chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: right wrist swollen after getting the shots.; 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 JOINT SWELLING (right wrist swollen after getting the shots.) 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 JOINT SWELLING (right wrist swollen after getting the shots.). At the time of the report, JOINT SWELLING (right wrist swollen after getting the shots.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported. Concomitant products were not provided.  Patient reported that his doctor said he saw other patients experiencing similar symptoms as the ones described.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Depressed mood, Feeling abnormal, Headache, Intermenstrual bleeding
Clinical narrative: I am really angry; now I am screwed up,Something is happening that shouldn't be happening; I am upset; soreness of the arm they received the dose in; Unusually bad headache last night; if twisting the muscle, it's tender; menstrual bleeding lightly; headache; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (menstrual bleeding lightly), ANGER (I am really angry), FEELING ABNORMAL (now I am screwed up,Something is happening that shouldn't be happening), DEPRESSED MOOD (I am upset) and PAIN IN EXTREMITY (soreness of the arm they received the dose in) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Postmenopause (reported to be postmenopausal for over 2 years now). Concomitant products included LITHIUM, LAMOTRIGINE, CLONAZEPAM (KLONOPIN), LEVOTHYROXINE SODIUM (SYNTHROID), OLANZAPINE (ZYPREXA) and MELATONIN for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HEADACHE (headache). On 04-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (menstrual bleeding lightly). On an unknown date, the patient experienced ANGER (I am really angry), FEELING ABNORMAL (now I am screwed up,Something is happening that shouldn't be happening), DEPRESSED MOOD (I am upset), PAIN IN EXTREMITY (soreness of the arm they received the dose in), HEADACHE (Unusually bad headache last night) and MYALGIA (if twisting the muscle, it's tender). The patient was treated with ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM HEADACHE) ongoing from 03-Aug-2021 for Headache, at a dose of 1 dosage form. On 03-Aug-2021, HEADACHE (headache) had resolved. On 04-Aug-2021, PAIN IN EXTREMITY (soreness of the arm they received the dose in) had resolved. At the time of the report, INTERMENSTRUAL BLEEDING (menstrual bleeding lightly), ANGER (I am really angry), FEELING ABNORMAL (now I am screwed up,Something is happening that shouldn't be happening), DEPRESSED MOOD (I am upset), HEADACHE (Unusually bad headache last night) and MYALGIA (if twisting the muscle, it's tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up was received. Additional events- anger, depressed mood, myalgia, headache and feeling abnormal were added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: I am really angry; now I am screwed up,Something is happening that shouldn't be happening; I am upset; soreness of the arm they received the dose in; Unusually bad headache last night; if twisting the muscle, it's tender; menstrual bleeding lightly; headache; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (menstrual bleeding lightly), ANGER (I am really angry), FEELING ABNORMAL (now I am screwed up,Something is happening that shouldn't be happening), DEPRESSED MOOD (I am upset) and PAIN IN EXTREMITY (soreness of the arm they received the dose in) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Postmenopause (reported to be postmenopausal for over 2 years now). Concomitant products included LITHIUM, LAMOTRIGINE, CLONAZEPAM (KLONOPIN), LEVOTHYROXINE SODIUM (SYNTHROID), OLANZAPINE (ZYPREXA) and MELATONIN for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HEADACHE (headache). On 04-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (menstrual bleeding lightly). On an unknown date, the patient experienced ANGER (I am really angry), FEELING ABNORMAL (now I am screwed up,Something is happening that shouldn't be happening), DEPRESSED MOOD (I am upset), PAIN IN EXTREMITY (soreness of the arm they received the dose in), HEADACHE (Unusually bad headache last night) and MYALGIA (if twisting the muscle, it's tender). The patient was treated with ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM HEADACHE) ongoing from 03-Aug-2021 for Headache, at a dose of 1 dosage form. On 03-Aug-2021, HEADACHE (headache) had resolved. On 04-Aug-2021, PAIN IN EXTREMITY (soreness of the arm they received the dose in) had resolved. At the time of the report, INTERMENSTRUAL BLEEDING (menstrual bleeding lightly), ANGER (I am really angry), FEELING ABNORMAL (now I am screwed up,Something is happening that shouldn't be happening), DEPRESSED MOOD (I am upset), HEADACHE (Unusually bad headache last night) and MYALGIA (if twisting the muscle, it's tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up was received. Additional events- anger, depressed mood, myalgia, headache and feeling abnormal were added.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unauthorized age group vaccinated/after the administration was given it was found that the patient who received it was 16 years old.