chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fibrin D dimer, Hyperacusis, Hyperhidrosis, Insomnia
Clinical narrative: Hearing sounds amplified; Sweating; Does not feel well; Trouble sleeping; tinnitus; migraine headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (tinnitus) and MIGRAINE (migraine headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced TINNITUS (tinnitus) (seriousness criterion disability) and MIGRAINE (migraine headache) (seriousness criterion disability). On an unknown date, the patient experienced HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping). The patient was treated with SUMATRIPTAN SUCCINATE (IMITREX DF) ongoing since an unknown date at a dose of 1 dosage form and METHYLPREDNISOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, TINNITUS (tinnitus), MIGRAINE (migraine headache), HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Fibrin D dimer: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications taken by the patient were not provided. Action taken with mRNA in response to the event/s was not applicable  Very limited information regarding the events has been provided at this time.  Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information include:In general tab reporter details updated ln patient tab lab data includedIn product tab vaccine information updated and treatment information added.In event tab 2 events are added; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Tinnitus
Clinical narrative: Hearing sounds amplified; Sweating; Does not feel well; Trouble sleeping; tinnitus; migraine headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (tinnitus) and MIGRAINE (migraine headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced TINNITUS (tinnitus) (seriousness criterion disability) and MIGRAINE (migraine headache) (seriousness criterion disability). On an unknown date, the patient experienced HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping). The patient was treated with SUMATRIPTAN SUCCINATE (IMITREX DF) ongoing since an unknown date at a dose of 1 dosage form and METHYLPREDNISOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, TINNITUS (tinnitus), MIGRAINE (migraine headache), HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Fibrin D dimer: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications taken by the patient were not provided. Action taken with mRNA in response to the event/s was not applicable  Very limited information regarding the events has been provided at this time.  Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information include:In general tab reporter details updated ln patient tab lab data includedIn product tab vaccine information updated and treatment information added.In event tab 2 events are added; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Dehydration, Nephrolithiasis
Clinical narrative: Stones in his Kidney; Badly dehydrated; Urine has been dark; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Stones in his Kidney) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DEHYDRATION (Badly dehydrated) and CHROMATURIA (Urine has been dark). On an unknown date, the patient experienced NEPHROLITHIASIS (Stones in his Kidney) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Stones in his Kidney), DEHYDRATION (Badly dehydrated) and CHROMATURIA (Urine has been dark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.  Patient states that these events were not related to vaccine and declined further follow up.  This case concerns a 60-year-old male with a serious unexpected event of nephrolithiasis, and nonserious unexpected dehydration and chromaturia. Event latency 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Follow-up was received on 23-may-2021. New event "Kidney stone" was added.; Sender's Comments: This case concerns a 60-year-old male with a serious unexpected event of nephrolithiasis, and nonserious unexpected dehydration and chromaturia. Event latency 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: In case it was pneumonia; Not feeling good since the vaccine; severe dizziness; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (In case it was pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported by reporter.  Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, HYDROCHLOROTHIAZIDE (THIAZIDE), MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (severe dizziness) and VERTIGO (vertigo). On an unknown date, the patient experienced PNEUMONIA (In case it was pneumonia) (seriousness criterion medically significant) and FEELING ABNORMAL (Not feeling good since the vaccine). At the time of the report, PNEUMONIA (In case it was pneumonia), DIZZINESS (severe dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (Not feeling good since the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, X-ray: inconclusive not able to determine if he had pneumonia. On an unknown date, SARS-CoV-2 test: negative tested twice for Covid-19 with Negative results both times.         On 23-APR-2021 with in one hour of vaccination the patient began to experience severe dizziness and vertigo. The patient did not receive any treatment medications for the reported events. The patient reported that he had not been feeling very good since the vaccine, stating "I don't think this is a coincidence me getting sick after I got the vaccine". He was evaluated at the Emergency Room this past Sunday on 5/23/2021, because he still wasn't feeling very good. He states he had an X-ray done and was they were not able to determine if he had pneumonia, however they treated him with IV antibiotics in case it was pneumonia. He reports feeling "a little better" since the IV antibiotics.  Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE details. Case upgraded to serious. additional adverse events were updated and narrative information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Headache, Musculoskeletal stiffness, Nodule
