chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site bruising
Clinical narrative: Vaccination site bruising; Inappropriate route of vaccination; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AZIA and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was  not reported.   This case was linked to MOD-2021-027009 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: break through case after first dose; Tested positive for COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (break through case after first dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jul-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 VACCINE BREAKTHROUGH INFECTION (break through case after first dose) (seriousness criterion medically significant) and COVID-19 (Tested positive for COVID). At the time of the report, VACCINE BREAKTHROUGH INFECTION (break through case after first dose) and COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID.     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 provided. Treatment information was not provided.  The patient worked in a school system.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 test positive and mRNA-1273 is assessed as not applicable. Vaccine breakthrough infection was reported. However, the patient tested positive for COVID19 after the first dose of the vaccine prior to complete schedule of vaccination, thus it is not considered as such.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Diarrhoea, Drug ineffective
Clinical narrative: difficulty of breathing; After having the virus, he got pretty sick; COVID-19; Lack of efficacy; low-grade fever with body temperature of 99 degrees Fahrenheit; soreness of his arm; cough; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty of breathing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A2A1 and 0311720A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Degenerative bone disease (Degenerative Disease).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of his arm), COUGH (cough), DIARRHOEA (Diarrhea) and PYREXIA (low-grade fever with body temperature of 99 degrees Fahrenheit). On an unknown date, the patient experienced DYSPNOEA (difficulty of breathing) (seriousness criterion hospitalization), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). an unknown date, the patient experienced ILLNESS (After having the virus, he got pretty sick). At the time of the report, DYSPNOEA (difficulty of breathing) had resolved and PAIN IN EXTREMITY (soreness of his arm), COUGH (cough), DIARRHOEA (Diarrhea), ILLNESS (After having the virus, he got pretty sick), COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of efficacy) and PYREXIA (low-grade fever with body temperature of 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99 (High) 99 degrees Fahrenheit. On 27-Jul-2021, SARS-CoV-2 test: positive (Positive) positive with Corona Virus.         Additional medical history includes history of VA . Treatment information was not provided.  Company Comment: 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. For the rest of the events: 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 is also a report of "drug ineffective".; Sender's Comments: 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. For the rest of the events: 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 is also a report of "drug ineffective".
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Illness, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: difficulty of breathing; After having the virus, he got pretty sick; COVID-19; Lack of efficacy; low-grade fever with body temperature of 99 degrees Fahrenheit; soreness of his arm; cough; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty of breathing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A2A1 and 0311720A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Degenerative bone disease (Degenerative Disease).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of his arm), COUGH (cough), DIARRHOEA (Diarrhea) and PYREXIA (low-grade fever with body temperature of 99 degrees Fahrenheit). On an unknown date, the patient experienced DYSPNOEA (difficulty of breathing) (seriousness criterion hospitalization), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). an unknown date, the patient experienced ILLNESS (After having the virus, he got pretty sick). At the time of the report, DYSPNOEA (difficulty of breathing) had resolved and PAIN IN EXTREMITY (soreness of his arm), COUGH (cough), DIARRHOEA (Diarrhea), ILLNESS (After having the virus, he got pretty sick), COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of efficacy) and PYREXIA (low-grade fever with body temperature of 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99 (High) 99 degrees Fahrenheit. On 27-Jul-2021, SARS-CoV-2 test: positive (Positive) positive with Corona Virus.         Additional medical history includes history of VA . Treatment information was not provided.  Company Comment: 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. For the rest of the events: 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 is also a report of "drug ineffective".; Sender's Comments: 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. For the rest of the events: 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 is also a report of "drug ineffective".
