chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain, Radiculitis brachial
Clinical narrative: She started to experience loss of strength below her elbow only on her right arm; She says it might be a brachial neuritis; On her left arm she has a radiating pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She started to experience loss of strength below her elbow only on her right arm), RADICULITIS BRACHIAL (She says it might be a brachial neuritis) and PAIN (On her left arm she has a radiating pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ASTHENIA (She started to experience loss of strength below her elbow only on her right arm), RADICULITIS BRACHIAL (She says it might be a brachial neuritis) and PAIN (On her left arm she has a radiating pain). At the time of the report, ASTHENIA (She started to experience loss of strength below her elbow only on her right arm), RADICULITIS BRACHIAL (She says it might be a brachial neuritis) and PAIN (On her left arm she has a radiating pain) outcome was unknown.            Relevant concomitant medications were not provided. Approximately in May patient started to experience the events. Treatment medication was not provided.   This case was linked to MOD-2021-292108 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Fever; Fatigue; Dizzy spells every 15 minutes/dizziness; Chills/severe chills; Aches and pains, entire body is aching every muscle; Headache/severe pounding headache; Nausea; Sweats/really sweaty; Entire body is aching every muscle and bone; Hot flashes; Then getting really cold; Haven't been able to sleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold) and INSOMNIA (Haven't been able to sleep) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold), INSOMNIA (Haven't been able to sleep), CHILLS (Chills/severe chills), MYALGIA (Aches and pains, entire body is aching every muscle), HEADACHE (Headache/severe pounding headache) and NAUSEA (Nausea). On 19-Aug-2021, the patient experienced DIZZINESS (Dizzy spells every 15 minutes/dizziness). On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold), INSOMNIA (Haven't been able to sleep), DIZZINESS (Dizzy spells every 15 minutes/dizziness), CHILLS (Chills/severe chills), PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Aches and pains, entire body is aching every muscle), HEADACHE (Headache/severe pounding headache) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication was not provided   This case was linked to MOD-2021-292142 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Insomnia, Myalgia, Nasopharyngitis
Clinical narrative: Fever; Fatigue; Dizzy spells every 15 minutes/dizziness; Chills/severe chills; Aches and pains, entire body is aching every muscle; Headache/severe pounding headache; Nausea; Sweats/really sweaty; Entire body is aching every muscle and bone; Hot flashes; Then getting really cold; Haven't been able to sleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold) and INSOMNIA (Haven't been able to sleep) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold), INSOMNIA (Haven't been able to sleep), CHILLS (Chills/severe chills), MYALGIA (Aches and pains, entire body is aching every muscle), HEADACHE (Headache/severe pounding headache) and NAUSEA (Nausea). On 19-Aug-2021, the patient experienced DIZZINESS (Dizzy spells every 15 minutes/dizziness). On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold), INSOMNIA (Haven't been able to sleep), DIZZINESS (Dizzy spells every 15 minutes/dizziness), CHILLS (Chills/severe chills), PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Aches and pains, entire body is aching every muscle), HEADACHE (Headache/severe pounding headache) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication was not provided   This case was linked to MOD-2021-292142 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Fatigue; Dizzy spells every 15 minutes/dizziness; Chills/severe chills; Aches and pains, entire body is aching every muscle; Headache/severe pounding headache; Nausea; Sweats/really sweaty; Entire body is aching every muscle and bone; Hot flashes; Then getting really cold; Haven't been able to sleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold) and INSOMNIA (Haven't been able to sleep) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold), INSOMNIA (Haven't been able to sleep), CHILLS (Chills/severe chills), MYALGIA (Aches and pains, entire body is aching every muscle), HEADACHE (Headache/severe pounding headache) and NAUSEA (Nausea). On 19-Aug-2021, the patient experienced DIZZINESS (Dizzy spells every 15 minutes/dizziness). On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HYPERHIDROSIS (Sweats/really sweaty), BONE PAIN (Entire body is aching every muscle and bone), HOT FLUSH (Hot flashes), NASOPHARYNGITIS (Then getting really cold), INSOMNIA (Haven't been able to sleep), DIZZINESS (Dizzy spells every 15 minutes/dizziness), CHILLS (Chills/severe chills), PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Aches and pains, entire body is aching every muscle), HEADACHE (Headache/severe pounding headache) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication was not provided   This case was linked to MOD-2021-292142 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not receive second dose on recommended window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose on recommended window) 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 22-Jun-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 PRODUCT DOSE OMISSION ISSUE (Did not receive second dose on recommended window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose on recommended window) had resolved.            No concomitant medications were provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experiencing a side effects after getting vaccinated a couple months ago; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing a side effects after getting vaccinated a couple months ago) 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 (Experiencing a side effects after getting vaccinated a couple months ago). At the time of the report, VACCINATION COMPLICATION (Experiencing a side effects after getting vaccinated a couple months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided by reporter. No treatment medications are provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Gout, Product dose omission issue
