chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, Pyrexia
Clinical narrative: tingling in left side of her face; Headache; fever; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (tingling in left side of her face), HEADACHE (Headache) and PYREXIA (fever) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PARAESTHESIA (tingling in left side of her face), HEADACHE (Headache) and PYREXIA (fever). At the time of the report, PARAESTHESIA (tingling in left side of her face), HEADACHE (Headache) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   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. Physician reported events experienced by a female patient in her 60s.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-295464 (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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: was a little bit sore after her first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (was a little bit sore after her first dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-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 MYALGIA (was a little bit sore after her first dose). At the time of the report, MYALGIA (was a little bit sore after her first dose) outcome was unknown.            No concomitant product information were provided by the reporter.  No treatment information was provided by the reporter.  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 MOD-2021-295504.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Splenic thrombosis
Clinical narrative: Blood clot  in a blood vessel to the spleen; This spontaneous case was reported by a consumer and describes the occurrence of SPLENIC THROMBOSIS (Blood clot  in a blood vessel to the spleen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced SPLENIC THROMBOSIS (Blood clot  in a blood vessel to the spleen) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 17-Mar-2021 to 03-Apr-2021 due to SPLENIC THROMBOSIS. The patient was treated with Surgery (Had the organ removed) for Splenic thrombosis. At the time of the report, SPLENIC THROMBOSIS (Blood clot  in a blood vessel to the spleen) outcome was unknown.            No concomitant medication provided.  No treatment information mentioned.  Company Comment:  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations
Clinical narrative: Palpitations; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations) and HEADACHE (Headaches). At the time of the report, PALPITATIONS (Palpitations) and HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medical information were reported. No treatment information was reported.  Company comment: Very limited information regarding these events has been provided at this time.   This case was linked to MOD-2021-295925 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time.
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Haematemesis, Pyrexia, Skin discolouration
Clinical narrative: Vomit blood; Darkening of lips; Eye irritation; HIgh fever with maximum 39.6°C Fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (Vomit blood) 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.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMATEMESIS (Vomit blood) (seriousness criterion medically significant), SKIN DISCOLOURATION (Darkening of lips), EYE IRRITATION (Eye irritation) and PYREXIA (HIgh fever with maximum 39.6°C Fever). At the time of the report, HAEMATEMESIS (Vomit blood), SKIN DISCOLOURATION (Darkening of lips), EYE IRRITATION (Eye irritation) and PYREXIA (HIgh fever with maximum 39.6°C Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Very limited information regarding these events has been provided at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Drug ineffective, Pyrexia
Clinical narrative: Lot of sneezing; 99 fever; Small chill; Lack of drug effect; Had a breakthrough case of covid, mild case; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (Had a breakthrough case of covid, mild case), SNEEZING (Lot of sneezing), PYREXIA (99 fever) and CHILLS (Small chill) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Had a breakthrough case of covid, mild case). On 22-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SNEEZING (Lot of sneezing), PYREXIA (99 fever) and CHILLS (Small chill). The patient was treated with MONOCLONAL ANTIBODIES for COVID-19, at a dose of 1 dosage form. At the time of the report, DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (Had a breakthrough case of covid, mild case), SNEEZING (Lot of sneezing), PYREXIA (99 fever) and CHILLS (Small chill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, Body temperature: 99 (High) 99 Fever. On 20-Jul-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive. On 24-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 26-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient also had a 24 hour test with positive COVID result.  Concomitant medications were not provided. Patient took monoclonal antibodies infusion as treatment for COVID-19.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Additional information received on 31 Aug 2021 contains new significant information. First dose date updated, new events added, lab data updated.; Sender's Comments: This report refers to a case of Drug ineffective for mRNA-1273, lot numbers unspecified. Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the compatibility of the events Sneezing, Pyrexia and Chills with a Covid-19 infection, these events are assessed as unlikely related to mRNA-1273.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sneezing
