chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: bumps around the place of the vaccine, like mosquito bites; warm to the touch; was itchy - ongoing; it hurt if she moved or touched it; The site of injection got swollen; chills; a little bit of a headache; general discomfort in the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (general discomfort in the area), RASH PAPULAR (bumps around the place of the vaccine, like mosquito bites), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (was itchy - ongoing) and VACCINATION SITE PAIN (it hurt if she moved or touched it) in a 48-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.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE DISCOMFORT (general discomfort in the area), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (was itchy - ongoing), VACCINATION SITE PAIN (it hurt if she moved or touched it), VACCINATION SITE SWELLING (The site of injection got swollen), CHILLS (chills) and HEADACHE (a little bit of a headache). On 12-Sep-2021, the patient experienced RASH PAPULAR (bumps around the place of the vaccine, like mosquito bites). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at a dose of Cream. On 11-Sep-2021, HEADACHE (a little bit of a headache) had resolved. On 14-Sep-2021, CHILLS (chills) outcome was unknown. At the time of the report, VACCINATION SITE DISCOMFORT (general discomfort in the area), RASH PAPULAR (bumps around the place of the vaccine, like mosquito bites), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (was itchy - ongoing), VACCINATION SITE PAIN (it hurt if she moved or touched it) and VACCINATION SITE SWELLING (The site of injection got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Heart burn medications
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dyspnoea, Fatigue, Feeling abnormal, Peripheral swelling
Clinical narrative: shortness of breath sometimes; Swelling in the legs; Blisters, blisters are like a sunburn, water blisters, blisters are starting to open up and sip; No energy; Ever since she got the first dose she has felt very very crummy,everything started and it got progressively worse, Sometimes she feels better, sometimes worse; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Ever since she got the first dose she has felt very very crummy,everything started and it got progressively worse, Sometimes she feels better, sometimes worse), DYSPNOEA (shortness of breath sometimes), PERIPHERAL SWELLING (Swelling in the legs), BLISTER (Blisters, blisters are like a sunburn, water blisters, blisters are starting to open up and sip) and FATIGUE (No energy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (In knees).    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced FEELING ABNORMAL (Ever since she got the first dose she has felt very very crummy,everything started and it got progressively worse, Sometimes she feels better, sometimes worse). On an unknown date, the patient experienced DYSPNOEA (shortness of breath sometimes), PERIPHERAL SWELLING (Swelling in the legs), BLISTER (Blisters, blisters are like a sunburn, water blisters, blisters are starting to open up and sip) and FATIGUE (No energy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Ever since she got the first dose she has felt very very crummy,everything started and it got progressively worse, Sometimes she feels better, sometimes worse), DYSPNOEA (shortness of breath sometimes), PERIPHERAL SWELLING (Swelling in the legs), BLISTER (Blisters, blisters are like a sunburn, water blisters, blisters are starting to open up and sip) and FATIGUE (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient regularly checked blood pressure, and states for the past month it has not been right. Patient mentions that the most difference are in the bottom numbers, which are higher than normal.  No relevant concomitant medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Coma, Fatigue, Loss of consciousness
Clinical narrative: Went into coma; Was knocked out; Had no energy; Very tired; Was in bed for 30hrs; This spontaneous case was reported by a consumer and describes the occurrence of COMA (Went into coma) and LOSS OF CONSCIOUSNESS (Was knocked out) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu-like illness in March 2021.   In July 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COMA (Went into coma) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Was knocked out) (seriousness criterion medically significant), ASTHENIA (Had no energy), BEDRIDDEN (Was in bed for 30hrs) and FATIGUE (Very tired). At the time of the report, COMA (Went into coma), LOSS OF CONSCIOUSNESS (Was knocked out), ASTHENIA (Had no energy) and FATIGUE (Very tired) outcome was unknown and BEDRIDDEN (Was in bed for 30hrs) had resolved.            Concomitant medications were not reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not Applicable.  Company Comment: This case concerns a 61-year-old male patient with previous medical history of Flu-like illness, who experienced the unexpected serious events of Coma and Loss of consciousness, non-serious unexpected events Asthenia and Bedridden and non-serious expected event of fatigue. Very limited information was provided regarding the events. The events were considered related to the product per the reporter's assessment. The rechallenge was unknown since there is limited information about the Moderna Covid-19 vaccine doses. The benefit-risk relationship of Covid-19 vaccine is not affected by this report.   