chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: LOSS OF TASTE; This spontaneous report received from a pharmacist concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from loss of taste. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Hypertensive emergency, Insomnia, Lymphadenopathy, Pain
Clinical narrative: Severe allergic reaction; her BP went up to 195; Burning pain,skin burning like a severe sun burn,Reaction of burning skin travelled across arm,across chest; Could not sleep at night; Lymph nodes swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Severe allergic reaction) and HYPERTENSIVE EMERGENCY (her BP went up to 195) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ALLERGY TO VACCINE (Severe allergic reaction) (seriousness criterion medically significant), HYPERTENSIVE EMERGENCY (her BP went up to 195) (seriousness criterion medically significant), PAIN (Burning pain,skin burning like a severe sun burn,Reaction of burning skin travelled across arm,across chest), INSOMNIA (Could not sleep at night) and LYMPHADENOPATHY (Lymph nodes swollen). At the time of the report, ALLERGY TO VACCINE (Severe allergic reaction), HYPERTENSIVE EMERGENCY (her BP went up to 195), PAIN (Burning pain,skin burning like a severe sun burn,Reaction of burning skin travelled across arm,across chest), INSOMNIA (Could not sleep at night) and LYMPHADENOPATHY (Lymph nodes swollen) 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 medication included diphenhydramine. On 19 Feb 2021, diphenhydramine was stopped and the burning pain returned. The patient talked more than normally she would.; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hypothermia, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (hypothermia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shingles (chicken pox and shingles in 2001). Concomitant products included ROSUVASTATIN for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced HYPOTHERMIA (hypothermia) (seriousness criteria medically significant) and RASH (Rash on the side of face and around eyes). The patient was treated with VALACYCLOVIR HYDROCHLORIDE (VALTREX) ongoing from January 2021 for Shingles, at an unspecified dose and frequency. At the time of the report, HYPOTHERMIA (hypothermia), HERPES ZOSTER (Shingles) and RASH (Rash on the side of face and around eyes) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 95 (Low) 95. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-118918 (E2B Linked Report). This case was linked to MOD-2021-118638 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Updated address and adverse events; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding (Medium blood flow, Not Spotting); panicking; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 3:47 PM, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) (seriousness criterion medically significant) and PANIC REACTION (panicking). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) and PANIC REACTION (panicking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not taking any blood thinners and had no Chronic Medical conditions.  Concomitant medications and treatment information was not provided.  The patient reported that it was not Hemorrhoids and was panicking because she heard someone died from bleeding after receiving the vaccine.  This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. 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: This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with COVID a few days later) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID a few days later) (seriousness criteria medically significant). At the time of the report, COVID-19 (Diagnosed with COVID a few days later) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Causality for event COVID-19 is not applicable; Sender's Comments: Causality for event COVID-19 is not applicable.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19) (seriousness criterion medically significant). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. Company comment: Causality for event COVID-19 is not applicable; Sender's Comments: Causality for event COVID-19 is not applicable
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Blood pressure fluctuation, Hallucination, olfactory, Palpitations, Paraesthesia oral
Clinical narrative: Olfactory hallucinations; Blood pressure spikes; Did not receive second dose; Agitated; Rapid heart beat; Tingly lips; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, OLFACTORY (Olfactory hallucinations) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips). On an unknown date, the patient experienced HALLUCINATION, OLFACTORY (Olfactory hallucinations) (seriousness criterion medically significant), BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). On 02-Mar-2021, AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips) had resolved. At the time of the report, HALLUCINATION, OLFACTORY (Olfactory hallucinations) and BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  The patient called in to report that she did not receive the 2nd dose. She reported that she was still experiencing side effects from the 1st dose of the vaccine.   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.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-May-2021 will be submitted with initial report. Follow-up information included new adverse events.; 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Olfactory hallucinations; Blood pressure spikes; Did not receive second dose; Agitated; Rapid heart beat; Tingly lips; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, OLFACTORY (Olfactory hallucinations) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips). On an unknown date, the patient experienced HALLUCINATION, OLFACTORY (Olfactory hallucinations) (seriousness criterion medically significant), BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). On 02-Mar-2021, AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips) had resolved. At the time of the report, HALLUCINATION, OLFACTORY (Olfactory hallucinations) and BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  The patient called in to report that she did not receive the 2nd dose. She reported that she was still experiencing side effects from the 1st dose of the vaccine.   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.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-May-2021 will be submitted with initial report. Follow-up information included new adverse events.; 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: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dehydration, Gastrointestinal haemorrhage, Hypotension