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group vaccinated/after the administration was given it was found that the patient who received it was 16 years old.) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group vaccinated/after the administration was given it was found that the patient who received it was 16 years old.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group vaccinated/after the administration was given it was found that the patient who received it was 16 years old.) outcome was unknown.        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 was received by the patient  No Treatment information was received by the patient.  No other side effects have been reported from the administration of the vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Pyrexia, Vaccination site induration, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch around injection site), EXTRA DOSE ADMINISTERED (Received a third dose), FATIGUE (Very tired), VACCINATION SITE INDURATION (Hard, the size of a silver dollar) and PYREXIA (Tiny fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD, Heart disorder, Blood pressure high, Asthma and Overweight. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Tiny fever). 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). On 04-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received a third dose). On 05-Aug-2021, the patient experienced FATIGUE (Very tired). On 06-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch around injection site) and VACCINATION SITE INDURATION (Hard, the size of a silver dollar). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever and Injection site pain, at an unspecified dose and frequency. On 06-Feb-2021, PYREXIA (Tiny fever) had resolved. On 04-Aug-2021, EXTRA DOSE ADMINISTERED (Received a third dose) had resolved. On 05-Aug-2021, FATIGUE (Very tired) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to the touch around injection site), VACCINATION SITE INDURATION (Hard, the size of a silver dollar) and VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown. No concomitant drugs were reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up information included new event (Extra dose administered) added. On 06-Aug-2021: Follow up information included new events added.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch around injection site), EXTRA DOSE ADMINISTERED (Received a third dose), FATIGUE (Very tired), VACCINATION SITE INDURATION (Hard, the size of a silver dollar) and PYREXIA (Tiny fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD, Heart disorder, Blood pressure high, Asthma and Overweight. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Tiny fever). 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). On 04-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received a third dose). On 05-Aug-2021, the patient experienced FATIGUE (Very tired). On 06-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch around injection site) and VACCINATION SITE INDURATION (Hard, the size of a silver dollar). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever and Injection site pain, at an unspecified dose and frequency. On 06-Feb-2021, PYREXIA (Tiny fever) had resolved. On 04-Aug-2021, EXTRA DOSE ADMINISTERED (Received a third dose) had resolved. On 05-Aug-2021, FATIGUE (Very tired) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to the touch around injection site), VACCINATION SITE INDURATION (Hard, the size of a silver dollar) and VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown. No concomitant drugs were reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up information included new event (Extra dose administered) added. On 06-Aug-2021: Follow up information included new events added.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Incorrect route of product administration, Injection site pain, Pain
Clinical narrative: Can't raise his arm over his shoulder; It feels excruciating to move arm/If he lifts his arm, it hurts/; if he lays down; Feels pain from that injection site from the first shot today/ was piercing and it hurt/ it got progressively worse; Injected right into the socket between the upper arm and shoulder/been having pain in that socket; injected right into the socket between the upper arm and shoulder; Soreness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Can't raise his arm over his shoulder), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected right into the socket between the upper arm and shoulder), PAIN (Soreness), PAIN (It feels excruciating to move arm/If he lifts his arm, it hurts/; if he lays down) and INJECTION SITE PAIN (Feels pain from that injection site from the first shot today/ was piercing and it hurt/ it got progressively worse) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected right into the socket between the upper arm and shoulder). On an unknown date, the patient experienced HYPOKINESIA (Can't raise his arm over his shoulder), PAIN (Soreness), PAIN (It feels excruciating to move arm/If he lifts his arm, it hurts/; if he lays down), INJECTION SITE PAIN (Feels pain from that injection site from the first shot today/ was piercing and it hurt/ it got progressively worse), PYREXIA (Fever) and ARTHRALGIA (Injected right into the socket between the upper arm and shoulder/been having pain in that socket). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN (ADVIL PM [DIPHENHYDRAMINE HYDROCHLORIDE;IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. On 20-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected right into the socket between the upper arm and shoulder) had resolved. At the time of the report, HYPOKINESIA (Can't raise his arm over his shoulder) outcome was unknown, PAIN (Soreness) and PYREXIA (Fever) had resolved and PAIN (It feels excruciating to move arm/If he lifts his arm, it hurts/; if he lays down), INJECTION SITE PAIN (Feels pain from that injection site from the first shot today/ was piercing and it hurt/ it got progressively worse) and ARTHRALGIA (Injected right into the socket between the upper arm and shoulder/been having pain in that socket) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Can't raise his arm over his shoulder; It feels excruciating to move arm/If he lifts his arm, it hurts/; if he lays down; Feels pain from that injection site from the first shot today/ was piercing and it hurt/ it got progressively worse; Injected right into the socket between the upper arm and shoulder/been having pain in that socket; injected right into the socket between the upper arm and shoulder; Soreness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Can't raise his arm over his shoulder), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected right into the socket between the upper arm and shoulder), PAIN (Soreness), PAIN (It feels excruciating to move arm/If he lifts his arm, it hurts/; if he lays down) and INJECTION SITE PAIN (Feels pain from that injection site from the first shot today/ was piercing and it hurt/ it got progressively worse) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected right into the socket between the upper arm and shoulder). On an unknown date, the patient experienced HYPOKINESIA (Can't raise his arm over his shoulder), PAIN (Soreness), PAIN (It feels excruciating to move arm/If he lifts his arm, it hurts/; if he lays down), INJECTION SITE PAIN (Feels pain from that injection site from the first shot today/ was piercing and it hurt/ it got progressively worse), PYREXIA (Fever) and ARTHRALGIA (Injected right into the socket between the upper arm and shoulder/been having pain in that socket). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN (ADVIL PM [DIPHENHYDRAMINE HYDROCHLORIDE;IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. On 20-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected right into the socket between the upper arm and shoulder) had resolved. At the time of the report, HYPOKINESIA (Can't raise his arm over his shoulder) outcome was unknown, PAIN (Soreness) and PYREXIA (Fever) had resolved and PAIN (It feels excruciating to move arm/If he lifts his arm, it hurts/; if he lays down), INJECTION SITE PAIN (Feels pain from that injection site from the first shot today/ was piercing and it hurt/ it got progressively worse) and ARTHRALGIA (Injected right into the socket between the upper arm and shoulder/been having pain in that socket) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site swelling
Clinical narrative: Swollen lump at injection site; Headache/ feels a light headache coming on; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/ feels a light headache coming on) and VACCINATION SITE SWELLING (Swollen lump at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced HEADACHE (Headache/ feels a light headache coming on). On 04-Aug-2021, the patient experienced VACCINATION SITE SWELLING (Swollen lump at injection site). The patient was treated with PARACETAMOL (TYLENOL) on 03-Aug-2021 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache/ feels a light headache coming on) and VACCINATION SITE SWELLING (Swollen lump at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlargement of lymph nodes; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (Enlargement of lymph nodes) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 039C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CITALOPRAM, CLONAZEPAM, LORATADINE, FISH OIL and IBUPROFEN for an unknown indication.   On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-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 LYMPHADENOPATHY (Enlargement of lymph nodes). At the time of the report, LYMPHADENOPATHY (Enlargement of lymph nodes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were added.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 pediatric patients came to pharmacy to receive their second dose of a COVID vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 pediatric patients came to pharmacy to receive their second dose of a COVID vaccine) in an adolescent patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 pediatric patients came to pharmacy to receive their second dose of a COVID vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 pediatric patients came to pharmacy to receive their second dose of a COVID vaccine) had resolved.            No concomitant medication reported.   No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Inappropriate schedule of product administration
