chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Intermenstrual bleeding
Clinical narrative: Noticed spotting/her cycle is due beginning of September/spotting continued until the evening; Earing a little bit cloudy; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Noticed spotting/her cycle is due beginning of September/spotting continued until the evening) and HYPOACUSIS (Earing a little bit cloudy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (Noticed spotting/her cycle is due beginning of September/spotting continued until the evening) and HYPOACUSIS (Earing a little bit cloudy). At the time of the report, INTERMENSTRUAL BLEEDING (Noticed spotting/her cycle is due beginning of September/spotting continued until the evening) and HYPOACUSIS (Earing a little bit cloudy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort, Eye swelling
Clinical narrative: ears feel like they are full of fluid; eye is swollen; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (ears feel like they are full of fluid) and EYE SWELLING (eye is swollen) 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 EAR DISCOMFORT (ears feel like they are full of fluid) and EYE SWELLING (eye is swollen). At the time of the report, EAR DISCOMFORT (ears feel like they are full of fluid) and EYE SWELLING (eye is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  No treatment  medication were provided
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Acquired Covid/Her symptoms were mild; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Acquired Covid/Her symptoms were mild) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Acquired Covid/Her symptoms were mild). At the time of the report, COVID-19 (Acquired Covid/Her symptoms were mild) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got my first dose 1/6/21 but did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got my first dose 1/6/21 but did not get the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got my first dose 1/6/21 but did not get the second dose). On 01-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Got my first dose 1/6/21 but did not get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose will be given more than 35 days after first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be given more than 35 days after first dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be given more than 35 days after first dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be given more than 35 days after first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided  No treatment medications were provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Vaccination site pain
Clinical narrative: felt  pins and needles sensations starting at the top of arm and going down; still having shooting pain on tops of both arms lasting 10 seconds every couple of days that felt like a needle scrape; having electrical and fizzing pains through either arm on doing strenuous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (having electrical and fizzing pains through either arm on doing strenuous), PARAESTHESIA (felt  pins and needles sensations starting at the top of arm and going down) and PAIN (still having shooting pain on tops of both arms lasting 10 seconds every couple of days that felt like a needle scrape) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-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 VACCINATION SITE PAIN (having electrical and fizzing pains through either arm on doing strenuous), PARAESTHESIA (felt  pins and needles sensations starting at the top of arm and going down) and PAIN (still having shooting pain on tops of both arms lasting 10 seconds every couple of days that felt like a needle scrape). At the time of the report, VACCINATION SITE PAIN (having electrical and fizzing pains through either arm on doing strenuous), PARAESTHESIA (felt  pins and needles sensations starting at the top of arm and going down) and PAIN (still having shooting pain on tops of both arms lasting 10 seconds every couple of days that felt like a needle scrape) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: live follow up appended : updated patient demographics, new events of pins and needles and shooting pain were added.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Feeling abnormal
Clinical narrative: Had lost of smell after having covid and it continues today after receiving the vaccine; Had lost of taste after having covid and it continues today after receiving the vaccine; soreness; was kind of feeling like coughing; not feeling good; body aches; (muscle pain) like somebody punching the arm; muscle pain; pain at the injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Had lost of smell after having covid and it continues today after receiving the vaccine), AGEUSIA (Had lost of taste after having covid and it continues today after receiving the vaccine), PAIN (soreness), COUGH (was kind of feeling like coughing) and FEELING ABNORMAL (not feeling good) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 15-Jul-2021. Concurrent medical conditions included Smell loss (Lost sense of smell) and Taste loss (Lost sense of taste). Concomitant products included VITAMINS NOS and NAPROXEN SODIUM (COMPLEMENT) for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced PAIN (soreness), COUGH (was kind of feeling like coughing), FEELING ABNORMAL (not feeling good), PAIN (body aches), PAIN IN EXTREMITY ((muscle pain) like somebody punching the arm), MYALGIA (muscle pain), VACCINATION SITE PAIN (pain at the injection site) and CHILLS (chills). On an unknown date, the patient experienced ANOSMIA (Had lost of smell after having covid and it continues today after receiving the vaccine) and AGEUSIA (Had lost of taste after having covid and it continues today after receiving the vaccine). On 07-Aug-2021, PAIN (soreness), COUGH (was kind of feeling like coughing), FEELING ABNORMAL (not feeling good), PAIN (body aches), PAIN IN