chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine that was punctured past 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine that was punctured past 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine that was punctured past 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine that was punctured past 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: feeling tired and lazy; Headache; aches all over; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired and lazy), HEADACHE (Headache) and MYALGIA (aches all over) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling tired and lazy), HEADACHE (Headache) and MYALGIA (aches all over). At the time of the report, FATIGUE (feeling tired and lazy), HEADACHE (Headache) and MYALGIA (aches all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.  It was reported that the patient is in her 60's age.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Given the vaccination at a conroe location yesterday morning and i it started to build in size on my arm last night today it feels; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Given the vaccination at a conroe location yesterday morning and i it started to build in size on my arm last night today it feels) 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 VACCINATION SITE SWELLING (Given the vaccination at a conroe location yesterday morning and i it started to build in size on my arm last night today it feels). At the time of the report, VACCINATION SITE SWELLING (Given the vaccination at a conroe location yesterday morning and i it started to build in size on my arm last night today it feels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Post herpetic neuralgia
Clinical narrative: her pain became worse/more PHN pain/middle of my back to the area under my left breast/increased pain; her post-herpetic neuralgia pain became worse; This spontaneous case was reported by a consumer and describes the occurrence of POST HERPETIC NEURALGIA (her post-herpetic neuralgia pain became worse) and PAIN (her pain became worse/more PHN pain/middle of my back to the area under my left breast/increased pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025A21A) for COVID-19 vaccination.     No specified medical history has been reported.  Concurrent medical conditions included Osteoarthritis since 01-Jan-1986, Post herpetic neuralgia (increased pain) since 14-Apr-2017 and Food allergy (Avocado, banana, pineapple). Concomitant products included AMLODIPINE BESILATE (AMLODIL [AMLODIPINE BESILATE]) for Blood pressure, METOPROLOL SUCCINATE (TOPROL XL) for Blood pressure high, APIXABAN (ELIQUIS) from 02-Jan-2019 to an unknown date for Heartbeats skipped.   On 11-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced POST HERPETIC NEURALGIA (her post-herpetic neuralgia pain became worse). On an unknown date, the patient experienced PAIN (her pain became worse/more PHN pain/middle of my back to the area under my left breast/increased pain). At the time of the report, POST HERPETIC NEURALGIA (her post-herpetic neuralgia pain became worse) and PAIN (her pain became worse/more PHN pain/middle of my back to the area under my left breast/increased pain) had not 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.   Patient had experienced significantly more post-herpetic neuralgia pain, which was radiating from middle of the back to the area under left breast.  Treatment medication was not provided. AREDs2 was used two per day   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received contains additional Significant Follow up reporter details updated, patient detail updated,medical history updated,product detail updated,concomitant coded
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Muscular weakness
Clinical narrative: Spinal Migraine; Leg weakness; 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 MIGRAINE (Spinal Migraine) and MUSCULAR WEAKNESS (Leg weakness) 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 MIGRAINE (Spinal Migraine) and MUSCULAR WEAKNESS (Leg weakness). At the time of the report, MIGRAINE (Spinal Migraine) and MUSCULAR WEAKNESS (Leg weakness) outcome was unknown.            No concomitant medication reported.  No treatment medication reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eating disorder, Headache, Rash, Somnolence
Clinical narrative: A bad welt on the arm; Could not eat; Was sleeping a lot; Rash all over the top of the arm; Extreme headaches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A bad welt on the arm), EATING DISORDER (Could not eat), SOMNOLENCE (Was sleeping a lot), RASH (Rash all over the top of the arm) and HEADACHE (Extreme headaches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia. Concomitant products included ATENOLOL for Tachycardia.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 URTICARIA (A bad welt on the arm), EATING DISORDER (Could not eat), SOMNOLENCE (Was sleeping a lot), RASH (Rash all over the top of the arm) and HEADACHE (Extreme headaches). At the time of the report, URTICARIA (A bad welt on the arm), EATING DISORDER (Could not eat), SOMNOLENCE (Was sleeping a lot), RASH (Rash all over the top of the arm) and HEADACHE (Extreme headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) Temperature elevated.         Treatment details was not reported by the reporter.   This case was linked to MOD-2021-314914 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: A bad welt on the arm; Could not eat; Was sleeping a lot; Rash all over the top of the arm; Extreme headaches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A bad welt on the arm), EATING DISORDER (Could not eat), SOMNOLENCE (Was sleeping a lot), RASH (Rash all over the top of the arm) and HEADACHE (Extreme headaches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia. Concomitant products included ATENOLOL for Tachycardia.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 URTICARIA (A bad welt on the arm), EATING DISORDER (Could not eat), SOMNOLENCE (Was sleeping a lot), RASH (Rash all over the top of the arm) and HEADACHE (Extreme headaches). At the time of the report, URTICARIA (A bad welt on the arm), EATING DISORDER (Could not eat), SOMNOLENCE (Was sleeping a lot), RASH (Rash all over the top of the arm) and HEADACHE (Extreme headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) Temperature elevated.         Treatment details was not reported by the reporter.   This case was linked to MOD-2021-314914 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Limited tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Limited tiredness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Limited tiredness). On 11-Feb-2021, FATIGUE (Limited tiredness) had resolved.            No relevant concomitant medications were reported. No treatment information was provided   This case was linked to MOD-2021-314586, MOD-2021-314933.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Non-Significant follow up received. Added patient pregnancy status