Clinical narrative: greater than 35 days between Moderna Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccines) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, 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 (greater than 35 days between Moderna Covid-19 vaccines). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccines) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Heart rate: 139 to 140 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patients reported Heart Rate was at 139 to 140 for those 3 days after receiving her vaccination. Concomitant medication was not provided. Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site bump; Vaccination site Itching; Swelling at vaccination site; vaccination site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Vaccination site bump), VACCINATION SITE PRURITUS (Vaccination site Itching), VACCINATION SITE SWELLING (Swelling at vaccination site) and VACCINATION SITE PAIN (vaccination site soreness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006d21a) for COVID-19 vaccination.     Concomitant products included OLANZAPINE for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE MASS (Vaccination site bump), VACCINATION SITE PRURITUS (Vaccination site Itching), VACCINATION SITE SWELLING (Swelling at vaccination site) and VACCINATION SITE PAIN (vaccination site soreness). At the time of the report, VACCINATION SITE MASS (Vaccination site bump), VACCINATION SITE PRURITUS (Vaccination site Itching), VACCINATION SITE SWELLING (Swelling at vaccination site) and VACCINATION SITE PAIN (vaccination site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Constant period (menstruation); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Constant period (menstruation)) 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 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Constant period (menstruation)). At the time of the report, HEAVY MENSTRUAL BLEEDING (Constant period (menstruation)) outcome was unknown.            No concomitant medication details were reported. No treatment medication details were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: very high pitch ringing in both ears/not going away; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (very high pitch ringing in both ears/not going away) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced TINNITUS (very high pitch ringing in both ears/not going away). At the time of the report, TINNITUS (very high pitch ringing in both ears/not going away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired dose of vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose of vaccine). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient given expired 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.  Reporter stated that vial was taken out of refrigerator at 03:00 PM on 03-Aug-2021 and punctured and was remained at room temperature until injection time on 04-AUG-2021 at 10:00 AM. No Treatment medication was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lips are showing visible fencing technique/lumpiness in lips; This spontaneous case was reported by a nurse and describes the occurrence of LIP SWELLING (lips are showing visible fencing technique/lumpiness in lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date. Previously administered products included for Diphtheria immunisation: TDAP (Immunization was also used for PERTUSSIS immunization and TETANUS immunization) on 14-Jul-2021. Concurrent medical conditions included Dermal filler injection (Patient was injected with Restylane Kysse) since 06-May-2021. Concomitant products included HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE LIDOCAINE) from 06-May-2021 to an unknown date for Lip cosmetic procedure.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (lips are showing visible fencing technique/lumpiness in lips). At the time of the report, LIP SWELLING (lips are showing visible fencing technique/lumpiness in lips) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Nausea, Rash
Clinical narrative: Felt awful; No energy; Light headed; Rashes on leg; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt awful), ASTHENIA (No energy), DIZZINESS (Light headed), RASH (Rashes on leg) and NAUSEA (Nauseous) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced FEELING ABNORMAL (Felt awful), ASTHENIA (No energy), DIZZINESS (Light headed) and RASH (Rashes on leg). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 28-Jun-2021, NAUSEA (Nauseous) had resolved. On 01-Jul-2021, FEELING ABNORMAL (Felt awful), ASTHENIA (No energy), DIZZINESS (Light headed) and RASH (Rashes on leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: Low grade fever; Wave of blurriness; Dizzy; O2 stats is a little lower; Cool sensation that felt like the drug moving through veins; Throat got a little tight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of VISION BLURRED (Wave of blurriness), DIZZINESS (Dizzy), OXYGEN SATURATION DECREASED (O2 stats is a little lower), FEELING ABNORMAL (Cool sensation that felt like the drug moving through veins) and THROAT TIGHTNESS (Throat got a little tight) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced VISION BLURRED (Wave of blurriness), DIZZINESS (Dizzy), OXYGEN SATURATION DECREASED (O2 stats is a little lower), FEELING ABNORMAL (Cool sensation that felt like the drug moving through veins) and THROAT TIGHTNESS (Throat got a little tight). On 03-Aug-2021, the patient experienced PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Wave of blurriness), DIZZINESS (Dizzy), OXYGEN SATURATION DECREASED (O2 stats is a little lower), FEELING ABNORMAL (Cool sensation that felt like the drug moving through veins), THROAT TIGHTNESS (Throat got a little tight) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, Oxygen saturation: 96 (Low) low.     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 reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Vision blurred
Clinical narrative: Low grade fever; Wave of blurriness; Dizzy; O2 stats is a little lower; Cool sensation that felt like the drug moving through veins; Throat got a little tight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of VISION BLURRED (Wave of blurriness), DIZZINESS (Dizzy), OXYGEN SATURATION DECREASED (O2 stats is a little lower), FEELING ABNORMAL (Cool sensation that felt like the drug moving through veins) and THROAT TIGHTNESS (Throat got a little tight) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced VISION BLURRED (Wave of blurriness), DIZZINESS (Dizzy), OXYGEN SATURATION DECREASED (O2 stats is a little lower), FEELING ABNORMAL (Cool sensation that felt like the drug moving through veins) and THROAT TIGHTNESS (Throat got a little tight). On 03-Aug-2021, the patient experienced PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Wave of blurriness), DIZZINESS (Dizzy), OXYGEN SATURATION DECREASED (O2 stats is a little lower), FEELING ABNORMAL (Cool sensation that felt like the drug moving through veins), THROAT TIGHTNESS (Throat got a little tight) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, Oxygen saturation: 96 (Low) low.     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 reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: numbers are high/numbers (sugar) are (now) very high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (numbers are high/numbers (sugar) are (now) very high) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included HYDROCODONE, INSULIN, METFORMIN, PIOGLITAZONE HYDROCHLORIDE (ACTOS), GLYBURIDE and LISINOPRIL for an unknown indication.    On 03-Aug-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 BLOOD GLUCOSE INCREASED (numbers are high/numbers (sugar) are (now) very high). The patient was treated with INSULIN for Blood sugar increased, at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (numbers are high/numbers (sugar) are (now) very high) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient noticed at morning that his sugar was up and also up a little last night. Wife said he had to take some insulin. Patient's blood sugar was up again at work and he had to take more (insulin).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient tested positive on 01-AUG-2021 and is experiencing minor symptoms such as a runny nose) and DRUG INEFFECTIVE (Covid-19 positive test after both vaccines) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 025J20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Positive) on 01-Aug-2021. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced COVID-19 (patient tested positive on 01-AUG-2021 and is experiencing minor symptoms such as a runny nose). On an unknown date, the patient experienced DRUG INEFFECTIVE (Covid-19 positive test after both vaccines). At the time of the report, COVID-19 (patient tested positive on 01-AUG-2021 and is experiencing minor symptoms such as a runny nose) and DRUG INEFFECTIVE (Covid-19 positive test after both vaccines) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On 01-Aug-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. No concomitant medications were reported. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Neck pain, Pain
Clinical narrative: a little soreness in her neck; She rubbed below her ear and it was a little sore; Soreness in the lymph nodes for about 2 days; Tiredness/ fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (a little soreness in her neck), PAIN (She rubbed below her ear and it was a little sore), LYMPH NODE PAIN (Soreness in the lymph nodes for about 2 days) and FATIGUE (Tiredness/ fatigue) in a 70-year-old female patient 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 NECK PAIN (a little soreness in her neck), PAIN (She rubbed below her ear and it was a little sore), LYMPH NODE PAIN (Soreness in the lymph nodes for about 2 days) and FATIGUE (Tiredness/ fatigue). At the time of the report, NECK PAIN (a little soreness in her neck), PAIN (She rubbed below her ear and it was a little sore), LYMPH NODE PAIN (Soreness in the lymph nodes for about 2 days) and FATIGUE (Tiredness/ fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication were reported. No lab data was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant event fu event added