Clinical narrative: Rheumatoid arthritis flared up; Lack of drug effect; Early morning stiffness; Nodule on extremity; Headache; Very tired; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up), DRUG INEFFECTIVE (Lack of drug effect), MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Nodule since 2019, Teetotaller (Abstains from alcohol.), Drug allergy (Associated manifestation for the sulfa drugs allergy was rash and for the ACE inhibitors allergy was chest tightness), Peanut allergy (Associated manifestation for the peanut allergy was rash) and Non-smoker.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up), MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) to be not related. No further causality assessments were provided for RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up) and DRUG INEFFECTIVE (Lack of drug effect).    Treatment information were included prednisone and acetaminophen.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Nodule and Musculoskeletal stiffness as these events are stated as unrelated by the HCP reporter.   This case was linked to MOD-2021-096000 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Nodule and Musculoskeletal stiffness as these events are stated as unrelated by the HCP reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flared up; Lack of drug effect; Early morning stiffness; Nodule on extremity; Headache; Very tired; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up), DRUG INEFFECTIVE (Lack of drug effect), MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Nodule since 2019, Teetotaller (Abstains from alcohol.), Drug allergy (Associated manifestation for the sulfa drugs allergy was rash and for the ACE inhibitors allergy was chest tightness), Peanut allergy (Associated manifestation for the peanut allergy was rash) and Non-smoker.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up), MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) to be not related. No further causality assessments were provided for RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up) and DRUG INEFFECTIVE (Lack of drug effect).    Treatment information were included prednisone and acetaminophen.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Nodule and Musculoskeletal stiffness as these events are stated as unrelated by the HCP reporter.   This case was linked to MOD-2021-096000 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Nodule and Musculoskeletal stiffness as these events are stated as unrelated by the HCP reporter.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Tinnitus, Vision blurred
Clinical narrative: Patient felt lightheaded, dizzy, popping and ringing in ears, blurred vision, and fainted for a few seconds. This occurred about 5-10 min following vaccination. Most likely a vasovagal syncope reaction. No history of allergic reactions nor syncope. After laying  patient down and elevating his legs, he felt much better. Patient remained in this position for about 15 minutes. He then sat up, ate a snack, and drank water and was observed for an additional 15 minutes. Vitals were within normal range. Patient stated feeling"normal" and "fine" after this and he was able to go home without additional issues.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Urticaria
Clinical narrative: PT reported to the Clinic around 1500. PT stated she received the second dose of the Moderna Vaccine around 1330. PT stated she started to break out in pin point hives on both arms around 1450. PT stated she has had hives after a flu vaccine before. PT states it was  over a decade ago. PT denies any difficulty breathing or any other symptoms. I called the on call provider and the PT was seen in clinic at 1536.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Got period 2 weeks early days after vaccine that?s heavier than normal
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash, SARS-CoV-2 test positive
Clinical narrative: Developed rash - bilateral axilla the day after she received Pfizer vaccine came in to Urgent Care on 5/5/2021 because rash had not cleared up   Administered depomedrol 40 mg IM x 1  Prescribed kenalog cream to apply to rash   ***Tested positive for SARS-CoV-2 on 4/12/2021***
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Gastrointestinal pain, Headache