Clinical narrative: I received first moderna shot in January 2021, 2 days later had severe recurrence of my gout; only receiving one dose in January 2021; This spontaneous case was reported by a physician and describes the occurrence of GOUT (I received first moderna shot in January 2021, 2 days later had severe recurrence of my gout) and PRODUCT DOSE OMISSION ISSUE (only receiving one dose in January 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gout.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced GOUT (I received first moderna shot in January 2021, 2 days later had severe recurrence of my gout) and PRODUCT DOSE OMISSION ISSUE (only receiving one dose in January 2021). In January 2021, PRODUCT DOSE OMISSION ISSUE (only receiving one dose in January 2021) had resolved. At the time of the report, GOUT (I received first moderna shot in January 2021, 2 days later had severe recurrence of my gout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter No treatment medication were provided by the reporter. Patient reported that he received only one dose in January.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: 21May2021: I was supposed to get the 2nd dose.; My arm was sore /  sore arm at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (21May2021: I was supposed to get the 2nd dose.) and VACCINATION SITE PAIN (My arm was sore /  sore arm at the injection site.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Elective surgery (Patient Had elective surgery on 19-May-2021.) on 19-May-2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore /  sore arm at the injection site.). On 19-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (21May2021: I was supposed to get the 2nd dose.). On 19-Aug-2021, PRODUCT DOSE OMISSION ISSUE (21May2021: I was supposed to get the 2nd dose.) had resolved. At the time of the report, VACCINATION SITE PAIN (My arm was sore /  sore arm at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided. Consent given for Safety follow up/contact with caller & HCP.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient experienced an unspecified side effect lasting more than 24 hours.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient experienced an unspecified side effect lasting more than 24 hours.) 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 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 (Patient experienced an unspecified side effect lasting more than 24 hours.). At the time of the report, VACCINATION COMPLICATION (Patient experienced an unspecified side effect lasting more than 24 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No treatment medications was provided.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Vaccination site pain, Vaccination site warmth
Clinical narrative: Soreness; I have a headache; On the second day I had face warm arm; Arm pain; 30 minutes after I received the vaccine I started feeling dizzy and after I got home the dizziness got worse; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (30 minutes after I received the vaccine I started feeling dizzy and after I got home the dizziness got worse), PAIN (Soreness), VACCINATION SITE WARMTH (On the second day I had face warm arm), VACCINATION SITE PAIN (Arm pain) and HEADACHE (I have a headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B21A) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced DIZZINESS (30 minutes after I received the vaccine I started feeling dizzy and after I got home the dizziness got worse). On 16-Aug-2021, the patient experienced VACCINATION SITE WARMTH (On the second day I had face warm arm) and VACCINATION SITE PAIN (Arm pain). On 19-Aug-2021, the patient experienced PAIN (Soreness) and HEADACHE (I have a headache). At the time of the report, DIZZINESS (30 minutes after I received the vaccine I started feeling dizzy and after I got home the dizziness got worse), PAIN (Soreness), VACCINATION SITE WARMTH (On the second day I had face warm arm), VACCINATION SITE PAIN (Arm pain) and HEADACHE (I have a headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information not provided by reporter.  Patient received her first dose of the Moderna COVID-19 vaccine on 15AUG2021 in the left nondominant arm lot number 053B21A expiration date unknown. The patient reports that after receiving the vaccine she started to experience dizziness, headache, arm pain and soreness. The symptoms are currently ongoing.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Patients received vaccine from vials that where in a freezer thought to have gone a temperature excursion; Patients received vaccine from vials that where in a freezer thought to have gone a temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received vaccine from vials that where in a freezer thought to have gone a temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Patients received vaccine from vials that where in a freezer thought to have gone a temperature excursion) 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 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received vaccine from vials that where in a freezer thought to have gone a temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Patients received vaccine from vials that where in a freezer thought to have gone a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received vaccine from vials that where in a freezer thought to have gone a temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Patients received vaccine from vials that where in a freezer thought to have gone a temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.  Additional information reported include that the data logger was faulty and not the freezer, so there is no actual excursion took place and the freezer had remained within range the whole time.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Discomfort, Lymphadenopathy, Mammogram
