chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: terrible itching on neck and chest; I got red spots on arms and legs of the body; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (terrible itching on neck and chest) and RASH MACULAR (I got red spots on arms and legs of the body) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included UTI from 11-Mar-2021 to 18-Mar-2021. Concurrent medical conditions included Drug allergy (Allergic to medications, food, and other products.), Food allergy (Allergic to medications, food, and other products.) and Allergy NOS (Allergic to medications, food, and other products.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, ATORVASTATIN, METOPROLOL and CALCIUM for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (terrible itching on neck and chest) and RASH MACULAR (I got red spots on arms and legs of the body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRETIC) on 11-Mar-2021 for Itching, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 11-Mar-2021 for Itching, at a dose of 1 dosage form and DIPHENHYDRAMINE on 11-Mar-2021 for Itching, at a dose of 1 dosage form. On 10-Apr-2021, RASH MACULAR (I got red spots on arms and legs of the body) was resolving. At the time of the report, PRURITUS (terrible itching on neck and chest) was resolving. Not Provided          The patient reported that at the beginning, there was just mild itching on neck area. It progressed after the 2nd shot to terrible itching on neck and chest. It was stated that Zyrtec or Allegra did not help the patient very much so she took Benadryl in the evenings.   This case was linked to MOD-2021-050242 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Tinnitus
Clinical narrative: tinnitus in both ears; low energy; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus in both ears) and ASTHENIA (low energy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-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 04-Apr-2021, the patient experienced TINNITUS (tinnitus in both ears) and ASTHENIA (low energy). At the time of the report, TINNITUS (tinnitus in both ears) and ASTHENIA (low energy) outcome was unknown.            No concomitant medication was reported. Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye pruritus, Headache, Ocular hyperaemia, Pyrexia
Clinical narrative: sneezing; cough off and on; Itchy eyes; Red eyes; headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), COUGH (cough off and on), EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Red eyes) and HEADACHE (headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 15-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced PYREXIA (fever). On 13-Jul-2021, the patient experienced HEADACHE (headaches). On an unknown date, the patient experienced SNEEZING (sneezing), COUGH (cough off and on), EYE PRURITUS (Itchy eyes) and OCULAR HYPERAEMIA (Red eyes). The patient was treated with IBUPROFEN from 12-Jun-2021 to 14-Jun-2021 for Fever, at an unspecified dose and frequency; ASCORBIC ACID (VITAMIN C ACID) at an unspecified dose and frequency; GUAIFENESIN (COUGH SYRUP E) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) from 13-Jul-2021 to 21-Jul-2021 for Headache, at an unspecified dose and frequency. On 14-Jun-2021, PYREXIA (fever) outcome was unknown. On 21-Jul-2021, SNEEZING (sneezing), COUGH (cough off and on), EYE PRURITUS (Itchy eyes) and OCULAR HYPERAEMIA (Red eyes) had resolved and HEADACHE (headaches) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: significant follow up received and updated vaccine doses information, reporter information, confirmed no medical case,  recovery date provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: sneezing; cough off and on; Itchy eyes; Red eyes; headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), COUGH (cough off and on), EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Red eyes) and HEADACHE (headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 15-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced PYREXIA (fever). On 13-Jul-2021, the patient experienced HEADACHE (headaches). On an unknown date, the patient experienced SNEEZING (sneezing), COUGH (cough off and on), EYE PRURITUS (Itchy eyes) and OCULAR HYPERAEMIA (Red eyes). The patient was treated with IBUPROFEN from 12-Jun-2021 to 14-Jun-2021 for Fever, at an unspecified dose and frequency; ASCORBIC ACID (VITAMIN C ACID) at an unspecified dose and frequency; GUAIFENESIN (COUGH SYRUP E) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) from 13-Jul-2021 to 21-Jul-2021 for Headache, at an unspecified dose and frequency. On 14-Jun-2021, PYREXIA (fever) outcome was unknown. On 21-Jul-2021, SNEEZING (sneezing), COUGH (cough off and on), EYE PRURITUS (Itchy eyes) and OCULAR HYPERAEMIA (Red eyes) had resolved and HEADACHE (headaches) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: significant follow up received and updated vaccine doses information, reporter information, confirmed no medical case,  recovery date provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Headache, Migraine, Nausea
Clinical narrative: Horrible migraine headaches; Stomach pain; Lighthead; Headache; Vomited; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lighthead), HEADACHE (Headache), VOMITING (Vomited) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021 at 11:00 AM, the patient experienced DIZZINESS (Lighthead) and HEADACHE (Headache). 23-Mar-2021 at 11:00 AM, the patient experienced VOMITING (Vomited) and NAUSEA (Nausea). The patient was treated with METHYLPREDNISOLONE (METHYL PRED) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Migraine and Nausea prophylaxis, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Lighthead) and HEADACHE (Headache) outcome was unknown and VOMITING (Vomited) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. Patient received an IV Cocktail of Benadryl, anti nausea and a medication to help with swelling.   This case was linked to MOD-2021-219131 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up 1 received on 06-JUL-2021 contains patient demographics, Dose information, Treatment medications, some Adverse events, AE outcomes were updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Horrible migraine headaches; Stomach pain; Lighthead; Headache; Vomited; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lighthead), HEADACHE (Headache), VOMITING (Vomited) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021 at 11:00 AM, the patient experienced DIZZINESS (Lighthead) and HEADACHE (Headache). 23-Mar-2021 at 11:00 AM, the patient experienced VOMITING (Vomited) and NAUSEA (Nausea). The patient was treated with METHYLPREDNISOLONE (METHYL PRED) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Migraine and Nausea prophylaxis, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Lighthead) and HEADACHE (Headache) outcome was unknown and VOMITING (Vomited) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. Patient received an IV Cocktail of Benadryl, anti nausea and a medication to help with swelling.   This case was linked to MOD-2021-219131 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up 1 received on 06-JUL-2021 contains patient demographics, Dose information, Treatment medications, some Adverse events, AE outcomes were updated.