Clinical narrative: Tingly from head to toe; Short of breath; Chest is like tight; Pains in intestine; Tired; Headache; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PARAESTHESIA (Tingly from head to toe) (seriousness criterion medically significant), DYSPNOEA (Short of breath) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest is like tight) (seriousness criterion medically significant), GASTROINTESTINAL PAIN (Pains in intestine) (seriousness criterion medically significant), FATIGUE (Tired) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Side effects started after 20 minutes of receiving the shot. Patient went to the hospital. Patient stated that she was sleeping well and drinking lots of water.  Concomitant product use was not provided by the reporter.  Treatment for the event included ibuprofen.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingly from head to toe; Short of breath; Chest is like tight; Pains in intestine; Tired; Headache; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PARAESTHESIA (Tingly from head to toe) (seriousness criterion medically significant), DYSPNOEA (Short of breath) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest is like tight) (seriousness criterion medically significant), GASTROINTESTINAL PAIN (Pains in intestine) (seriousness criterion medically significant), FATIGUE (Tired) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Side effects started after 20 minutes of receiving the shot. Patient went to the hospital. Patient stated that she was sleeping well and drinking lots of water.  Concomitant product use was not provided by the reporter.  Treatment for the event included ibuprofen.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Herpes zoster, Rash, Vaccination site erythema
Clinical narrative: Herpes; shingles; rash that spread; small heart shaped redness on left shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES VIRUS INFECTION (Herpes) 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 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (Herpes) (seriousness criterion medically significant), HERPES ZOSTER (shingles), RASH (rash that spread) and VACCINATION SITE ERYTHEMA (small heart shaped redness on left shoulder). At the time of the report, HERPES VIRUS INFECTION (Herpes), HERPES ZOSTER (shingles), RASH (rash that spread) and VACCINATION SITE ERYTHEMA (small heart shaped redness on left shoulder) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-142373 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: Broke out on the whole face, neck, arm and hand/looked like he had a mix of Measleas and Rubella/that is how bad his rash was; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MORBILLIFORM (Broke out on the whole face, neck, arm and hand/looked like he had a mix of Measleas and Rubella/that is how bad his rash was) 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 RASH MORBILLIFORM (Broke out on the whole face, neck, arm and hand/looked like he had a mix of Measleas and Rubella/that is how bad his rash was) (seriousness criterion hospitalization). At the time of the report, RASH MORBILLIFORM (Broke out on the whole face, neck, arm and hand/looked like he had a mix of Measleas and Rubella/that is how bad his rash was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: blood clot in the left lower leg; left ankle swelling; left foot pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in the left lower leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL for Hypertension.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced JOINT SWELLING (left ankle swelling) and PAIN IN EXTREMITY (left foot pain). On 12-May-2021, the patient experienced THROMBOSIS (blood clot in the left lower leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot in the left lower leg), JOINT SWELLING (left ankle swelling) and PAIN IN EXTREMITY (left foot pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Ultrasound scan: abnormal (abnormal) Diagnosed with blood clot in the left lower leg.         Other concomitant medication include statin for cholesterol. Treatment medication for events included Xarelto. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Seizure, Syncope
Clinical narrative: Dizziness/ dizzy; Weakness/ very weak; Seizures; Fainted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizures), SYNCOPE (Fainted), DIZZINESS (Dizziness/ dizzy) and ASTHENIA (Weakness/ very weak) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization and medically significant) and SYNCOPE (Fainted) (seriousness criteria hospitalization and medically significant). On 16-May-2021, the patient experienced DIZZINESS (Dizziness/ dizzy) (seriousness criterion hospitalization) and ASTHENIA (Weakness/ very weak) (seriousness criterion hospitalization). The patient was hospitalized on 07-May-2021 due to SEIZURE and SYNCOPE, then on 16-May-2021 due to ASTHENIA and DIZZINESS. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SEIZURE (Seizures) and SYNCOPE (Fainted) outcome was unknown and DIZZINESS (Dizziness/ dizzy) and ASTHENIA (Weakness/ very weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Description: During the day of the injection, at 5 to 10 minutes, the patient fainted and had seizures that required hospitalization. Also, on 16 May 2021 the patient required hospitalization again because of the dizziness and weakness. The patient was still dizzy and was very weak. The patient had a consult with a neurologist and who told that the symptoms were probably becasue of the vaccine.  Other treatment information included unspecified pill for dizziness at the hospital.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Intentional product use issue, Muscular weakness, Myalgia