This case was linked to MOD-2021-319992 (Patient Link).; Sender's Comments: This case concerns a 61-year-old male patient with previous medical history of Flu-like illness, who experienced the unexpected serious events of Coma and Loss of consciousness, non-serious unexpected events Asthenia and Bedridden and non-serious expected event of fatigue. Very limited information was provided regarding the events.The events were considered related to the product per the reporter's assessment. The rechallenge was unknown since there is limited information about the Moderna Covid-19 vaccine doses. The benefit-risk relationship of Covid-19 vaccine is not affected by this report.report.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of SARS-CoV-2 positive test (tested positive/must have already had COVID-19 when got the shot although didn't know it) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 23, 2021, patient experienced SARS-CoV-2 positive test (tested positive/must have already had COVID-19 when got the shot although didn't know it). At the time of the report, SARS-CoV-2 positive test (tested positive/must have already had COVID-19 when got the shot although didn't know it) outcome: unknown. Diagnostic results: On Aug 23, 2021, SARS-CoV-2 positive test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information not provided. Patient received antibodies on August 26. This case linked to MOD-2021-319706 (patient link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Inappropriate schedule of product administration, Insomnia, Pollakiuria
Clinical narrative: Frequent urination; Dry mouth; Disrupting her sleep; Injections 21 days apart; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination), DRY MOUTH (Dry mouth), INSOMNIA (Disrupting her sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Injections 21 days apart) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Injections 21 days apart). On an unknown date, the patient experienced POLLAKIURIA (Frequent urination), DRY MOUTH (Dry mouth) and INSOMNIA (Disrupting her sleep). On 21-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Injections 21 days apart) had resolved. At the time of the report, POLLAKIURIA (Frequent urination), DRY MOUTH (Dry mouth) and INSOMNIA (Disrupting her sleep) outcome was unknown.            The patient developed side effects of frequent urination and dry mouth that were actually disrupting her sleep she can not go anywhere without water.  No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-319687 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little pain in the arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little pain in the arm at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A, 056A21A and 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Wheelchair user (a double-leg amputee). Concomitant products included INSULIN ISOPHANE BOVINE (INSULIN NPH [INSULIN ISOPHANE BOVINE]), CLOPIDOGREL, GABAPENTIN, DULOXETINE, ASPIRIN [ACETYLSALICYLIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication, LISINOPRIL.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Little pain in the arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Little pain in the arm at the injection site) outcome was unknown.            Concomitant products included Probiotic pills (NOS) for an unknown indication.  No treatment information was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered > 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post puncture) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  Number of doses/vials was one. The vial was initially stored in the refrigerator on 13-Sep-2021. Date(s) and time(S) vial was first punctured on 13-Sep-2021. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: something they experienced but didn't bother them; 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 VACCINATION COMPLICATION (something they experienced but didn't bother them) 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 (something they experienced but didn't bother them). At the time of the report, VACCINATION COMPLICATION (something they experienced but didn't bother them) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant and no treatment were provided   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Heart rate abnormal, Heart rate increased, Impaired work ability
Clinical narrative: heart rate wouldn't stay elevated all the time; it felt like butterflies in the chest; I missed 4 days of work due to this; I was nauseous during that time too; I was having twinges in my chest; after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I was having twinges in my chest), HEART RATE INCREASED (after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight), HEART RATE ABNORMAL (heart rate wouldn't stay elevated all the time), FEELING ABNORMAL (it felt like butterflies in the chest) and IMPAIRED WORK ABILITY (I missed 4 days of work due to this) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TOPIRAMATE, MONTELUKAST SODIUM (SINGULAIR), ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CHEST PAIN (I was having twinges in my chest) and HEART RATE INCREASED (after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight). In April 2021, the patient experienced HEART RATE ABNORMAL (heart rate wouldn't stay elevated all the time), FEELING ABNORMAL (it felt like butterflies in the chest), IMPAIRED WORK ABILITY (I missed 4 days of work due to this) and NAUSEA (I was nauseous during that time too). In April 2021, CHEST PAIN (I was having twinges in my chest), HEART RATE INCREASED (after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight), HEART RATE ABNORMAL (heart rate wouldn't stay elevated all the time), FEELING ABNORMAL (it felt like butterflies in the chest), IMPAIRED WORK ABILITY (I missed 4 days of work due to this) and NAUSEA (I was nauseous during that time too) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: heart rate wouldn't stay elevated all the time; it felt like butterflies in the chest; I missed 4 days of work due to this; I was nauseous during that