chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain, Pyrexia, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: she cannot move; waking up in the middle of the night due to pain; hives popped up on the injection site; fatigue; headache; fever; 3 inches wheal on arm of injection site- allergic and inflamed; feeling unwell; mild transient side effects; scratchy throat; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (mild transient side effects), OROPHARYNGEAL DISCOMFORT (scratchy throat), HYPOKINESIA (she cannot move), MALAISE (feeling unwell) and PAIN (waking up in the middle of the night due to pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ADVERSE EVENT (mild transient side effects), OROPHARYNGEAL DISCOMFORT (scratchy throat), MALAISE (feeling unwell), VACCINATION SITE REACTION (3 inches wheal on arm of injection site- allergic and inflamed), PYREXIA (fever) and HEADACHE (headache). On 07-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (hives popped up on the injection site) and FATIGUE (fatigue). On an unknown date, the patient experienced HYPOKINESIA (she cannot move) and PAIN (waking up in the middle of the night due to pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CIMETIDINE (TAGAMET [CIMETIDINE]) at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (mild transient side effects), OROPHARYNGEAL DISCOMFORT (scratchy throat), HYPOKINESIA (she cannot move), MALAISE (feeling unwell), PAIN (waking up in the middle of the night due to pain), VACCINATION SITE REACTION (3 inches wheal on arm of injection site- allergic and inflamed), VACCINATION SITE URTICARIA (hives popped up on the injection site), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product  use was reported.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, COVID-19, SARS-CoV-2 test
Clinical narrative: Back pain; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and BACK PAIN (Back pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On 07-Apr-2021, the patient experienced BACK PAIN (Back pain). At the time of the report, COVID-19 (Tested positive for COVID) and BACK PAIN (Back pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified thyroid medication.   Patient had throat ache, mild chest pain and headache due to COVID-19. Treatment medications included Vitamin C, Vitamin D, Magnesium, Ibuprofen, Robitusin since 01-Apr-2021 and started by taking the vitamins and then on the following days, started adding some medicines.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain in arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). On 06-Mar-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071231 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071231:Crosslink (MOD21-071889)
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vaccination site bruising
Clinical narrative: bruise on her arm; head cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (head cold) and VACCINATION SITE BRUISING (bruise on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-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 04-Apr-2021, the patient experienced NASOPHARYNGITIS (head cold). On an unknown date, the patient experienced VACCINATION SITE BRUISING (bruise on her arm). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (head cold) was resolving and VACCINATION SITE BRUISING (bruise on her arm) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment for the event included allergy medicine which did not help. The patient took guaifenesin (Mucinex) and was helping.   Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD21-072083, MOD21-072096 (E2B Linked Report).; Sender's Comments:  MOD21-072083: MOD21-072096:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Patient had cough, no taste, no smell, fever, headache and was tired due to COVID.  Treatment medications included over the counter pain relievers and unspecified cough medicine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site swelling
Clinical narrative: Hives on the left side of body, near the stomach and waist/Itchy hives, around 6 in total; Left arm swelled a little bit; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives on the left side of body, near the stomach and waist/Itchy hives, around 6 in total) and VACCINATION SITE SWELLING (Left arm swelled a little bit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy NOS.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Left arm swelled a little bit). On 07-Apr-2021, the patient experienced URTICARIA (Hives on the left side of body, near the stomach and waist/Itchy hives, around 6 in total). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on the left side of body, near the stomach and waist/Itchy hives, around 6 in total) and VACCINATION SITE SWELLING (Left arm swelled a little bit) 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Horrendous pain the left arm from shoulder to tip of fingers), GAIT DISTURBANCE (Little bit unstable in walking) and VACCINATION SITE SWELLING (Swelling in the arm of injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Horrendous pain the left arm from shoulder to tip of fingers), GAIT DISTURBANCE (Little bit unstable in walking) and VACCINATION SITE SWELLING (Swelling in the arm of injection). The patient was treated with OXYCODONE at an unspecified dose and frequency. On 30-Mar-2021, PAIN IN EXTREMITY (Horrendous pain the left arm from shoulder to tip of fingers), GAIT DISTURBANCE (Little bit unstable in walking) and VACCINATION SITE SWELLING (Swelling in the arm of injection) had resolved. Not Provided          Concomitant medications reported by the patient also included pill for blood pressure and vitamin supplements.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Apr-2021, VACCINATION SITE PAIN (sore arm) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment included ice.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Under age got the first dose of Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age got the first dose of Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age got the first dose of Moderna vaccine). On 08-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age got the first dose of Moderna vaccine) had resolved. Not Provided      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 product use was not provided by the reporter. No treatment information was provided.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Fall, Fatigue, Knee deformity
