chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Insomnia, Underdose
Clinical narrative: loosing sleep; During the injection some of the vaccine spilled down his arm/must have missed the portion of the dose; during his second dose the vaccine came out of a joint; This spontaneous case was reported by a physician and describes the occurrence of INSOMNIA (loosing sleep), UNDERDOSE (During the injection some of the vaccine spilled down his arm/must have missed the portion of the dose) and DEVICE CONNECTION ISSUE (during his second dose the vaccine came out of a joint) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included Back pain in 1978. Previously administered products included for an unreported indication: neck pain in 1978. Concurrent medical conditions included Immunocompromised (lost his spleen 42 years ago), Allergy to animal dander, Insomnia in 2000 and BPH in 2000. Concomitant products included TAMSULOSIN for BPH, METAXALONE for Back pain, OMEGA-3-ACID ETHYL ESTER (LOVAZA) and ROSUVASTATIN for High cholesterol, TRAZODONE for Insomnia, MELOXICAM for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced UNDERDOSE (During the injection some of the vaccine spilled down his arm/must have missed the portion of the dose) and DEVICE CONNECTION ISSUE (during his second dose the vaccine came out of a joint). On an unknown date, the patient experienced INSOMNIA (loosing sleep). On 23-Mar-2021, UNDERDOSE (During the injection some of the vaccine spilled down his arm/must have missed the portion of the dose) and DEVICE CONNECTION ISSUE (during his second dose the vaccine came out of a joint) had resolved. At the time of the report, INSOMNIA (loosing sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   meloxicam used as anti inflammatory medication. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up information received contains no new Information. On 03-Aug-2021: Follow up received on 03 Aug 2021 contains added medical history, concomitant medications, added event - Insomnia
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Had chills and lo-grade fever for 36 hours after shot, swollen reddened injection site for up to 6 days, very achy and tired for 3 days after injection
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Had chills and lo-grade fever for 36 hours after shot, swollen reddened injection site for up to 6 days, very achy and tired for 3 days after injection
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admisison
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Discomfort, Dizziness, Immediate post-injection reaction
Clinical narrative: As I received the shot I developed a sensation of painful cold in what felt to be my arm bone immediately above my elbow and my elbow joint. Additionally, immediately following the shot I felt faint, and advised the provider of such.  She said it wasn't an issue and I went out to sit 15 minutes before leaving. That night I awoke to extreme pain in my hip joints. Since that time I have experienced, though diminishing, random pain in my elbow, shoulder, hips and knee that come and go without rhyme or reason. Despite having issues with arthritis, I never had that extreme pain until that night. And for a couple of months after, would experience moderate discomfort and mobility weakness especially when going up and down stairs. This was a year ago, I did initially indicate on the on-line system that I had a negative experience, but then my connection shut down and failed to continue to work. I called for technical assistance, but it failed again. After that, I quit trying. There didn't seem to be much concern. Now I am trying to recall accurately, and have done so to the best of my ability. I didn't make notes as the medical staff I spoke with didn't seem to feel it was anything serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral coldness
Clinical narrative: As I received the shot I developed a sensation of painful cold in what felt to be my arm bone immediately above my elbow and my elbow joint. Additionally, immediately following the shot I felt faint, and advised the provider of such.  She said it wasn't an issue and I went out to sit 15 minutes before leaving. That night I awoke to extreme pain in my hip joints. Since that time I have experienced, though diminishing, random pain in my elbow, shoulder, hips and knee that come and go without rhyme or reason. Despite having issues with arthritis, I never had that extreme pain until that night. And for a couple of months after, would experience moderate discomfort and mobility weakness especially when going up and down stairs. This was a year ago, I did initially indicate on the on-line system that I had a negative experience, but then my connection shut down and failed to continue to work. I called for technical assistance, but it failed again. After that, I quit trying. There didn't seem to be much concern. Now I am trying to recall accurately, and have done so to the best of my ability. I didn't make notes as the medical staff I spoke with didn't seem to feel it was anything serious.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Petechiae, Pyrexia
Clinical narrative: fever, palpitations, HR 110-120, petechia. Started last nght
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2d vaccine; breakthrough case admission
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Injection site reaction, Menstruation irregular, Rash erythematous, Tinnitus
Clinical narrative: 7 days following vaccine, large area of bumpy red skin around vaccine site, lasted approximately 5 days. For 6 months following vaccine, menses became much heavier and irregular. This returned to normal after approximately 6 months. B/L Tinnitus developed sometime after vaccination, unsure of the exact date related to vaccine but was within a month.  Never had tinnitus in the past.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram change, Malaise, Myocarditis
