chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anovulatory cycle, Infertility female, Menstruation irregular
Clinical narrative: Irregular period; Unable to get pregnant; causing me not to ovulate; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Irregular period), INFERTILITY FEMALE (Unable to get pregnant) and ANOVULATORY CYCLE (causing me not to ovulate) 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.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MENSTRUATION IRREGULAR (Irregular period), INFERTILITY FEMALE (Unable to get pregnant) and ANOVULATORY CYCLE (causing me not to ovulate). At the time of the report, MENSTRUATION IRREGULAR (Irregular period) had not resolved and INFERTILITY FEMALE (Unable to get pregnant) and ANOVULATORY CYCLE (causing me not to ovulate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: seem to have some hives; small itc; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (seem to have some hives) and PRURITUS (small itc) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 URTICARIA (seem to have some hives) and PRURITUS (small itc). At the time of the report, URTICARIA (seem to have some hives) and PRURITUS (small itc) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.                   No treatment medication was reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given expired (shortdated) vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (shortdated) vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (shortdated) vaccine). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (shortdated) vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) 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 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) was resolving.            The consumer stated that he received second dose on 24 Aug 2021 and experienced diarrhea in the night. He compared it to getting a colonoscopy.   The consumer stated that his symptoms continued until Saturday 28Aug2021 and on 30Aug2021, it was definitely subsided somewhat.  No concomitant product use was provided by the reporter.   No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Pyrexia, Vomiting
Clinical narrative: Weak for 3 days; Fever; Throwing up; Got really sick for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick for 12 hours), ASTHENIA (Weak for 3 days), PYREXIA (Fever) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got really sick for 12 hours), ASTHENIA (Weak for 3 days), PYREXIA (Fever) and VOMITING (Throwing up). At the time of the report, ILLNESS (Got really sick for 12 hours), ASTHENIA (Weak for 3 days), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: little feverish,little fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little feverish,little fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Emphysema, Anxiety, COPD, Chest pain (Might be due to stress) and Hypoxemia.    On 29-Aug-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 (little feverish,little fever). At the time of the report, PYREXIA (little feverish,little fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were provided. No treatment information was  reported. Patient had low oxygen level.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received event  outcome updated from unknown to recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Vaccination site pain
Clinical narrative: while I was standing, I felt kind of dizzy,I couldn't tell what was near or far from me ,I felt woozy; very weak; had a headache; I was very tired; I had arm pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (while I was standing, I felt kind of dizzy,I couldn't tell what was near or far from me ,I felt woozy), ASTHENIA (very weak), HEADACHE (had a headache), FATIGUE (I was very tired) and VACCINATION SITE PAIN (I had arm pain at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (while I was standing, I felt kind of dizzy,I couldn't tell what was near or far from me ,I felt woozy), ASTHENIA (very weak), HEADACHE (had a headache), FATIGUE (I was very tired) and VACCINATION SITE PAIN (I had arm pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (while I was standing, I felt kind of dizzy,I couldn't tell what was near or far from me ,I felt woozy) and VACCINATION SITE PAIN (I had arm pain at the injection site) outcome was unknown and ASTHENIA (very weak), HEADACHE (had a headache) and FATIGUE (I was very tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Patient did not see a doctor for any of the side effects. On 15-Apr-2021, the patient felt tired, weak and had a headache.   This case was linked to MOD-2021-301237 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the back of my neck), ASTHENIA (It took more energy to do things/Weakness), FEELING ABNORMAL (Just didn't feel like myself), FATIGUE (Very tired) and VACCINATION SITE PAIN (Sore at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced NECK PAIN (Pain in the back of my neck), ASTHENIA (It took more energy to do things/Weakness), FEELING ABNORMAL (Just didn't feel like myself), FATIGUE (Very tired), VACCINATION SITE PAIN (Sore at the injection site), MYALGIA (Body aches), HEADACHE (Headache/pain in the back of my head) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Neck pain, Asthenia, Headache, Joint pain, Myalgia, Fatigue and Vaccination site pain, at a dose of 1 dosage form. At the time of the report, NECK PAIN (Pain in the back of my neck), ASTHENIA (It took more energy to do things/Weakness), FEELING ABNORMAL (Just didn't feel like myself), FATIGUE (Very tired), VACCINATION SITE PAIN (Sore at the injection site), MYALGIA (Body aches), HEADACHE (Headache/pain in the back of my head) and ARTHRALGIA (Joint pain) outcome was unknown. No concomitant medication details were provided. On 13-May-2021 patient  felt very tired, weak, had a headache, and joint pain. On 14May2021 patient felt tired. It took more energy to do things. Patient didn't see a Doctor  for any of the side effects. This case was linked to MOD-2021-301173.