 2nd Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Report extreme reactions to 2nd Moderna 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report extreme reactions to 2nd Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Report extreme reactions to 2nd Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old patient received Moderna booster) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old patient received Moderna booster). On 12-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old patient received Moderna booster) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   8-year-old patient accidentally received the first dose of Moderna COVID-19 vaccine on 12 Nov 2021 (from a 14 dose size vial). 0.25ml of Moderna COVID-19 booster vaccine was drawn up to be given to the father but mistakenly was given to the 8 year old daughter. Pharmacist stated that the 8 year old patient did not have any previous COVID-19 vaccines of any brand, this was her first time to be vaccinated with the COVID-19 vaccine.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of administered incorrect dose (recently given the Moderna booster, and received 50mL instead of 25mL) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 50mL. On an unknown date, patient administered incorrect dose (recently given the Moderna booster, and received 50mL instead of 25mL). At the time of the report, administered incorrect dose (recently given the Moderna booster, and received 50mL instead of 25mL) resolved. No concomitant medication or treatment information reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Dehydration, Renal function test, Somnolence, Thirst decreased
Clinical narrative: She wasn't less thirsty than before; She is dehydrated; Started having bladder infections; Really sleepy; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Started having bladder infections), DEHYDRATION (She is dehydrated), THIRST DECREASED (She wasn't less thirsty than before) and SOMNOLENCE (Really sleepy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Eye pain (Chronic eye pain.) and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, LISINOPRIL for Diabetes, PARACETAMOL (TYLENOL [PARACETAMOL]) for Eye pain, PIOGLITAZONE HYDROCHLORIDE (ACTOS) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced SOMNOLENCE (Really sleepy). In July 2021, the patient experienced CYSTITIS (Started having bladder infections). On 12-Nov-2021, the patient experienced DEHYDRATION (She is dehydrated). On an unknown date, the patient experienced THIRST DECREASED (She wasn't less thirsty than before). The patient was treated with CEFATRIZINE PROPYLENEGLYCOLATE (CEFTIN [CEFATRIZINE PROPYLENEGLYCOLATE]) for Adverse event, at an unspecified dose and frequency. On 14-May-2021, SOMNOLENCE (Really sleepy) had resolved. At the time of the report, CYSTITIS (Started having bladder infections), DEHYDRATION (She is dehydrated) and THIRST DECREASED (She wasn't less thirsty than before) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, Renal function test: abnormal (abnormal) Dehydrated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant product use included steroid shot occasionally for joints. The patient was really sleepy for ten days, but was ok with that and wasn't less thirsty than before, it wasn't progressing.   This case was linked to MOD-2021-385712 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain
Clinical narrative: sore throat; sore muscle; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MYALGIA (sore muscle) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced MYALGIA (sore muscle) and HEADACHE (headache). On 12-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat), MYALGIA (sore muscle) and HEADACHE (headache) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were provided by the reporter.     On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) had not resolved.            The concomitant medication includes blood thinner as reported by the reporter. No treatment information was reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Reflex syncope/fainting episode; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Reflex syncope/fainting episode) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Comirnaty (Patient had received Comirnaty primary series.). Past adverse reactions to the above products included No adverse event with Comirnaty.    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SYNCOPE (Reflex syncope/fainting episode). At the time of the report, SYNCOPE (Reflex syncope/fainting episode) outcome was unknown.            No concomitant product information was provided.  Treatment information was not provided.  Patient received Moderna vaccine booster on Tuesday. On Thursday evening, he experienced a fainting episode, went to emergency room and diagnosed as reflex syncope.  Company Comment: This case concerns a male subject of unknown age, with a medical history of receiving the Comirnaty vaccine primary series, who experienced the unexpected event of Syncope, diagnosed as "reflex syncope" in the emergency room. The event occurred 2 days after the booster dose of mRNA 1273 VACCINE. Rechallenge is not applicable as no additional dosing is expected to be given. The patient's medical history of receiving the Comirnaty vaccine primary series  remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report. Event Syncope was upgraded as serious as per list; however, based on information available and, as per medical judgement, it is assessed as non-serious.; Sender's Comments: This case concerns a male subject of unknown age, with a medical history of receiving the Comirnaty vaccine primary series, who experienced the unexpected event of Syncope, diagnosed as "reflex syncope" in the emergency room. The event occurred 2 days after the booster dose of mRNA 1273 VACCINE. Rechallenge is not applicable as no additional dosing is expected to be given. The patient's medical history of receiving the Comirnaty vaccine primary series  remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report. Event Syncope was upgraded as serious as per IME list; however, based on information available and, as per medical judgement, it is assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: like someone beat me up; 101.3 F; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (like someone beat me up), PYREXIA (101.3 F), CHILLS (chills) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 017B21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Depression, Headache and Blood cholesterol abnormal. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety depression, ATORVASTATIN CALCIUM (LIPITOR) for Blood cholesterol abnormal, VITAMINS NOS for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced FEELING ABNORMAL (like someone beat me up), CHILLS (chills) and MYALGIA (body aches). 12-Nov-2021, the patient experienced PYREXIA (101.3 F). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (like someone beat me up), PYREXIA (101.3 F), CHILLS (chills) and MYALGIA (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, Body temperature: 101.3 (High) 101.3 F.         Concomitant medication also includes unspecified headache medication.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Warmpatient had two circles under the injection site which were itchy, red, and warm; two circles below the injection site; patient had two circles under the injection site which were itchy, red, and warm; patient had two circles under the injection site which were itchy, red, and warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmpatient had two circles under the injection site which were itchy, red, and warm), VACCINATION SITE REACTION (two circles below the injection site), VACCINATION SITE ERYTHEMA (patient had two circles under the injection site which were itchy, red, and warm) and VACCINATION SITE PRURITUS (patient had two circles under the injection site which were itchy, red, and warm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 031A21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Anxiety, ETHINYLESTRADIOL, LEVONORGESTREL (CHATEAL) for Birth control, LEVOTHYROXINE and LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder NOS, OMEPRAZOLE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE WARMTH (Warmpatient had two circles under the injection site which were itchy, red, and warm), VACCINATION SITE REACTION (two circles below the injection site), VACCINATION SITE ERYTHEMA (patient had two circles under the injection site which were itchy, red, and warm) and VACCINATION SITE PRURITUS (patient had two circles under the injection site which were itchy, red, and warm). At the time of the report, VACCINATION SITE WARMTH (Warmpatient had two circles under the injection site which were itchy, red, and warm) outcome was unknown, VACCINATION SITE REACTION (two circles below the injection site) and VACCINATION SITE ERYTHEMA (patient had two circles under the injection site which were itchy, red, and warm) was resolving and VACCINATION SITE PRURITUS (patient had two circles under the injection site which were itchy, red, and warm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   A couple of days after the second patient had two circles under the injection and still had one of the circles but it is a lighter color.  Patient received booster shot on 11Nov2021 in left non-dominant arm. Lot number: 067F21A.  Patient is taking concomitant medication Omeprazole for reflux.  No treatment medication provided.   This case was linked to MOD-2021-386014 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Tremor
Clinical narrative: shaking really bad after full dose booster/Hands are shaking after full dose booster; Full dose booster received because of age/ gave a full dose; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking really bad after full dose booster/Hands are shaking after full dose booster) and ACCIDENTAL OVERDOSE (Full dose booster received because of age/ gave a full dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Full dose booster received because of age/ gave a full dose). On 12-Nov-2021, the patient experienced TREMOR (shaking really bad after full dose booster/Hands are shaking after full dose booster). On 11-Nov-2021, ACCIDENTAL OVERDOSE (Full dose booster received because of age/ gave a full dose) had resolved. At the time of the report, TREMOR (shaking really bad after full dose booster/Hands are shaking after full dose booster) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a booster shot from an expired lot; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster shot from an expired lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster shot from an expired lot). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received a booster shot from an expired lot) had resolved. Not Provided          No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain under both arms since yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain under both arms since yesterday) 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 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain under both arms since yesterday). At the time of the report, PAIN IN EXTREMITY (Pain under both arms since yesterday) had not resolved.            No concomitant medications were reported.  Non drug treatment include Ice.   This case was linked to MOD-2021-033149 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: feeling severe arm soreness; headache; very fatigued; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (feeling severe arm soreness), HEADACHE (headache) and FATIGUE (very fatigued) 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 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE PAIN (feeling severe arm soreness), HEADACHE (headache) and FATIGUE (very fatigued). At the time of the report, VACCINATION SITE PAIN (feeling severe arm soreness), HEADACHE (headache) and FATIGUE (very fatigued) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE PAIN (feeling severe arm soreness), HEADACHE (headache) and FATIGUE (very fatigued) to be possibly related.    No concomitant medication details was reported. No treatment medication details was reported.  This spontaneous case concerns a patient, of unknown age and unknown gender, with no relevant medical history, who experienced the unexpected, non-serious event of pain in extremity with other associated expected, non-serious events. The events occurred 1 day after administration of the third dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and unknown gender, with no relevant medical history, who experienced the unexpected, non-serious event of pain in extremity with other associated expected, non-serious events. The events occurred 1 day after administration of the third dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea, Nervousness, Pyrexia