EXTREMITY ((muscle pain) like somebody punching the arm), MYALGIA (muscle pain), VACCINATION SITE PAIN (pain at the injection site) and CHILLS (chills) had resolved. At the time of the report, ANOSMIA (Had lost of smell after having covid and it continues today after receiving the vaccine) and AGEUSIA (Had lost of taste after having covid and it continues today after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Had lost of smell after having covid and it continues today after receiving the vaccine; Had lost of taste after having covid and it continues today after receiving the vaccine; soreness; was kind of feeling like coughing; not feeling good; body aches; (muscle pain) like somebody punching the arm; muscle pain; pain at the injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Had lost of smell after having covid and it continues today after receiving the vaccine), AGEUSIA (Had lost of taste after having covid and it continues today after receiving the vaccine), PAIN (soreness), COUGH (was kind of feeling like coughing) and FEELING ABNORMAL (not feeling good) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 15-Jul-2021. Concurrent medical conditions included Smell loss (Lost sense of smell) and Taste loss (Lost sense of taste). Concomitant products included VITAMINS NOS and NAPROXEN SODIUM (COMPLEMENT) for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced PAIN (soreness), COUGH (was kind of feeling like coughing), FEELING ABNORMAL (not feeling good), PAIN (body aches), PAIN IN EXTREMITY ((muscle pain) like somebody punching the arm), MYALGIA (muscle pain), VACCINATION SITE PAIN (pain at the injection site) and CHILLS (chills). On an unknown date, the patient experienced ANOSMIA (Had lost of smell after having covid and it continues today after receiving the vaccine) and AGEUSIA (Had lost of taste after having covid and it continues today after receiving the vaccine). On 07-Aug-2021, PAIN (soreness), COUGH (was kind of feeling like coughing), FEELING ABNORMAL (not feeling good), PAIN (body aches), PAIN IN EXTREMITY ((muscle pain) like somebody punching the arm), MYALGIA (muscle pain), VACCINATION SITE PAIN (pain at the injection site) and CHILLS (chills) had resolved. At the time of the report, ANOSMIA (Had lost of smell after having covid and it continues today after receiving the vaccine) and AGEUSIA (Had lost of taste after having covid and it continues today after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Not receiving 2nd dose on time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not receiving 2nd dose on time) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008c21a and 052e21a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not receiving 2nd dose on time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not receiving 2nd dose on time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic carcinoma
Clinical narrative: pancreatic cancer diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATIC CARCINOMA (pancreatic cancer diagnosis) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PANCREATIC CARCINOMA (pancreatic cancer diagnosis) (seriousness criterion medically significant). At the time of the report, PANCREATIC CARCINOMA (pancreatic cancer diagnosis) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient started taking the chemotherapy on 16Mar2021 for the event pancreatic cancer diagnosis.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information is not suspected. Based on reporter's causality the event "Pancreatic cancer" is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after the second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache after the second vaccine). At the time of the report, HEADACHE (headache after the second vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Medical History information was reported.  No concomitant medication were reported.   No information on treatment is provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: received the first dose of the Moderna vaccine they got COVID; had to wait 90 days until they received 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 COVID-19 (received the first dose of the Moderna vaccine they got COVID) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days until they received 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (received the first dose of the Moderna vaccine they got COVID) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days until they received the second dose). At the time of the report, COVID-19 (received the first dose of the Moderna vaccine they got COVID) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days until they received the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.            No concomitant medication was provided.  No treatment information was provided.  Patient  received second Covid vaccine last Wednesday and tested positive for COVID on Sunday.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus inadequate control
Clinical narrative: Blood sugar has been very elevated/Had lots of issues bringing his blood sugar down/Seems like his insulin is no even effective since the vaccine/Increased the dosage of insulin/Cannot control; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (Blood sugar has been very elevated/Had lots of issues bringing his blood sugar down/Seems like his insulin is no even effective since the vaccine/Increased the dosage of insulin/Cannot control) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), INSULIN LISPRO (HUMALOG) and INSULIN DEGLUDEC (TRESIBA) for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Blood sugar has been very elevated/Had lots of issues bringing his blood sugar down/Seems like his insulin is no even effective since the vaccine/Increased the dosage of insulin/Cannot control) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Blood sugar has been very elevated/Had lots of issues bringing his blood sugar down/Seems like his insulin is no even effective since the vaccine/Increased the dosage of insulin/Cannot control) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Blood glucose: high (High) over 300.