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the back of my neck), ASTHENIA (It took more energy to do things/Weakness), FEELING ABNORMAL (Just didn't feel like myself), FATIGUE (Very tired) and VACCINATION SITE PAIN (Sore at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced NECK PAIN (Pain in the back of my neck), ASTHENIA (It took more energy to do things/Weakness), FEELING ABNORMAL (Just didn't feel like myself), FATIGUE (Very tired), VACCINATION SITE PAIN (Sore at the injection site), MYALGIA (Body aches), HEADACHE (Headache/pain in the back of my head) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Neck pain, Asthenia, Headache, Joint pain, Myalgia, Fatigue and Vaccination site pain, at a dose of 1 dosage form. At the time of the report, NECK PAIN (Pain in the back of my neck), ASTHENIA (It took more energy to do things/Weakness), FEELING ABNORMAL (Just didn't feel like myself), FATIGUE (Very tired), VACCINATION SITE PAIN (Sore at the injection site), MYALGIA (Body aches), HEADACHE (Headache/pain in the back of my head) and ARTHRALGIA (Joint pain) outcome was unknown. No concomitant medication details were provided. On 13-May-2021 patient  felt very tired, weak, had a headache, and joint pain. On 14May2021 patient felt tired. It took more energy to do things. Patient didn't see a Doctor  for any of the side effects. This case was linked to MOD-2021-301173.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Photopsia, Sensation of foreign body
Clinical narrative: vertical lines at different angles that look like neon colors happens periodically; when I touch hair it is sensitive; weird psychological sensations; cold chills and I am sitting in front of heater but it is hot outside; cold chills and I am sitting in front of heater but it is hot outside; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (vertical lines at different angles that look like neon colors happens periodically), SENSATION OF FOREIGN BODY (when I touch hair it is sensitive), FEELING ABNORMAL (weird psychological sensations), the first episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside) and the second episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PHOTOPSIA (vertical lines at different angles that look like neon colors happens periodically), SENSATION OF FOREIGN BODY (when I touch hair it is sensitive), FEELING ABNORMAL (weird psychological sensations), the first episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside) and the second episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside). At the time of the report, PHOTOPSIA (vertical lines at different angles that look like neon colors happens periodically), SENSATION OF FOREIGN BODY (when I touch hair it is sensitive), FEELING ABNORMAL (weird psychological sensations) and the last episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside) had not resolved.            concomitant and treatment drugs were not provided
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose from a vial with more than 12 hours of punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    In 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 EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment information was mentioned.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.) 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 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.). At the time of the report, VACCINATION SITE PAIN (Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  Patient would call back if he had any symptoms after getting the 2nd shot.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow Up Received on 01sep21 includes Significant Information and Reporter Declined FU
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity, Product dose omission issue, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Napped for 3 hours), TACHYCARDIA (Heart rate was Tachycardia at 100 beat per minutes), DIARRHOEA (Explosive diarrhea compared to colonoscopy prep/Loose stool every 3 hours), PAIN IN EXTREMITY (he had pain in his arm of injection) and FATIGUE (he was very tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cold (cold(upper respiratory tract infection) lasted 10 days) from 01-Jan-2021 to January 2021. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced SOMNOLENCE (Napped for 3 hours) and FATIGUE (he was very tired). On 09-May-2021, the patient experienced TACHYCARDIA (Heart rate was Tachycardia at 100 beat per minutes), DIARRHEA (Explosive diarrhea compared to colonoscopy prep/Loose stool every 3 hours) and PYREXIA (Fever at 101/Fever at 100). In May 2021, the patient experienced PAIN IN EXTREMITY (he had pain in his arm of injection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Elected not to get his 2nd dose because of his side effects for the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Loose stools, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Napped for 3 hours), TACHYCARDIA (Heart rate was Tachycardia at 100 beat per minutes), DIARRHOEA (Explosive diarrhea compared to colonoscopy prep/Loose stool every 3 hours), PAIN IN EXTREMITY (he had pain in his arm of injection), FATIGUE (he was very tired), PYREXIA (Fever at 