Clinical narrative: a shaky feeling/still very shaky today; a loss of appetite; Low grade fever; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (a shaky feeling/still very shaky today), DECREASED APPETITE (a loss of appetite), PYREXIA (Low grade fever) and NAUSEA (nauseated) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 014M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibrillation (She also mentions that she has had a fib for 10 years and her doctor told her in September that she is now in a fib all the time.).   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced NERVOUSNESS (a shaky feeling/still very shaky today), DECREASED APPETITE (a loss of appetite), PYREXIA (Low grade fever) and NAUSEA (nauseated). At the time of the report, NERVOUSNESS (a shaky feeling/still very shaky today) had not resolved, DECREASED APPETITE (a loss of appetite) and NAUSEA (nauseated) outcome was unknown and PYREXIA (Low grade fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Patient stated that fever is coming down & that she is still very shaky today.  No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-385899.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red at injection site; Swelling at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        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 reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue geographic
Clinical narrative: Geographic tongue; This spontaneous case was reported by a nurse and describes the occurrence of TONGUE GEOGRAPHIC (Geographic tongue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 032M20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TONGUE GEOGRAPHIC (Geographic tongue). At the time of the report, TONGUE GEOGRAPHIC (Geographic tongue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient reported that they had geographic tongue 7 days after receiving the booster dose of the Moderna Covid-19 vaccine and mentioned that it was resolving at the time of the call.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Neck pain
Clinical narrative: I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing); neck pain; it is still a little tender; arm pain, soreness in arm; shoulder pain; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing)), NECK PAIN (neck pain), TENDERNESS (it is still a little tender), PAIN IN EXTREMITY (arm pain, soreness in arm) and ARTHRALGIA (shoulder pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 038A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Patient history is not reported. Concomitant products included FOLIC ACID for Blood pressure high, GABAPENTIN, TIZANIDINE and IBUPROFEN for an unknown indication.On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing)), NECK PAIN (neck pain), TENDERNESS (it is still a little tender), PAIN IN EXTREMITY (arm pain, soreness in arm), ARTHRALGIA (shoulder pain), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing)), NECK PAIN (neck pain), TENDERNESS (it is still a little tender), PAIN IN EXTREMITY (arm pain, soreness in arm), ARTHRALGIA (shoulder pain), CHILLS (chills) and HEADACHE (headache) outcome was unknown.    No concomitant medication was reported.No treatment medication was reported.This case was linked to MOD-2021-385903 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 12-Nov-2021: Follow-up received contains: events added and reporter information added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing); neck pain; it is still a little tender; arm pain, soreness in arm; shoulder pain; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing)), NECK PAIN (neck pain), TENDERNESS (it is still a little tender), PAIN IN EXTREMITY (arm pain, soreness in arm) and ARTHRALGIA (shoulder pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 038A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Patient history is not reported. Concomitant products included FOLIC ACID for Blood pressure high, GABAPENTIN, TIZANIDINE and IBUPROFEN for an unknown indication.On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing)), NECK PAIN (neck pain), TENDERNESS (it is still a little tender), PAIN IN EXTREMITY (arm pain, soreness in arm), ARTHRALGIA (shoulder pain), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing)), NECK PAIN (neck pain), TENDERNESS (it is still a little tender), PAIN IN EXTREMITY (arm pain, soreness in arm), ARTHRALGIA (shoulder pain), CHILLS (chills) and HEADACHE (headache) outcome was unknown.    No concomitant medication was reported.No treatment medication was reported.This case was linked to MOD-2021-385903 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 12-Nov-2021: Follow-up received contains: events added and reporter information added.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Rash, Swelling, Vaccination site induration
Clinical narrative: painful; hard spot belowthe elbow; warm rash from elbow to wrist; warm rash from elbow to wrist; swelling increased a bit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm rash from elbow to wrist), SWELLING (swelling increased a bit), PAIN (painful), VACCINATION SITE INDURATION (hard spot belowthe elbow) and RASH (warm rash from elbow to wrist) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol and Hypertension. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), CLONIDINE and AMLODIPINE for an unknown indication. On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced FEELING HOT (warm rash from elbow to wrist), SWELLING (swelling increased a bit) and RASH (warm rash from elbow to wrist). On an unknown date, the patient experienced PAIN (painful) and VACCINATION SITE INDURATION (hard spot belowthe elbow). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for Adverse event, at a dose of 1 dosage form twice a day. At the time of the report, FEELING HOT (warm rash from elbow to wrist), PAIN (painful) and RASH (warm rash from elbow to wrist) outcome was unknown and SWELLING (swelling increased a bit) and VACCINATION SITE INDURATION (hard spot belowthe elbow) had not resolved. This case was linked to MOD-2021-385971 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 002B21A and 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. It was stated that Concomitant medications were lots however denied to provide details of medications and No treatment information was provided by reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: swollen and has a diameter of 2-3 inches; itchy; arm is red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen and has a diameter of 2-3 inches), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (arm is red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PERIPHERAL SWELLING (swollen and has a diameter of 2-3 inches), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (arm is red). At the time of the report, PERIPHERAL SWELLING (swollen and has a diameter of 2-3 inches), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (arm is red) outcome was unknown.            No concomitant medication were given. Patient stated that no treatment was done
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever after her 1st dose that only lasted 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after her 1st dose that only lasted 24 hours) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Fibrillation (For 10 years and her doctor told her in September that she is now in a fib all the time). On 31-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 (Fever after her 1st dose that only lasted 24 hours). At the time of the report, PYREXIA (Fever after her 1st dose that only lasted 24 hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No Concomitant medication was reported. No treatment medications were reported. This case was linked to MOD-2021-385873 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: Catch the virus and have a mild case; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Catch the virus and have a mild case) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VIRAL INFECTION (Catch the virus and have a mild case). At the time of the report, VIRAL INFECTION (Catch the virus and have a mild case) outcome was unknown.            No concomitant medication reported.  No treatment medication reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Vaccination site pain
Clinical narrative: kind of felt loopy; lightheaded; arm was generally sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was generally sore), FEELING ABNORMAL (kind of felt loopy) and DIZZINESS (lightheaded) in a 38-year-old female patient 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 VACCINATION SITE PAIN (arm was generally sore), FEELING ABNORMAL (kind of felt loopy) and DIZZINESS (lightheaded). At the time of the report, VACCINATION SITE PAIN (arm was generally sore), FEELING ABNORMAL (kind of felt loopy) and DIZZINESS (lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient states she got her flu shot and felt kind of tired, have bump which is hot to touch, looks like insect bite and she states this is unusual after flu shot.   This case was linked to MOD-2021-385924 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Had a little bit of soreness after the booster shot, but "nothing like the kick" the second shot had; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Had a little bit of soreness after the booster shot, but "nothing like the kick" the second shot had) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included Anxiety (He said he had a lot of anxiety.).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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Had a little bit of soreness after the booster shot, but "nothing like the kick" the second shot had). At the time of the report, MYALGIA (Had a little bit of soreness after the booster shot, but "nothing like the kick" the second shot had) outcome was unknown.    Concomitant medication was not provided.Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site induration, Vaccination site mass, Vaccination site warmth
Clinical narrative: Dose arm had big lump of size of small grapefruit or big orange/Had big bump; Super sleepy the day after; Had big bump hot to touch / super-hot; Was hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Dose arm had big lump of size of small grapefruit or big orange/Had big bump), SOMNOLENCE (Super sleepy the day after), VACCINATION SITE WARMTH (Had big bump hot to touch / super-hot) and VACCINATION SITE INDURATION (Was hard) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Patient had a bump and which was hot to touch which looked like insect bite.). Past adverse reactions to the above products included Tiredness with Flu shot.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Dose arm had big lump of size of small grapefruit or big orange/Had big bump), SOMNOLENCE (Super sleepy the day after), VACCINATION SITE WARMTH (Had big bump hot to touch / super-hot) and VACCINATION SITE INDURATION (Was hard). At the time of the report, VACCINATION SITE MASS (Dose arm had big lump of size of small grapefruit or big orange/Had big bump) and SOMNOLENCE (Super sleepy the day after) outcome was unknown and VACCINATION SITE WARMTH (Had big bump hot to touch / super-hot) and VACCINATION SITE INDURATION (Was hard) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant and treatment medications were reported. The patient had big bump hot to touch was hard and lasted for couple of weeks. The day after patient also felt super sleepy.  No treatment information was provided.   This case was linked to MOD-2021-385913 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that a vaccination provider gave an expired booster dose to an immunocompromised patient. The dose came from a vial that had been punctured 48 earlier, on 08Nov2021.  No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-385906 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: had heart problems; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (had heart problems) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (had heart problems). At the time of the report, CARDIAC DISORDER (had heart problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.