Clinical narrative: No control at all; fell down by the bed; cannot stand; Cannot lift her arm; not able to think properly; feeling weak; Walk around with the help of walker , but cannot straighten up her knees; Walk around with the help of walker , but cannot straighten up her knees; tired easily; bad reaction; no muscle control; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (bad reaction), MUSCLE DISORDER (no muscle control), MUSCLE DISORDER (No control at all), FALL (fell down by the bed) and DYSSTASIA (cannot stand) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL for Blood pressure management, APIXABAN (ELIQUIS) for Clot blood, RIVASTIGMINE for Sinus infection, HYDROCHLOROTHIAZIDE, BENAZEPRIL, POTASSIUM CHLORIDE and GABAPENTIN for an unknown indication.   On 24-Mar-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 25-Mar-2021, the patient experienced VACCINATION COMPLICATION (bad reaction), MUSCLE DISORDER (no muscle control), FALL (fell down by the bed), DYSSTASIA (cannot stand), LIMB DISCOMFORT (Cannot lift her arm), THINKING ABNORMAL (not able to think properly), ASTHENIA (feeling weak), WALKING AID USER (Walk around with the help of walker , but cannot straighten up her knees), KNEE DEFORMITY (Walk around with the help of walker , but cannot straighten up her knees) and FATIGUE (tired easily). On an unknown date, the patient experienced MUSCLE DISORDER (No control at all). At the time of the report, VACCINATION COMPLICATION (bad reaction), MUSCLE DISORDER (no muscle control), MUSCLE DISORDER (No control at all), FALL (fell down by the bed), DYSSTASIA (cannot stand), LIMB DISCOMFORT (Cannot lift her arm), THINKING ABNORMAL (not able to think properly), ASTHENIA (feeling weak), WALKING AID USER (Walk around with the help of walker , but cannot straighten up her knees) and FATIGUE (tired easily) outcome was unknown and KNEE DEFORMITY (Walk around with the help of walker , but cannot straighten up her knees) had not resolved.            No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle disorder, Thinking abnormal, Vaccination complication, Walking aid user
Clinical narrative: No control at all; fell down by the bed; cannot stand; Cannot lift her arm; not able to think properly; feeling weak; Walk around with the help of walker , but cannot straighten up her knees; Walk around with the help of walker , but cannot straighten up her knees; tired easily; bad reaction; no muscle control; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (bad reaction), MUSCLE DISORDER (no muscle control), MUSCLE DISORDER (No control at all), FALL (fell down by the bed) and DYSSTASIA (cannot stand) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL for Blood pressure management, APIXABAN (ELIQUIS) for Clot blood, RIVASTIGMINE for Sinus infection, HYDROCHLOROTHIAZIDE, BENAZEPRIL, POTASSIUM CHLORIDE and GABAPENTIN for an unknown indication.   On 24-Mar-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 25-Mar-2021, the patient experienced VACCINATION COMPLICATION (bad reaction), MUSCLE DISORDER (no muscle control), FALL (fell down by the bed), DYSSTASIA (cannot stand), LIMB DISCOMFORT (Cannot lift her arm), THINKING ABNORMAL (not able to think properly), ASTHENIA (feeling weak), WALKING AID USER (Walk around with the help of walker , but cannot straighten up her knees), KNEE DEFORMITY (Walk around with the help of walker , but cannot straighten up her knees) and FATIGUE (tired easily). On an unknown date, the patient experienced MUSCLE DISORDER (No control at all). At the time of the report, VACCINATION COMPLICATION (bad reaction), MUSCLE DISORDER (no muscle control), MUSCLE DISORDER (No control at all), FALL (fell down by the bed), DYSSTASIA (cannot stand), LIMB DISCOMFORT (Cannot lift her arm), THINKING ABNORMAL (not able to think properly), ASTHENIA (feeling weak), WALKING AID USER (Walk around with the help of walker , but cannot straighten up her knees) and FATIGUE (tired easily) outcome was unknown and KNEE DEFORMITY (Walk around with the help of walker , but cannot straighten up her knees) had not resolved.            No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: almost fainted; dizzy; Had to hold on to the walls because I felt very weak and dizzy; severe headache; tired; shaking with chills; Arm ache after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (almost fainted), DIZZINESS (dizzy), ASTHENIA (Had to hold on to the walls because I felt very weak and dizzy), HEADACHE (severe headache) and FATIGUE (tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2011, Hypothyroidism since 1996 and Sjogren's since 2007. Concomitant products included LOSARTAN, METOPROLOL, AMLODIPINE, ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm ache after second dose). On 01-Apr-2021, the patient experienced PRESYNCOPE (almost fainted), DIZZINESS (dizzy), ASTHENIA (Had to hold on to the walls because I felt very weak and dizzy), HEADACHE (severe headache), FATIGUE (tired) and CHILLS (shaking with chills). On 01-Apr-2021, VACCINATION SITE PAIN (Arm ache after second dose) had resolved. On 02-Apr-2021, PRESYNCOPE (almost fainted) had resolved. At the time of the report, DIZZINESS (dizzy), ASTHENIA (Had to hold on to the walls because I felt very weak and dizzy), HEADACHE (severe headache), FATIGUE (tired) and CHILLS (shaking with chills) outcome was unknown.            Patient has fainted about 6 times in the past & knew that she was about to faint so laid down on the  bathroom floor for about 5 hours floor.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Followup was received on 04-May-2021.Added concomitant medication, patient medical history ,Updated contact information,patient demographics, event outcome