Clinical narrative: Covid-19; GI bleed; low blood pressure; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (GI bleed) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 22-Feb-2021, the patient experienced COVID-19 (Covid-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (GI bleed) (seriousness criterion medically significant), HYPOTENSION (low blood pressure) and DEHYDRATION (Dehydration). The patient was hospitalized from 22-Feb-2021 to 28-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Covid-19), GASTROINTESTINAL HAEMORRHAGE (GI bleed), HYPOTENSION (low blood pressure) and DEHYDRATION (Dehydration) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication provided. Treatment medications included dexamethasone and remdesivir.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Correction for initial version: As per the initial source document, patient was admitted in hospital for 4 days due to COVID-19 but the case was not coded as serious based on hospitalization seriousness criteria. The correction has been made on 18-May-2021 upon identification. On 12-May-2021: Follow up received included events low blood pressure, dehydration, GI bleed were added
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Headache, Hypertension, Vertigo
Clinical narrative: Stroke; Vertigo; Dizziness; High Blood Pressure; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. Treatment information provided included steroids. Patient stated he in now in a walker due to having a stroke.  Very limited information regarding these events has been provided at this time.  Further information has been requested. However, the patient may deny additional follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Event fell diagnosed as stroke  (Seriousness criteria - medically significant).; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested. However, the patient may deny additional follow-up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Erythema, Fatigue, Headache
Clinical narrative: pink disscolouration; swelling below cheek bones; missed second dose; Chills; felt tired; headache; gland swelling; pain in lower part of arm; Hard Knot; cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in an 84-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.     The patient's past medical history included Cardiac disorder (heart condition) since an unknown date, Asthma since an unknown date, Drooling (excessive saliva while sleeping) since an unknown date, allergy (allergies-scheduled to have scope to check vocal chords.) since an unknown date, Dysautonomia since an unknown date and Sleep apnea (uses a CPAP machine for sleep apnea,) since an unknown date. Concurrent medical conditions included Throat discomfort. Concomitant products included ERYTHROMYCIN STEARATE (ERITHRIN [ERYTHROMYCIN STEARATE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Hard Knot). On an unknown date, the patient experienced LYMPHADENOPATHY (gland swelling), PAIN IN EXTREMITY (pain in lower part of arm), ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, CELLULITIS (cellulitis), LYMPHADENOPATHY (gland swelling) and PAIN IN EXTREMITY (pain in lower part of arm) had not resolved, VACCINATION SITE MASS (Hard Knot) outcome was unknown and ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patients treatment medication included high-power antibiotics, cephalexin (Keflex )for 6 days. Self treated swollen lymph nodes with heat. 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 13-May-2021: added the event (missed dose) and treatment medication; 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Product dose omission issue, Swelling, Vaccination site mass
Clinical narrative: pink disscolouration; swelling below cheek bones; missed second dose; Chills; felt tired; headache; gland swelling; pain in lower part of arm; Hard Knot; cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in an 84-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.     The patient's past medical history included Cardiac disorder (heart condition) since an unknown date, Asthma since an unknown date, Drooling (excessive saliva while sleeping) since an unknown date, allergy (allergies-scheduled to have scope to check vocal chords.) since an unknown date, Dysautonomia since an unknown date and Sleep apnea (uses a CPAP machine for sleep apnea,) since an unknown date. Concurrent medical conditions included Throat discomfort. Concomitant products included ERYTHROMYCIN STEARATE (ERITHRIN [ERYTHROMYCIN STEARATE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Hard Knot). On an unknown date, the patient experienced LYMPHADENOPATHY (gland swelling), PAIN IN EXTREMITY (pain in lower part of arm), ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, CELLULITIS (cellulitis), LYMPHADENOPATHY (gland swelling) and PAIN IN EXTREMITY (pain in lower part of arm) had not resolved, VACCINATION SITE MASS (Hard Knot) outcome was unknown and ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patients treatment medication included high-power antibiotics, cephalexin (Keflex )for 6 days. Self treated swollen lymph nodes with heat. 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 13-May-2021: added the event (missed dose) and treatment medication; 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Thrombosis
