chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Ear pain, Eye pruritus, Headache, Myalgia
Clinical narrative: chest congestion; sneezing; sinus pain; ear pain; itchy eyes; coughing up phlemn; body ache; fever; chills; Sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) 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 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache). On an unknown date, the patient experienced PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant), SNEEZING (sneezing), SINUS PAIN (sinus pain), EAR PAIN (ear pain), EYE PRURITUS (itchy eyes), PRODUCTIVE COUGH (coughing up phlemn), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PULMONARY CONGESTION (chest congestion) and PRODUCTIVE COUGH (coughing up phlemn) was resolving and SNEEZING (sneezing), SINUS PAIN (sinus pain), EAR PAIN (ear pain), EYE PRURITUS (itchy eyes), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Case upgraded to serious with addition of event chest congestion. Dosage details added. New event sore arm reported. Outcome of productive cough changed from unknown to resolving.; 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: Pain in extremity, Productive cough, Pulmonary congestion, Pyrexia, Sinus pain
Clinical narrative: chest congestion; sneezing; sinus pain; ear pain; itchy eyes; coughing up phlemn; body ache; fever; chills; Sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) 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 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache). On an unknown date, the patient experienced PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant), SNEEZING (sneezing), SINUS PAIN (sinus pain), EAR PAIN (ear pain), EYE PRURITUS (itchy eyes), PRODUCTIVE COUGH (coughing up phlemn), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PULMONARY CONGESTION (chest congestion) and PRODUCTIVE COUGH (coughing up phlemn) was resolving and SNEEZING (sneezing), SINUS PAIN (sinus pain), EAR PAIN (ear pain), EYE PRURITUS (itchy eyes), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Case upgraded to serious with addition of event chest congestion. Dosage details added. New event sore arm reported. Outcome of productive cough changed from unknown to resolving.; 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: Sneezing
Clinical narrative: chest congestion; sneezing; sinus pain; ear pain; itchy eyes; coughing up phlemn; body ache; fever; chills; Sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) 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 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache). On an unknown date, the patient experienced PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant), SNEEZING (sneezing), SINUS PAIN (sinus pain), EAR PAIN (ear pain), EYE PRURITUS (itchy eyes), PRODUCTIVE COUGH (coughing up phlemn), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PULMONARY CONGESTION (chest congestion) and PRODUCTIVE COUGH (coughing up phlemn) was resolving and SNEEZING (sneezing), SINUS PAIN (sinus pain), EAR PAIN (ear pain), EYE PRURITUS (itchy eyes), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Case upgraded to serious with addition of event chest congestion. Dosage details added. New event sore arm reported. Outcome of productive cough changed from unknown to resolving.; 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: Hypersensitivity, Throat tightness
Clinical narrative: upper back of her throat was closing; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (upper back of her throat was closing) and HYPERSENSITIVITY (allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002540) for COVID-19 vaccination.     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 an unknown date, the patient experienced THROAT TIGHTNESS (upper back of her throat was closing) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction) (seriousness criterion medically significant). At the time of the report, THROAT TIGHTNESS (upper back of her throat was closing) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Neuralgia, Neuropathy peripheral, Pain
Clinical narrative: back hurts so bad, doctors diagnosed with neuropathy/Pain in extremity/Neuralgia/Paresthesia; flu like symptoms; pain that started in her foot and traveled up the body; nerve and joint pain in her feet, legs, knees, groin and arms, such bad aches and pains and nerve pains; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (back hurts so bad, doctors diagnosed with neuropathy/Pain in extremity/Neuralgia/Paresthesia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (back hurts so bad, doctors diagnosed with neuropathy/Pain in extremity/Neuralgia/Paresthesia) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (pain that started in her foot and traveled up the body) and NEURALGIA (nerve and joint pain in her feet, legs, knees, groin and arms, such bad aches and pains and nerve pains). The patient was treated with GABAPENTIN at an unspecified dose and frequency; PREGABALIN (LYRICA) at an unspecified dose and frequency and MELOXICAM at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (back hurts so bad, doctors diagnosed with neuropathy/Pain in extremity/Neuralgia/Paresthesia), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (pain that started in her foot and traveled up the body) and NEURALGIA (nerve and joint pain in her feet, legs, knees, groin and arms, such bad aches and pains and nerve pains) had not resolved.            Treatment information included Epidural gabapentin.  Based on the current available information and temporal association between the use of the product and the start date of 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac hypertrophy, Cardiac murmur, Night sweats, Product dose omission issue