101/Fever at 100) and PRODUCT DOSE OMISSION ISSUE (Elected not to get his 2nd dose because of his side effects for the 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Patient received vaccine on Wednesday. On Thursday and Friday, he was very tired and he napped for 3 hours. Patient  had a fever of 101 On 9 may 2021 and 10 May 2021 and it reduced to 100 on 11-MAY-2021. On 9 May 2021 and 10 May 2021, his heart rate was Tachycardia at 100 beat per minutes, could had possibly been 110 beats per minutes, his resting heart rate is 50 beats per minutes. He called his doctor on 11 May 2021 and they were talks about getting him a pacemaker. Patient stated that he stayed  hydrated and he felt better. This was his 1st vaccine since 1976, he is concerned he had a reaction to the vaccine or component of the vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Napped for 3 hours), TACHYCARDIA (Heart rate was Tachycardia at 100 beat per minutes), DIARRHOEA (Explosive diarrhea compared to colonoscopy prep/Loose stool every 3 hours), PAIN IN EXTREMITY (he had pain in his arm of injection) and FATIGUE (he was very tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cold (cold(upper respiratory tract infection) lasted 10 days) from 01-Jan-2021 to January 2021. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced SOMNOLENCE (Napped for 3 hours) and FATIGUE (he was very tired). On 09-May-2021, the patient experienced TACHYCARDIA (Heart rate was Tachycardia at 100 beat per minutes), DIARRHEA (Explosive diarrhea compared to colonoscopy prep/Loose stool every 3 hours) and PYREXIA (Fever at 101/Fever at 100). In May 2021, the patient experienced PAIN IN EXTREMITY (he had pain in his arm of injection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Elected not to get his 2nd dose because of his side effects for the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Loose stools, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Napped for 3 hours), TACHYCARDIA (Heart rate was Tachycardia at 100 beat per minutes), DIARRHOEA (Explosive diarrhea compared to colonoscopy prep/Loose stool every 3 hours), PAIN IN EXTREMITY (he had pain in his arm of injection), FATIGUE (he was very tired), PYREXIA (Fever at 101/Fever at 100) and PRODUCT DOSE OMISSION ISSUE (Elected not to get his 2nd dose because of his side effects for the 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Patient received vaccine on Wednesday. On Thursday and Friday, he was very tired and he napped for 3 hours. Patient  had a fever of 101 On 9 may 2021 and 10 May 2021 and it reduced to 100 on 11-MAY-2021. On 9 May 2021 and 10 May 2021, his heart rate was Tachycardia at 100 beat per minutes, could had possibly been 110 beats per minutes, his resting heart rate is 50 beats per minutes. He called his doctor on 11 May 2021 and they were talks about getting him a pacemaker. Patient stated that he stayed  hydrated and he felt better. This was his 1st vaccine since 1976, he is concerned he had a reaction to the vaccine or component of the vaccine.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she got the Delta Variant on 01AUG2021; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she got the Delta Variant on 01AUG2021) and DRUG INEFFECTIVE (Drug ineffective) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Bladder discomfort. Concomitant products included LEVOTHYROXINE, LOSARTAN and ROSUVASTATIN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced COVID-19 (she got the Delta Variant on 01AUG2021) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (she got the Delta Variant on 01AUG2021) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient  reported that she got the Delta Variant on 01-AUG-2021, after that she got an anti-body infusion.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: having several reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having several reactions) 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 VACCINATION COMPLICATION (having several reactions). At the time of the report, VACCINATION COMPLICATION (having several reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Shooting pains from left leg down to toes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Shooting pains from left leg down to toes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020S21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Aug-2021, the patient experienced PAIN (Shooting pains from left leg down to toes). At the time of the report, PAIN (Shooting pains from left leg down to toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose/received expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose/received expired doses) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose/received expired doses). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose/received expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. The treatment information was  not provided.  Action taken with the drug in response to events was not applicable.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given expired (shortdated) vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (shortdated) vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (shortdated) vaccine). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (shortdated) vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Feeling abnormal, Gait disturbance, Heart rate