Clinical narrative: Blurred vision; Fast heart rate; Tingling; numbness of skin especially limbs and face; Muscle weakness; 2nd dose not taken; Sore arm; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Fast heart rate), PARAESTHESIA (Tingling), HYPOAESTHESIA (numbness of skin especially limbs and face), MUSCULAR WEAKNESS (Muscle weakness) and VISION BLURRED (Blurred vision) in a 40-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 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heart rate) (seriousness criterion hospitalization), PARAESTHESIA (Tingling) (seriousness criterion hospitalization), HYPOAESTHESIA (numbness of skin especially limbs and face) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion hospitalization), VISION BLURRED (Blurred vision) (seriousness criterion hospitalization), INTENTIONAL PRODUCT USE ISSUE (2nd dose not taken) and MYALGIA (Sore arm). The patient was hospitalized from 08-Jan-2021 to 09-Jan-2021 due to HEART RATE INCREASED, HYPOAESTHESIA, MUSCULAR WEAKNESS and PARAESTHESIA. At the time of the report, HEART RATE INCREASED (Fast heart rate), PARAESTHESIA (Tingling), HYPOAESTHESIA (numbness of skin especially limbs and face), MUSCULAR WEAKNESS (Muscle weakness), VISION BLURRED (Blurred vision), INTENTIONAL PRODUCT USE ISSUE (2nd dose not taken) and MYALGIA (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information, if any, was not provided by the reporter. Treatment information for the events included metoprolol (unknown dose/directions) and acupuncture treatment to get the nerve sensation back.  On 05 Jan 2021, the patient went to an emergency room due to the events. On 08 Jan 2021, the patient went back to the hospital and was admitted. Blood work and a stress test were performed. Results of these tests were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: Blurred vision; Fast heart rate; Tingling; numbness of skin especially limbs and face; Muscle weakness; 2nd dose not taken; Sore arm; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Fast heart rate), PARAESTHESIA (Tingling), HYPOAESTHESIA (numbness of skin especially limbs and face), MUSCULAR WEAKNESS (Muscle weakness) and VISION BLURRED (Blurred vision) in a 40-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 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heart rate) (seriousness criterion hospitalization), PARAESTHESIA (Tingling) (seriousness criterion hospitalization), HYPOAESTHESIA (numbness of skin especially limbs and face) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion hospitalization), VISION BLURRED (Blurred vision) (seriousness criterion hospitalization), INTENTIONAL PRODUCT USE ISSUE (2nd dose not taken) and MYALGIA (Sore arm). The patient was hospitalized from 08-Jan-2021 to 09-Jan-2021 due to HEART RATE INCREASED, HYPOAESTHESIA, MUSCULAR WEAKNESS and PARAESTHESIA. At the time of the report, HEART RATE INCREASED (Fast heart rate), PARAESTHESIA (Tingling), HYPOAESTHESIA (numbness of skin especially limbs and face), MUSCULAR WEAKNESS (Muscle weakness), VISION BLURRED (Blurred vision), INTENTIONAL PRODUCT USE ISSUE (2nd dose not taken) and MYALGIA (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information, if any, was not provided by the reporter. Treatment information for the events included metoprolol (unknown dose/directions) and acupuncture treatment to get the nerve sensation back.  On 05 Jan 2021, the patient went to an emergency room due to the events. On 08 Jan 2021, the patient went back to the hospital and was admitted. Blood work and a stress test were performed. Results of these tests were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Fatigue, Hepatitis infectious mononucleosis, Vaccination site pain
Clinical narrative: Hepatitis infectious mononucleosis; tired; Sore Left Injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS INFECTIOUS MONONUCLEOSIS (Hepatitis infectious mononucleosis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, IBUPROFEN for an unknown indication.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Injection site arm). On 06-May-2021, the patient experienced FATIGUE (tired). On 17-May-2021, the patient experienced HEPATITIS INFECTIOUS MONONUCLEOSIS (Hepatitis infectious mononucleosis) (seriousness criterion medically significant). The patient was treated with AZITHROMYCIN ongoing since an unknown date at an unspecified dose and frequency and AMOXICILLIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEPATITIS INFECTIOUS MONONUCLEOSIS (Hepatitis infectious mononucleosis), VACCINATION SITE PAIN (Sore Left Injection site arm) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Alanine aminotransferase: 620 (Inconclusive) 620. On 12-May-2021, Aspartate aminotransferase: 540 (Inconclusive) 540. On 14-May-2021, Alanine aminotransferase: 650 (Inconclusive) 650. On 14-May-2021, Aspartate aminotransferase: 330 (Inconclusive) 330.         Blood work was drawn on 19-May-2021; results unknown/ not reported.  Treatment: Patient received Azithromycin on 12-May-2021 but was not able to tolerate because of vomiting so he was switched to Amoxicillin which was stopped on 19-May-2021.  The patient had been taking levocetirizine for allergies since early spring 2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Basophil count, Lymphocyte count, Lymphoma, Monocyte count, Neutrophil count