Sex: U
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: sores on tongue; 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 GLOSSODYNIA (sores on tongue) 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 GLOSSODYNIA (sores on tongue). At the time of the report, GLOSSODYNIA (sores on tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Nausea, Vomiting
Clinical narrative: I have had extreme heartburn; nausea; and vomitting the last week; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (I have had extreme heartburn), NAUSEA (nausea) and VOMITING (and vomitting the last week) 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, the patient experienced DYSPEPSIA (I have had extreme heartburn), NAUSEA (nausea) and VOMITING (and vomitting the last week). At the time of the report, DYSPEPSIA (I have had extreme heartburn), NAUSEA (nausea) and VOMITING (and vomitting the last week) outcome was unknown.            no concomitant and treatment drugs were provided.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) 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 ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Painful respiration, Product administered to patient of inappropriate age
Clinical narrative: sharp pain when breathing after having her first dose; a few kids were complaining of the same thing; 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 PAINFUL RESPIRATION (sharp pain when breathing after having her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a few kids were complaining of the same thing) 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 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 PAINFUL RESPIRATION (sharp pain when breathing after having her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a few kids were complaining of the same thing). At the time of the report, PAINFUL RESPIRATION (sharp pain when breathing after having her first dose) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a few kids were complaining of the same thing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Reporter stated that there was no clarification as to whether this was with the Moderna vaccine. No other information was provided. Consent was not received to contact school nurse. No contact information was provided for nurse on campus.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: Pain in Left arm; Cannot move the left arm/cannot raise up the hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in Left arm) and HYPOKINESIA (Cannot move the left arm/cannot raise up the hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in Left arm) and HYPOKINESIA (Cannot move the left arm/cannot raise up the hand). At the time of the report, PAIN IN EXTREMITY (Pain in Left arm) and HYPOKINESIA (Cannot move the left arm/cannot raise up the hand) outcome was unknown.            No concomitant medications were reported.   No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: TCR form received on 28-JUN-2021 included no new information.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: in the middle of the night night he developed a terrible nosebleed. Every since then he continues to have the nosebleeds in the middle of the night once, twice or more a week / now it is in the middle of the day; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (in the middle of the night night he developed a terrible nosebleed. Every since then he continues to have the nosebleeds in the middle of the night once, twice or more a week / now it is in the middle of the day) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced EPISTAXIS (in the middle of the night night he developed a terrible nosebleed. Every since then he continues to have the nosebleeds in the middle of the night once, twice or more a week / now it is in the middle of the day). At the time of the report, EPISTAXIS (in the middle of the night night he developed a terrible nosebleed. Every since then he continues to have the nosebleeds in the middle of the night once, twice or more a week / now it is in the middle of the day) 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dehydration, Ear discomfort, Muscle spasms, Nausea
Clinical narrative: Cramps in her legs; Dehydration; Kept getting worse; Feels like something in her ears; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps in her legs), DEHYDRATION (Dehydration), CONDITION AGGRAVATED (Kept getting worse), EAR DISCOMFORT (Feels like something in her ears) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026B21A) for COVID-19 vaccination.     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 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Cramps in her legs), DEHYDRATION (Dehydration), CONDITION AGGRAVATED (Kept getting worse), EAR DISCOMFORT (Feels like something in her ears) and NAUSEA (Nausea). At the time of the report, MUSCLE SPASMS (Cramps in her legs), DEHYDRATION (Dehydration), CONDITION AGGRAVATED (Kept getting worse), EAR DISCOMFORT (Feels like something in her ears) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported.  Treatment medication included magnesium tablets   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: NNI
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Good reaction relating to modern vaccine/No longer in any pain/Turned off autoimmune overresponse/The vaccine caused an intense flair; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Good reaction relating to modern vaccine/No longer in any pain/Turned off autoimmune overresponse/The vaccine caused an intense flair) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS.    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 THERAPEUTIC RESPONSE UNEXPECTED (Good reaction relating to modern vaccine/No longer in any pain/Turned off autoimmune overresponse/The vaccine caused an intense flair). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Good reaction relating to modern vaccine/No longer in any pain/Turned off autoimmune overresponse/The vaccine caused an intense flair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back injury, Inappropriate schedule of product administration, Intentional product use issue, Joint injury