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Myalgia
Clinical narrative: Huge migraine; Super sore all over; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Huge migraine) and MYALGIA (Super sore all over) 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 MIGRAINE (Huge migraine) and MYALGIA (Super sore all over). At the time of the report, MIGRAINE (Huge migraine) and MYALGIA (Super sore all over) had resolved.  No concomitant medication was reported. No treatment information was provided. Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-220651 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Maternal exposure during pregnancy, Product dose omission issue
Clinical narrative: Worried about the different strains; "vaccinated with the first dose 5 months ago and never received the second dose"; she found out right after the first dose that she was pregnant. Her OBGYN recommended she should not get the second dose in her first trimester; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ANXIETY (Worried about the different strains), PRODUCT DOSE OMISSION ISSUE ("vaccinated with the first dose 5 months ago and never received the second dose") and MATERNAL EXPOSURE DURING PREGNANCY (she found out right after the first dose that she was pregnant. Her OBGYN recommended she should not get the second dose in her first trimester) in a 27-year-old female patient 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ANXIETY (Worried about the different strains), PRODUCT DOSE OMISSION ISSUE ("vaccinated with the first dose 5 months ago and never received the second dose") and MATERNAL EXPOSURE DURING PREGNANCY (she found out right after the first dose that she was pregnant. Her OBGYN recommended she should not get the second dose in her first trimester). At the time of the report, ANXIETY (Worried about the different strains), PRODUCT DOSE OMISSION ISSUE ("vaccinated with the first dose 5 months ago and never received the second dose") and MATERNAL EXPOSURE DURING PREGNANCY (she found out right after the first dose that she was pregnant. Her OBGYN recommended she should not get the second dose in her first trimester) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided by the reporter. No concomitant medication provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant Live follow-up with reporter details, Patient Demography, Reported event verbatim, Vaccination route, updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: left side of chest stabbing pains; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN ("left side of chest stabbing pains") and DYSPNOEA ("shortness of breath") in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for Blood pressure high, ROSUVASTATIN, LEVOTHYROXINE, DULOXETINE, BUPROPION and FERROUS SULFATE for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced CHEST PAIN ("left side of chest stabbing pains") and DYSPNOEA ("shortness of breath"). At the time of the report, CHEST PAIN ("left side of chest stabbing pains") and DYSPNOEA ("shortness of breath") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.  Patient had symptoms after receiving first dose of Moderna vaccine and stated that the vaccine site kept patient there for 30 minutes and after got home experienced "shortness of breath" and "left side of chest stabbing pains" which is ongoing.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received included non significant follow up as contact details of reporter updated
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my right upper arm is tender and in pain. It hurts to raise my arm. I sleep with a pillow under it at night because it hurts to lie on it.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (my right upper arm is tender and in pain. It hurts to raise my arm. I sleep with a pillow under it at night because it hurts to lie on it.) 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 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (my right upper arm is tender and in pain. It hurts to raise my arm. I sleep with a pillow under it at night because it hurts to lie on it.). At the time of the report, PAIN IN EXTREMITY (my right upper arm is tender and in pain. It hurts to raise my arm. I sleep with a pillow under it at night because it hurts to lie on it.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was received by the patient No Treatment information was received by the patient.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Cases of shingles following COVID-19 vaccinations; 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 HERPES ZOSTER (Cases of shingles following COVID-19 vaccinations) 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 HERPES ZOSTER (Cases of shingles following COVID-19 vaccinations). At the time of the report, HERPES ZOSTER (Cases of shingles following COVID-19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. No treatment medications were reported