chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pyrexia, SARS-CoV-2 antibody test negative, Sinusitis, Vaccination site erythema
Clinical narrative: Felt like she had the flu; Sinus infection; injection arm hot; It's getting hotter and bigger; injection arm red; fever; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Felt like she had the flu), SINUSITIS (Sinus infection), VACCINATION SITE WARMTH (injection arm hot), VACCINATION SITE SWELLING (It's getting hotter and bigger) and VACCINATION SITE ERYTHEMA (injection arm red) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Felt like she had the flu), SINUSITIS (Sinus infection), VACCINATION SITE WARMTH (injection arm hot), VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE ERYTHEMA (injection arm red) and PYREXIA (fever). At the time of the report, INFLUENZA (Felt like she had the flu), SINUSITIS (Sinus infection), VACCINATION SITE WARMTH (injection arm hot), VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE ERYTHEMA (injection arm red) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) negative.         Concomitant medications included pain medication and a medication for chronic angioedema of the intestines.  No treatment medications were reported.  Upon internal review on 04-AUG-2021, the age was corrected to 44 years.   This case was linked to MOD-2021-269267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received and contain Non-significant information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Felt like she had the flu; Sinus infection; injection arm hot; It's getting hotter and bigger; injection arm red; fever; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Felt like she had the flu), SINUSITIS (Sinus infection), VACCINATION SITE WARMTH (injection arm hot), VACCINATION SITE SWELLING (It's getting hotter and bigger) and VACCINATION SITE ERYTHEMA (injection arm red) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Felt like she had the flu), SINUSITIS (Sinus infection), VACCINATION SITE WARMTH (injection arm hot), VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE ERYTHEMA (injection arm red) and PYREXIA (fever). At the time of the report, INFLUENZA (Felt like she had the flu), SINUSITIS (Sinus infection), VACCINATION SITE WARMTH (injection arm hot), VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE ERYTHEMA (injection arm red) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) negative.         Concomitant medications included pain medication and a medication for chronic angioedema of the intestines.  No treatment medications were reported.  Upon internal review on 04-AUG-2021, the age was corrected to 44 years.   This case was linked to MOD-2021-269267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received and contain Non-significant information.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered dose of the Moderna COVID-19 vaccine from an expired vial.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered dose of the Moderna COVID-19 vaccine from an expired vial.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0J1021A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered dose of the Moderna COVID-19 vaccine from an expired vial.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered dose of the Moderna COVID-19 vaccine from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave 1 shot 1 day past; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 1 shot 1 day past) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021 at 10:46 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Jul-2021 at 12:05 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 1 shot 1 day past). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 1 shot 1 day past) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: dont have menstruation/It should be but its late since 8 day; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION DELAYED (dont have menstruation/It should be but its late since 8 day) 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 29-Jun-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 MENSTRUATION DELAYED (dont have menstruation/It should be but its late since 8 day). At the time of the report, MENSTRUATION DELAYED (dont have menstruation/It should be but its late since 8 day) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Suffering from mild and recurring headaches for the last month; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Suffering from mild and recurring headaches for the last month) 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 15-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Suffering from mild and recurring headaches for the last month). At the time of the report, HEADACHE (Suffering from mild and recurring headaches for the last month) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: was due to receive her the second dose of the Moderna Covid-19 vaccine   on   17Jul2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (was due to receive her the second dose of the Moderna Covid-19 vaccine   on   17Jul2021) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-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 PRODUCT DOSE OMISSION ISSUE (was due to receive her the second dose of the Moderna Covid-19 vaccine   on   17Jul2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (was due to receive her the second dose of the Moderna Covid-19 vaccine   on   17Jul2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: numbness in her left arm/numbness on the left side of the face, cheek, and a little bit down her neck; numbness in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in her left arm/numbness on the left side of the face, cheek, and a little bit down her neck) and HYPOAESTHESIA EYE (numbness in the left eye) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma (Glaucoma of left eye.). Concomitant products included VITAMINS NOS for an unknown indication.    On 29-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 HYPOAESTHESIA (numbness in her left arm/numbness on the left side of the face, cheek, and a little bit down her neck) and HYPOAESTHESIA EYE (numbness in the left eye). At the time of the report, HYPOAESTHESIA (numbness in her left arm/numbness on the left side of the face, cheek, and a little bit down her neck) had not resolved and HYPOAESTHESIA EYE (numbness in the left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After the vaccination, Patient experienced numbness in her left arm, Left side of her face, cheeks and a little bit down her neck. Treatment medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Nausea, Pollakiuria