time too; I was having twinges in my chest; after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I was having twinges in my chest), HEART RATE INCREASED (after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight), HEART RATE ABNORMAL (heart rate wouldn't stay elevated all the time), FEELING ABNORMAL (it felt like butterflies in the chest) and IMPAIRED WORK ABILITY (I missed 4 days of work due to this) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TOPIRAMATE, MONTELUKAST SODIUM (SINGULAIR), ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CHEST PAIN (I was having twinges in my chest) and HEART RATE INCREASED (after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight). In April 2021, the patient experienced HEART RATE ABNORMAL (heart rate wouldn't stay elevated all the time), FEELING ABNORMAL (it felt like butterflies in the chest), IMPAIRED WORK ABILITY (I missed 4 days of work due to this) and NAUSEA (I was nauseous during that time too). In April 2021, CHEST PAIN (I was having twinges in my chest), HEART RATE INCREASED (after 30 minutes, my heart rate was at 129 beats per minute/it accelerated to 165 bpm overnight), HEART RATE ABNORMAL (heart rate wouldn't stay elevated all the time), FEELING ABNORMAL (it felt like butterflies in the chest), IMPAIRED WORK ABILITY (I missed 4 days of work due to this) and NAUSEA (I was nauseous during that time too) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (History of prostate cancer (10 years ago).). Previously administered products included for an unreported indication: AMLODIPINE, LATANOPROST, MULTIVITAMIN & MINERAL, TAMSULOSIN and SERTRALINE. Concurrent medical conditions included Prediabetes, Hypertension, Benign prostatic hyperplasia, Hernia (Left in wall hernia) and Depression.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  The patient received their first dose of the vaccine on 24-Jan-2021 and experienced a sore arm.   This case was linked to MOD-2021-319746.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight sore arm after her 2nd Moderna dose; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (slight sore arm after her 2nd Moderna 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (slight sore arm after her 2nd Moderna dose). At the time of the report, VACCINATION SITE PAIN (slight sore arm after her 2nd Moderna dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-319756 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Body aches; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Exhaustion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Allergy to antibiotic (Keflex), Allergy to antibiotic (Ceclor) and Perimenopause (take HRT). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 23-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Exhaustion). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 24-Jan-2021, PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Exhaustion) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient had an antibody test- No results provided Concomitant medications included pill for menopause taken orally  Patient had her periods after taking the vaccine   This case was linked to MOD-2021-022373 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: On an unspecified date after getting the 1st dose, got sick for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (On an unspecified date after getting the 1st dose, got sick for a week) in a 63-year-old female patient 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. In June 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 ILLNESS (On an unspecified date after getting the 1st dose, got sick for a week). At the time of the report, ILLNESS (On an unspecified date after getting the 1st dose, got sick for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown, dechallenge unknown, rechallenge positive.  Treatment information was not provided.   This case was linked to MOD-2021-319876 (Patient Link).; Sender's Comments: This case concerns a 63-year-old, female patient with unknown medical history, who experienced the unexpected non-serious event of illness was noticed after first dose and unexpected non-serious events of illness, short of breath, fever, sinusitis, and ear infection after second dose.  The rechallenge is noticed for illness. The reporter did not provide the causality assessment. The benefit-risk relationship of Spikevax in not affected by this report.  NOTE:: The case has another case  (non-serious MOD-2021-319876) registered for the events after second dose.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: extra warmth on my upper arm; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (extra warmth on my upper arm) and VACCINATION SITE ERYTHEMA (Redness) 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 (extra warmth on my upper arm) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (extra warmth on my upper arm) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Musculoskeletal pain, Pain in extremity, Vaccination complication