Clinical narrative: Lot of sneezing; 99 fever; Small chill; Lack of drug effect; Had a breakthrough case of covid, mild case; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (Had a breakthrough case of covid, mild case), SNEEZING (Lot of sneezing), PYREXIA (99 fever) and CHILLS (Small chill) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Had a breakthrough case of covid, mild case). On 22-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SNEEZING (Lot of sneezing), PYREXIA (99 fever) and CHILLS (Small chill). The patient was treated with MONOCLONAL ANTIBODIES for COVID-19, at a dose of 1 dosage form. At the time of the report, DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (Had a breakthrough case of covid, mild case), SNEEZING (Lot of sneezing), PYREXIA (99 fever) and CHILLS (Small chill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, Body temperature: 99 (High) 99 Fever. On 20-Jul-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive. On 24-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 26-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient also had a 24 hour test with positive COVID result.  Concomitant medications were not provided. Patient took monoclonal antibodies infusion as treatment for COVID-19.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Additional information received on 31 Aug 2021 contains new significant information. First dose date updated, new events added, lab data updated.; Sender's Comments: This report refers to a case of Drug ineffective for mRNA-1273, lot numbers unspecified. Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the compatibility of the events Sneezing, Pyrexia and Chills with a Covid-19 infection, these events are assessed as unlikely related to mRNA-1273.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Heart rate, Heart rate irregular
Clinical narrative: a-fib; irregular heart beat; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (a-fib) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardioversion in May 2021 and Cardiac ablation on 18-Aug-2021. Concurrent medical conditions included Heart disorder and Blood pressure abnormal. Concomitant products included CLONIDINE, LOSARTAN and AMLODIPINE for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ATRIAL FIBRILLATION (a-fib) (seriousness criterion medically significant) and HEART RATE IRREGULAR (irregular heart beat). The patient was treated with Surgery for Atrial fibrillation. At the time of the report, ATRIAL FIBRILLATION (a-fib) and HEART RATE IRREGULAR (irregular heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Heart rate: irregular (abnormal) irregular. On 09-Apr-2021, Electrocardiogram: atrial fibrillation (abnormal) atrial fibrillation. On an unknown date, Heart rate: very slow (abnormal) very slow heart rate.         Concomitant medications included blood pressure medicine. It was reported that patient developed atrial fibrillation exactly two week after his second dose of Moderna COVID19 Vaccine.  He stayed in normal rhythm for about a day and a half. He was preparing to go back to the hospital to start a new atrial fibrillation medication because he had a very slow heart rate.  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.; 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: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Eye haemorrhage, Feeling abnormal, Hyperhidrosis
Clinical narrative: large broken blood vessel in his left eye on outer edge of the iris; He felt terrible/He felt emotionally terrible for 5 to 10 minutes; He felt depressed; His right arm was sore on that day after 2nd dose/He had body aches; chills on next day; At night, he sweated a lot.; His right arm was sore on that day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (large broken blood vessel in his left eye on outer edge of the iris) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (His right arm was sore on that day after receiving 2nd dose). On 22-Aug-2021, the patient experienced MYALGIA (His right arm was sore on that day after 2nd dose/He had body aches), CHILLS (chills on next day) and HYPERHIDROSIS (At night, he sweated a lot.). On 24-Aug-2021, the patient experienced FEELING ABNORMAL (He felt terrible/He felt emotionally terrible for 5 to 10 minutes) and DEPRESSED MOOD (He felt depressed). On 25-Aug-2021, the patient experienced EYE HAEMORRHAGE (large broken blood vessel in his left eye on outer edge of the iris) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE HAEMORRHAGE (large broken blood vessel in his left eye on outer edge of the iris), MYALGIA (His right arm was sore on that day after 2nd dose/He had body aches), CHILLS (chills on next day), HYPERHIDROSIS (At