Clinical narrative: heart thickening; heart murmur; night sweats; haven't gotten the second one; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC HYPERTROPHY (heart thickening) and CARDIAC MURMUR (heart murmur) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-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 CARDIAC HYPERTROPHY (heart thickening) (seriousness criterion hospitalization), CARDIAC MURMUR (heart murmur) (seriousness criterion hospitalization), NIGHT SWEATS (night sweats) and PRODUCT DOSE OMISSION ISSUE (haven't gotten the second one). The patient was hospitalized from 16-May-2021 to 09-Jun-2021 due to CARDIAC HYPERTROPHY and CARDIAC MURMUR. At the time of the report, CARDIAC HYPERTROPHY (heart thickening), CARDIAC MURMUR (heart murmur), NIGHT SWEATS (night sweats) and PRODUCT DOSE OMISSION ISSUE (haven't gotten the second one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter. Treatment medication 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 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Helicobacter infection, Pain, Vaccination site pain
Clinical narrative: Pain aggravated; Her right arm is still hurting at the injection site it hurts to sleep on it; Tired all the time; H Pylori; Diarrhea; This spontaneous case was reported by a nurse and describes the occurrence of HELICOBACTER INFECTION (H Pylori) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HELICOBACTER INFECTION (H Pylori) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and FATIGUE (Tired all the time). On an unknown date, the patient experienced PAIN (Pain aggravated) and VACCINATION SITE PAIN (Her right arm is still hurting at the injection site it hurts to sleep on it). At the time of the report, HELICOBACTER INFECTION (H Pylori) had resolved, DIARRHOEA (Diarrhea), FATIGUE (Tired all the time) and VACCINATION SITE PAIN (Her right arm is still hurting at the injection site it hurts to sleep on it) had not resolved and PAIN (Pain aggravated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was noted the patient's right arm was still hurting at the injection site it hurt to sleep on it, raise it, or sometimes doing simple things like reaching. She felt pain that is getting worse not better.  Treatment for the event of H Pylori included unknown antibiotic. No concomitant medications were reported.  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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L2012 and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (Shingles virus). Concurrent medical conditions included Diabetes (Sugar).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in July 2021 due to BELL'S PALSY. At the time of the report, BELL'S PALSY (Bell's palsy) outcome was unknown.            Concomitant medication information was not provided.  The patient stated that he received steroids and antiviral medications and stated that they thought it came from the shingles virus.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fall, Impaired driving ability
Clinical narrative: husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred; can't drive anymore; first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) and CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement and Carpal tunnel syndrome. Concurrent medical conditions included Overweight and High cholesterol.    On 10-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) (seriousness criterion medically significant). On 26-Jun-2021, the patient experienced FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) (seriousness criterion hospitalization). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (can't drive anymore). The patient was hospitalized for 2 days due to FALL. The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of 325 milligram once a day and ATORVASTATIN CALCIUM (LIPITOR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred), CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) and IMPAIRED DRIVING ABILITY (can't drive anymore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not provided.  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. The patient's medical history of Hypercholesterolemia and being overweight are possible confounding factors.; 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. The patient's medical history of Hypercholesterolemia and being overweight are possible confounding factors.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Myalgia, Osteoarthritis, Pain
Clinical narrative: Pain manifested in the right arm; Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain; Pain spread to the other side of the body; Pain; Osteoarthritis; Loss of memory; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, CLONAZEPAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced AMNESIA (Loss of memory). On 17-Jul-2021, the patient experienced OSTEOARTHRITIS (Osteoarthritis) (seriousness criterion disability) and PAIN (Pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain manifested in the right arm), ARTHRALGIA (Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain) and MYALGIA (Pain spread to the other side of the body). At the time of the report, OSTEOARTHRITIS (Osteoarthritis), AMNESIA (Loss of memory), PAIN IN EXTREMITY (Pain manifested in the right arm), PAIN (Pain), ARTHRALGIA (Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain) and MYALGIA (Pain spread to the other side of the body) outcome was unknown.            Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine)( Intramuscular), the reporter did not provide any causality assessments.   Laboratory investigations performed included blood test, MRI (Magnetic resonance imaging), urine test and X-Ray test all performed on an unknown date whose results are not provided.  Additional information reported included that the patient visited emergency room on 17 Jul 2021. The patient also reported that pain started to manifest the right arm and she had to keep it in a certain position for it to subside.  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. Very limited information regarding this events has been provided at this time. No further information is expected at this time   This case was linked to MOD-2021-265771 (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. Very limited information regarding this events has been provided at this time. No further information is expected at this time
