chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: Neuropathy; intermittent numbness in fingers; nerve pain; feeling pins and needles sensation going into limbs including both arms and legs; nerve pain, muscle pain, and joint pain at the site where she received her  vaccine; joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Fibromyalgia since 11-Apr-2020, Allergy to antibiotic (Bactrim), Allergy to antibiotic (Erythromycin) and Osteoporosis. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) from 12-May-2012 to an unknown date for Osteoporosis, CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), HYPOAESTHESIA (intermittent numbness in fingers), NEURALGIA (nerve pain), PARAESTHESIA (feeling pins and needles sensation going into limbs including both arms and legs), VACCINATION SITE PAIN (nerve pain, muscle pain, and joint pain at the site where she received her  vaccine), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), HYPOAESTHESIA (intermittent numbness in fingers), NEURALGIA (nerve pain), PARAESTHESIA (feeling pins and needles sensation going into limbs including both arms and legs), VACCINATION SITE PAIN (nerve pain, muscle pain, and joint pain at the site where she received her  vaccine), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20 JUL 2021. Reporter information added, Patient's demographics added, Medical history added, Dose route and anatomical location updated, Concomitant medication added, Vaccination facility information added, One Event  Neuropathy added.; 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; however, concurrent medical condition of Fibromyalgia could be a contributory factor for the events.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood sodium, Blood sodium abnormal, Chest pain
Clinical narrative: patient was very sick even ended up in the ICU, almost die; elevated blood sugar; sodium out of control; almost died; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient was very sick even ended up in the ICU, almost die), CHEST PAIN (chest pain), BLOOD GLUCOSE INCREASED (elevated blood sugar), BLOOD SODIUM ABNORMAL (sodium out of control) and NEAR DEATH EXPERIENCE (almost died ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 ILLNESS (patient was very sick even ended up in the ICU, almost die) (seriousness criterion hospitalization), CHEST PAIN (chest pain) (seriousness criterion hospitalization), BLOOD GLUCOSE INCREASED (elevated blood sugar) (seriousness criterion hospitalization), BLOOD SODIUM ABNORMAL (sodium out of control) (seriousness criterion hospitalization) and NEAR DEATH EXPERIENCE (almost died ) (seriousness criterion medically significant). At the time of the report, ILLNESS (patient was very sick even ended up in the ICU, almost die), CHEST PAIN (chest pain), BLOOD GLUCOSE INCREASED (elevated blood sugar) and NEAR DEATH EXPERIENCE (almost died ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: other (High) Increased. On an unknown date, Blood sodium: out of control (abnormal) abnormal.         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 09-Jul-2021: Follow-up received on 09-Jul-2021 updated patient initial. On 20-Jul-2021: significant follow up: Events added: Sickness (hospitalization), Chest pain. Lab data added: Blood glucose and Blood sodium . Case upgraded to serious.; 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: F
Vaccine: COVID19
Symptoms: Illness, Near death experience
Clinical narrative: patient was very sick even ended up in the ICU, almost die; elevated blood sugar; sodium out of control; almost died; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient was very sick even ended up in the ICU, almost die), CHEST PAIN (chest pain), BLOOD GLUCOSE INCREASED (elevated blood sugar), BLOOD SODIUM ABNORMAL (sodium out of control) and NEAR DEATH EXPERIENCE (almost died ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 ILLNESS (patient was very sick even ended up in the ICU, almost die) (seriousness criterion hospitalization), CHEST PAIN (chest pain) (seriousness criterion hospitalization), BLOOD GLUCOSE INCREASED (elevated blood sugar) (seriousness criterion hospitalization), BLOOD SODIUM ABNORMAL (sodium out of control) (seriousness criterion hospitalization) and NEAR DEATH EXPERIENCE (almost died ) (seriousness criterion medically significant). At the time of the report, ILLNESS (patient was very sick even ended up in the ICU, almost die), CHEST PAIN (chest pain), BLOOD GLUCOSE INCREASED (elevated blood sugar) and NEAR DEATH EXPERIENCE (almost died ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: other (High) Increased. On an unknown date, Blood sodium: out of control (abnormal) abnormal.         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 09-Jul-2021: Follow-up received on 09-Jul-2021 updated patient initial. On 20-Jul-2021: significant follow up: Events added: Sickness (hospitalization), Chest pain. Lab data added: Blood glucose and Blood sodium . Case upgraded to serious.; 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling of body temperature change, Hyperhidrosis, Loss of consciousness, Malaise