Clinical narrative: Constipation; Nausea; Peeing a lot and that is worse; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), POLLAKIURIA (Peeing a lot and that is worse) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hip replacement on 28-Jun-2021.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced POLLAKIURIA (Peeing a lot and that is worse). On 26-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 27-Jul-2021, the patient experienced CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown and POLLAKIURIA (Peeing a lot and that is worse) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient reported that he was on medications since hip replacement that could cause a bladder infection.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient have not received second dose and more than 42 days after first dose have passed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient have not received second dose and more than 42 days after first dose have passed) 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. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient have not received second dose and more than 42 days after first dose have passed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient have not received second dose and more than 42 days after first dose have passed) 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.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Palpitations, Pustule
Clinical narrative: Pustules; bumps/itchy bumpy rash that spread to elbow; Right arm had normal soreness and aches  associated with a vaccine; heart was beating very fast and she felt it thumping that night; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PUSTULE (Pustules), RASH PRURITIC (bumps/itchy bumpy rash that spread to elbow), PAIN IN EXTREMITY (Right arm had normal soreness and aches  associated with a vaccine), PALPITATIONS (heart was beating very fast and she felt it thumping that night) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-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 PUSTULE (Pustules), RASH PRURITIC (bumps/itchy bumpy rash that spread to elbow), PAIN IN EXTREMITY (Right arm had normal soreness and aches  associated with a vaccine), PALPITATIONS (heart was beating very fast and she felt it thumping that night), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with HYDROCORTISONE ACETATE (CORTISONE [HYDROCORTISONE ACETATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PUSTULE (Pustules), RASH PRURITIC (bumps/itchy bumpy rash that spread to elbow), PAIN IN EXTREMITY (Right arm had normal soreness and aches  associated with a vaccine), PALPITATIONS (heart was beating very fast and she felt it thumping that night), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No Concomitant medications were provided.   This case was linked to MOD-2021-052069 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Pustules; bumps/itchy bumpy rash that spread to elbow; Right arm had normal soreness and aches  associated with a vaccine; heart was beating very fast and she felt it thumping that night; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PUSTULE (Pustules), RASH PRURITIC (bumps/itchy bumpy rash that spread to elbow), PAIN IN EXTREMITY (Right arm had normal soreness and aches  associated with a vaccine), PALPITATIONS (heart was beating very fast and she felt it thumping that night) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-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 PUSTULE (Pustules), RASH PRURITIC (bumps/itchy bumpy rash that spread to elbow), PAIN IN EXTREMITY (Right arm had normal soreness and aches  associated with a vaccine), PALPITATIONS (heart was beating very fast and she felt it thumping that night), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with HYDROCORTISONE ACETATE (CORTISONE [HYDROCORTISONE ACETATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PUSTULE (Pustules), RASH PRURITIC (bumps/itchy bumpy rash that spread to elbow), PAIN IN EXTREMITY (Right arm had normal soreness and aches  associated with a vaccine), PALPITATIONS (heart was beating very fast and she felt it thumping that night), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No Concomitant medications were provided.   This case was linked to MOD-2021-052069 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given from a vial that had been punctured for more than 24 hours/gave two Moderna vaccines that were expired by 14; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given from a vial that had been punctured for more than 24 hours/gave two Moderna vaccines that were expired by 14) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 039C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given from a vial that had been punctured for more than 24 hours/gave two Moderna vaccines that were expired by 14). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given from a vial that had been punctured for more than 24 hours/gave two Moderna vaccines that were expired by 14) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Reporter wants to know if there is a need  to revaccinate their patients.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received contains No New Information
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia, Restlessness
