chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body dysmorphic disorder, Cold sweat, Dehydration, Dizziness, Dyspnoea
Clinical narrative: My migraines have gotten worse; dizzy spells; My allergies have gotten worse; Don't eat much; My arm is still sore from where the injection was; nausea; High fever; Intravenous route of administration; Body felt like brittle glass; cold sweat; dehydrated; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweat), DEHYDRATION (dehydrated), DYSPNOEA (trouble breathing), MIGRAINE (My migraines have gotten worse) and BODY DYSMORPHIC DISORDER (Body felt like brittle glass) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine NOS. Concurrent medical conditions included Food allergy and Chemical sensitivity.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced COLD SWEAT (cold sweat), DEHYDRATION (dehydrated), DYSPNOEA (trouble breathing), BODY DYSMORPHIC DISORDER (Body felt like brittle glass), NAUSEA (nausea), PYREXIA (High fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration). On an unknown date, the patient experienced MIGRAINE (My migraines have gotten worse), DIZZINESS (dizzy spells), HYPERSENSITIVITY (My allergies have gotten worse), EATING DISORDER (Don't eat much) and INJECTION SITE PAIN (My arm is still sore from where the injection was). On 10-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration) had resolved. At the time of the report, COLD SWEAT (cold sweat), DEHYDRATION (dehydrated), DYSPNOEA (trouble breathing), BODY DYSMORPHIC DISORDER (Body felt like brittle glass), NAUSEA (nausea) and PYREXIA (High fever) had not resolved and MIGRAINE (My migraines have gotten worse), DIZZINESS (dizzy spells), HYPERSENSITIVITY (My allergies have gotten worse), EATING DISORDER (Don't eat much) and INJECTION SITE PAIN (My arm is still sore from where the injection was) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Hypersensitivity, Incorrect route of product administration, Injection site pain, Migraine
Clinical narrative: My migraines have gotten worse; dizzy spells; My allergies have gotten worse; Don't eat much; My arm is still sore from where the injection was; nausea; High fever; Intravenous route of administration; Body felt like brittle glass; cold sweat; dehydrated; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweat), DEHYDRATION (dehydrated), DYSPNOEA (trouble breathing), MIGRAINE (My migraines have gotten worse) and BODY DYSMORPHIC DISORDER (Body felt like brittle glass) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine NOS. Concurrent medical conditions included Food allergy and Chemical sensitivity.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced COLD SWEAT (cold sweat), DEHYDRATION (dehydrated), DYSPNOEA (trouble breathing), BODY DYSMORPHIC DISORDER (Body felt like brittle glass), NAUSEA (nausea), PYREXIA (High fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration). On an unknown date, the patient experienced MIGRAINE (My migraines have gotten worse), DIZZINESS (dizzy spells), HYPERSENSITIVITY (My allergies have gotten worse), EATING DISORDER (Don't eat much) and INJECTION SITE PAIN (My arm is still sore from where the injection was). On 10-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration) had resolved. At the time of the report, COLD SWEAT (cold sweat), DEHYDRATION (dehydrated), DYSPNOEA (trouble breathing), BODY DYSMORPHIC DISORDER (Body felt like brittle glass), NAUSEA (nausea) and PYREXIA (High fever) had not resolved and MIGRAINE (My migraines have gotten worse), DIZZINESS (dizzy spells), HYPERSENSITIVITY (My allergies have gotten worse), EATING DISORDER (Don't eat much) and INJECTION SITE PAIN (My arm is still sore from where the injection was) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: My migraines have gotten worse; dizzy spells; My allergies have gotten worse; Don't eat much; My arm is still sore from where the injection was; nausea; High fever; Intravenous route of administration; Body felt like brittle glass; cold sweat; dehydrated; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweat), DEHYDRATION (dehydrated), DYSPNOEA (trouble breathing), MIGRAINE (My migraines have gotten worse) and BODY DYSMORPHIC DISORDER (Body felt like brittle glass) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine NOS. Concurrent medical conditions included Food allergy and Chemical sensitivity.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced COLD SWEAT (cold sweat), DEHYDRATION (dehydrated), DYSPNOEA (trouble breathing), BODY DYSMORPHIC DISORDER (Body felt like brittle glass), NAUSEA (nausea), PYREXIA (High fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration). On an unknown date, the patient experienced MIGRAINE (My migraines have gotten worse), DIZZINESS (dizzy spells), HYPERSENSITIVITY (My allergies have gotten worse), EATING DISORDER (Don't eat much) and INJECTION SITE PAIN (My arm is still sore from where the injection was). On 10-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration) had resolved. At the time of the report, COLD SWEAT (cold sweat), DEHYDRATION (dehydrated), DYSPNOEA (trouble breathing), BODY DYSMORPHIC DISORDER (Body felt like brittle glass), NAUSEA (nausea) and PYREXIA (High fever) had not resolved and MIGRAINE (My migraines have gotten worse), DIZZINESS (dizzy spells), HYPERSENSITIVITY (My allergies have gotten worse), EATING DISORDER (Don't eat much) and INJECTION SITE PAIN (My arm is still sore from where the injection was) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: sight 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 VISUAL IMPAIRMENT (sight problems) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Thrombosis (Patients had blood clot that affected their retina and they can hardly see with that eye).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced VISUAL IMPAIRMENT (sight problems). At the time of the report, VISUAL IMPAIRMENT (sight problems) outcome was unknown.            Patient reported, saw online that other people had sight problems after getting the vaccine. Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bruxism, Fatigue, Headache, Migraine