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain manifested in the right arm; Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain; Pain spread to the other side of the body; Pain; Osteoarthritis; Loss of memory; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, CLONAZEPAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced AMNESIA (Loss of memory). On 17-Jul-2021, the patient experienced OSTEOARTHRITIS (Osteoarthritis) (seriousness criterion disability) and PAIN (Pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain manifested in the right arm), ARTHRALGIA (Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain) and MYALGIA (Pain spread to the other side of the body). At the time of the report, OSTEOARTHRITIS (Osteoarthritis), AMNESIA (Loss of memory), PAIN IN EXTREMITY (Pain manifested in the right arm), PAIN (Pain), ARTHRALGIA (Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain) and MYALGIA (Pain spread to the other side of the body) outcome was unknown.            Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine)( Intramuscular), the reporter did not provide any causality assessments.   Laboratory investigations performed included blood test, MRI (Magnetic resonance imaging), urine test and X-Ray test all performed on an unknown date whose results are not provided.  Additional information reported included that the patient visited emergency room on 17 Jul 2021. The patient also reported that pain started to manifest the right arm and she had to keep it in a certain position for it to subside.  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. Very limited information regarding this events has been provided at this time. No further information is expected at this time   This case was linked to MOD-2021-265771 (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. Very limited information regarding this events has been provided at this time. No further information is expected at this time
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Staphylococcal infection
Clinical narrative: Developed a staph infection/staph infection was on leg and butt had spots all over body; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Developed a staph infection/staph infection was on leg and butt had spots all over body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. a    No Medical History information was reported.    On 21-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced STAPHYLOCOCCAL INFECTION (Developed a staph infection/staph infection was on leg and butt had spots all over body) (seriousness criterion medically significant). The patient was treated with CEFAZOLINE [CEFAZOLIN] for Staphylococcal infection, at an unspecified dose and frequency. At the time of the report, STAPHYLOCOCCAL INFECTION (Developed a staph infection/staph infection was on leg and butt had spots all over body) outcome was unknown.            Patient stated that she was taking some concomitant medications but did not provide further details. She had photos of the same for proof if needed.  Patient was unsure on the onset date for the event post dose 1 and mentioned it as 03-Jun-2021 or 04-Jun-2021.  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.  More information has been requested.   This case was linked to MOD-2021-265886 (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 event, a causal relationship cannot be excluded.  More information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Exophthalmos, Headache, Ocular discomfort, Vaccination complication
Clinical narrative: Eyes feel full bulging; Pressure in eyes is different; Vaccine messed up; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EXOPHTHALMOS (Eyes feel full bulging) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Glaucoma. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN, LISINOPRIL, PREGABALIN (LYRICA), BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) and PILOCARPINE for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXOPHTHALMOS (Eyes feel full bulging) (seriousness criterion medically significant), OCULAR DISCOMFORT (Pressure in eyes is different), VACCINATION COMPLICATION (Vaccine messed up) and HEADACHE (Headache). At the time of the report, EXOPHTHALMOS (Eyes feel full bulging), OCULAR DISCOMFORT (Pressure in eyes is different), VACCINATION COMPLICATION (Vaccine messed up) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) Dramatic change in blood sugar, close to double..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  On an unknown date, a week after vaccination, the patient had high blood sugar which had a dramatic change and was closer to double. The patient was upset about the referral of the physician regarding the questions of blood sugar and eye pressure.  Very limited information regarding these events have been provided. Further information has been requested. Possible confounding factors are the patient's medical history of Glaucoma and Diabetes mellitus.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested. Possible confounding factors are the patient's medical history of Glaucoma and Diabetes mellitus.