Clinical narrative: Swelling on left breast,later moved to her right breast; Discomfort lymph gland under her armpit; Lymph gland under her armpit started to swell/Irritable lymph gland under her armpit; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Swelling on left breast,later moved to her right breast), DISCOMFORT (Discomfort lymph gland under her armpit) and LYMPHADENOPATHY (Lymph gland under her armpit started to swell/Irritable lymph gland under her armpit) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-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 BREAST SWELLING (Swelling on left breast,later moved to her right breast), DISCOMFORT (Discomfort lymph gland under her armpit) and LYMPHADENOPATHY (Lymph gland under her armpit started to swell/Irritable lymph gland under her armpit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BREAST SWELLING (Swelling on left breast,later moved to her right breast), DISCOMFORT (Discomfort lymph gland under her armpit) and LYMPHADENOPATHY (Lymph gland under her armpit started to swell/Irritable lymph gland under her armpit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: normal (normal) The mammogram did not show any malignant.         Concomitant medication were not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: a hard time to breath/shortness of breath like an asthma attack; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (a hard time to breath/shortness of breath like an asthma attack) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 002a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient has asthma since she was 6 years old). Concomitant products included VITAMIN D [VITAMIN D NOS], OMEPRAZOLE, ATORVASTATIN, AMLODIPINE, ALENDRONATE SODIUM (ALENDRONATE) and ASCORBIC ACID, ZINC (VITAMIN C + ZINC) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-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 DYSPNOEA (a hard time to breath/shortness of breath like an asthma attack) and PYREXIA (fever). At the time of the report, DYSPNOEA (a hard time to breath/shortness of breath like an asthma attack) and PYREXIA (fever) outcome was unknown.            Treatment information was not provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History was provided.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant Medications were provided. No Treatment Medications were provided.   This case was linked to MOD-2021-293338, MOD-2021-293337 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: follow up : Reporter details were updated, Outcome of the event was updated as recovered
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient days after vial was initially punctured/ vaccine was given from a vial punctured more than 12 hours ago) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) 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) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient days after vial was initially punctured/ vaccine was given from a vial punctured more than 12 hours ago). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient days after vial was initially punctured/ vaccine was given from a vial punctured more than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medications were not provided.Treatment medication was not provided. Medical assistant stated that a vaccine that was stored in the refrigerator between 4.1 C to 4.4 C, initially punctured at 9 am on 18AUG2021 was administered to a patient at 8:45 am on 20AUG2021. The vial was picked from the hospital which was 5 minutes away from the vaccination site. After this 5 minutes vial was put in the refrigerator on 17 Aug 2021. It was punctured on 18 Aug 2021 and dose was given on 20 Aug 2021. Vial had not suffered any temperature excursion and was had been less than 24 hours exposed to room temperature. Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Significant Follow-up received included dose 1 details, and patient's age.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I felt really fatigued / really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I felt really fatigued / really tired) 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 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 FATIGUE (I felt really fatigued / really tired). At the time of the report, FATIGUE (I felt really fatigued / really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.  No treatment information was mentioned.   This case was linked to MOD-2021-293546 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Is it ok to use advil for minor muscle aches in the first 24 hours post vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Is it ok to use advil for minor muscle aches in the first 24 hours post vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Is it ok to use advil for minor muscle aches in the first 24 hours post vaccine). At the time of the report, MYALGIA (Is it ok to use advil for minor muscle aches in the first 24 hours post vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant mediation was reported. No treatment information was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: got very loud tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (got very loud tinnitus) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus. Concomitant products included LISINOPRIL for an unknown indication.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (got very loud tinnitus). At the time of the report, TINNITUS (got very loud tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Application site discolouration, Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Injection site hot; Arms and head was itchy; Faint pink mark where it was red; Very itchy; Became bumpy; Red rash on the injection site; Red rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site hot), PRURITUS (Arms and head was itchy), APPLICATION SITE DISCOLOURATION (Faint pink mark where it was red), INJECTION SITE PRURITUS (Very itchy) and INJECTION SITE URTICARIA (Became bumpy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation (Patient has Afib, and is on blood thinners.). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Injection site hot), PRURITUS (Arms and head was itchy), APPLICATION SITE DISCOLOURATION (Faint pink mark where it was red), INJECTION SITE PRURITUS (Very itchy), INJECTION SITE URTICARIA (Became bumpy), INJECTION SITE RASH (Red rash on the injection site) and INJECTION SITE ERYTHEMA (Red rash on the injection site). At the time of the report, INJECTION SITE WARMTH (Injection site hot), PRURITUS (Arms and head was itchy), APPLICATION SITE DISCOLOURATION (Faint pink mark where it was red), INJECTION SITE PRURITUS (Very itchy), INJECTION SITE URTICARIA (Became bumpy), INJECTION SITE RASH (Red rash on the injection site) and INJECTION SITE ERYTHEMA (Red rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient put cold compresses on injection site and used cortisone cream.  The patient's second dose was scheduled for 28Aug2021.  Patient had a procedure for her Afib however it didn't work out. So on 07Sep2021 patient was going to cardiologist to see what needs to be done (medication or a procedure) to get her heart back in rhythm.