Clinical narrative: I'm feeling very poorly, shaking so bad; I'm feeling very poorly, shaking so bad; The pain was so bad in my feet last night that I couldn't walk; The pain was so bad in my feet last night that I couldn't walk; I think I'm dehydrated because my pulse is around 100; temperature was 100, went to 102; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I'm feeling very poorly, shaking so bad), TREMOR (I'm feeling very poorly, shaking so bad), PAIN IN EXTREMITY (The pain was so bad in my feet last night that I couldn't walk), GAIT DISTURBANCE (The pain was so bad in my feet last night that I couldn't walk) and DEHYDRATION (I think I'm dehydrated because my pulse is around 100) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028E2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Brain tumor. Concomitant products included GABAPENTIN, ATENOLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FLUTICASONE PROPIONATE (FLOVENT) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 29-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced FEELING ABNORMAL (I'm feeling very poorly, shaking so bad), TREMOR (I'm feeling very poorly, shaking so bad), PAIN IN EXTREMITY (The pain was so bad in my feet last night that I couldn't walk), GAIT DISTURBANCE (The pain was so bad in my feet last night that I couldn't walk), DEHYDRATION (I think I'm dehydrated because my pulse is around 100) and PYREXIA (temperature was 100, went to 102). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (I'm feeling very poorly, shaking so bad), TREMOR (I'm feeling very poorly, shaking so bad), PAIN IN EXTREMITY (The pain was so bad in my feet last night that I couldn't walk), GAIT DISTURBANCE (The pain was so bad in my feet last night that I couldn't walk), DEHYDRATION (I think I'm dehydrated because my pulse is around 100) and PYREXIA (temperature was 100, went to 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) temperature was 100, went to 102. On an unknown date, Heart rate: (High) Pulse rate was around 100.         Reportedly,Patient took third dose of the vaccine with LOT 028E2119 or 088E2119.   This case was linked to MOD-2021-037906, MOD-2021-036365 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: I'm feeling very poorly, shaking so bad; I'm feeling very poorly, shaking so bad; The pain was so bad in my feet last night that I couldn't walk; The pain was so bad in my feet last night that I couldn't walk; I think I'm dehydrated because my pulse is around 100; temperature was 100, went to 102; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I'm feeling very poorly, shaking so bad), TREMOR (I'm feeling very poorly, shaking so bad), PAIN IN EXTREMITY (The pain was so bad in my feet last night that I couldn't walk), GAIT DISTURBANCE (The pain was so bad in my feet last night that I couldn't walk) and DEHYDRATION (I think I'm dehydrated because my pulse is around 100) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028E2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Brain tumor. Concomitant products included GABAPENTIN, ATENOLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FLUTICASONE PROPIONATE (FLOVENT) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 29-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced FEELING ABNORMAL (I'm feeling very poorly, shaking so bad), TREMOR (I'm feeling very poorly, shaking so bad), PAIN IN EXTREMITY (The pain was so bad in my feet last night that I couldn't walk), GAIT DISTURBANCE (The pain was so bad in my feet last night that I couldn't walk), DEHYDRATION (I think I'm dehydrated because my pulse is around 100) and PYREXIA (temperature was 100, went to 102). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (I'm feeling very poorly, shaking so bad), TREMOR (I'm feeling very poorly, shaking so bad), PAIN IN EXTREMITY (The pain was so bad in my feet last night that I couldn't walk), GAIT DISTURBANCE (The pain was so bad in my feet last night that I couldn't walk), DEHYDRATION (I think I'm dehydrated because my pulse is around 100) and PYREXIA (temperature was 100, went to 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) temperature was 100, went to 102. On an unknown date, Heart rate: (High) Pulse rate was around 100.         Reportedly,Patient took third dose of the vaccine with LOT 028E2119 or 088E2119.   This case was linked to MOD-2021-037906, MOD-2021-036365 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I had the 1st shot in June can I get the second shot/Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had the 1st shot in June can I get the second shot/Beyond 35 days for 2nd dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had the 1st shot in June can I get the second shot/Beyond 35 days for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had the 1st shot in June can I get the second shot/Beyond 35 days for 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received: first dose date updated, consent obtained. On 01-Sep-2021: Follow-up received on 01-sep-2021 having no new information
Sex: U
Vaccine: COVID19
Symptoms: Cold sweat, Illness, Lymphadenopathy, Nausea, Neck pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (sick), swelling (armpit), neck pain/soreness, cold sweat and lymphadenopathy (lymph nodes are swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (sick), swelling (armpit), neck pain/soreness, cold sweat, lymphadenopathy (lymph nodes are swollen) and nausea. At the time of the report, illness (sick): not resolved; and swelling (armpit), neck pain/soreness, cold sweat, lymphadenopathy (lymph nodes are swollen) and nausea outcome: unknown. Concomitant medication and treatment information not reported. This case linked to MOD-2021-301413 (patient link). Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (sick), swelling (armpit), neck pain/soreness, cold sweat and lymphadenopathy (lymph nodes are swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (sick), swelling (armpit), neck pain/soreness, cold sweat, lymphadenopathy (lymph nodes are swollen) and nausea. At the time of the report, illness (sick): not resolved; and swelling (armpit), neck pain/soreness, cold sweat, lymphadenopathy (lymph nodes are swollen) and nausea outcome: unknown. Concomitant medication and treatment information not reported. This case linked to MOD-2021-301413 (patient link). Reporter did not allow further contact.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Gait disturbance, Myalgia