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in each lung) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CALCIUM FRUCTOBORATE, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, HYALURONIC ACID (MOVE FREE JOINT HEALTH) for Joint disorder NOS, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 21-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced THROMBOSIS (blood clot in each lung) (seriousness criteria medically significant and life threatening). On 28-Feb-2021 at 6:00 PM, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, THROMBOSIS (blood clot in each lung) outcome was unknown and DYSPNOEA (shortness of breath) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Computerised tomogram: blood clot (abnormal) Blood clot in both lung. On 21Jan2021, patient had received the first dose of Moderna Covid-19 vaccine and about 4-5 days later,  he began to noticed that his breathing was labored.  At the time of the report, the patient did not think much about the labored breathing since he was older in age and thought it was due to exercise. Patient received second dose of Moderna COVID-19 Vaccine on 18-Feb-2021 and he reported that his breathing became more laboring where he needed to stop walking to catch his breath. He had 2 scan which revealed that he have a blood clot at each lung and he was prescribed Xarelto 15 mg twice a day, then he will begin Xarelto 20mg once a day on 20-MAY-2021. Patient is on Kirkland C  500mg   as a concomitant medication as well. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant FU- outcome of the event.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Electrocardiogram, Inappropriate schedule of product administration
Clinical narrative: Stroke; Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021 at 10:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021). On 06-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. On 30-Apr-2021 at 10:30 AM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood test: normal (normal) Normal. On 01-May-2021, Computerised tomogram: normal (normal) Normal. On 01-May-2021, Electrocardiogram: normal (normal) Normal.         Concomitant medications were not reported.  On 30 Apr 2021, the patient's right arm was numb and he had no feeling in it. He went to the emergency room on 01 May 2021. They thought he had a blood clot. His EKG, blood tests and CAT scan were normal. The patient reported his arm was still numb on 04 May 2021. It's like it was limp; he couldn't coordinate his hand when he tried to mow the law. He stated that he had no feeling in his arm and can't control his right hand. The patient was reported to have been diagnosed with a stroke on 06 May 2021 2021 and was to start rehab on 07 May 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.   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.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Stroke added as an event.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Adverse reaction, Rash
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over the body) and ADVERSE REACTION (Bad reaction) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. The patient's past medical history included Anemia. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), AMLODIPINE for Blood pressure high, FOLIC ACID for Folic acid supplementation, FERROUS SULFATE for Iron supplementation, TRAMADOL for Pain, PREDNISONE and HYDROXYCHLOROQUINE for Rheumatoid arthritis, SUCRALFATE for Stomach discomfort, FOLINIC ACID for Vitamin supplementation. On 09-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced RASH (Rash all over the body) (seriousness criteria hospitalization). On an unknown date, the patient experienced ADVERSE REACTION (Bad reaction) (seriousness criteria hospitalization). The patient was hospitalized for 1 day due to ADVERSE REACTION and RASH. At the time of the report, RASH (Rash all over the body) was resolving and ADVERSE REACTION (Bad reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included acyclovir and dexamethasone. Company comment: Based on current available information and the temporal association between product 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 and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Blindness transient, Body temperature, Constipation, Eyelid ptosis, Faecal disimpaction
Clinical narrative: transient loss of vision L eye; Urinary retention; constipation; L arm swelling & pain; Episodic ptosis; L arm swelling & pain; fever; headaches; possible TIA; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye) and URINARY RETENTION (Urinary retention) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (possible TIA) (seriousness criterion medically significant). On an unknown date, the patient experienced BLINDNESS TRANSIENT (transient loss of vision L eye) (seriousness criterion medically significant), URINARY RETENTION (Urinary retention) (seriousness criterion medically significant), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye), URINARY RETENTION (Urinary retention), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: increased (High) increased. On 02-May-2021, Faecal disimpaction: abnormal Fecal manual dis-impaction for 2 days.. In May 2021, Urine output: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  On 06-May-2021, the patient reported that she called 911 and went to the emergency room for possible TIA (transient ischemic attack).  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start 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 of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pyrexia, Transient ischaemic attack