Clinical narrative: shivering jaw clenched; experienced 2-3 hours of chest pain severe heart burn; felt nauseated sick to stomach; running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever; fatigue; Headache; migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn), NAUSEA (felt nauseated sick to stomach) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Treatment received: Steroids) in November 2020.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn), NAUSEA (felt nauseated sick to stomach) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever). In August 2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigue) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of took 4 total that morning; CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 14-Aug-2021, BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever) had resolved. On 17-Aug-2021, MIGRAINE (migraine), NAUSEA (felt nauseated sick to stomach) and FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Body temperature: 103 degrees f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitants were reported.   Patient stated that Tried to have crackers and bread to settle stomach, went to lay back down took more ibuprofen took 4 total that morning. Slept until 10:30-11AM. Could not drink water, nauseated. Patient had COVID-19 last year in November2020 and said that  symptoms from 1st dose was similar to COVID-19 she had except for the nausea. Patient was in bed the most of the day. Patient woke up 3pm tried to eat soup broth and experienced 2-3 hours of chest pain ,severe heart burn.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Non-cardiac chest pain, Pyrexia
Clinical narrative: shivering jaw clenched; experienced 2-3 hours of chest pain severe heart burn; felt nauseated sick to stomach; running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever; fatigue; Headache; migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn), NAUSEA (felt nauseated sick to stomach) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Treatment received: Steroids) in November 2020.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn), NAUSEA (felt nauseated sick to stomach) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever). In August 2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigue) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of took 4 total that morning; CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 14-Aug-2021, BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever) had resolved. On 17-Aug-2021, MIGRAINE (migraine), NAUSEA (felt nauseated sick to stomach) and FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Body temperature: 103 degrees f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitants were reported.   Patient stated that Tried to have crackers and bread to settle stomach, went to lay back down took more ibuprofen took 4 total that morning. Slept until 10:30-11AM. Could not drink water, nauseated. Patient had COVID-19 last year in November2020 and said that  symptoms from 1st dose was similar to COVID-19 she had except for the nausea. Patient was in bed the most of the day. Patient woke up 3pm tried to eat soup broth and experienced 2-3 hours of chest pain ,severe heart burn.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive 2nd dose of the Moderna vaccine in over 36 days after 1st dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive 2nd dose of the Moderna vaccine in over 36 days after 1st dose of the Moderna vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive 2nd dose of the Moderna vaccine in over 36 days after 1st dose of the Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive 2nd dose of the Moderna vaccine in over 36 days after 1st dose of the Moderna vaccine) had resolved.            The concomitant medications were not reported. The treatment information was not provided.  Patient reported that she had not received the second dose of Moderna vaccine. She reported that people who had COVID-19 have more antibodies and also she expressed her interest in clinical trial participation.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-296287 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted covid after receiving the first dose of the vaccine; 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 COVID-19 (contracted covid after receiving the first dose of the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted covid after receiving the first dose of the vaccine). At the time of the report, COVID-19 (contracted covid after receiving the first dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Allergic to pen K).   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-182314 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Nerve injury