Clinical narrative: Developed chest pain, malaise 24-48 hours after vaccine and presented to ER, where he had elevated troponin, echo and EKG changes consistent with acute myopericarditis.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Developed chest pain, malaise 24-48 hours after vaccine and presented to ER, where he had elevated troponin, echo and EKG changes consistent with acute myopericarditis.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood triglycerides, Decreased immune responsiveness, Muscle twitching
Clinical narrative: Immune system is low; Muscle twitches in arms and leg; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED IMMUNE RESPONSIVENESS (Immune system is low) and MUSCLE TWITCHING (Muscle twitches in arms and leg) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy since an unknown date. Concurrent medical conditions included Insomnia, Menopausal and Hypertension. Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED IMMUNE RESPONSIVENESS (Immune system is low) and MUSCLE TWITCHING (Muscle twitches in arms and leg). At the time of the report, DECREASED IMMUNE RESPONSIVENESS (Immune system is low) and MUSCLE TWITCHING (Muscle twitches in arms and leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood triglycerides: high (High) High.         Concomitant medication include PTSD, insomnia and  blood pressure medication.  Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Amyotrophic lateral sclerosis, Aphasia, Aspiration, COVID-19
Clinical narrative: Patient is a 74-year-old who presented with shortness of breath, weight loss, decreased tube feedings through her PEG tube, recurrent emesis and possible aspiration with multilobar pneumonia in the presence of ALS.  Patient required intubation, fluid boluses, Levophed, antibiotics.  Infectious Disease was also on consult.  Patient tested positive for COVID-19 on 02/17.  Was treated with remdesivir as well.   Patient continued to show improvement on the ventilator.  She was weaned down close to being extubated and was tolerating pressure support ventilation adequately.  He started to wake up better on that.  Scopolamine patch was started but showed no improvement in her secretions that were mostly oral and not from her lungs.  Case was discussed with her daughter and spouse in detail.  They understood the current clinical condition.  The patient had been suffering from significant difficulty to her life with recurrent aspirations limiting her activity.  She had not been significantly verbal since September.  And most recently had not been able to tolerate PEG tube feedings either.  At this point the family decided for a one-way extubation.  If the patient is stabilized and did well to continue current care.  However if the patient had any respiratory deterioration then to consider comfort measures.  Patient was extubated on 02/24.  Patient initially was briefly doing adequately well but subsequently started requiring increasing amounts of oxygen, level of consciousness also declined.  Family requested change of plan of care to comfort measures.  These were instituted.  Patient died on 02/25 at 12:09 p.m.   Cause of death was acute respiratory failure.  Secondary to multifocal pneumonia.  Secondary to recurrent aspirations.  Secondary to ALS.  Tobacco did not contribute to the patient's death.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Depressed level of consciousness, Dyspnoea, Endotracheal intubation, Feeding tube user
Clinical narrative: Patient is a 74-year-old who presented with shortness of breath, weight loss, decreased tube feedings through her PEG tube, recurrent emesis and possible aspiration with multilobar pneumonia in the presence of ALS.  Patient required intubation, fluid boluses, Levophed, antibiotics.  Infectious Disease was also on consult.  Patient tested positive for COVID-19 on 02/17.  Was treated with remdesivir as well.   Patient continued to show improvement on the ventilator.  She was weaned down close to being extubated and was tolerating pressure support ventilation adequately.  He started to wake up better on that.  Scopolamine patch was started but showed no improvement in her secretions that were mostly oral and not from her lungs.  Case was discussed with her daughter and spouse in detail.  They understood the current clinical condition.  The patient had been suffering from significant difficulty to her life with recurrent aspirations limiting her activity.  She had not been significantly verbal since September.  And most recently had not been able to tolerate PEG tube feedings either.  At this point the family decided for a one-way extubation.  If the patient is stabilized and did well to continue current care.  However if the patient had any respiratory deterioration then to consider comfort measures.  Patient was extubated on 02/24.  Patient initially was briefly doing adequately well but subsequently started requiring increasing amounts of oxygen, level of consciousness also declined.  Family requested change of plan of care to comfort measures.  These were instituted.  Patient died on 02/25 at 12:09 p.m.   Cause of death was acute respiratory failure.  Secondary to multifocal pneumonia.  Secondary to recurrent aspirations.  Secondary to ALS.  Tobacco did not contribute to the patient's death.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrostomy, Loss of personal independence in daily activities, Mechanical ventilation, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Patient is a 74-year-old who presented with shortness of breath, weight loss, decreased tube feedings through her PEG tube, recurrent emesis and possible aspiration with multilobar pneumonia in the presence of ALS.  Patient required intubation, fluid boluses, Levophed, antibiotics.  Infectious Disease was also on consult.  Patient tested positive for COVID-19 on 02/17.  Was treated with remdesivir as well.   Patient continued to show improvement on the ventilator.  She was weaned down close to being extubated and was tolerating pressure support ventilation adequately.  He started to wake up better on that.  Scopolamine patch was started but showed no improvement in her secretions that were mostly oral and not from her lungs.  Case was discussed with her daughter and spouse in detail.  