Clinical narrative: transient loss of vision L eye; Urinary retention; constipation; L arm swelling & pain; Episodic ptosis; L arm swelling & pain; fever; headaches; possible TIA; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye) and URINARY RETENTION (Urinary retention) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (possible TIA) (seriousness criterion medically significant). On an unknown date, the patient experienced BLINDNESS TRANSIENT (transient loss of vision L eye) (seriousness criterion medically significant), URINARY RETENTION (Urinary retention) (seriousness criterion medically significant), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye), URINARY RETENTION (Urinary retention), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: increased (High) increased. On 02-May-2021, Faecal disimpaction: abnormal Fecal manual dis-impaction for 2 days.. In May 2021, Urine output: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  On 06-May-2021, the patient reported that she called 911 and went to the emergency room for possible TIA (transient ischemic attack).  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start 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 of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Urinary retention, Urine output
Clinical narrative: transient loss of vision L eye; Urinary retention; constipation; L arm swelling & pain; Episodic ptosis; L arm swelling & pain; fever; headaches; possible TIA; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye) and URINARY RETENTION (Urinary retention) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (possible TIA) (seriousness criterion medically significant). On an unknown date, the patient experienced BLINDNESS TRANSIENT (transient loss of vision L eye) (seriousness criterion medically significant), URINARY RETENTION (Urinary retention) (seriousness criterion medically significant), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye), URINARY RETENTION (Urinary retention), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: increased (High) increased. On 02-May-2021, Faecal disimpaction: abnormal Fecal manual dis-impaction for 2 days.. In May 2021, Urine output: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  On 06-May-2021, the patient reported that she called 911 and went to the emergency room for possible TIA (transient ischemic attack).  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start 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 of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Gait disturbance, Palpitations, Pruritus
Clinical narrative: heart palpitations; itching all over the body; cannot walk very long, and legs are shaky.; short of breath; Athma exacerbations; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (short of breath), PALPITATIONS (heart palpitations) and PRURITUS (itching all over the body) in a 61-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.     The patient's past medical history included Gastric bypass. Concurrent medical conditions included Asthma.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (short of breath) (seriousness criterion medically significant) and ASTHMA (Athma exacerbations). On an unknown date, the patient experienced PALPITATIONS (heart palpitations) (seriousness criterion medically significant), PRURITUS (itching all over the body) (seriousness criterion medically significant) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.). At the time of the report, DYSPNOEA (short of breath) and ASTHMA (Athma exacerbations) had not resolved and PALPITATIONS (heart palpitations), PRURITUS (itching all over the body) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patients treatment medication information included oxygen treatment, Benadryl, and prednisone.  Company comment: 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 08-May-2021: Additional Information Was received. Updated the reporters information and added events(Palpitations , Pruritus, Gait Disturbance); 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Coma, Confusional state
Clinical narrative: feel weak; this one really scared me; bone pain; Dizzy; arm is still painful; I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened; Joint pain; Achy, body pain; worst experience, I was in coma for 2 days; hallucinated; was sweating all over; Did not eat in two days; not woke up, just sleep; This spontaneous case was reported by a consumer and describes the occurrence of COMA (worst experience, I was in coma for 2 days) and HALLUCINATION (hallucinated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE and Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine and PNEUMOCOCCAL VACCINE.    On 05-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced COMA (worst experience, I was in coma for 2 days) (seriousness criterion medically significant), HALLUCINATION (hallucinated) (seriousness criterion medically significant), HYPERHIDROSIS (was sweating all over), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep), BONE PAIN (bone pain), DIZZINESS (Dizzy), PAIN IN EXTREMITY (arm is still painful), CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened), ARTHRALGIA (Joint pain) and MYALGIA (Achy, body pain). On 07-May-2021, the patient experienced FEAR (this one really scared me) and ASTHENIA (feel weak). On 07-May-2021, COMA (worst experience, I was in coma for 2 days), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep) and CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened) had resolved. At the time of the report, HALLUCINATION (hallucinated), HYPERHIDROSIS (was sweating all over), FEAR (this one really scared me), DIZZINESS (Dizzy) and MYALGIA (Achy, body pain) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (feel weak), PAIN IN EXTREMITY (arm is still painful) and ARTHRALGIA (Joint pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient did not receive any treatment medication. No concomitant medication was reported.   The patient spoke to his doctor about not getting the 2nd shot.  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.