Clinical narrative: Knee injury; Back injury; Unable to get his second vaccine on time due to medical issues; Came back on 01-Jun-2021 to get second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of JOINT INJURY (Knee injury), BACK INJURY (Back injury), INTENTIONAL PRODUCT USE ISSUE (Unable to get his second vaccine on time due to medical issues) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Came back on 01-Jun-2021 to get second dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-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) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Came back on 01-Jun-2021 to get second dose). On an unknown date, the patient experienced JOINT INJURY (Knee injury), BACK INJURY (Back injury) and INTENTIONAL PRODUCT USE ISSUE (Unable to get his second vaccine on time due to medical issues). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Came back on 01-Jun-2021 to get second dose) had resolved. At the time of the report, JOINT INJURY (Knee injury) and BACK INJURY (Back injury) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Unable to get his second vaccine on time due to medical issues) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nervousness, Product dose omission issue, Vaccination site erythema, Vaccination site swelling
Clinical narrative: did not receive her second shot; nervous and "anxious" because of side reaction; red circle spread till elbow area; swollen injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive her second shot), NERVOUSNESS (nervous and "anxious" because of side reaction), MYALGIA (sore arm), VACCINATION SITE ERYTHEMA (red circle spread till elbow area) and VACCINATION SITE SWELLING (swollen injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced MYALGIA (sore arm). On 27-Jan-2021, the patient experienced NERVOUSNESS (nervous and "anxious" because of side reaction), VACCINATION SITE ERYTHEMA (red circle spread till elbow area) and VACCINATION SITE SWELLING (swollen injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive her second shot). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, NERVOUSNESS (nervous and "anxious" because of side reaction), MYALGIA (sore arm), VACCINATION SITE ERYTHEMA (red circle spread till elbow area) and VACCINATION SITE SWELLING (swollen injection site) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive her second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient treated symptoms by warm compress.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: extreme pain; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme pain) and VACCINATION SITE SWELLING (swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (extreme pain) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE PAIN (extreme pain) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not  reported.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (missed 2nd dose of Moderna vaccine/passed 42 days after the 1st dose) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. April 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product dose omission issue (missed 2nd dose of Moderna vaccine/passed 42 days after the 1st dose). At the time of the report, product dose omission issue (missed 2nd dose of Moderna vaccine/passed 42 days after the 1st dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042b21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021 at 11:00 AM, the patient experienced MIGRAINE (Migraines). The patient was treated with METHYLPREDNISOLONE for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraines) was resolving.            No Concomitant medications was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.    This case was linked to MOD-2021-219055 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: ADR form was received on 06-JUL-2021 contains updated patient demographics, Outcome of the event was updated from Not recovered to Resolving /recovering, Vaccine information was updated, Treatment medication was added
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild localized arm soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild localized arm soreness at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (parents told me I had a penicillin reaction once AS A CHILD (8-9 years of age).    On 17-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild localized arm soreness at injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Mild localized arm soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Sleep disorder
Clinical narrative: Woke up; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Woke up) and HEADACHE (Headache) 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 SLEEP DISORDER (Woke up) and HEADACHE (Headache). At the time of the report, SLEEP DISORDER (Woke up) and HEADACHE (Headache) outcome was unknown.            For four days after second vaccination, the patient had been waking up by a severe headache.  No relevant concomitant medications were reported. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Palpitations
Clinical narrative: Racing of heart throughout the night after 1st dose; Could not sleep at night after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Racing of heart throughout the night after 1st dose) and INSOMNIA (Could not sleep at night after the 1st dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PALPITATIONS (Racing of heart throughout the night after 1st dose) and INSOMNIA (Could not sleep at night after the 1st dose). On 05-Mar-2021, PALPITATIONS (Racing of heart throughout the night after 1st dose) and INSOMNIA (Could not sleep at night after the 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non-significant follow-up
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Violent shakes after vaccination/shaking violently for about 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violent shakes after vaccination/shaking violently for about 15 minutes) 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, the patient experienced TREMOR (Violent shakes after vaccination/shaking violently for about 15 minutes). At the time of the report, TREMOR (Violent shakes after vaccination/shaking violently for about 15 minutes) outcome was unknown.             The patient took (PII) and the shaking had reduced.  Action taken with mRNA-1273 in response to the event was reported as not applicable.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Pruritus, Rash