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Injection site hot; Arms and head was itchy; Faint pink mark where it was red; Very itchy; Became bumpy; Red rash on the injection site; Red rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site hot), PRURITUS (Arms and head was itchy), APPLICATION SITE DISCOLOURATION (Faint pink mark where it was red), INJECTION SITE PRURITUS (Very itchy) and INJECTION SITE URTICARIA (Became bumpy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation (Patient has Afib, and is on blood thinners.). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Injection site hot), PRURITUS (Arms and head was itchy), APPLICATION SITE DISCOLOURATION (Faint pink mark where it was red), INJECTION SITE PRURITUS (Very itchy), INJECTION SITE URTICARIA (Became bumpy), INJECTION SITE RASH (Red rash on the injection site) and INJECTION SITE ERYTHEMA (Red rash on the injection site). At the time of the report, INJECTION SITE WARMTH (Injection site hot), PRURITUS (Arms and head was itchy), APPLICATION SITE DISCOLOURATION (Faint pink mark where it was red), INJECTION SITE PRURITUS (Very itchy), INJECTION SITE URTICARIA (Became bumpy), INJECTION SITE RASH (Red rash on the injection site) and INJECTION SITE ERYTHEMA (Red rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient put cold compresses on injection site and used cortisone cream.  The patient's second dose was scheduled for 28Aug2021.  Patient had a procedure for her Afib however it didn't work out. So on 07Sep2021 patient was going to cardiologist to see what needs to be done (medication or a procedure) to get her heart back in rhythm.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received a Johnson&Johnson COVID-19 vaccine 7 plus weeks after receiving the first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received a Johnson&Johnson COVID-19 vaccine 7 plus weeks after receiving the first dose of the Moderna COVID-19 vaccine) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received a Johnson&Johnson COVID-19 vaccine 7 plus weeks after receiving the first dose of the Moderna COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received a Johnson&Johnson COVID-19 vaccine 7 plus weeks after receiving the first dose of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not reported  Patient had received a Johnson & Johnson COVID-19 vaccine after 7weeks of first dose and also not entirely sure that the first dose was Moderna/Pfizer
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after receiving first dose of Moderna Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19 after receiving first dose of Moderna Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received 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-19 after receiving first dose of Moderna Vaccine). At the time of the report, COVID-19 (Tested positive for COVID-19 after receiving first dose of Moderna Vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Lightheadedness) and FEELING ABNORMAL (It is still sore, know exactly where receive the shot, can feel it exactly) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 039C21A) for COVID-19 vaccination. No Medical History information was reported.On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Lightheadedness) and FEELING ABNORMAL (It is still sore, know exactly where receive the shot, can feel it exactly). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Lightheadedness) and FEELING ABNORMAL (It is still sore, know exactly where receive the shot, can feel it exactly) had not resolved. Concomitant product use was not provided. Treatment information was not  provided. Patient received both doses of the Moderna COVID-19 Vaccine and called to report a sore arm still today and a lightheadedness that is ongoing.The patient said that thought the lightheadedness was going to pass but has been going on. The symptoms started between 4 to 6 days after the second dose and have been having it since. He is going to see the doctor next Friday.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medication were not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: same night woke up with 1/2 of her face numb; tingling sensation; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (same night woke up with 1/2 of her face numb) and PARAESTHESIA (tingling sensation) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced HYPOAESTHESIA (same night woke up with 1/2 of her face numb) and PARAESTHESIA (tingling sensation). At the time of the report, HYPOAESTHESIA (same night woke up with 1/2 of her face numb) and PARAESTHESIA (tingling sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After receiving the vaccine, the same night she woke up with 1/2 of her face numb and had tingling sensation. Patient did not take any medicine to subsided the face numb and tingling sensations.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever 99-99.5/Fever 101/Fever 102.5; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever 99-99.5/Fever 101/Fever 102.5) 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 20-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 21-Aug-2021, the patient experienced PYREXIA (Low grade fever 99-99.5/Fever 101/Fever 102.5). On 21-Aug-2021, PYREXIA (Low grade fever 99-99.5/Fever 101/Fever 102.5) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: 101 Friday and 102.5 Friday Eve. On 21-Aug-2021, Body temperature: 99-99.5 Saturday. On 22-Aug-2021, Body temperature: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue
Clinical narrative: After the shot he started coughing, and been fatigue; After the shot he started coughing, and been fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (After the shot he started coughing, and been fatigue) and FATIGUE (After the shot he started coughing, and been fatigue) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (After the shot he started coughing, and been fatigue) and FATIGUE (After the shot he started coughing, and been fatigue). At the time of the report, COUGH (After the shot he started coughing, and been fatigue) and FATIGUE (After the shot he started coughing, and been fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Past recommended interval received first dose mid May; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past recommended interval received first dose mid May) 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.    In May 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 PRODUCT DOSE OMISSION ISSUE (Past recommended interval received first dose mid May). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past recommended interval received first dose mid May) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No Treatment medications was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment details were provided by reporter.