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: transient ischemic event also known as a mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (transient ischemic event also known as a mini stroke) 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 TRANSIENT ISCHAEMIC ATTACK (transient ischemic event also known as a mini stroke) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (transient ischemic event also known as a mini stroke) outcome was unknown.            The patient experienced Transient Ischemic attack also known as a mini stroke after the second dose and went to ER.  No concomitant medications were reported. No treatment medications were reported.  Very limited information regarding the event  has been provided at this time.; Sender's Comments: Very limited information regarding the event  has been provided at this time.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Inflammation, Internal haemorrhage
Clinical narrative: onset of rheumatoid autoimmune symptoms; suspected internal bleeding from clotting; brain fog; numbness in feet/legs; high inflammation; persistent daily headaches; 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 INTERNAL HAEMORRHAGE (suspected internal bleeding from clotting) 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 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 RHEUMATIC DISORDER (onset of rheumatoid autoimmune symptoms), INTERNAL HAEMORRHAGE (suspected internal bleeding from clotting) (seriousness criterion medically significant), FEELING ABNORMAL (brain fog), HYPOAESTHESIA (numbness in feet/legs), INFLAMMATION (high inflammation) and HEADACHE (persistent daily headaches). At the time of the report, RHEUMATIC DISORDER (onset of rheumatoid autoimmune symptoms), INTERNAL HAEMORRHAGE (suspected internal bleeding from clotting), FEELING ABNORMAL (brain fog), HYPOAESTHESIA (numbness in feet/legs), INFLAMMATION (high inflammation) and HEADACHE (persistent daily headaches) outcome was unknown.            Patient went hiking the day before and was perfectly healthy. No concomitant medications were reported. Treatment information was not provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rheumatic disorder
Clinical narrative: onset of rheumatoid autoimmune symptoms; suspected internal bleeding from clotting; brain fog; numbness in feet/legs; high inflammation; persistent daily headaches; 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 INTERNAL HAEMORRHAGE (suspected internal bleeding from clotting) 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 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 RHEUMATIC DISORDER (onset of rheumatoid autoimmune symptoms), INTERNAL HAEMORRHAGE (suspected internal bleeding from clotting) (seriousness criterion medically significant), FEELING ABNORMAL (brain fog), HYPOAESTHESIA (numbness in feet/legs), INFLAMMATION (high inflammation) and HEADACHE (persistent daily headaches). At the time of the report, RHEUMATIC DISORDER (onset of rheumatoid autoimmune symptoms), INTERNAL HAEMORRHAGE (suspected internal bleeding from clotting), FEELING ABNORMAL (brain fog), HYPOAESTHESIA (numbness in feet/legs), INFLAMMATION (high inflammation) and HEADACHE (persistent daily headaches) outcome was unknown.            Patient went hiking the day before and was perfectly healthy. No concomitant medications were reported. Treatment information was not provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Pleural effusion
Clinical narrative: cardiac effusion following vaccination; plural effusion following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (cardiac effusion following vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERICARDIAL EFFUSION (cardiac effusion following vaccination) (seriousness criterion medically significant) and PLEURAL EFFUSION (plural effusion following vaccination). At the time of the report, PERICARDIAL EFFUSION (cardiac effusion following vaccination) and PLEURAL EFFUSION (plural effusion following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The patient developed pleural effusion and cardiac effusion about a month after the second dose.  Treatment information was not provided.  Very limited information regarding the events has been provided at this time; Sender's Comments: Very limited information regarding the events has been provided at this time
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Gait disturbance, Gastrointestinal disorder, Illness
Clinical narrative: really sick for two months; lost Twenty pounds; had GI problem; serious fatigue; couldn't go to work, couldn't drive the car; couldn't go to work, couldn't drive the car; barely walk up and down the stairs; hairs started falling out; so much of hair fell out that I had to buy a wig; got a very bad skin raise/very bad reaction; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 21Jan2021 as dose 1, single and dose 2, single via an unspecified route of administration on 12Feb2021 (Lot number: unknown), for covid-19 immunization. The patient medical history and concomitant medications were not reported. Lot number was not provided as the patient hung up abruptly/transfer incomplete. It was stated that, on unspecified date in 2021, the patient was really sick for two months, had lost twenty pounds, had GI problem, serious fatigue, could not go to work and could not drive the car, could barely walk up and down the stairs and took therapy in the Mar2021 and went back to work but after that, on unknown dates in 2021, the hairs started falling out and so much of hair fell out that, the patient had to buy a wig. The patient stated, did not know why these symptoms happened, but it was interfering with business and with everything but got better and what not. Reportedly, now since an unknown date in 2021, the patient got a very bad skin raise and it was persistent, no matter what had been taken, had course of medicine so they did not work, used steroid cream, prescription creams, tried ointment creams and nothing worked (Unspecified Medication). The patient stated these were very bad reaction. The patient was now concerned about hair loss and skin raise. Reportedly, PC filed conservatively. Therapeutic measures were taken for all the events. The outcome of the events got a very bad skin raise/very bad reaction, hairs started falling out and so much of hair fell out that I had to buy a wig was not recovered and outcome was recovering for the rest of the events.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Impaired driving ability, Impaired work ability, Skin reaction, Weight, Weight decreased