They understood the current clinical condition.  The patient had been suffering from significant difficulty to her life with recurrent aspirations limiting her activity.  She had not been significantly verbal since September.  And most recently had not been able to tolerate PEG tube feedings either.  At this point the family decided for a one-way extubation.  If the patient is stabilized and did well to continue current care.  However if the patient had any respiratory deterioration then to consider comfort measures.  Patient was extubated on 02/24.  Patient initially was briefly doing adequately well but subsequently started requiring increasing amounts of oxygen, level of consciousness also declined.  Family requested change of plan of care to comfort measures.  These were instituted.  Patient died on 02/25 at 12:09 p.m.   Cause of death was acute respiratory failure.  Secondary to multifocal pneumonia.  Secondary to recurrent aspirations.  Secondary to ALS.  Tobacco did not contribute to the patient's death.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Salivary hypersecretion, Vomiting, Weight decreased
Clinical narrative: Patient is a 74-year-old who presented with shortness of breath, weight loss, decreased tube feedings through her PEG tube, recurrent emesis and possible aspiration with multilobar pneumonia in the presence of ALS.  Patient required intubation, fluid boluses, Levophed, antibiotics.  Infectious Disease was also on consult.  Patient tested positive for COVID-19 on 02/17.  Was treated with remdesivir as well.   Patient continued to show improvement on the ventilator.  She was weaned down close to being extubated and was tolerating pressure support ventilation adequately.  He started to wake up better on that.  Scopolamine patch was started but showed no improvement in her secretions that were mostly oral and not from her lungs.  Case was discussed with her daughter and spouse in detail.  They understood the current clinical condition.  The patient had been suffering from significant difficulty to her life with recurrent aspirations limiting her activity.  She had not been significantly verbal since September.  And most recently had not been able to tolerate PEG tube feedings either.  At this point the family decided for a one-way extubation.  If the patient is stabilized and did well to continue current care.  However if the patient had any respiratory deterioration then to consider comfort measures.  Patient was extubated on 02/24.  Patient initially was briefly doing adequately well but subsequently started requiring increasing amounts of oxygen, level of consciousness also declined.  Family requested change of plan of care to comfort measures.  These were instituted.  Patient died on 02/25 at 12:09 p.m.   Cause of death was acute respiratory failure.  Secondary to multifocal pneumonia.  Secondary to recurrent aspirations.  Secondary to ALS.  Tobacco did not contribute to the patient's death.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admisson
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admisson
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a 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 VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: surgery; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (surgery) 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, 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 SURGERY (surgery). At the time of the report, SURGERY (surgery) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       On an unknown date, SARS-CoV-2 test was Negative.  No concomitant medications were provided.   No treatment medications were provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Feeling bad; Shortness of Breath; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), DYSPNOEA (Shortness of Breath), PYREXIA (Fever) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 004C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL for an unknown indication.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced FEELING ABNORMAL (Feeling bad), DYSPNOEA (Shortness of Breath), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Feeling bad), DYSPNOEA (Shortness of Breath), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: The needle separated from the syringe; Patient was not administered the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (The needle separated from the syringe) and UNDERDOSE (Patient was not administered the full dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced DEVICE CONNECTION ISSUE (The needle separated from the syringe) and UNDERDOSE (Patient was not administered the full dose). On 23-Jul-2021, DEVICE CONNECTION ISSUE (The needle separated from the syringe) and UNDERDOSE (Patient was not administered the full dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: non significant follow up added
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Symptom free from Chronic Idiopathic Urticaria; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Symptom free from Chronic Idiopathic Urticaria) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Drug allergy.   On 15-May-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-Jul-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Symptom free from Chronic Idiopathic Urticaria). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Symptom free from Chronic Idiopathic Urticaria) outcome was unknown.            The patient treatment data was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Strabismus, Vaccination site haemorrhage, Vision blurred