night, he sweated a lot.), FEELING ABNORMAL (He felt terrible/He felt emotionally terrible for 5 to 10 minutes), DEPRESSED MOOD (He felt depressed) and PAIN IN EXTREMITY (His right arm was sore on that day after receiving 2nd dose) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details were 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. Further information has been requested.; 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. Further information has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: large broken blood vessel in his left eye on outer edge of the iris; He felt terrible/He felt emotionally terrible for 5 to 10 minutes; He felt depressed; His right arm was sore on that day after 2nd dose/He had body aches; chills on next day; At night, he sweated a lot.; His right arm was sore on that day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (large broken blood vessel in his left eye on outer edge of the iris) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (His right arm was sore on that day after receiving 2nd dose). On 22-Aug-2021, the patient experienced MYALGIA (His right arm was sore on that day after 2nd dose/He had body aches), CHILLS (chills on next day) and HYPERHIDROSIS (At night, he sweated a lot.). On 24-Aug-2021, the patient experienced FEELING ABNORMAL (He felt terrible/He felt emotionally terrible for 5 to 10 minutes) and DEPRESSED MOOD (He felt depressed). On 25-Aug-2021, the patient experienced EYE HAEMORRHAGE (large broken blood vessel in his left eye on outer edge of the iris) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE HAEMORRHAGE (large broken blood vessel in his left eye on outer edge of the iris), MYALGIA (His right arm was sore on that day after 2nd dose/He had body aches), CHILLS (chills on next day), HYPERHIDROSIS (At night, he sweated a lot.), FEELING ABNORMAL (He felt terrible/He felt emotionally terrible for 5 to 10 minutes), DEPRESSED MOOD (He felt depressed) and PAIN IN EXTREMITY (His right arm was sore on that day after receiving 2nd dose) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details were 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. Further information has been requested.; 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. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Non-Hodgkin's lymphoma
Clinical narrative: Non-Hodgkin's lymphoma; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of NON-HODGKIN'S LYMPHOMA (Non-Hodgkin's lymphoma) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NON-HODGKIN'S LYMPHOMA (Non-Hodgkin's lymphoma) (seriousness criterion medically significant). At the time of the report, NON-HODGKIN'S LYMPHOMA (Non-Hodgkin's lymphoma) 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.   Concomitant products were not provided. Treatment medication were not reported.  The reporter's cousin was diagnosed with non-Hodgkin's lymphoma after her cousin got the Moderna Covid-19 vaccine. The attending physician of her cousin said that they may have had the non-Hodgkin's lymphoma prior to getting the vaccine.  Company Comment: Very limited information regarding this event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypoaesthesia, Joint stiffness
Clinical narrative: hemmorhage of my right retina; numbness and tingling in her fingers, knee, and feet; numbness and tingling in her fingers, knee, and feet; swelling in joints; stiffness in joints; joint pain; patient felt an achiness throughout her entire body with extreme fatigue; body aches/ patient felt an achiness throughout her entire body; chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL HAEMORRHAGE (hemmorhage of my right retina), HYPOAESTHESIA (numbness and tingling in her fingers, knee, and feet) and PARAESTHESIA (numbness and tingling in her fingers, knee, and feet) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NUTRIENTS NOS (SUPER GREENS), THUJA OCCIDENTALIS (THUJA) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (body aches/ patient felt an achiness throughout her entire body). On 01-May-2021, the patient experienced RETINAL HAEMORRHAGE (hemmorhage of my right retina) (seriousness criterion medically significant), HYPOAESTHESIA (numbness and tingling in her fingers, knee, and feet) (seriousness criterion medically significant), PARAESTHESIA (numbness and tingling in her fingers, knee, and feet) (seriousness criterion medically significant), JOINT SWELLING (swelling in joints), JOINT STIFFNESS (stiffness in joints), ARTHRALGIA (joint pain) and FATIGUE (patient felt an achiness throughout her entire body with extreme fatigue). At the time of the report, RETINAL HAEMORRHAGE (hemmorhage of my right retina), HYPOAESTHESIA (numbness and tingling in her fingers, knee, and feet), PARAESTHESIA (numbness and tingling in her fingers, knee, and feet), JOINT SWELLING (swelling in joints), JOINT STIFFNESS (stiffness in joints), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (low grade fever), FATIGUE (patient felt an achiness throughout her entire body with extreme fatigue) and MYALGIA (body aches/ patient felt an achiness throughout her entire body) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No treatment medication details was reported.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Myalgia, Paraesthesia, Pyrexia, Retinal haemorrhage