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vaccination site pain
Clinical narrative: almost fainted; dizzy; Had to hold on to the walls because I felt very weak and dizzy; severe headache; tired; shaking with chills; Arm ache after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (almost fainted), DIZZINESS (dizzy), ASTHENIA (Had to hold on to the walls because I felt very weak and dizzy), HEADACHE (severe headache) and FATIGUE (tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2011, Hypothyroidism since 1996 and Sjogren's since 2007. Concomitant products included LOSARTAN, METOPROLOL, AMLODIPINE, ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm ache after second dose). On 01-Apr-2021, the patient experienced PRESYNCOPE (almost fainted), DIZZINESS (dizzy), ASTHENIA (Had to hold on to the walls because I felt very weak and dizzy), HEADACHE (severe headache), FATIGUE (tired) and CHILLS (shaking with chills). On 01-Apr-2021, VACCINATION SITE PAIN (Arm ache after second dose) had resolved. On 02-Apr-2021, PRESYNCOPE (almost fainted) had resolved. At the time of the report, DIZZINESS (dizzy), ASTHENIA (Had to hold on to the walls because I felt very weak and dizzy), HEADACHE (severe headache), FATIGUE (tired) and CHILLS (shaking with chills) outcome was unknown.            Patient has fainted about 6 times in the past & knew that she was about to faint so laid down on the  bathroom floor for about 5 hours floor.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Followup was received on 04-May-2021.Added concomitant medication, patient medical history ,Updated contact information,patient demographics, event outcome
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: rash kind of like having hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash kind of like having hives) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (rash kind of like having hives). At the time of the report, URTICARIA (rash kind of like having hives) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment was received. Patient had rash kind of like having hives all over her body but mostly on her eyes, nose, on her face and neck and shoulders. Patent took second dose on 25-FEB-2021 with lot no. 010A21A.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm; Pain has radiated out; Sore arm (radiated out); Tenderness and extremely painful on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Pain has radiated out), MYALGIA (Sore arm (radiated out)) and VACCINATION SITE PAIN (Tenderness and extremely painful on the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00TM200A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sciatic nerve injury (sciatic nerve problem). Concomitant products included GABAPENTIN for Sciatic nerve neuropathy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 PAIN IN EXTREMITY (Sore arm), PAIN (Pain has radiated out), MYALGIA (Sore arm (radiated out)) and VACCINATION SITE PAIN (Tenderness and extremely painful on the injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PAIN (Pain has radiated out) outcome was unknown and MYALGIA (Sore arm (radiated out)) and VACCINATION SITE PAIN (Tenderness and extremely painful on the injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use also included anti-inflammatory medications.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up information included reporter details was updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hair growth rate abnormal, Myalgia
Clinical narrative: Hair has not grown since; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HAIR GROWTH RATE ABNORMAL (Hair has not grown since) and MYALGIA (Muscle pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A71A and 00FM201) for COVID-19 vaccination.     Concomitant products included ATENOLOL, CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA), ALENDRONATE SODIUM (FOSAMAX), LISINOPRIL, METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), SIMVASTATIN and SERTRALINE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced HAIR GROWTH RATE ABNORMAL (Hair has not grown since) and MYALGIA (Muscle pain). At the time of the report, HAIR GROWTH RATE ABNORMAL (Hair has not grown since) and MYALGIA (Muscle pain) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; Fever 101F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Fever 101F) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. bm9807 and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever 101F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and PYREXIA (Fever 101F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) fever 101°F.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use included diabetes medication.  Patient reported that he was doing fine.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up information included event outcome was updated to recovered.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 immunization.     Concurrent medical conditions included Hypertension since June 1997, GERD since July 2000 and Osteoporosis since November 2002. Concomitant products included QUINAPRIL from July 1997 to an unknown date, LANSOPRAZOLE (PREVACID) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID Arm). At the time of the report, VACCINATION SITE REACTION (COVID Arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-071278 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Reporter contact details were updated, patient demographic details were updated, current conditions were added, concomitant medications were added.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-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 08-Apr-2021, the patient experienced PAIN (Achy). At the time of the report, PAIN (Achy) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Tired) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tired). On 20-Mar-2021, HEADACHE (Headache) and FATIGUE (Tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified asthma inhaler.