Clinical narrative: shingles; nerve damage; 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 HERPES ZOSTER (shingles) and NERVE INJURY (nerve damage) 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 HERPES ZOSTER (shingles) and NERVE INJURY (nerve damage). At the time of the report, HERPES ZOSTER (shingles) and NERVE INJURY (nerve damage) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  It was reported that these people are in support groups for vaccinated people with symptoms.  No treatment details were reported.   This case was linked to MOD-2021-296653, MOD-2021-296654 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Feeling abnormal, Heart rate increased
Clinical narrative: lightheadedness; mild chest pain; feeling yucky; resting heart rate went up / had 3 episodes of rapid heart rate; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (mild chest pain), FEELING ABNORMAL (feeling yucky), DIZZINESS (lightheadedness), HEART RATE INCREASED (resting heart rate went up / had 3 episodes of rapid heart rate) and PYREXIA (fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced FEELING ABNORMAL (feeling yucky), HEART RATE INCREASED (resting heart rate went up / had 3 episodes of rapid heart rate), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced CHEST PAIN (mild chest pain) and DIZZINESS (lightheadedness). In May 2021, HEART RATE INCREASED (resting heart rate went up / had 3 episodes of rapid heart rate) had resolved. At the time of the report, CHEST PAIN (mild chest pain), FEELING ABNORMAL (feeling yucky), DIZZINESS (lightheadedness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-296280 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lightheadedness; mild chest pain; feeling yucky; resting heart rate went up / had 3 episodes of rapid heart rate; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (mild chest pain), FEELING ABNORMAL (feeling yucky), DIZZINESS (lightheadedness), HEART RATE INCREASED (resting heart rate went up / had 3 episodes of rapid heart rate) and PYREXIA (fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced FEELING ABNORMAL (feeling yucky), HEART RATE INCREASED (resting heart rate went up / had 3 episodes of rapid heart rate), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced CHEST PAIN (mild chest pain) and DIZZINESS (lightheadedness). In May 2021, HEART RATE INCREASED (resting heart rate went up / had 3 episodes of rapid heart rate) had resolved. At the time of the report, CHEST PAIN (mild chest pain), FEELING ABNORMAL (feeling yucky), DIZZINESS (lightheadedness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-296280 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Product dose omission issue, Pyrexia, Vaccination site pain
Clinical narrative: Doses 7 months apart; Sore arm; Fever  of 100.8 F; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Doses 7 months apart), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever  of 100.8 F) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever  of 100.8 F). On 25-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Doses 7 months apart). On 09-Jan-2021, VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever  of 100.8 F) had resolved. On 25-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Doses 7 months apart) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 100.8 (High) 100.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  It was reported that the patient had an appointment to take his second dose on 25-Aug-2021.  Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Illness, Nausea
Clinical narrative: was so sick; nauseous/throwing up; terrible aches & pains in her neck; headache; tired; her arm hurts; aches & pains in her neck and back with her back feeling like it was broken; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was so sick), NAUSEA (nauseous/throwing up), NECK PAIN (terrible aches & pains in her neck), HEADACHE (headache) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 ILLNESS (was so sick), NAUSEA (nauseous/throwing up), NECK PAIN (terrible aches & pains in her neck), HEADACHE (headache), FATIGUE (tired), PAIN IN EXTREMITY (her arm hurts), BACK PAIN (aches & pains in her neck and back with her back feeling like it was broken) and VOMITING (Throwing up). At the time of the report, ILLNESS (was so sick), NAUSEA (nauseous/throwing up), NECK PAIN (terrible aches & pains in her neck), HEADACHE (headache), FATIGUE (tired), PAIN IN EXTREMITY (her arm hurts), BACK PAIN (aches & pains in her neck and back with her back feeling like it was broken) and VOMITING (Throwing up) outcome was unknown.            No concomitant medication listed.   No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Vomiting