Clinical narrative: Restless; could not sleep well; headache; left shoulder feeling pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of RESTLESSNESS (Restless), INSOMNIA (could not sleep well), HEADACHE (headache) and ARTHRALGIA (left shoulder feeling pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (taking medication regularly.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESTLESSNESS (Restless), INSOMNIA (could not sleep well), HEADACHE (headache) and ARTHRALGIA (left shoulder feeling pain). At the time of the report, RESTLESSNESS (Restless), INSOMNIA (could not sleep well), HEADACHE (headache) and ARTHRALGIA (left shoulder feeling pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitants were not provided. Treatment was not given. Patient asked that he could take Panadol for headache and restless.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Nasal congestion, Purpura, Rash
Clinical narrative: Started seeing pools of blood underneath the skin / little blue spots underneath the skin on the legs; was not well overall; Rash; Congestion; her body felt very very strange, like something was moving, the body just felt so different; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), FEELING ABNORMAL (her body felt very very strange, like something was moving, the body just felt so different), PURPURA (Started seeing pools of blood underneath the skin / little blue spots underneath the skin on the legs), MALAISE (was not well overall) and RASH (Rash) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054LZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Low platelets (She has low platelets (condition prior to the vaccination), has always suffered with low platelets, not low to the point of being hospitalized,  always around 105000.).    On 09-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 NASAL CONGESTION (Congestion), FEELING ABNORMAL (her body felt very very strange, like something was moving, the body just felt so different), PURPURA (Started seeing pools of blood underneath the skin / little blue spots underneath the skin on the legs), MALAISE (was not well overall) and RASH (Rash). At the time of the report, NASAL CONGESTION (Congestion), FEELING ABNORMAL (her body felt very very strange, like something was moving, the body just felt so different), MALAISE (was not well overall) and RASH (Rash) outcome was unknown and PURPURA (Started seeing pools of blood underneath the skin / little blue spots underneath the skin on the legs) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave two Moderna vaccines that were expired by 14 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave two Moderna vaccines that were expired by 14 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 039C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave two Moderna vaccines that were expired by 14 hours). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (gave two Moderna vaccines that were expired by 14 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non significant follow up added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Decreased appetite, Dysphagia, Headache
Clinical narrative: felt as if she had covid again/ felt the same symptomatology (like when she had covid); 5 centimeters protuberance in the injection site; Back pain; she had no appetite; she couldn't swallow water but it wasn't like her throat was closing; had body weakness; felt like the swelling was tightening her; had headache like if her head is going to explode; Nauseas; Muscle pain/Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (felt as if she had covid again/ felt the same symptomatology (like when she had covid)), VACCINATION SITE MASS (5 centimeters protuberance in the injection site), BACK PAIN (Back pain), DECREASED APPETITE (she had no appetite) and DYSPHAGIA (she couldn't swallow water but it wasn't like her throat was closing) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025Z1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID 2 times in the past and was hospitalized.). Concomitant products included GABAPENTIN for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced SUSPECTED COVID-19 (felt as if she had covid again/ felt the same symptomatology (like when she had covid)), VACCINATION SITE MASS (5 centimeters protuberance in the injection site), BACK PAIN (Back pain), DECREASED APPETITE (she had no appetite), DYSPHAGIA (she couldn't swallow water but it wasn't like her throat was closing), ASTHENIA (had body weakness), VACCINATION SITE SWELLING (felt like the swelling was tightening her), HEADACHE (had headache like if her head is going to explode), NAUSEA (Nauseas), MYALGIA (Muscle pain/Body ache) and PYREXIA (Fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 500 mg and CAFFEINE (CAFEINE) for Myalgia and Headache, at a dose of 32.5 mg. At the time of the report, SUSPECTED COVID-19 (felt as if she had covid again/ felt the same symptomatology (like when she had covid)), BACK PAIN (Back pain), DECREASED APPETITE (she had no appetite), DYSPHAGIA (she couldn't swallow water but it wasn't like her throat was closing), ASTHENIA (had body weakness), HEADACHE (had headache like if her head is going to explode), NAUSEA (Nauseas), MYALGIA (Muscle pain/Body ache) and PYREXIA (Fever) was resolving and VACCINATION SITE MASS (5 centimeters protuberance in the injection site) and VACCINATION SITE SWELLING (felt like the swelling was tightening her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug included anti-inflammatory medications and thyroid medications.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Suspected COVID-19, Vaccination site mass