Clinical narrative: passed out; severe reaction/Idiosyncratic Vaccine Reaction; severe right thigh and buttock pain; developed sweats; severe right thigh and buttock pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 39-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 PHENTERMINE (ADIPEX [PHENTERMINE]) and PIROXICAM (PAXIL [PIROXICAM]) for an unknown indication.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), VACCINATION COMPLICATION (severe reaction/Idiosyncratic Vaccine Reaction), PAIN IN EXTREMITY (severe right thigh and buttock pain), HYPERHIDROSIS (developed sweats) and MUSCULOSKELETAL PAIN (severe right thigh and buttock pain). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), VACCINATION COMPLICATION (severe reaction/Idiosyncratic Vaccine Reaction), PAIN IN EXTREMITY (severe right thigh and buttock pain), HYPERHIDROSIS (developed sweats) and MUSCULOSKELETAL PAIN (severe right thigh and buttock pain) 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 treatment medication information was mentioned by reporter.  Company comment: This case concerns a 39-year-old, female patient with no relevant medical history who experienced the unexpected event of Loss of consciousness. The event occurred twelve hours after receiving the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273is not affected by this report.; Sender's Comments: This case concerns a 39-year-old, female patient with no relevant medical history who experienced the unexpected event of Loss of consciousness. The event occurred twelve hours after receiving the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Coma, Fatigue, Knee deformity
Clinical narrative: went into coma; had no energy; was knocked out/ was in bed for 30hrs; very tired; This spontaneous case was reported by a consumer and describes the occurrence of COMA (went into coma) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu-like illness in March 2021.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, 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 COMA (went into coma) (seriousness criterion medically significant), ASTHENIA (had no energy), KNEE DEFORMITY (was knocked out/ was in bed for 30hrs) and FATIGUE (very tired). At the time of the report, COMA (went into coma), ASTHENIA (had no energy), KNEE DEFORMITY (was knocked out/ was in bed for 30hrs) and FATIGUE (very tired) outcome was unknown.            No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter  This case concerns a 61 year-old, male subject with no significant medical history, who experienced the unexpected event of coma and non-serious events of asthenia, knee deformity and fatigue. The event occurred on an unknown date. The rechallenge is not applicable in this case. The reporter's assessment is not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 61 year-old, male subject with no significant medical history, who experienced the unexpected event of coma and non-serious events of asthenia, knee deformity and fatigue. The event occurred on an unknown date. The rechallenge is not applicable in this case. The reporter's assessment is not provided. The benefit-risk relationship of the vaccine is not affected by this report
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hair injury, Myalgia, Pyrexia
Clinical narrative: hair hurting; fever ( 102.7 F ); chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of HAIR INJURY (hair hurting), PYREXIA (fever ( 102.7 F )), CHILLS (chills) and MYALGIA (body ache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced HAIR INJURY (hair hurting), PYREXIA (fever ( 102.7 F )), CHILLS (chills) and MYALGIA (body ache). At the time of the report, HAIR INJURY (hair hurting), CHILLS (chills) and MYALGIA (body ache) outcome was unknown and PYREXIA (fever ( 102.7 F )) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, Body temperature: 102.7 (High) fever ( 102.7 F ).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: COVID arm immediately after vaccination; a red COVID arm immediately after vaccination; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (COVID arm immediately after vaccination) and VACCINATION SITE ERYTHEMA (a red COVID arm immediately after vaccination) 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 SITE REACTION (COVID arm immediately after vaccination) and VACCINATION SITE ERYTHEMA (a red COVID arm immediately after vaccination). At the time of the report, VACCINATION SITE REACTION (COVID arm immediately after vaccination) and VACCINATION SITE ERYTHEMA (a red COVID arm immediately after vaccination) 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 medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired 26Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired 26Aug2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 EXPIRED PRODUCT ADMINISTERED (expired 26Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired 26Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.  The physician received notice from lab director that a vial with lot number 036A21A expired 26Aug2021. Since 27Aug2021, has provided 1-2 vaccines per day. She states there was a total of 9 doses administered to 9 different patients. The physician states that the information for the 9 patients are not available.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pruritus, Vaccination complication
Clinical narrative: like a lot of itchy/stopped itching; started to get red; reaction; started having bruises on the legs and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (like a lot of itchy/stopped itching), ERYTHEMA (started to get red), CONTUSION (started having bruises on the legs and hands) and VACCINATION COMPLICATION (reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CONTUSION (started having bruises on the legs and hands). On an unknown date, the patient experienced PRURITUS (like a lot of itchy/stopped itching), ERYTHEMA (started to get red) and VACCINATION COMPLICATION (reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (like a lot of itchy/stopped itching) had resolved and ERYTHEMA (started to get red), CONTUSION (started having bruises on the legs and hands) and VACCINATION COMPLICATION (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patients information lost while documenting and RA crashed.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Red spot at the injection site; Soreness and pain (at injection site); Itched a little bit (Injection site); Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Red spot at the injection site), VACCINATION SITE PAIN (Soreness and pain (at injection site)) and VACCINATION SITE PRURITUS (Itched a little bit (Injection site)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included LISINOPRIL for Rise in blood pressure.