Clinical narrative: Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good); She has been experiencing a lot of anxiety; She was not feeling well; Her husband states that she looked pale; She was sweaty; She was hot and cold; very sore arm, like she was punched in the arm; 7 hours later, she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included ETONOGESTREL (NEXPLANON) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good)) (seriousness criterion medically significant), ANXIETY (She has been experiencing a lot of anxiety), MALAISE (She was not feeling well), PALLOR (Her husband states that she looked pale), HYPERHIDROSIS (She was sweaty), FEELING OF BODY TEMPERATURE CHANGE (She was hot and cold), PAIN IN EXTREMITY (very sore arm, like she was punched in the arm) and PYREXIA (7 hours later, she had a fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 17-Jun-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good)), ANXIETY (She has been experiencing a lot of anxiety), MALAISE (She was not feeling well), PALLOR (Her husband states that she looked pale), HYPERHIDROSIS (She was sweaty), FEELING OF BODY TEMPERATURE CHANGE (She was hot and cold), PAIN IN EXTREMITY (very sore arm, like she was punched in the arm) and PYREXIA (7 hours later, she had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Pyrexia
Clinical narrative: Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good); She has been experiencing a lot of anxiety; She was not feeling well; Her husband states that she looked pale; She was sweaty; She was hot and cold; very sore arm, like she was punched in the arm; 7 hours later, she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included ETONOGESTREL (NEXPLANON) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good)) (seriousness criterion medically significant), ANXIETY (She has been experiencing a lot of anxiety), MALAISE (She was not feeling well), PALLOR (Her husband states that she looked pale), HYPERHIDROSIS (She was sweaty), FEELING OF BODY TEMPERATURE CHANGE (She was hot and cold), PAIN IN EXTREMITY (very sore arm, like she was punched in the arm) and PYREXIA (7 hours later, she had a fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 17-Jun-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good)), ANXIETY (She has been experiencing a lot of anxiety), MALAISE (She was not feeling well), PALLOR (Her husband states that she looked pale), HYPERHIDROSIS (She was sweaty), FEELING OF BODY TEMPERATURE CHANGE (She was hot and cold), PAIN IN EXTREMITY (very sore arm, like she was punched in the arm) and PYREXIA (7 hours later, she had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension
Clinical narrative: Extreme Headache after Second Dose; Extreme High Blood Pressure after Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Extreme Headache after Second Dose) and HYPERTENSION (Extreme High Blood Pressure after Second Dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Extreme Headache after Second Dose) (seriousness criterion hospitalization) and HYPERTENSION (Extreme High Blood Pressure after Second Dose) (seriousness criterion hospitalization). At the time of the report, HEADACHE (Extreme Headache after Second Dose) and HYPERTENSION (Extreme High Blood Pressure after Second Dose) outcome was unknown.            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.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting after 1st shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting after 1st shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting after 1st shot) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting after 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided. Treatment medication was not reported.  Very limited information regarding this event has been provided at this time. Details including the date of vaccination and onset of syncope, medical history, concomitant medications, tests/diagnostics, and treatment are required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details including the date of vaccination and onset of syncope, medical history, concomitant medications, tests/diagnostics, and treatment are required for further assessment.