Clinical narrative: Splotchy red patch would come on face after itching then go away for a few days, then again; Itching from neck upwards; Splotchy red patch would come on face after itching then go away for a few days, then again; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Splotchy red patch would come on face after itching then go away for a few days, then again), PRURITUS (Itching from neck upwards), CHILLS (Chills), HEADACHE (Headache) and RASH (Splotchy red patch would come on face after itching then go away for a few days, then again) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 03-Jun-2021, the patient experienced ERYTHEMA (Splotchy red patch would come on face after itching then go away for a few days, then again), PRURITUS (Itching from neck upwards) and RASH (Splotchy red patch would come on face after itching then go away for a few days, then again). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 28-May-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (Splotchy red patch would come on face after itching then go away for a few days, then again), PRURITUS (Itching from neck upwards) and RASH (Splotchy red patch would come on face after itching then go away for a few days, then again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Patient has been taking Topical Retinoid for Acne as concomitant medication.  Action taken with mRNA-1273 in response to the event was reported as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 patients were administered doses from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients were administered doses from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (7 patients were administered doses from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients were administered doses from expired vial) 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.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) 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 RASH (rash). At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-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 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   21 patients received the expired Moderna Covid-19 vaccine since 28APR2021.  Action taken with mRNA-1273 in response to the event was reported as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: had better breathing and perfect oxygen level after receiving the Moderna COVID-19 vaccine; 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 THERAPEUTIC RESPONSE UNEXPECTED (had better breathing and perfect oxygen level after receiving the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (had better breathing and perfect oxygen level after receiving the Moderna COVID-19 vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (had better breathing and perfect oxygen level after receiving the Moderna COVID-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided Treatment medication was not provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Its black and blue; A lot of itching on left arm where they gave me the injection; it's still sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLORATION (Its black and blue), VACCINATION SITE PRURITUS (A lot of itching on left arm where they gave me the injection) and VACCINATION SITE PAIN (it's still sore) 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 VACCINATION SITE DISCOLORATION (Its black and blue), VACCINATION SITE PRURITUS (A lot of itching on left arm where they gave me the injection) and VACCINATION SITE PAIN (it's still sore). At the time of the report, VACCINATION SITE DISCOLORATION (Its black and blue) and VACCINATION SITE PRURITUS (A lot of itching on left arm where they gave me the injection) outcome was unknown and VACCINATION SITE PAIN (it's still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Cough
Clinical narrative: I received my second dose an hour ago.  Now I'm coughing; I received my second dose an hour ago.  Now fluttery feeling in my chest; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (I received my second dose an hour ago.  Now I'm coughing) and CHEST DISCOMFORT (I received my second dose an hour ago.  Now fluttery feeling in my chest) 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 COUGH (I received my second dose an hour ago.  Now I'm coughing) and CHEST DISCOMFORT (I received my second dose an hour ago.  Now fluttery feeling in my chest). At the time of the report, COUGH (I received my second dose an hour ago.  Now I'm coughing) and CHEST DISCOMFORT (I received my second dose an hour ago.  Now fluttery feeling in my chest) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was reported as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: lasting joint pain after the vaccinatiob; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (lasting joint pain after the vaccinatiob) 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 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 ARTHRALGIA (lasting joint pain after the vaccinatiob). At the time of the report, ARTHRALGIA (lasting joint pain after the vaccinatiob) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not provided by the reporter.   Reporter did not allow further contact
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) 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 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: she had better breathing and perfect oxygen level; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (she had better breathing and perfect oxygen level) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Diabetic neuropathy, Heart disease, unspecified, Allergy NOS and Long COVID since 15-Nov-2020. Concomitant products included LORATADINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and FAMOTIDINE for Allergy, INSULIN for Diabetes, GABAPENTIN for Diabetic neuropathy, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Gastrooesophageal reflux, VERAPAMIL, ISOSORBIDE and CARVEDILOL for Heart disease, unspecified, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Post-traumatic stress disorder.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (she had better breathing and perfect oxygen level). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (she had better breathing and perfect oxygen level) 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 treatment medication provided. No adverse events reported but therapeutic benefit was mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up document was attached on 18-Jun-2021 which contains no new information.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.