Clinical narrative: was so sick; nauseous/throwing up; terrible aches & pains in her neck; headache; tired; her arm hurts; aches & pains in her neck and back with her back feeling like it was broken; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was so sick), NAUSEA (nauseous/throwing up), NECK PAIN (terrible aches & pains in her neck), HEADACHE (headache) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 ILLNESS (was so sick), NAUSEA (nauseous/throwing up), NECK PAIN (terrible aches & pains in her neck), HEADACHE (headache), FATIGUE (tired), PAIN IN EXTREMITY (her arm hurts), BACK PAIN (aches & pains in her neck and back with her back feeling like it was broken) and VOMITING (Throwing up). At the time of the report, ILLNESS (was so sick), NAUSEA (nauseous/throwing up), NECK PAIN (terrible aches & pains in her neck), HEADACHE (headache), FATIGUE (tired), PAIN IN EXTREMITY (her arm hurts), BACK PAIN (aches & pains in her neck and back with her back feeling like it was broken) and VOMITING (Throwing up) outcome was unknown.            No concomitant medication listed.   No treatment information provided.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Headache, Illness, Interchange of vaccine products, Product dose omission issue
Clinical narrative: patient never received the second dose; she got the two shots of Pfizer; Patient was so ill; Patient was positive for covid; high fever; Horrific headache on the lower right side of head / headache never stopped; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Patient was so ill), COVID-19 (Patient was positive for covid), HEADACHE (Horrific headache on the lower right side of head / headache never stopped), PYREXIA (high fever) and PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Gout.   On 12-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 received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Horrific headache on the lower right side of head / headache never stopped). On 20-Jan-2021, the patient experienced COVID-19 (Patient was positive for covid) and PYREXIA (high fever). On 29-Jan-2021, the patient experienced ILLNESS (Patient was so ill). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) and INTERCHANGE OF VACCINE PRODUCTS (she got the two shots of Pfizer). On 08-Feb-2021, COVID-19 (Patient was positive for covid) had resolved with sequelae. At the time of the report, ILLNESS (Patient was so ill), HEADACHE (Horrific headache on the lower right side of head / headache never stopped) and PYREXIA (high fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) and INTERCHANGE OF VACCINE PRODUCTS (she got the two shots of Pfizer) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 08-Feb-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received monoclonal antibodies on 29 Jan 2021 The neurologist made her wait 100 days after receiving the monoclonal antibodies and she got the two shots of Pfizer and the patient is now taking migraine medicine. Patient taking Medicine for Gout as concomitant.  The neurologist of the patient made her wait 100 days after receiving the monoclonal antibodies and then patient got two shots of Pfizer.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: patient never received the second dose; she got the two shots of Pfizer; Patient was so ill; Patient was positive for covid; high fever; Horrific headache on the lower right side of head / headache never stopped; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Patient was so ill), COVID-19 (Patient was positive for covid), HEADACHE (Horrific headache on the lower right side of head / headache never stopped), PYREXIA (high fever) and PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Gout.   On 12-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 received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Horrific headache on the lower right side of head / headache never stopped). On 20-Jan-2021, the patient experienced COVID-19 (Patient was positive for covid) and PYREXIA (high fever). On 29-Jan-2021, the patient experienced ILLNESS (Patient was so ill). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) and INTERCHANGE OF VACCINE PRODUCTS (she got the two shots of Pfizer). On 08-Feb-2021, COVID-19 (Patient was positive for covid) had resolved with sequelae. At the time of the report, ILLNESS (Patient was so ill), HEADACHE (Horrific headache on the lower right side of head / headache never stopped) and PYREXIA (high fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) and INTERCHANGE OF VACCINE PRODUCTS (she got the two shots of Pfizer) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 08-Feb-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received monoclonal antibodies on 29 Jan 2021 The neurologist made her wait 100 days after receiving the monoclonal antibodies and she got the two shots of Pfizer and the patient is now taking migraine medicine. Patient taking Medicine for Gout as concomitant.  The neurologist of the patient made her wait 100 days after receiving the monoclonal antibodies and then patient got two shots of Pfizer.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not  provided.  Pateint was received the second dose (lot # FD8448) of Pfizer.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer COVID19 Vaccine in 04Jul2021 and a dose (lot 052E21A) of Moderna COVID19 Vaccine today 25Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer COVID19 Vaccine in 04Jul2021 and a dose (lot # 052E21A) of Moderna COVID19 Vaccine today 25Aug2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized with COVID) on 06-Jul-2021 and Organ transplant. Previously administered products included for COVID-19 vaccination: Pfizer Biotech vaccine on 04-Jul-2021.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer COVID19 Vaccine in 04Jul2021 and a dose (lot # 052E21A) of Moderna COVID19 Vaccine today 25Aug2021) (seriousness criterion hospitalization). The patient was hospitalized from 06-Jul-2021 to 13-Jul-2021 due to INTERCHANGE OF VACCINE PRODUCTS. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Pfizer COVID19 Vaccine in 04Jul2021 and a dose (lot # 052E21A) of Moderna COVID19 Vaccine today 25Aug2021) 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.   No concomitant medication reported. No treatment information was reported.  company comment: This report refers to a case of Interchange of vaccine products for mRNA-1273 (lot # 052E21A).  with no associated adverse events. Further information has been requested.; Sender's Comments: This report refers to a case of Interchange of vaccine products for mRNA-1273 (lot # 052E21A).  with no associated adverse events. Further information has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Injection site pruritus, Muscle spasms, Muscle twitching