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced HEADACHE (Headache). On 10-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at the injection site), VACCINATION SITE PAIN (Soreness and pain (at injection site)) and VACCINATION SITE PRURITUS (Itched a little bit (Injection site)). The patient was treated with HYDROCORTISONE for Itch, at an unspecified dose and frequency. On 31-Aug-2021, HEADACHE (Headache) had resolved. On 10-Sep-2021, VACCINATION SITE PRURITUS (Itched a little bit (Injection site)) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at the injection site) and VACCINATION SITE PAIN (Soreness and pain (at injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also had concomitants for cholesterol (NOS).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Poor quality sleep, Vaccination complication
Clinical narrative: Not sleeping well; "how do I report a side effect"; Full body muscle aches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Full body muscle aches), POOR QUALITY SLEEP (Not sleeping well) and VACCINATION COMPLICATION ("how do I report a side effect") in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Nerve pain and Fibromyalgia. Concomitant products included PREGABALIN (LYRICA) for nerve pain and Fibromyalgia.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Full body muscle aches), POOR QUALITY SLEEP (Not sleeping well) and VACCINATION COMPLICATION ("how do I report a side effect"). At the time of the report, MYALGIA (Full body muscle aches) had resolved and POOR QUALITY SLEEP (Not sleeping well) and VACCINATION COMPLICATION ("how do I report a side effect") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication  was not provided .   This case was linked to MOD-2021-320061 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant follow up appended- vaccination site complication added as an event
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Pneumonia
Clinical narrative: pneumonia; cough; feel sick; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced MALAISE (feel sick). On 29-Aug-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and COUGH (cough). At the time of the report, PNEUMONIA (pneumonia) and MALAISE (feel sick) outcome was unknown and COUGH (cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by reporter.  Treatment information was not provided.  Company Comment: This case concerns a female patient of an unknown age with no relevant medical history who experienced unexpected event of pneumonia. The event occurred 10 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event pneumonia is marked serious by the auto-seriousness tool. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.; Sender's Comments: This case concerns a female patient of an unknown age with no relevant medical history who experienced unexpected event of pneumonia. The event occurred 10 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event pneumonia is marked serious by the auto-seriousness tool. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Ended up with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Ended up with COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced COVID-19 (Ended up with COVID). At the time of the report, COVID-19 (Ended up with COVID) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nasopharyngitis, Pyrexia
Clinical narrative: Cold; shivering, Chills; fever ramped up all day long; horrible joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), CHILLS (shivering, Chills), PYREXIA (fever ramped up all day long) and ARTHRALGIA (horrible joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A, #016B21A and #048F21A) for COVID-19 vaccination.     The patient's past medical history included Blood disorder NOS (that makes her susceptible to Deep vein thrombosis), Fever (from January until February) and Fatigue (from January until February). Concurrent medical conditions included Allergy to antibiotic (Allergic to tetracycline) and Allergy to antibiotic (Allergic to clindamycin). Concomitant products included VALSARTAN and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) 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 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold), CHILLS (shivering, Chills), PYREXIA (fever ramped up all day long) and ARTHRALGIA (horrible joint pain). On 13-Sep-2021, CHILLS (shivering, Chills) and ARTHRALGIA (horrible joint pain) had resolved. On 14-Sep-2021, PYREXIA (fever ramped up all day long) had resolved. At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information provided. It was reported that she might had COVID-19 in January 2021 but there were no available COVID-19 test that time.   This case was linked to MOD-2021-320892 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: >36 days after getting first dose; Covid diagnosis after getting first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>36 days after getting first dose) and COVID-19 (Covid diagnosis after getting first dose) 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 27-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 PRODUCT DOSE OMISSION ISSUE (>36 days after getting first dose) and COVID-19 (Covid diagnosis after getting first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>36 days after getting first dose) had resolved and COVID-19 (Covid diagnosis after getting first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.  Patient was scheduled to get the second dose on 24-Apr-2021 but did not. Patient was diagnosed with COVID 19 and has been under quarantine for a week and will continue until the 16-Sep-2021.