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temperature next day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature next day after receiving 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-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) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (Temperature next day after receiving 2nd dose). At the time of the report, PYREXIA (Temperature next day after receiving 2nd dose) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Heart rate, Heart rate increased, Hypertension, Oropharyngeal pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (scratchy throat), HYPERTENSION (High blood pressure), HEART RATE INCREASED (Pulse over 120) and COUGH (uncontrollable cough) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 01-Mar-2021. Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (scratchy throat), HYPERTENSION (High blood pressure), HEART RATE INCREASED (Pulse over 120) and COUGH (uncontrollable cough). On 20-Mar-2021, OROPHARYNGEAL PAIN (scratchy throat) and HYPERTENSION (High blood pressure) had resolved. At the time of the report, HEART RATE INCREASED (Pulse over 120) and COUGH (uncontrollable cough) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. In March 2021, Heart rate: 120 (High) 120. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (scratchy throat), HYPERTENSION (High blood pressure), HEART RATE INCREASED (Pulse over 120) and COUGH (uncontrollable cough) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 01-Mar-2021. Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (scratchy throat), HYPERTENSION (High blood pressure), HEART RATE INCREASED (Pulse over 120) and COUGH (uncontrollable cough). On 20-Mar-2021, OROPHARYNGEAL PAIN (scratchy throat) and HYPERTENSION (High blood pressure) had resolved. At the time of the report, HEART RATE INCREASED (Pulse over 120) and COUGH (uncontrollable cough) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. In March 2021, Heart rate: 120 (High) 120. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was not discarded after the 6 hours, patient was accidently given the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was not discarded after the 6 hours, patient was accidently given the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included DULAGLUTIDE (TRULICITY), OXYBUTYNIN CHLORIDE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FAMOTIDINE, METOPROLOL TARTRATE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ROPINIROLE, EZETIMIBE and METFORMIN HYDROCHLORIDE (METFORMIN ER) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was not discarded after the 6 hours, patient was accidently given the vaccine). On 07-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was not discarded after the 6 hours, patient was accidently given the vaccine) had resolved. Not Provided      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.   Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe body ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe body ache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MYALGIA (Severe body ache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (Severe body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; Little warmness; Little body ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS, FEELING HOT, and MYALGIA in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039AZ14 and 036AZIA) for COVID-19 vaccination.     Concomitant products included VITAMINS for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS, FEELING HOT, and MYALGIA. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS, FEELING HOT, and MYALGIA had not resolved. Not Provided.          Action taken with mRNA-1273 in response to the event was not applicable.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, CARVEDILOL and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested Positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter was calling on behalf of their husband who received their first dose and tested positive for COVID.  Concomitant product used by the patient also included unspecified statin.  No treatment information was provided.   This case was linked to MOD-2021-071112 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site was hot; Injection site was itchy; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red) 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 SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red). At the time of the report, VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that their injection site was itchy, red, and hot. The patient did not confirm whether they received Moderna COVID19 vaccine.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071301 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071301:crosslinked
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product substitution issue
Clinical narrative: vaccine administered to unauthorized age of 17 yrs; He thought he was receiving the Pfizer vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to unauthorized age of 17 yrs) and PRODUCT SUBSTITUTION ISSUE (He thought he was receiving the Pfizer vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to unauthorized age of 17 yrs) and PRODUCT SUBSTITUTION ISSUE (He thought he was receiving the Pfizer vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to unauthorized age of 17 yrs) and PRODUCT SUBSTITUTION ISSUE (He thought he was receiving the Pfizer vaccine) 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.   Reporter wanted information about next steps to take. She was guided with information, if the dose is administered at the age of 16 to 17, patient can administer the second dose. Hence, patient being 17 years old can get his second dose 28 days later.   Concomitant medications were not reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Weakness; Fever; Nausea; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter was calling on behalf of their friend who had COVID and then received the first dose of the vaccine on 31-Mar-2021. The patient experienced fever, nausea, headache, chills, and weakness.  No Concomitant product use was reported. No treatment information was provided.