Clinical narrative: A bit pink; Chest tightness; Weird sensation initially on the left arm then it resolved and moved to his right leg; Right leg started twitching; Feels like cramping and constantly present from the knee down to the right calf area.; Itchy (area of the injection); Rash at the area of the injection; Swelling at the area of the injection (left arm); This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.) and VACCINATION SITE ERYTHEMA (A bit pink) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthmatic attack.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced CHEST DISCOMFORT (Chest tightness). In August 2021, the patient experienced FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.), INJECTION SITE PRURITUS (Itchy (area of the injection)), VACCINATION SITE RASH (Rash at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection (left arm)). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (A bit pink). At the time of the report, CHEST DISCOMFORT (Chest tightness), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.), VACCINATION SITE ERYTHEMA (A bit pink), INJECTION SITE PRURITUS (Itchy (area of the injection)), VACCINATION SITE RASH (Rash at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection (left arm)) had not resolved and FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg) was resolving.        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 reported that symptom started, few hours after the vaccination on the same day (15Aug2021).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: A bit pink; Chest tightness; Weird sensation initially on the left arm then it resolved and moved to his right leg; Right leg started twitching; Feels like cramping and constantly present from the knee down to the right calf area.; Itchy (area of the injection); Rash at the area of the injection; Swelling at the area of the injection (left arm); This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.) and VACCINATION SITE ERYTHEMA (A bit pink) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthmatic attack.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced CHEST DISCOMFORT (Chest tightness). In August 2021, the patient experienced FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.), INJECTION SITE PRURITUS (Itchy (area of the injection)), VACCINATION SITE RASH (Rash at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection (left arm)). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (A bit pink). At the time of the report, CHEST DISCOMFORT (Chest tightness), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.), VACCINATION SITE ERYTHEMA (A bit pink), INJECTION SITE PRURITUS (Itchy (area of the injection)), VACCINATION SITE RASH (Rash at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection (left arm)) had not resolved and FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg) was resolving.        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 reported that symptom started, few hours after the vaccination on the same day (15Aug2021).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not gotten second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not gotten second 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not gotten second vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not gotten second vaccine) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Peripheral swelling, Skin mass
Clinical narrative: arm has swollen up; had a really bad day. He thought it would go down; has knots in his left arm / it is like a golf ball on his arm; was also real sick; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm has swollen up), FEELING ABNORMAL (had a really bad day. He thought it would go down), SKIN MASS (has knots in his left arm / it is like a golf ball on his arm) and ILLNESS (was also real sick) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A, 041L20A1 and 088D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-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 PERIPHERAL SWELLING (arm has swollen up), FEELING ABNORMAL (had a really bad day. He thought it would go down), SKIN MASS (has knots in his left arm / it is like a golf ball on his arm) and ILLNESS (was also real sick). At the time of the report, PERIPHERAL SWELLING (arm has swollen up), FEELING ABNORMAL (had a really bad day. He thought it would go down) and SKIN MASS (has knots in his left arm / it is like a golf ball on his arm) outcome was unknown and ILLNESS (was also real sick) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  Treatment included a cold wash cloth was put on the patient's arm. No concomitant medications reported.