Sex: F
Vaccine: COVID19
Symptoms: Lipoma, Vaccination site necrosis
Clinical narrative: fat necrosis near injection site left; several large lipomas; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NECROSIS (fat necrosis near injection site left) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) unknown. On an unknown date, the patient experienced VACCINATION SITE NECROSIS (fat necrosis near injection site left) (seriousness criterion medically significant) and LIPOMA (several large lipomas). At the time of the report, VACCINATION SITE NECROSIS (fat necrosis near injection site left) and LIPOMA (several large lipomas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided. Treatment medication was not reported.  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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diplegia, Muscular weakness
Clinical narrative: Feels weak from waste down, Left arm is weak; Feels very weak; Went home paralyzed from waste down; This spontaneous case was reported by a consumer and describes the occurrence of DIPLEGIA (Went home paralyzed from waste down) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIPLEGIA (Went home paralyzed from waste down) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Feels weak from waste down, Left arm is weak) and ASTHENIA (Feels very weak). On 20-May-2021, DIPLEGIA (Went home paralyzed from waste down) had resolved. At the time of the report, MUSCULAR WEAKNESS (Feels weak from waste down, Left arm is weak) and ASTHENIA (Feels very weak) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had cold before her second dose. Patient reported to agent that mostly her legs were affected. Patient also called EMS and they did not transport her to hospital. Patient states that she has not taken any medications to help subside the possible adverse events. No concomitant medications were mentioned.  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-2021-263043 (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: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Suspected COVID-19
Clinical narrative: covid19-like symptoms; 1st dose 2nd of feb/Wanted to get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (covid19-like symptoms) 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.     Concurrent medical conditions included Diabetes.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (covid19-like symptoms) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (1st dose 2nd of feb/Wanted to get the 2nd dose). At the time of the report, SUSPECTED COVID-19 (covid19-like symptoms) and PRODUCT DOSE OMISSION ISSUE (1st dose 2nd of feb/Wanted to get the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.  Patient stayed a long time in the Hospital and after that in a rehab center.  Very limited information regarding the event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer metastatic, Polycythaemia vera, SARS-CoV-2 antibody test
Clinical narrative: polycythemia Vera; Metastatic breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of POLYCYTHAEMIA VERA (polycythemia Vera) and BREAST CANCER METASTATIC (Metastatic breast cancer) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 032L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ANASTROZOLE (ARIMIDEX), INSULIN DEGLUDEC (TRESIBA), SEMAGLUTIDE (OZEMPIC), CELECOXIB (CELEBREX), GABAPENTIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POLYCYTHAEMIA VERA (polycythemia Vera) (seriousness criterion medically significant) and BREAST CANCER METASTATIC (Metastatic breast cancer) (seriousness criterion medically significant). At the time of the report, POLYCYTHAEMIA VERA (polycythemia Vera) and BREAST CANCER METASTATIC (Metastatic breast cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, SARS-CoV-2 antibody test: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: 3-4 days later had Covid-19, she was hospitalized for 30 days; caller received the 1st dose but lost the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (3-4 days later had Covid-19, she was hospitalized for 30 days) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose but lost the 2nd dose). On 05-Feb-2021, the patient experienced COVID-19 (3-4 days later had Covid-19, she was hospitalized for 30 days) (seriousness criterion hospitalization prolonged). The patient was hospitalized for 30 days due to COVID-19. On 02-Feb-2021, PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose but lost the 2nd dose) had resolved. At the time of the report, COVID-19 (3-4 days later had Covid-19, she was hospitalized for 30 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.   Callers mother received first dose on 02 Feb 2021, 3-4 days later had Covid-19, she was hospitalized for 30 days.   No treatment information was provided.  Company Comment: Based on biological implausibility, a causal relationship between the reported event COVID-19  and the administration of mRNA-1273  is assessed as unlikely. Causality for the event Product dose omission issue is not applicable.; Sender's Comments: Based on biological implausibility, a causal relationship between the reported event COVID-19  and the administration of mRNA-1273  is assessed as unlikely. Causality for the event Product dose omission issue is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: got Guillain-Barre syndrome; This spontaneous case was reported by an other health care professional and describes the occurrence of GUILLAIN-BARRE SYNDROME (got Guillain-Barre syndrome) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (got Guillain-Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (got Guillain-Barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Vertigo, Vomiting