Clinical narrative: hemmorhage of my right retina; numbness and tingling in her fingers, knee, and feet; numbness and tingling in her fingers, knee, and feet; swelling in joints; stiffness in joints; joint pain; patient felt an achiness throughout her entire body with extreme fatigue; body aches/ patient felt an achiness throughout her entire body; chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL HAEMORRHAGE (hemmorhage of my right retina), HYPOAESTHESIA (numbness and tingling in her fingers, knee, and feet) and PARAESTHESIA (numbness and tingling in her fingers, knee, and feet) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NUTRIENTS NOS (SUPER GREENS), THUJA OCCIDENTALIS (THUJA) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (body aches/ patient felt an achiness throughout her entire body). On 01-May-2021, the patient experienced RETINAL HAEMORRHAGE (hemmorhage of my right retina) (seriousness criterion medically significant), HYPOAESTHESIA (numbness and tingling in her fingers, knee, and feet) (seriousness criterion medically significant), PARAESTHESIA (numbness and tingling in her fingers, knee, and feet) (seriousness criterion medically significant), JOINT SWELLING (swelling in joints), JOINT STIFFNESS (stiffness in joints), ARTHRALGIA (joint pain) and FATIGUE (patient felt an achiness throughout her entire body with extreme fatigue). At the time of the report, RETINAL HAEMORRHAGE (hemmorhage of my right retina), HYPOAESTHESIA (numbness and tingling in her fingers, knee, and feet), PARAESTHESIA (numbness and tingling in her fingers, knee, and feet), JOINT SWELLING (swelling in joints), JOINT STIFFNESS (stiffness in joints), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (low grade fever), FATIGUE (patient felt an achiness throughout her entire body with extreme fatigue) and MYALGIA (body aches/ patient felt an achiness throughout her entire body) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No treatment medication details was reported.  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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Influenza, Myalgia, Pain, Vaccination site swelling
Clinical narrative: allergic reaction; It appeared as if she had an exit wound where the shot was given, at the bottom of where the shot was given; hurt everywhere; There was swelling at injection site,like a golf ball; worse case of the flu,like a flu on steroids,every flu symptom that you could think of; Pain was so bad she was crying; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (worse case of the flu,like a flu on steroids,every flu symptom that you could think of), PAIN (Pain was so bad she was crying), HYPERSENSITIVITY (allergic reaction), MYALGIA (hurt everywhere) and VACCINATION SITE SWELLING (There was swelling at injection site,like a golf ball) in a 59-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.     Concurrent medical conditions included Allergy (had an over the top allergic reaction.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INFLUENZA (worse case of the flu,like a flu on steroids,every flu symptom that you could think of). 09-Apr-2021, the patient experienced PAIN (Pain was so bad she was crying), MYALGIA (hurt everywhere) and VACCINATION SITE SWELLING (There was swelling at injection site,like a golf ball). On 23-Apr-2021, the patient experienced WOUND (It appeared as if she had an exit wound where the shot was given, at the bottom of where the shot was given). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, INFLUENZA (worse case of the flu,like a flu on steroids,every flu symptom that you could think of), PAIN (Pain was so bad she was crying), HYPERSENSITIVITY (allergic reaction), MYALGIA (hurt everywhere), VACCINATION SITE SWELLING (There was swelling at injection site,like a golf ball) and WOUND (It appeared as if she had an exit wound where the shot was given, at the bottom of where the shot was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient went to the drug store and they confirmed  had an allergic reaction.  patient bought antihistamine for the treatment of the allergic reaction patient had, patient said the allergic reaction occurred when the flu symptoms and pain subsided No concomitant 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. Further information has been requested.; 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. Further information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: allergic reaction; It appeared as if she had an exit wound where the shot was given, at the bottom of where the shot was given; hurt everywhere; There was swelling at injection site,like a golf ball; worse case of the flu,like a flu on steroids,every flu symptom that you could think of; Pain was so bad she was crying; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (worse case of the flu,like a flu on steroids,every flu symptom that you could think of), PAIN (Pain was so bad she was crying), HYPERSENSITIVITY (allergic reaction), MYALGIA (hurt everywhere) and VACCINATION SITE SWELLING (There was swelling at injection site,like a golf ball) in a 59-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.     