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Catatonia, Dehydration, Headache, Pain in extremity, Staring
Clinical narrative: Sore arm; Headache; Unresponsive/he was standing in aisle just staring; Catatonic; Dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of STARING (Unresponsive/he was standing in aisle just staring), CATATONIA (Catatonic), DEHYDRATION (Dehydrated), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035B21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Autistic disorder. Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced HEADACHE (Headache). On 09-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). In 2021, the patient experienced STARING (Unresponsive/he was standing in aisle just staring), CATATONIA (Catatonic) and DEHYDRATION (Dehydrated). At the time of the report, STARING (Unresponsive/he was standing in aisle just staring), CATATONIA (Catatonic), DEHYDRATION (Dehydrated) and PAIN IN EXTREMITY (Sore arm) outcome was unknown and HEADACHE (Headache) had resolved.            No concomitant medications were provided. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past medical history may remain a confounder. 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. However, the patient's past medical history may remain a confounder. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: One mother had a mini stroke; This spontaneous case was reported by a nurse and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (One mother had 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (One mother had a mini stroke) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (One mother had a mini stroke) 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 medication of the patient was not reported.  No treatment information was provided by the reporter  Company comment Very limited information regarding this event has been provided at this time.  However, 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-2021-294118 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  However, 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: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Possible side effect related to blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Possible side effect related to blood clots) 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 THROMBOSIS (Possible side effect related to blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Possible side effect related to blood clots) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant product information were provided by the reporter.  No treatment information was provided by the reporter.  Company comment Very limited information regarding this event has been provided at this time.  However, 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. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  However, 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. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Drug ineffective, Feeling abnormal, Hypersomnia
Clinical narrative: Lack of efficacy; Sleeping a little longer than usual; She had aches and pains (joint); She had aches and pains (muscle); Felt very bad; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy), HYPERSOMNIA (Sleeping a little longer than usual), ARTHRALGIA (She had aches and pains (joint)), MYALGIA (She had aches and pains (muscle)) and FEELING ABNORMAL (Felt very bad) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced ARTHRALGIA (She had aches and pains (joint)), MYALGIA (She had aches and pains (muscle)), FEELING ABNORMAL (Felt very bad) and CHILLS (Chills). On 14-Aug-2021, the patient experienced HYPERSOMNIA (Sleeping a little longer than usual). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of efficacy). On 17-May-2021, ARTHRALGIA (She had aches and pains (joint)) outcome was unknown, MYALGIA (She had aches and pains (muscle)), FEELING ABNORMAL (Felt very bad) and CHILLS (Chills) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and HYPERSOMNIA (Sleeping a little longer than usual) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         She received her first dose of Moderna covid-19 vaccine on 14-APR-2021 with lot no.007B21A No concomitant medications reported. Patient took advil at 12th hour of 15-APR-2021 and 3 times after.  Company Comment: This is a case of Drug ineffective with associated adverse events and Patient tested positive for COVID-19 after receiving 2 doses Moderna vaccine in the correct interval (25-35 days).  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing  COVID-19 infection. Based on the current available information and temporal association between the use of the product and the start date of the events, of Hypersomnia, Arthralgia, Myalgia, feeling abnormal and Chills, a causal relationship cannot be excluded.; Sender's Comments: This is a case of Drug ineffective with associated adverse events and Patient tested positive for COVID-19 after receiving 2 doses Moderna vaccine in the correct interval (25-35 days).  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing  COVID-19 infection. Based on the current available information and temporal association between the use of the product and the start date of the events, of Hypersomnia, Arthralgia, Myalgia, feeling abnormal and Chills, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; Sleeping a little longer than usual; She had aches and pains (joint); She had aches and pains (muscle); Felt very bad; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy), HYPERSOMNIA (Sleeping a little longer than usual), ARTHRALGIA (She had aches and pains (joint)), MYALGIA (She had aches and pains (muscle)) and FEELING ABNORMAL (Felt very bad) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced ARTHRALGIA (She had aches and pains (joint)), MYALGIA (She had aches and pains (muscle)), FEELING ABNORMAL (Felt very bad) and CHILLS (Chills). On 14-Aug-2021, the patient experienced HYPERSOMNIA (Sleeping a little longer than usual). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of efficacy). On 17-May-2021, ARTHRALGIA (She had aches and pains (joint)) outcome was unknown, MYALGIA (She had aches and pains (muscle)), FEELING ABNORMAL (Felt very bad) and CHILLS (Chills) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and HYPERSOMNIA (Sleeping a little longer than usual) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         She received her first dose of Moderna covid-19 vaccine on 14-APR-2021 with lot no.007B21A No concomitant medications reported. Patient took advil at 12th hour of 15-APR-2021 and 3 times after.  Company Comment: This is a case of Drug ineffective with associated adverse events and Patient tested positive for COVID-19 after receiving 2 doses Moderna vaccine in the correct interval (25-35 days).  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing  COVID-19 infection. Based on the current available information and temporal association between the use of the product and the start date of the events, of Hypersomnia, Arthralgia, Myalgia, feeling abnormal and Chills, a causal relationship cannot be excluded.; Sender's Comments: This is a case of Drug ineffective with associated adverse events and Patient tested positive for COVID-19 after receiving 2 doses Moderna vaccine in the correct interval (25-35 days).  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing  COVID-19 infection. Based on the current available information and temporal association between the use of the product and the start date of the events, of Hypersomnia, Arthralgia, Myalgia, feeling abnormal and Chills, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tongue tingled a for a few mins; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA ORAL (tongue tingled a for a few mins) 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 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PARAESTHESIA ORAL (tongue tingled a for a few mins). In 2021, PARAESTHESIA ORAL (tongue tingled a for a few mins) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow up document was received it included no new information
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Seizure
Clinical narrative: Headaches over the weekend; Seizure; Left arm was sore for about 4 days; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) 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 LEVETIRACETAM and DIVALPROEX for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced PAIN IN EXTREMITY. On 19-Aug-2021, the patient experienced SEIZURE (seriousness criterion medically significant). On 21-Aug-2021, the patient experienced HEADACHE. On 19-Aug-2021, SEIZURE had resolved. On 22-Aug-2021, PAIN IN EXTREMITY and HEADACHE had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was 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. 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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomyopathy, Lacrimation increased, Myocarditis, Paraesthesia, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMYOPATHY and MYOCARDITIS in an 85-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.     Concurrent medical conditions included Blood pressure high, Thyroid disorder, and Anxiety. Concomitant products included PREDNISONE for an unknown indication.  On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced SWELLING FACE. In July 2021, the patient experienced PERIPHERAL SWELLING. In August 2021, the patient experienced CARDIOMYOPATHY (seriousness criterion medically significant) and MYOCARDITIS (seriousness criterion medically significant). On an unknown date, the patient experienced LACRIMATION INCREASED, SKIN EXFOLIATION, PARAESTHESIA, PRURITUS, SKIN DISCOLOURATION, and RASH. At the time of the report, CARDIOMYOPATHY, MYOCARDITIS, SWELLING FACE, LACRIMATION INCREASED, SKIN EXFOLIATION, PARAESTHESIA, PRURITUS, PERIPHERAL SWELLING, SKIN DISCOLOURATION, and RASH outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.  Concomitant product was provided as Concomitant: BP medicines, Thyroid medicine, Anxiety medicine, Pain medicine Lab data was not provided.  Treatment product was provided as topical and oral steroids.   Caller is calling to report adverse event for her father. Her father received his 1st dose on 11Mar2021. After 3 days of receiving vaccine, he started with ride side of facial swelling. He also had dripping in eyes. His back was rashy. His body turned red in color. He had tingling in his arm and back. It was itchy. His skin turned white flaky like dandruff. Sometime in July2021, he had moderate swelling in his legs and feet. He is also diagnosed with cardiomyopathy and myocarditis in 2nd week of August. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin discolouration, Skin exfoliation, Swelling face
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMYOPATHY and MYOCARDITIS in an 85-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.     Concurrent medical conditions included Blood pressure high, Thyroid disorder, and Anxiety. Concomitant products included PREDNISONE for an unknown indication.  On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced SWELLING FACE. In July 2021, the patient experienced PERIPHERAL SWELLING. In August 2021, the patient experienced CARDIOMYOPATHY (seriousness criterion medically significant) and MYOCARDITIS (seriousness criterion medically significant). On an unknown date, the patient experienced LACRIMATION INCREASED, SKIN EXFOLIATION, PARAESTHESIA, PRURITUS, SKIN DISCOLOURATION, and RASH. At the time of the report, CARDIOMYOPATHY, MYOCARDITIS, SWELLING FACE, LACRIMATION INCREASED, SKIN EXFOLIATION, PARAESTHESIA, PRURITUS, PERIPHERAL SWELLING, SKIN DISCOLOURATION, and RASH outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.  Concomitant product was provided as Concomitant: BP medicines, Thyroid medicine, Anxiety medicine, Pain medicine Lab data was not provided.  Treatment product was provided as topical and oral steroids.   Caller is calling to report adverse event for her father. Her father received his 1st dose on 11Mar2021. After 3 days of receiving vaccine, he started with ride side of facial swelling. He also had dripping in eyes. His back was rashy. His body turned red in color. He had tingling in his arm and back. It was itchy. His skin turned white flaky like dandruff. Sometime in July2021, he had moderate swelling in his legs and feet. He is also diagnosed with cardiomyopathy and myocarditis in 2nd week of August. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Facial asymmetry, Headache, Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: left side of her face is drooping but she can move it; face is numb like she's been to dentist; tingling in left side of her face; headache; fever; This spontaneous case was reported by a physician and describes the occurrence of FACIAL ASYMMETRY (left side of her face is drooping but she can move it), HYPOAESTHESIA (face is numb like she's been to dentist), PARAESTHESIA (tingling in left side of her face), HEADACHE (headache) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FACIAL ASYMMETRY (left side of her face is drooping but she can move it), HYPOAESTHESIA (face is numb like she's been to dentist), PARAESTHESIA (tingling in left side of her face), HEADACHE (headache) and PYREXIA (fever). At the time of the report, FACIAL ASYMMETRY (left side of her face is drooping but she can move it) and HYPOAESTHESIA (face is numb like she's been to dentist) had not resolved, PARAESTHESIA (tingling in left side of her face) outcome was unknown and HEADACHE (headache) and PYREXIA (fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information mentioned.  Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested   This case was linked to MOD-2021-295432 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Myocarditis
Clinical narrative: Myocarditis inflammation; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis inflammation) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Heart rate: 130 (High) heart rate around 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported. "Patient mentions another girl at the hospital (patient 2, reported in a crosslinked case) experienced accelerated the heat rate around 130, in January, and now has to see a cardiologist all the time for a  myocarditis inflammation caused by the vaccine."  Company Comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding
Clinical narrative: Once she did, she had her period for about 8 weeks; did not menstruate for 3 months following vaccine; This is a spontaneous report from a contactable HCP (reporting for self). A 46-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as a single dose (at the age of 46 years old) for COVID-19 immunization. The dose number was not reported. There was no other vaccine administered in the 4 weeks prior. Medical history included penicillin allergy. The patient did not have COVID prior to vaccination. Concomitant medication(s) included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported.  The reporter (patient) stated she did not menstruate for 3 months following vaccine. Once she did, she had her period for about 8 weeks. She was not in menopause and was always very regular. There was no treatment received for the event(s). The patient recovered from "did not menstruate for 3 months" on an unknown date. The outcome of the event "her period for about 8 weeks" was recovering. The patient was not COVID tested post vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Lip swelling, Nausea, Throat tightness
Clinical narrative: DIZZY; THROAT TIGHTNESS; SWOLLEN UPPER LIP; DIFFICULTY BREATHING; NAUSEA; VOMITING; This is a Spontaneous report from a Contactable Nurse. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 07Jul2021 at 10:30 (at the age of 38-years-old) (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, and schizophreniform disorder from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations four weeks prior to the vaccination. The patient previously took Gemifloxacin (MANUFACTURER UNKNOWN), nabumetone (MANUFACTURER UNKNOWN) and cyclobenzaprine (MANUFACTURER UNKNOWN) and experienced drug hypersensitivity; and experienced latex allergy. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 12Jun2021 (Batch/Lot Number EW0179) for COVD-19 immunisation. The patient experienced dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting all on 07Jul2021 at 10:45. The patient was taken to ER via ambulance by EMS. Therapeutic measures were taken as a result of dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting which included epinephrine 0.15 dose x1 in right thigh, and IV Benadryl and solumedrol in the ER. The clinical outcome of the dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting was recovered on an unknown date. It was unknown if the patient was tested for COVID post vaccination.    Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the events dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DIZZY; THROAT TIGHTNESS; SWOLLEN UPPER LIP; DIFFICULTY BREATHING; NAUSEA; VOMITING; This is a Spontaneous report from a Contactable Nurse. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 07Jul2021 at 10:30 (at the age of 38-years-old) (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, and schizophreniform disorder from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations four weeks prior to the vaccination. The patient previously took Gemifloxacin (MANUFACTURER UNKNOWN), nabumetone (MANUFACTURER UNKNOWN) and cyclobenzaprine (MANUFACTURER UNKNOWN) and experienced drug hypersensitivity; and experienced latex allergy. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 12Jun2021 (Batch/Lot Number EW0179) for COVD-19 immunisation. The patient experienced dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting all on 07Jul2021 at 10:45. The patient was taken to ER via ambulance by EMS. Therapeutic measures were taken as a result of dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting which included epinephrine 0.15 dose x1 in right thigh, and IV Benadryl and solumedrol in the ER. The clinical outcome of the dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting was recovered on an unknown date. It was unknown if the patient was tested for COVID post vaccination.    Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the events dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm hurt so bad; patient couldn't move the arm, could not lift her arm for 3 or 4 days.; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8727) as DOSE 1, SINGLE, via an unspecified route of administration, administered in Arm Left on 25Mar2021 between 10 to 11pm in the morning for covid-19 immunization. The patient medical history included ongoing inflammation due to allergies. The patient had cancer last year, did not have chemotherapy and doctors encouraged the caller to get Vaccine. The patient concomitant medications were not reported. The patient previously took Pneumonia and flu vaccine. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. After receiving the first dose of vaccine on 25Mar2021, the patient's arm hurt so bad (pain in extremity) and patient couldn't move the arm, mobility decreased on 25Mar2021. The patient stated that the arm was still hurting. The patient reported that certain ways the arm hurt more. It definitely hurt where the needle was put. The patient just recently had blood tests done and they were pretty normal. The clinical outcome of the event was Not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: really tired; very cold; This is a spontaneous report from a contactable consumer (Patient) reporting for herself.  A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 22Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced really tired (fatigue) and very cold (nasopharyngitis) on an unspecified date. Clinical course of events includes; she stated that it didn't start right away but that lately she's been really tired and very cold every second day. She will feel fine the next back but then back to being tired and cold the following day. She relayed, "I feel so cold and I cant do anything, I wasn't this way before." She would like to know if this is due to the vaccine. The outcome for the event was unknown.  Information on the lot/ batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose: sore arm; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 (at the age of 53-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. No medical history. On Mar2021, the patient experienced first dose: sore arm. Outcome of the event was unknown.    Additional Context: The caller is calling about the Pfizer covid vaccine. The caller finally got this number to report her side effects. The caller had the shot from withheld on 27Apr2021 at 4:00pm. Wednesday the caller was perfectly fine, this was great. The caller is perfectly healthy. Thursday morning at 5:00 am the caller got up to go to work and had straight blood when peeing. At this point the caller didn't have any pain, she was just peeing blood. The caller went to work and her pee got brighter red as the day went on. By the end of the day the caller had pain in the lower part of her stomach and back on one side. It got to the point to where the caller went to the emergency care and did a peed test for a UTI, it came back negative. They sent the caller to the hospital where they did a scan on her stomach and couldn't find anything. At that point they treated the caller for kidney stones. It turned out the caller has a kidney stone and keeps getting them since the shot. The caller is hoping that she can stop the kidney stones from forming. The caller got this shot to keep her safe but now this happened from the shot.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a rash on my arm and all over my chest and stomach; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2) via unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced i have a rash on my arm and all over my chest and stomach on an unspecified date. The clinical course was reported as follows consumer started, "I got the second Pfizer shot yesterday and I have a rash on my arm and all over my chest and stomach. I just wanted to report that and I don't know if that is common or what's the 'deal with that', what's with the rash?". Consumer stated, "I did it exactly the way they told me. My second shot was on 02Aug and my first shot was 3 weeks before that. The first one was 12Jul (Confirmed as 12Jul2021)." The outcome of event was unknown  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lactation disorder, Menstrual disorder
Clinical narrative: my milk supply started to dry up within 24 hours of vaccine.; my first menstrual cycle since giving birth occurred; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old nonpregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ey0584) 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 10:00, as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not  diagnosed for COVID 19. Since the vaccination, has not been tested for COVID-19. The patient did not take any vaccines within 4 weeks prior vaccination On 30Jul2021, at 21:00, the patient experienced my milk supply started to dry up within 24 hours of vaccine (lactation disorder) and Within 72 hours of vaccine, first menstrual cycle since giving birth occurred (menstrual disorder). The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101008335 maternal case/fetal case
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Pollakiuria
Clinical narrative: I have like heart burn stomach pain; I have like heart burn stomach pain; I have frequent urination; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 06Aug2021 13:20 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced frequent urination on an unspecified date in Aug2021 and like heart burn stomach pain on 07Aug2021. It was reported that, patient felt fine on the day of vaccination and didn't have any symptoms, patient got up this morning and had two, patient did not know two things that occurred that did not have yesterday, one was patient had frequent urination had to go every two hours and peed every two hours, with normally patient did not pee like every 4 to 5 hours so, did not know that was reaction to the shot or vaccine and the second one, patient had like heart burn stomach pain and patient had like stomach seen since, woke up this morning it growls all the time like need to fed, like had ache in the wall but patient eat like every 4 hours and did not have that problem yet today after the shot but that just started this morning. Patient thought may be could find out if that was the a reaction to Pfizer COVID shot and wanted to know if it had anything to do with this vaccine. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.