Clinical narrative: really sick for two months; lost Twenty pounds; had GI problem; serious fatigue; couldn't go to work, couldn't drive the car; couldn't go to work, couldn't drive the car; barely walk up and down the stairs; hairs started falling out; so much of hair fell out that I had to buy a wig; got a very bad skin raise/very bad reaction; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 21Jan2021 as dose 1, single and dose 2, single via an unspecified route of administration on 12Feb2021 (Lot number: unknown), for covid-19 immunization. The patient medical history and concomitant medications were not reported. Lot number was not provided as the patient hung up abruptly/transfer incomplete. It was stated that, on unspecified date in 2021, the patient was really sick for two months, had lost twenty pounds, had GI problem, serious fatigue, could not go to work and could not drive the car, could barely walk up and down the stairs and took therapy in the Mar2021 and went back to work but after that, on unknown dates in 2021, the hairs started falling out and so much of hair fell out that, the patient had to buy a wig. The patient stated, did not know why these symptoms happened, but it was interfering with business and with everything but got better and what not. Reportedly, now since an unknown date in 2021, the patient got a very bad skin raise and it was persistent, no matter what had been taken, had course of medicine so they did not work, used steroid cream, prescription creams, tried ointment creams and nothing worked (Unspecified Medication). The patient stated these were very bad reaction. The patient was now concerned about hair loss and skin raise. Reportedly, PC filed conservatively. Therapeutic measures were taken for all the events. The outcome of the events got a very bad skin raise/very bad reaction, hairs started falling out and so much of hair fell out that I had to buy a wig was not recovered and outcome was recovering for the rest of the events.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Wig wearer
Clinical narrative: really sick for two months; lost Twenty pounds; had GI problem; serious fatigue; couldn't go to work, couldn't drive the car; couldn't go to work, couldn't drive the car; barely walk up and down the stairs; hairs started falling out; so much of hair fell out that I had to buy a wig; got a very bad skin raise/very bad reaction; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 21Jan2021 as dose 1, single and dose 2, single via an unspecified route of administration on 12Feb2021 (Lot number: unknown), for covid-19 immunization. The patient medical history and concomitant medications were not reported. Lot number was not provided as the patient hung up abruptly/transfer incomplete. It was stated that, on unspecified date in 2021, the patient was really sick for two months, had lost twenty pounds, had GI problem, serious fatigue, could not go to work and could not drive the car, could barely walk up and down the stairs and took therapy in the Mar2021 and went back to work but after that, on unknown dates in 2021, the hairs started falling out and so much of hair fell out that, the patient had to buy a wig. The patient stated, did not know why these symptoms happened, but it was interfering with business and with everything but got better and what not. Reportedly, now since an unknown date in 2021, the patient got a very bad skin raise and it was persistent, no matter what had been taken, had course of medicine so they did not work, used steroid cream, prescription creams, tried ointment creams and nothing worked (Unspecified Medication). The patient stated these were very bad reaction. The patient was now concerned about hair loss and skin raise. Reportedly, PC filed conservatively. Therapeutic measures were taken for all the events. The outcome of the events got a very bad skin raise/very bad reaction, hairs started falling out and so much of hair fell out that I had to buy a wig was not recovered and outcome was recovering for the rest of the events.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Limb injury, Malaise, Myalgia
Clinical narrative: right  of the arm has a node in it ;  its very hot, its very pain full; Arm pain; Redness; Muscle pain; I do not feel well; pain on the injection site; its very hot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 17Jul2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. It was reported that the patient received the second dose yesterday (17Jul2021) and on an unspecified date, the patient experienced pain on the injection site, a lot of muscle pain, there was a node there, lot of redness, a lot of arm pain. The right of the arm had a node in it, it was very hot, it was very pain full, and patient did not feel well. The outcome of the events was unknown.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: right  of the arm has a node in it ;  its very hot, its very pain full; Arm pain; Redness; Muscle pain; I do not feel well; pain on the injection site; its very hot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 17Jul2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. It was reported that the patient received the second dose yesterday (17Jul2021) and on an unspecified date, the patient experienced pain on the injection site, a lot of muscle pain, there was a node there, lot of redness, a lot of arm pain. The right of the arm had a node in it, it was very hot, it was very pain full, and patient did not feel well. The outcome of the events was unknown.  Information about lot/batch has been requested.