Concurrent medical conditions included Allergy (had an over the top allergic reaction.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INFLUENZA (worse case of the flu,like a flu on steroids,every flu symptom that you could think of). 09-Apr-2021, the patient experienced PAIN (Pain was so bad she was crying), MYALGIA (hurt everywhere) and VACCINATION SITE SWELLING (There was swelling at injection site,like a golf ball). On 23-Apr-2021, the patient experienced WOUND (It appeared as if she had an exit wound where the shot was given, at the bottom of where the shot was given). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, INFLUENZA (worse case of the flu,like a flu on steroids,every flu symptom that you could think of), PAIN (Pain was so bad she was crying), HYPERSENSITIVITY (allergic reaction), MYALGIA (hurt everywhere), VACCINATION SITE SWELLING (There was swelling at injection site,like a golf ball) and WOUND (It appeared as if she had an exit wound where the shot was given, at the bottom of where the shot was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient went to the drug store and they confirmed  had an allergic reaction.  patient bought antihistamine for the treatment of the allergic reaction patient had, patient said the allergic reaction occurred when the flu symptoms and pain subsided No concomitant 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. Further information has been requested.; 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. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Pain, Paraesthesia
Clinical narrative: Came down with Covid; Lack of drug effect; Curled tingling feet; Achy; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Came down with Covid), DRUG INEFFECTIVE (Lack of drug effect), PARAESTHESIA (Curled tingling feet), PAIN (Achy) and FEELING ABNORMAL (Brain fog) 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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PARAESTHESIA (Curled tingling feet), PAIN (Achy) and FEELING ABNORMAL (Brain fog). On 21-Aug-2021, the patient experienced COVID-19 (Came down with Covid) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Came down with Covid) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and PARAESTHESIA (Curled tingling feet), PAIN (Achy) and FEELING ABNORMAL (Brain fog) had resolved.            Concomitant drug was not reported. Treatment medication was not reported. The patient was exposed at school pick up line on the 17-Aug-2021.   This case was linked to MOD-2021-295917 (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 Lack of drug effect, Paraesthesia, Pain and Feeling abnormal, a causal relationship cannot be excluded. However, based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, hence, for the event COVID-19, causality is assessed as not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hip fracture, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: Broken hips; runny nose every morning; sound like a lot of cold a lot of times; sneezing; exhausted, tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broken hips) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drug).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced RHINORRHOEA (runny nose every morning), NASOPHARYNGITIS (sound like a lot of cold a lot of times), SNEEZING (sneezing) and FATIGUE (exhausted, tiredness). On an unknown date, the patient experienced HIP FRACTURE (Broken hips) (seriousness criterion medically significant). At the time of the report, HIP FRACTURE (Broken hips), RHINORRHOEA (runny nose every morning), NASOPHARYNGITIS (sound like a lot of cold a lot of times), SNEEZING (sneezing) and FATIGUE (exhausted, tiredness) outcome was unknown.            Concomitant medication were not reported. Treatment medications were not reported.  company comment:Based on the current available information and temporal association between the use of the product and the start date of the events (rhinorrhoea, nasopharyngitis, sneezing, fatigue), a causal relationship cannot be excluded.   Very limited information regarding the event hip fracture has been provided at this time.Further information has been requested.; 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 (rhinorrhoea, nasopharyngitis, sneezing, fatigue), a causal relationship cannot be excluded.   Very limited information regarding the event hip fracture has been provided at this time.Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hot flush, Paraesthesia, Skin reaction, Swelling