Clinical narrative: Completely deaf in his right ear; Vertigo; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Completely deaf in his right ear) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy. Concomitant products included ALLOPURINOL for Gout.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced DEAFNESS (Completely deaf in his right ear) (seriousness criteria disability and medically significant), VERTIGO (Vertigo) and VOMITING (Vomiting). The patient was treated with DIAZEPAM (VALIUM) for Dizziness, at an unspecified dose and frequency. At the time of the report, DEAFNESS (Completely deaf in his right ear), VERTIGO (Vertigo) and VOMITING (Vomiting) outcome was unknown.            The concomitant medications were reported as some unknown medications for blood pressure which the patient was taking since the age of 20.  The laboratory tests were reported as some unknown tests for brain tumor and the results came out negative. Also patient underwent several laboratory tests to rule out for virus, autoimmune disease to detect the reason behind deafness. The results were came out as normal. The patient consulted ear nose throat last week to rectify the reason behind deafness.  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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Aneurysm, Headache, Product dose omission issue, Vomiting
Clinical narrative: aneurysm; vomiting; greater than 35 days between doses of Moderna Covid-19 vaccine.; headache; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (aneurysm) and VOMITING (vomiting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0258218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 13-Mar-2021, the patient experienced VOMITING (vomiting) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced ANEURYSM (aneurysm) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and PRODUCT DOSE OMISSION ISSUE (greater than 35 days between doses of Moderna Covid-19 vaccine.). The patient was hospitalized for 14 days due to ANEURYSM and VOMITING. The patient was treated with Surgery for Aneurysm. At the time of the report, ANEURYSM (aneurysm), VOMITING (vomiting), PRODUCT DOSE OMISSION ISSUE (greater than 35 days between doses of Moderna Covid-19 vaccine.) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  Patient received his first Moderna Covid-19 vaccine on 03 MAR 2021, the patient reports having a headache. On 13 MAR 2021, the patient experienced vomiting and went to the hospital. The patient was found to have an aneurysm and was admitted to the hospital for surgery. The patient was discharged from the hospital 2 weeks later.  This case concerns a 65 year old male who was hospitalized due to Aneurysm with unknown days after receiving 1st dose of the vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: This case concerns a 65 year old male who was hospitalized due to Aneurysm with unknown days after receiving 1st dose of the vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: left side weakness; muscle weakness; dizziness; arm site injection pain; nausea; chills; body ache; low grade fever; headache; vomiting; twitching; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPARESIS (left side weakness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced MUSCLE TWITCHING (twitching). On an unknown date, the patient experienced HEMIPARESIS (left side weakness) (seriousness criterion medically significant), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness), VACCINATION SITE PAIN (arm site injection pain), NAUSEA (nausea), CHILLS (chills), MYALGIA (body ache), PYREXIA (low grade fever), HEADACHE (headache) and VOMITING (vomiting). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes simplex type II, at an unspecified dose and frequency; PHENTERMINE HYDROCHLORIDE (ADIPEX-P) for Weight loss, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEMIPARESIS (left side weakness), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness), MUSCLE TWITCHING (twitching), VACCINATION SITE PAIN (arm site injection pain), NAUSEA (nausea), CHILLS (chills), MYALGIA (body ache), PYREXIA (low grade fever), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Electrocardiogram: normal (normal) normal. In 2021, Laboratory test: normal (normal) normal.         Concomitant product was not provided.  Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hemiparesis, Laboratory test, Muscle twitching, Muscular weakness
Clinical narrative: left side weakness; muscle weakness; dizziness; arm site injection pain; nausea; chills; body ache; low grade fever; headache; vomiting; twitching; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPARESIS (left side weakness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced MUSCLE TWITCHING (twitching). On an unknown date, the patient experienced HEMIPARESIS (left side weakness) (seriousness criterion medically significant), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness), VACCINATION SITE PAIN (arm site injection pain), NAUSEA (nausea), CHILLS (chills), MYALGIA (body ache), PYREXIA (low grade fever), HEADACHE (headache) and VOMITING (vomiting). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes simplex type II, at an unspecified dose and frequency; PHENTERMINE HYDROCHLORIDE (ADIPEX-P) for Weight loss, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEMIPARESIS (left side weakness), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness), MUSCLE TWITCHING (twitching), VACCINATION SITE PAIN (arm site injection pain), NAUSEA (nausea), CHILLS (chills), MYALGIA (body ache), PYREXIA (low grade fever), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Electrocardiogram: normal (normal) normal. In 2021, Laboratory test: normal (normal) normal.         Concomitant product was not provided.  Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: left side weakness; muscle weakness; dizziness; arm site injection pain; nausea; chills; body ache; low grade fever; headache; vomiting; twitching; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPARESIS (left side weakness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced MUSCLE TWITCHING (twitching). On an unknown date, the patient experienced HEMIPARESIS (left side weakness) (seriousness criterion medically significant), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness), VACCINATION SITE PAIN (arm site injection pain), NAUSEA (nausea), CHILLS (chills), MYALGIA (body ache), PYREXIA (low grade fever), HEADACHE (headache) and VOMITING (vomiting). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes simplex type II, at an unspecified dose and frequency; PHENTERMINE HYDROCHLORIDE (ADIPEX-P) for Weight loss, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEMIPARESIS (left side weakness), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (dizziness), MUSCLE TWITCHING (twitching), VACCINATION SITE PAIN (arm site injection pain), NAUSEA (nausea), CHILLS (chills), MYALGIA (body ache), PYREXIA (low grade fever), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Electrocardiogram: normal (normal) normal. In 2021, Laboratory test: normal (normal) normal.         Concomitant product was not provided.  Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots in right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots in right leg) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 029A21A) for COVID-19 vaccination.     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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots in right leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots in right leg) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding the event has been provided at this time.  No further information is expected.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received provided no new information; Sender's Comments: Very limited information regarding the event has been provided at this time.  No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Plasma cell myeloma
Clinical narrative: Myeloma; This spontaneous case was reported by a consumer and describes the occurrence of PLASMA CELL MYELOMA (Myeloma) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PLASMA CELL MYELOMA (Myeloma) (seriousness criterion medically significant). At the time of the report, PLASMA CELL MYELOMA (Myeloma) outcome was unknown.            No concomitant medications were reported.  On an unknown date, blood tests were conducted and antibody count was reported as 236236 (units and antibody type not specified).  No treatment medications were reported.    Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information was requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Hypoacusis, Product dose omission issue, Tinnitus
Clinical narrative: hearing loss/high frequency hearing loss; ringing of her ears; everything sounds muffled and silenced; Greater than 35 days since the patient received her First Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss/high frequency hearing loss), TINNITUS (ringing of her ears), HYPOACUSIS (everything sounds muffled and silenced) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her First Moderna Covid-19 vaccine.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (hearing loss/high frequency hearing loss) (seriousness criterion medically significant), TINNITUS (ringing of her ears) (seriousness criterion medically significant), HYPOACUSIS (everything sounds muffled and silenced) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her First Moderna Covid-19 vaccine.) (seriousness criterion medically significant). At the time of the report, DEAFNESS (hearing loss/high frequency hearing loss), TINNITUS (ringing of her ears) and HYPOACUSIS (everything sounds muffled and silenced) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her First Moderna Covid-19 vaccine.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Acoustic stimulation tests: abnormal (abnormal) lost half of high frequency hearing; low frequency hearing within range. In June 2021, Acoustic stimulation tests: approaching normal (Inconclusive) high frequency hearing getting better; ringing in ears improving.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   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.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Post-acute COVID-19 syndrome
Clinical narrative: 10 days later I ended up in hospital for 5 days with post covid issues; I was still so sick; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (10 days later I ended up in hospital for 5 days with post covid issues) in a  patient of an unknown age and gender 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 COVID-19 in December 2020.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (10 days later I ended up in hospital for 5 days with post covid issues) (seriousness criterion hospitalization) and ILLNESS (I was still so sick). The patient was hospitalized for 5 days due to POST-ACUTE COVID-19 SYNDROME. At the time of the report, POST-ACUTE COVID-19 SYNDROME (10 days later I ended up in hospital for 5 days with post covid issues) and ILLNESS (I was still so sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       Concomitant product use was not provided by the reporter.   The patient reported having COVID-19 in end of December and getting the first vaccine dose in end of January. The patient was hospitalized 10 days after vaccination for 5 days and did not receive the second vaccine dose scheduled in end of February.  No treatment information was 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. Unlikely, that the events are related to the vaccine.; 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. Unlikely, that the events are related to the vaccine.