Clinical narrative: blood in the bandage\ bandage was soaked; blurred vision; having to squint; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (blood in the bandage\ bandage was soaked), VISION BLURRED (blurred vision) and STRABISMUS (having to squint) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PYRIDOXINE HYDROCHLORIDE (VITAMIN B6), VITAMIN C [ASCORBIC ACID], VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN A [RETINOL] for an unknown indication.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (blood in the bandage\ bandage was soaked), VISION BLURRED (blurred vision) and STRABISMUS (having to squint). At the time of the report, VACCINATION SITE HAEMORRHAGE (blood in the bandage\ bandage was soaked) outcome was unknown and VISION BLURRED (blurred vision) and STRABISMUS (having to squint) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Chills; Body ache; incredible headache; intense and prolongued nausea; I felt exhausted; Fever; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), MYALGIA (Body ache), HEADACHE (incredible headache), NAUSEA (intense and prolongued nausea) and FATIGUE (I felt exhausted) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G10A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Mild allergic to latex-red extremely itchy rash) and Paralysis legs (partial paralysis in both legs from traumatic injuries) since 1995. Concomitant products included FINASTERIDE from 11-May-2020 to an unknown date, VITAMIN E [VITAMIN E NOS], VITAMIN D3, PROBIOTICS NOS and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-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 CHILLS (Chills), MYALGIA (Body ache), HEADACHE (incredible headache), NAUSEA (intense and prolongued nausea), FATIGUE (I felt exhausted) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), MYALGIA (Body ache), HEADACHE (incredible headache), NAUSEA (intense and prolongued nausea), FATIGUE (I felt exhausted) and PYREXIA (Fever) had resolved.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable   This case was linked to MOD-2021-032966 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Body ache; incredible headache; intense and prolongued nausea; I felt exhausted; Fever; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), MYALGIA (Body ache), HEADACHE (incredible headache), NAUSEA (intense and prolongued nausea) and FATIGUE (I felt exhausted) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G10A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Mild allergic to latex-red extremely itchy rash) and Paralysis legs (partial paralysis in both legs from traumatic injuries) since 1995. Concomitant products included FINASTERIDE from 11-May-2020 to an unknown date, VITAMIN E [VITAMIN E NOS], VITAMIN D3, PROBIOTICS NOS and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-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 CHILLS (Chills), MYALGIA (Body ache), HEADACHE (incredible headache), NAUSEA (intense and prolongued nausea), FATIGUE (I felt exhausted) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), MYALGIA (Body ache), HEADACHE (incredible headache), NAUSEA (intense and prolongued nausea), FATIGUE (I felt exhausted) and PYREXIA (Fever) had resolved.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable   This case was linked to MOD-2021-032966 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: hands were swelling like barbeque; cannot move his fingers; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands were swelling like barbeque) and MOBILITY DECREASED (cannot move his fingers) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced PERIPHERAL SWELLING (hands were swelling like barbeque) and MOBILITY DECREASED (cannot move his fingers). At the time of the report, PERIPHERAL SWELLING (hands were swelling like barbeque) and MOBILITY DECREASED (cannot move his fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking Kratom organic drug supplement concomitantly. The patient went to the doctor and had laboratory tests. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Almost received vaccine when breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Almost received vaccine when breastfeeding) in a  neonate of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the neonate was diagnosed with EXPOSURE VIA BREAST MILK (Almost received vaccine when breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Almost received vaccine when breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported  Treatment information was not reported
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Some arm pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some arm pain) and PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Some arm pain) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Some arm pain) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-265941 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) 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) at an unspecified dose. On an unknown date, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported by reporter. No concomitant medications were reported by reporter.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Feeling abnormal, Pyrexia
Clinical narrative: feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.; covid-19; Fever; light cough; like I had a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (like I had a sinus infection), COUGH (light cough), FEELING ABNORMAL (feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.), COVID-19 (covid-19) and PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUSITIS (like I had a sinus infection). On 22-Jul-2021, the patient experienced COUGH (light cough). On 23-Jul-2021, the patient experienced FEELING ABNORMAL (feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.). 23-Jul-2021, the patient experienced COVID-19 (covid-19). 23-Jul-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD & SINUS) for Sinusitis, at an unspecified dose and frequency; PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED SINUS) for Sinusitis, at an unspecified dose and frequency and SODIUM CHLORIDE (SALINE NASAL MIST) for Sinusitis, at an unspecified dose and frequency. At the time of the report, SINUSITIS (like I had a sinus infection), COUGH (light cough), FEELING ABNORMAL (feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.), COVID-19 (covid-19) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, Body temperature: 101 (High) 101. On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient also used steam for relieving symptoms.  No concomitant medication was provided.   This case was linked to MOD-2021-265911 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinusitis
Clinical narrative: feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.; covid-19; Fever; light cough; like I had a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (like I had a sinus infection), COUGH (light cough), FEELING ABNORMAL (feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.), COVID-19 (covid-19) and PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUSITIS (like I had a sinus infection). On 22-Jul-2021, the patient experienced COUGH (light cough). On 23-Jul-2021, the patient experienced FEELING ABNORMAL (feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.). 23-Jul-2021, the patient experienced COVID-19 (covid-19). 23-Jul-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD & SINUS) for Sinusitis, at an unspecified dose and frequency; PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED SINUS) for Sinusitis, at an unspecified dose and frequency and SODIUM CHLORIDE (SALINE NASAL MIST) for Sinusitis, at an unspecified dose and frequency. At the time of the report, SINUSITIS (like I had a sinus infection), COUGH (light cough), FEELING ABNORMAL (feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.), COVID-19 (covid-19) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, Body temperature: 101 (High) 101. On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient also used steam for relieving symptoms.  No concomitant medication was provided.   This case was linked to MOD-2021-265911 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Stored in the refrigerator for more than 30 days; Administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication was not provided.   This case was linked to MOD-2021-265450 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) 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.   Concomitant product use was not provided by the reporter.   No treatment information was provided. HCP claimed that the vaccines did not experience temperature excursion while in the refrigerator. They would like to seek guidance as to how to proceed in this situation like whether they should give an extra dose or not? Crosslinked with MOD21-122955, MOD21-122993, MOD21-122994, MOD21-122995, MOD21-122996, MOD21-122998, MOD21-122999, MOD21-123000, MOD21-123001, MOD21-123002, MOD21-123003, MOD21-123004, MOD21-123005, MOD21-123006, MOD21-123007, MOD21-123008 and MOD21-123009.   This case was linked to MOD-2021-265450 (Patient Link).   Reporter did not allow further contact
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Sweating a lot after second dose; Fatigue after second dose; Headache after second dose; Muscle Pain  after second dose; Joint Pain after second dose; Fever 98.7 F (Usually 98.2 F) after second dose; Chills after second dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating a lot after second dose), FATIGUE (Fatigue after second dose), HEADACHE (Headache after second dose), MYALGIA (Muscle Pain  after second dose) and ARTHRALGIA (Joint Pain after second dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating a lot after second dose), FATIGUE (Fatigue after second dose), HEADACHE (Headache after second dose), MYALGIA (Muscle Pain  after second dose), ARTHRALGIA (Joint Pain after second dose), PYREXIA (Fever 98.7 F (Usually 98.2 F) after second dose) and CHILLS (Chills after second dose). At the time of the report, HYPERHIDROSIS (Sweating a lot after second dose), FATIGUE (Fatigue after second dose), HEADACHE (Headache after second dose), MYALGIA (Muscle Pain  after second dose), ARTHRALGIA (Joint Pain after second dose), PYREXIA (Fever 98.7 F (Usually 98.2 F) after second dose) and CHILLS (Chills after second dose) outcome was unknown.            Treatment medication was not provided
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Sweating a lot after second dose; Fatigue after second dose; Headache after second dose; Muscle Pain  after second dose; Joint Pain after second dose; Fever 98.7 F (Usually 98.2 F) after second dose; Chills after second dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating a lot after second dose), FATIGUE (Fatigue after second dose), HEADACHE (Headache after second dose), MYALGIA (Muscle Pain  after second dose) and ARTHRALGIA (Joint Pain after second dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating a lot after second dose), FATIGUE (Fatigue after second dose), HEADACHE (Headache after second dose), MYALGIA (Muscle Pain  after second dose), ARTHRALGIA (Joint Pain after second dose), PYREXIA (Fever 98.7 F (Usually 98.2 F) after second dose) and CHILLS (Chills after second dose). At the time of the report, HYPERHIDROSIS (Sweating a lot after second dose), FATIGUE (Fatigue after second dose), HEADACHE (Headache after second dose), MYALGIA (Muscle Pain  after second dose), ARTHRALGIA (Joint Pain after second dose), PYREXIA (Fever 98.7 F (Usually 98.2 F) after second dose) and CHILLS (Chills after second dose) outcome was unknown.            Treatment medication was not provided
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy since I got my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy since I got my first 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 DIZZINESS (dizzy since I got my first vaccine). At the time of the report, DIZZINESS (dizzy since I got my first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment and concomitant drugs information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No concomitant medications were provided.   No treatment was reported for the events.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Inflammatory response; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammatory response) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available (could be Pfizer's)) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammatory response). At the time of the report, INFLAMMATION (Inflammatory response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided  No treatment medications were provided.