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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 event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed Second Dose; 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 (Missed 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 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 (Missed Second Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed Second Dose) 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 medications were not reported by the reporter Treatment drugs were not reported by the reporter   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days; Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication were provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) 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 03-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 (more than 36 days from first vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: caller got thse second dose more than 36 days after the first/Got 2nd dose beyond 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller got thse second dose more than 36 days after the first/Got 2nd dose beyond 42 days) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller got thse second dose more than 36 days after the first/Got 2nd dose beyond 42 days). On 21-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller got thse second dose more than 36 days after the first/Got 2nd dose beyond 42 days) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up information received and  Reporter information was added, Patient demographics updated, Suspect product Dose-1 and Dose-2 information was updated and event verbatim was updated
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: feeling sick with flu symptoms; second dose not received in allowed time window; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (feeling sick with flu symptoms) and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time window) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling sick with flu symptoms) and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time window). At the time of the report, MALAISE (feeling sick with flu symptoms) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time window) 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 treatment medication provided by reporter. No concomitant medication provided by reporter. No lab data history provided by reporter   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Lymphadenopathy, Pruritus, Swelling face, Urticaria
Clinical narrative: Right side of her face was swollen; Swollen lips; Swollen lymph nodes at her occiput (the back of her head); Hives, Raised Hives, Hives leaves a pink area on her skin for few day; Itchy Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives, Raised Hives, Hives leaves a pink area on her skin for few day), PRURITUS (Itchy Hives), SWELLING FACE (Right side of her face was swollen), LIP SWELLING (Swollen lips) and LYMPHADENOPATHY (Swollen lymph nodes at her occiput (the back of her head)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced URTICARIA (Hives, Raised Hives, Hives leaves a pink area on her skin for few day), PRURITUS (Itchy Hives) and LYMPHADENOPATHY (Swollen lymph nodes at her occiput (the back of her head)). On an unknown date, the patient experienced SWELLING FACE (Right side of her face was swollen) and LIP SWELLING (Swollen lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives, Raised Hives, Hives leaves a pink area on her skin for few day), PRURITUS (Itchy Hives), SWELLING FACE (Right side of her face was swollen), LIP SWELLING (Swollen lips) and LYMPHADENOPATHY (Swollen lymph nodes at her occiput (the back of her head)) outcome was unknown.            Concomitant medications were not provided by reporter.  The hives start in the same place every single time, it starts on the right side of patient's stomach about the size of a quarter then draws a line across patient's stomach to the left side of stomach and it is about the size of her palm. Patient thought that patient was having a stroke. At the ER, patient was treated with IV Steroid. Patient took over the counter Benadryl after the episode in 07-Aug-2021. Patient's healthcare provider was not sure what was going on with patient and referred patient to a Dermatologist, Hematologist and an Allergist.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: temperature excursions; Patient was administered expired Moderna vaccine; 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 EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) 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. No treatment medication were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 10-Aug-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: someone received an expired dose; 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 EXPIRED PRODUCT ADMINISTERED (someone received an expired 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (someone received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (someone received an expired dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: The patient is over 3 months late for second dose of vaccine; 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 PRODUCT DOSE OMISSION ISSUE (The patient is over 3 months late for second dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient is over 3 months late for second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient is over 3 months late for second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea
Clinical narrative: it's getting slightly worse/more noticeable than it was on Saturday; having a lot of shortness of breath/I have not taken a satisfying breath of air since Saturday/I have to take a deep breath to take a good breath of air; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having a lot of shortness of breath/I have not taken a satisfying breath of air since Saturday/I have to take a deep breath to take a good breath of air) and CONDITION AGGRAVATED (it's getting slightly worse/more noticeable than it was on Saturday) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced DYSPNOEA (having a lot of shortness of breath/I have not taken a satisfying breath of air since Saturday/I have to take a deep breath to take a good breath of air). On 11-Aug-2021, the patient experienced CONDITION AGGRAVATED (it's getting slightly worse/more noticeable than it was on Saturday). At the time of the report, DYSPNOEA (having a lot of shortness of breath/I have not taken a satisfying breath of air since Saturday/I have to take a deep breath to take a good breath of air) and CONDITION AGGRAVATED (it's getting slightly worse/more noticeable than it was on Saturday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that even her yawns are not satisfying. Concomitant product information was not reported. Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph node pain, Myalgia, Parosmia
Clinical narrative: Blurry vision; Altered taste; altered smell; Tender lymph nodes; Body aches; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), TASTE DISORDER (Altered taste), PAROSMIA (altered smell), LYMPH NODE PAIN (Tender lymph nodes) and MYALGIA (Body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VISION BLURRED (Blurry vision), TASTE DISORDER (Altered taste), PAROSMIA (altered smell), LYMPH NODE PAIN (Tender lymph nodes), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, VISION BLURRED (Blurry vision), TASTE DISORDER (Altered taste) and PAROSMIA (altered smell) outcome was unknown and LYMPH NODE PAIN (Tender lymph nodes), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was  provided by the reporter
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Vision blurred
Clinical narrative: Blurry vision; Altered taste; altered smell; Tender lymph nodes; Body aches; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), TASTE DISORDER (Altered taste), PAROSMIA (altered smell), LYMPH NODE PAIN (Tender lymph nodes) and MYALGIA (Body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VISION BLURRED (Blurry vision), TASTE DISORDER (Altered taste), PAROSMIA (altered smell), LYMPH NODE PAIN (Tender lymph nodes), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, VISION BLURRED (Blurry vision), TASTE DISORDER (Altered taste) and PAROSMIA (altered smell) outcome was unknown and LYMPH NODE PAIN (Tender lymph nodes), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was  provided by the reporter
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Swelling face, Swelling of eyelid
Clinical narrative: Swollen forehead; Swollen scalp; Swollen eyelid; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen forehead), SKIN SWELLING (Swollen scalp) and SWELLING OF EYELID (Swollen eyelid) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE MODERNA (Lot #: 016C21A Arm of injection: Left) on 27-Apr-2021.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swollen forehead), SKIN SWELLING (Swollen scalp) and SWELLING OF EYELID (Swollen eyelid). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Swollen forehead), SKIN SWELLING (Swollen scalp) and SWELLING OF EYELID (Swollen eyelid) outcome was unknown.            The patient  experienced swollen forehead four different times. The  swelling moved from forehead up to the scalp of her hair then came down to the top of her eye lid and then her inner eye lid. She did not remember the 1st time she had the symptoms, but it was very mild, the 2nd time was in mid-May, the third time was 6 weeks ago, and the fourth time was 2 weeks ago.  Patient's healthcare provider thought it was shingles and she was on antiviral.  She confirmed that she had no previous use of face fillers. She did not provide her healthcare provider's information.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had first COVID vaccine 3+months ago did not get second COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had first COVID vaccine 3+months ago did not get second COVID vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had first COVID vaccine 3+months ago did not get second COVID vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had first COVID vaccine 3+months ago did not get second COVID vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received and contains no new information.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in his arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced MYALGIA (soreness in his arm). In March 2021, MYALGIA (soreness in his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally received a third dose of the Moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient accidentally received a third dose of the Moderna covid-19 vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Patient accidentally received a third dose of the Moderna covid-19 vaccine). On 11-Aug-2021, EXTRA DOSE ADMINISTERED (Patient accidentally received a third dose of the Moderna covid-19 vaccine) had resolved.            no medical history was reported no concomitant medication were reported no treatment medication were reported Patient  accidentally received a third dose on 11 Aug 2021
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea, Vomiting
Clinical narrative: lost appetite; at times I have to vomit; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite), VOMITING (at times I have to vomit) and NAUSEA (nausea) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (lost appetite), VOMITING (at times I have to vomit) and NAUSEA (nausea). The patient was treated with ONDANSETRON ongoing since an unknown date for Nausea, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (lost appetite), VOMITING (at times I have to vomit) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.