Clinical narrative: arms started shaking, legs started shaking; tingling in arms, tingling in legs; Hot flashes; swelling of her neck; swelling of her face; Skin reactions; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (arms started shaking, legs started shaking), PARAESTHESIA (tingling in arms, tingling in legs), HOT FLUSH (Hot flashes), SWELLING (swelling of her neck) and SWELLING FACE (swelling of her face) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.     On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced TREMOR (arms started shaking, legs started shaking) (seriousness criterion hospitalization), PARAESTHESIA (tingling in arms, tingling in legs) (seriousness criterion hospitalization), HOT FLUSH (Hot flashes) (seriousness criterion hospitalization), SWELLING (swelling of her neck) (seriousness criterion hospitalization) and SWELLING FACE (swelling of her face) (seriousness criterion hospitalization). In August 2021, the patient experienced ANXIETY (anxiety). On an unknown date, the patient experienced SKIN REACTION (Skin reactions). The patient was hospitalized from 12-Aug-2021 to 18-Aug-2021 due to HOT FLUSH, PARAESTHESIA, SWELLING, SWELLING FACE and TREMOR. The patient was treated with ALPRAZOLAM (XANAX) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (arms started shaking, legs started shaking), PARAESTHESIA (tingling in arms, tingling in legs), HOT FLUSH (Hot flashes), SWELLING (swelling of her neck), SWELLING FACE (swelling of her face) and SKIN REACTION (Skin reactions) outcome was unknown and ANXIETY (anxiety) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was hospitalized from 12-Aug-2021 to 18-Aug-2021.  Lab investigation performed included  EKG, stress test, MRI of her brain and spine, bloodwork, and a CT of her lungs with unknown result.  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, more information is required for further assessment. Follow up is expected.; 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, more information is required for further assessment. Follow up is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tremor
Clinical narrative: arms started shaking, legs started shaking; tingling in arms, tingling in legs; Hot flashes; swelling of her neck; swelling of her face; Skin reactions; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (arms started shaking, legs started shaking), PARAESTHESIA (tingling in arms, tingling in legs), HOT FLUSH (Hot flashes), SWELLING (swelling of her neck) and SWELLING FACE (swelling of her face) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.     On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced TREMOR (arms started shaking, legs started shaking) (seriousness criterion hospitalization), PARAESTHESIA (tingling in arms, tingling in legs) (seriousness criterion hospitalization), HOT FLUSH (Hot flashes) (seriousness criterion hospitalization), SWELLING (swelling of her neck) (seriousness criterion hospitalization) and SWELLING FACE (swelling of her face) (seriousness criterion hospitalization). In August 2021, the patient experienced ANXIETY (anxiety). On an unknown date, the patient experienced SKIN REACTION (Skin reactions). The patient was hospitalized from 12-Aug-2021 to 18-Aug-2021 due to HOT FLUSH, PARAESTHESIA, SWELLING, SWELLING FACE and TREMOR. The patient was treated with ALPRAZOLAM (XANAX) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (arms started shaking, legs started shaking), PARAESTHESIA (tingling in arms, tingling in legs), HOT FLUSH (Hot flashes), SWELLING (swelling of her neck), SWELLING FACE (swelling of her face) and SKIN REACTION (Skin reactions) outcome was unknown and ANXIETY (anxiety) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was hospitalized from 12-Aug-2021 to 18-Aug-2021.  Lab investigation performed included  EKG, stress test, MRI of her brain and spine, bloodwork, and a CT of her lungs with unknown result.  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, more information is required for further assessment. Follow up is expected.; 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, more information is required for further assessment. Follow up is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: A difficult time breathing; Welts all over his body; A full blown rash / rash kind of resolving; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (A difficult time breathing), URTICARIA (Welts all over his body) and RASH (A full blown rash / rash kind of resolving) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced DYSPNOEA (A difficult time breathing), URTICARIA (Welts all over his body) and RASH (A full blown rash / rash kind of resolving). At the time of the report, DYSPNOEA (A difficult time breathing) and URTICARIA (Welts all over his body) had resolved and RASH (A full blown rash / rash kind of resolving) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist recommended Benadryl to the patient.  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, very limited information regarding these events has been provided at this time. Case downgraded to non-serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint, given that medical intervention was not needed. Further information is not expected.; 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, very limited information regarding these events has been provided at this time. Case downgraded to non-serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint, given that medical intervention was not needed. Further information is not expected.