Clinical narrative: congestion; head fog; not sleeping well; cough on and off; not walking well; sore arm for three or four days, it started hurting a couple days after the shot; cold chills; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion), FEELING ABNORMAL (head fog), POOR QUALITY SLEEP (not sleeping well), COUGH (cough on and off) and GAIT DISTURBANCE (not walking well) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congestion), FEELING ABNORMAL (head fog), POOR QUALITY SLEEP (not sleeping well), COUGH (cough on and off), GAIT DISTURBANCE (not walking well), MYALGIA (sore arm for three or four days, it started hurting a couple days after the shot) and CHILLS (cold chills). At the time of the report, NASAL CONGESTION (congestion), FEELING ABNORMAL (head fog), POOR QUALITY SLEEP (not sleeping well), COUGH (cough on and off), GAIT DISTURBANCE (not walking well), MYALGIA (sore arm for three or four days, it started hurting a couple days after the shot) and CHILLS (cold chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient says she thinks she might be in the early stages of dementia and that she might be a long hauler.  Concomitant medication was not provided.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Poor quality sleep
Clinical narrative: congestion; head fog; not sleeping well; cough on and off; not walking well; sore arm for three or four days, it started hurting a couple days after the shot; cold chills; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion), FEELING ABNORMAL (head fog), POOR QUALITY SLEEP (not sleeping well), COUGH (cough on and off) and GAIT DISTURBANCE (not walking well) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congestion), FEELING ABNORMAL (head fog), POOR QUALITY SLEEP (not sleeping well), COUGH (cough on and off), GAIT DISTURBANCE (not walking well), MYALGIA (sore arm for three or four days, it started hurting a couple days after the shot) and CHILLS (cold chills). At the time of the report, NASAL CONGESTION (congestion), FEELING ABNORMAL (head fog), POOR QUALITY SLEEP (not sleeping well), COUGH (cough on and off), GAIT DISTURBANCE (not walking well), MYALGIA (sore arm for three or four days, it started hurting a couple days after the shot) and CHILLS (cold chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient says she thinks she might be in the early stages of dementia and that she might be a long hauler.  Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Pain in extremity, Vaccination site movement impairment
Clinical narrative: Hand doesn't stop hurting; The left arm (where the patient received the injection) from the shoulder down to the elbow the patient could not move it; Cannot move my hands and hands are completely dead; It has gone worse over time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hand doesn't stop hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (The left arm (where the patient received the injection) from the shoulder down to the elbow the patient could not move it), HYPOAESTHESIA (Cannot move my hands and hands are completely dead) and CONDITION AGGRAVATED (It has gone worse over time) 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 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced PAIN IN EXTREMITY (Hand doesn't stop hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (The left arm (where the patient received the injection) from the shoulder down to the elbow the patient could not move it), HYPOAESTHESIA (Cannot move my hands and hands are completely dead) and CONDITION AGGRAVATED (It has gone worse over time). At the time of the report, PAIN IN EXTREMITY (Hand doesn't stop hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (The left arm (where the patient received the injection) from the shoulder down to the elbow the patient could not move it), HYPOAESTHESIA (Cannot move my hands and hands are completely dead) and CONDITION AGGRAVATED (It has gone worse over time) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant product use was provided by the reporter.    No treatment medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment history was reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsy), MYALGIA (sore left arm) and HEADACHE (headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-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 SOMNOLENCE (drowsy), MYALGIA (sore left arm) and HEADACHE (headache). At the time of the report, SOMNOLENCE (drowsy), MYALGIA (sore left arm) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment medications were not reported. This case was linked to MOD-2021-301574..
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Infected with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Infected with COVID) 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 COVID-19 (Infected with COVID). At the time of the report, COVID-19 (Infected with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Infected with COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.