Clinical narrative: felt as if she had covid again/ felt the same symptomatology (like when she had covid); 5 centimeters protuberance in the injection site; Back pain; she had no appetite; she couldn't swallow water but it wasn't like her throat was closing; had body weakness; felt like the swelling was tightening her; had headache like if her head is going to explode; Nauseas; Muscle pain/Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (felt as if she had covid again/ felt the same symptomatology (like when she had covid)), VACCINATION SITE MASS (5 centimeters protuberance in the injection site), BACK PAIN (Back pain), DECREASED APPETITE (she had no appetite) and DYSPHAGIA (she couldn't swallow water but it wasn't like her throat was closing) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025Z1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID 2 times in the past and was hospitalized.). Concomitant products included GABAPENTIN for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced SUSPECTED COVID-19 (felt as if she had covid again/ felt the same symptomatology (like when she had covid)), VACCINATION SITE MASS (5 centimeters protuberance in the injection site), BACK PAIN (Back pain), DECREASED APPETITE (she had no appetite), DYSPHAGIA (she couldn't swallow water but it wasn't like her throat was closing), ASTHENIA (had body weakness), VACCINATION SITE SWELLING (felt like the swelling was tightening her), HEADACHE (had headache like if her head is going to explode), NAUSEA (Nauseas), MYALGIA (Muscle pain/Body ache) and PYREXIA (Fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 500 mg and CAFFEINE (CAFEINE) for Myalgia and Headache, at a dose of 32.5 mg. At the time of the report, SUSPECTED COVID-19 (felt as if she had covid again/ felt the same symptomatology (like when she had covid)), BACK PAIN (Back pain), DECREASED APPETITE (she had no appetite), DYSPHAGIA (she couldn't swallow water but it wasn't like her throat was closing), ASTHENIA (had body weakness), HEADACHE (had headache like if her head is going to explode), NAUSEA (Nauseas), MYALGIA (Muscle pain/Body ache) and PYREXIA (Fever) was resolving and VACCINATION SITE MASS (5 centimeters protuberance in the injection site) and VACCINATION SITE SWELLING (felt like the swelling was tightening her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug included anti-inflammatory medications and thyroid medications.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: felt as if she had covid again/ felt the same symptomatology (like when she had covid); 5 centimeters protuberance in the injection site; Back pain; she had no appetite; she couldn't swallow water but it wasn't like her throat was closing; had body weakness; felt like the swelling was tightening her; had headache like if her head is going to explode; Nauseas; Muscle pain/Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (felt as if she had covid again/ felt the same symptomatology (like when she had covid)), VACCINATION SITE MASS (5 centimeters protuberance in the injection site), BACK PAIN (Back pain), DECREASED APPETITE (she had no appetite) and DYSPHAGIA (she couldn't swallow water but it wasn't like her throat was closing) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025Z1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID 2 times in the past and was hospitalized.). Concomitant products included GABAPENTIN for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced SUSPECTED COVID-19 (felt as if she had covid again/ felt the same symptomatology (like when she had covid)), VACCINATION SITE MASS (5 centimeters protuberance in the injection site), BACK PAIN (Back pain), DECREASED APPETITE (she had no appetite), DYSPHAGIA (she couldn't swallow water but it wasn't like her throat was closing), ASTHENIA (had body weakness), VACCINATION SITE SWELLING (felt like the swelling was tightening her), HEADACHE (had headache like if her head is going to explode), NAUSEA (Nauseas), MYALGIA (Muscle pain/Body ache) and PYREXIA (Fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 500 mg and CAFFEINE (CAFEINE) for Myalgia and Headache, at a dose of 32.5 mg. At the time of the report, SUSPECTED COVID-19 (felt as if she had covid again/ felt the same symptomatology (like when she had covid)), BACK PAIN (Back pain), DECREASED APPETITE (she had no appetite), DYSPHAGIA (she couldn't swallow water but it wasn't like her throat was closing), ASTHENIA (had body weakness), HEADACHE (had headache like if her head is going to explode), NAUSEA (Nauseas), MYALGIA (Muscle pain/Body ache) and PYREXIA (Fever) was resolving and VACCINATION SITE MASS (5 centimeters protuberance in the injection site) and VACCINATION SITE SWELLING (felt like the swelling was tightening her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug included anti-inflammatory medications and thyroid medications.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 103 degree fever after the second dose; 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 PYREXIA (103 degree fever after the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (103 degree fever after the second dose). At the time of the report, PYREXIA (103 degree fever after the second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) Fever-103 degree.         No concomitant medication were provided. No treatment information were provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Oral pain
Clinical narrative: Mouth was sensitive to things; Little bumps here and there; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Mouth was sensitive to things) and ORAL DISORDER (Little bumps here and there) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced ORAL PAIN (Mouth was sensitive to things) and ORAL DISORDER (Little bumps here and there). At the time of the report, ORAL PAIN (Mouth was sensitive to things) and ORAL DISORDER (Little bumps here and there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that her friend recommended "some natural thing" for the immune system, but it didn't work.   This case was linked to MOD-2021-269633 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia
Clinical narrative: could not sleep well; injected on left shoulder feeling pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep well), ARTHRALGIA (injected on left shoulder feeling pain) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Blood pressure high, Hypercholesterolaemia (high cholesterol) and Kidney stone.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (could not sleep well), ARTHRALGIA (injected on left shoulder feeling pain) and HEADACHE (headache). At the time of the report, INSOMNIA (could not sleep well), ARTHRALGIA (injected on left shoulder feeling pain) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Over 35 days since 1st dose; 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 PRODUCT DOSE OMISSION ISSUE (Over 35 days since 1st dose) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Over 35 days since 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Over 35 days since 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.  Patient was not comfortable giving any additional AE information nor with follow up from Safety.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 virus test was positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.    No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Oedema, Skin mass
Clinical narrative: Severe hypersensitivity reaction; Nodules and severe edema to lips; Nodules and severe edema to lips; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Severe hypersensitivity reaction), OEDEMA (Nodules and severe edema to lips) and SKIN MASS (Nodules and severe edema to lips) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Severe hypersensitivity reaction), OEDEMA (Nodules and severe edema to lips) and SKIN MASS (Nodules and severe edema to lips). At the time of the report, HYPERSENSITIVITY (Severe hypersensitivity reaction), OEDEMA (Nodules and severe edema to lips) and SKIN MASS (Nodules and severe edema to lips) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Malaise, Nausea
Clinical narrative: Started to feel sick; Coughing; Very thirsty; Weak (she couldn't even walk); Diarrhea; Started vomiting; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started to feel sick), COUGH (Coughing), THIRST (Very thirsty), ASTHENIA (Weak (she couldn't even walk)) and DIARRHOEA (Diarrhea) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic, Blood pressure, Cholesterol and Penicillin allergy.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced MALAISE (Started to feel sick), COUGH (Coughing), THIRST (Very thirsty), ASTHENIA (Weak (she couldn't even walk)), DIARRHOEA (Diarrhea), VOMITING (Started vomiting) and NAUSEA (Nauseated). At the time of the report, MALAISE (Started to feel sick), COUGH (Coughing), THIRST (Very thirsty), ASTHENIA (Weak (she couldn't even walk)), DIARRHOEA (Diarrhea), VOMITING (Started vomiting) and NAUSEA (Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was taking medications for diabetes, blood pressure, and cholesterol. After 20 minutes of vaccination, the patient went to a restaurant and ate shrimp. When she got home, she started to felt sick and started vomiting and was also nauseated. The patient just drank water, Gatorade, and milk.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Thirst, Vomiting
Clinical narrative: Started to feel sick; Coughing; Very thirsty; Weak (she couldn't even walk); Diarrhea; Started vomiting; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started to feel sick), COUGH (Coughing), THIRST (Very thirsty), ASTHENIA (Weak (she couldn't even walk)) and DIARRHOEA (Diarrhea) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic, Blood pressure, Cholesterol and Penicillin allergy.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced MALAISE (Started to feel sick), COUGH (Coughing), THIRST (Very thirsty), ASTHENIA (Weak (she couldn't even walk)), DIARRHOEA (Diarrhea), VOMITING (Started vomiting) and NAUSEA (Nauseated). At the time of the report, MALAISE (Started to feel sick), COUGH (Coughing), THIRST (Very thirsty), ASTHENIA (Weak (she couldn't even walk)), DIARRHOEA (Diarrhea), VOMITING (Started vomiting) and NAUSEA (Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was taking medications for diabetes, blood pressure, and cholesterol. After 20 minutes of vaccination, the patient went to a restaurant and ate shrimp. When she got home, she started to felt sick and started vomiting and was also nauseated. The patient just drank water, Gatorade, and milk.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Fall, Head injury, Hypotension, Loss of consciousness
Clinical narrative: Patient was given first COVID-19 vaccine, Janssen J&J. Approximately 1-2 minutes after administration patient fainted. Patient denies fainting episode previously with any vaccine. Patient fell and hit her head as she passed out. Emergency services were called in and the patient was evaluated for appropriate treatment of cut in head as well as low blood pressure.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration, Syncope
Clinical narrative: Patient was given first COVID-19 vaccine, Janssen J&J. Approximately 1-2 minutes after administration patient fainted. Patient denies fainting episode previously with any vaccine. Patient fell and hit her head as she passed out. Emergency services were called in and the patient was evaluated for appropriate treatment of cut in head as well as low blood pressure.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Erythema, Headache
Clinical narrative: Red swelling in arm  (size of tea cup saucer); painful for 2 days now itchy Sore neck, back, joints event without movement.  100.5 fever, chills and headache. Nausea
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Red swelling in arm  (size of tea cup saucer); painful for 2 days now itchy Sore neck, back, joints event without movement.  100.5 fever, chills and headache. Nausea
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Red swelling in arm  (size of tea cup saucer); painful for 2 days now itchy Sore neck, back, joints event without movement.  100.5 fever, chills and headache. Nausea