Clinical narrative: Possible Lymphoma Diagnosis; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHOMA (Possible Lymphoma Diagnosis) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient's antibody response was noted as 'robust' and it did not require any hospitalization at the time.) in March 2021.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced LYMPHOMA (Possible Lymphoma Diagnosis) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Possible Lymphoma Diagnosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Basophil count (0.01-0.07): 0 (Inconclusive) basophils: 0. On 03-May-2021, Lymphocyte count (17.0-48): 55.0 (Inconclusive) lymphocytes: 55.0. On 03-May-2021, Monocyte count (6-13): 4.0 (Inconclusive) monocytes 4.0. On 03-May-2021, Neutrophil count (0.99-3.2): 7.44 (Inconclusive) Total Neutrophil Level: 7.44. On 03-May-2021, Neutrophil percentage (38-73): 36 (Inconclusive) Differential: Neutrophils 36.0. On 03-May-2021, White blood cell count (3.6-9.9): 12.6 (Inconclusive) WBC 12.6.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not reported. No concomitant medications reported.  Additional diagnostic results: On 03-May-2021, Markers: CD5 positive/dim, CD19 positive/mod, CD20 positive/dim, CD23 positive/dim, CD38 positive/dim, CD45 positive/bright, HLA-BR positive/mod, S-Lambda positive/dim. Evidence of Monoclonal B cell population CD5+CD23+B-CLL phenotype.  As of 19-MAY-2021, the patient has not been officially diagnosed with Lymphoma, but it is suspected.  Company comment: Very limited information regarding this event has been provided at this time. Further follow up is not possible.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further follow up is not possible.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil percentage, White blood cell count
Clinical narrative: Possible Lymphoma Diagnosis; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHOMA (Possible Lymphoma Diagnosis) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient's antibody response was noted as 'robust' and it did not require any hospitalization at the time.) in March 2021.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced LYMPHOMA (Possible Lymphoma Diagnosis) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Possible Lymphoma Diagnosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Basophil count (0.01-0.07): 0 (Inconclusive) basophils: 0. On 03-May-2021, Lymphocyte count (17.0-48): 55.0 (Inconclusive) lymphocytes: 55.0. On 03-May-2021, Monocyte count (6-13): 4.0 (Inconclusive) monocytes 4.0. On 03-May-2021, Neutrophil count (0.99-3.2): 7.44 (Inconclusive) Total Neutrophil Level: 7.44. On 03-May-2021, Neutrophil percentage (38-73): 36 (Inconclusive) Differential: Neutrophils 36.0. On 03-May-2021, White blood cell count (3.6-9.9): 12.6 (Inconclusive) WBC 12.6.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not reported. No concomitant medications reported.  Additional diagnostic results: On 03-May-2021, Markers: CD5 positive/dim, CD19 positive/mod, CD20 positive/dim, CD23 positive/dim, CD38 positive/dim, CD45 positive/bright, HLA-BR positive/mod, S-Lambda positive/dim. Evidence of Monoclonal B cell population CD5+CD23+B-CLL phenotype.  As of 19-MAY-2021, the patient has not been officially diagnosed with Lymphoma, but it is suspected.  Company comment: Very limited information regarding this event has been provided at this time. Further follow up is not possible.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further follow up is not possible.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Product dose omission issue
Clinical narrative: Bell's Palsy; Missed second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the vaccine). The patient was hospitalized from 20-Apr-2021 to 22-Apr-2021 due to BELL'S PALSY. The patient was treated with VALACICLOVIR at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's Palsy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided to the patient with unspecified steroids.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. This report also refers to a case of Product dose omission issue for mRNA-1273, lot unknown with no associated AEs.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. This report also refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain in extremity
Clinical narrative: blacked out twice; Sore arm/ sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out twice) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2007, Angioplasty in 2007 and Stent placement in 2007. Concurrent medical conditions included Chronic obstructive pulmonary disease, Blood pressure abnormal, Gastroesophageal reflux disease and Psychosis. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT) for Chronic obstructive pulmonary disease, METOPROLOL and ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder and Blood pressure abnormal, VILAZODONE HYDROCHLORIDE (VIIBRYD), DESVENLAFAXINE, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), IPRATROPIUM BROMIDE and SALBUTAMOL SULFATE (ALBUTEROL SULFATE) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (blacked out twice) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Sore arm/ sore left arm). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out twice) and PAIN IN EXTREMITY (Sore arm/ sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included psychosis medication (not specified).  The patient had sore arm and  was blacked out twice after the vaccine. According to the patient, his sore left arm went away for two days and again came back after a week and then went away. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-148160 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.