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever  of 104; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever  of 104) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever  of 104). At the time of the report, PYREXIA (fever  of 104) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (abnormal) fever of 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Not feeling good; Headache; Fever; Tested positive for COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19), MALAISE (Not feeling good), HEADACHE (Headache) and PYREXIA (Fever) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19). On an unknown date, the patient experienced MALAISE (Not feeling good), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19), MALAISE (Not feeling good), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: Felt really bad; had fever/Running a fever; Kinda tired; Headache; Chilling (chills); knees hurt (when he does not have knee pain normall); felt sick to stomach and still does; Congestion in throat; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (felt sick to stomach and still does), THROAT TIGHTNESS (Congestion in throat), FEELING ABNORMAL (Felt really bad), ARTHRALGIA (knees hurt (when he does not have knee pain normall)) and PYREXIA (had fever/Running a fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced FATIGUE (Kinda tired). On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Felt really bad) and PYREXIA (had fever/Running a fever). In September 2021, the patient experienced ABDOMINAL DISCOMFORT (felt sick to stomach and still does), THROAT TIGHTNESS (Congestion in throat), ARTHRALGIA (knees hurt (when he does not have knee pain normall)), HEADACHE (Headache) and CHILLS (Chilling (chills)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, ABDOMINAL DISCOMFORT (felt sick to stomach and still does) had not resolved and THROAT TIGHTNESS (Congestion in throat), FEELING ABNORMAL (Felt really bad), ARTHRALGIA (knees hurt (when he does not have knee pain normall)), PYREXIA (had fever/Running a fever), FATIGUE (Kinda tired), HEADACHE (Headache) and CHILLS (Chilling (chills)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 101.8 (High) 101.8.     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 relevant concomitant medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia, Throat tightness
Clinical narrative: Felt really bad; had fever/Running a fever; Kinda tired; Headache; Chilling (chills); knees hurt (when he does not have knee pain normall); felt sick to stomach and still does; Congestion in throat; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (felt sick to stomach and still does), THROAT TIGHTNESS (Congestion in throat), FEELING ABNORMAL (Felt really bad), ARTHRALGIA (knees hurt (when he does not have knee pain normall)) and PYREXIA (had fever/Running a fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced FATIGUE (Kinda tired). On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Felt really bad) and PYREXIA (had fever/Running a fever). In September 2021, the patient experienced ABDOMINAL DISCOMFORT (felt sick to stomach and still does), THROAT TIGHTNESS (Congestion in throat), ARTHRALGIA (knees hurt (when he does not have knee pain normall)), HEADACHE (Headache) and CHILLS (Chilling (chills)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, ABDOMINAL DISCOMFORT (felt sick to stomach and still does) had not resolved and THROAT TIGHTNESS (Congestion in throat), FEELING ABNORMAL (Felt really bad), ARTHRALGIA (knees hurt (when he does not have knee pain normall)), PYREXIA (had fever/Running a fever), FATIGUE (Kinda tired), HEADACHE (Headache) and CHILLS (Chilling (chills)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 101.8 (High) 101.8.     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 relevant concomitant medications were reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Approximately 30 minutes after receiving the vaccine the following occurred: I began sweating profusely and coughing. I began coughing so hard, I could not catch my breath between coughs. I began feeling dizzy and light headed. This lasted for approximately 1 hour.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Thrombosis
Clinical narrative: I am on nexplanon and haven?t had a period in nearly 6 years, replaced 2x now. I maybe have light spotting if anything. Not even a full 48 hours after my vaccine I wake up to the heaviest most painful period of my life, with the hugest clots I have ever seen. Concerned me quite a bit, but heard from other that they had similar experiences after the first shot. When the period ended up lasting  9 days, ended today, that?s when I knew there was an issue. Prior to nexplanon, my periods would average 3-4 days and super light flow. I have never had an issue with heavy bleeding, cramping and clots. And before im told it?s because I haven?t had an actual period in so long, NO! I know my body and that WAS NOT normal! Not to mention, reading about and being told by numerous other females that experienced this EXACT symptom after their first vaccine, that tells me it is related! This needs to be listed as a potential side effect for females or something needs to be changed in this vaccine. That reaction CANNOT be normal, nor healthy.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain, Electrocardiogram abnormal, Heart rate irregular
Clinical narrative: Woke up the next morning with abnormal heart beat, pain in chest. Did an ecg using my apple watch and it said Afib. Went to er and doctor did ecg and confirmed Afib. Reset on its own 2 hours later while in the waiting room.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity
Clinical narrative: had no allergy, which is very strong in August to pollen Artemisia.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Injection site pain, Musculoskeletal stiffness
Clinical narrative: 9/4/21 Injection site painful all throughout arm. Had stomach pain, Nerve pain in some fingers. Left side pain and very Tired. 9/5/21 Woke up with severe muscular pain in my left shoulder going up the left side of my neck. This continued for 2 days and developed into a stiff neck on 9/7/21. The neck stiffness continued for over a week. 9/14/21 I experienced nerve pain in  a tooth in my upper left jaw. 9/20/21 My upper lip broke out in a fever blister.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Neuralgia, Oral herpes, Pain
Clinical narrative: 9/4/21 Injection site painful all throughout arm. Had stomach pain, Nerve pain in some fingers. Left side pain and very Tired. 9/5/21 Woke up with severe muscular pain in my left shoulder going up the left side of my neck. This continued for 2 days and developed into a stiff neck on 9/7/21. The neck stiffness continued for over a week. 9/14/21 I experienced nerve pain in  a tooth in my upper left jaw. 9/20/21 My upper lip broke out in a fever blister.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: 9/4/21 Injection site painful all throughout arm. Had stomach pain, Nerve pain in some fingers. Left side pain and very Tired. 9/5/21 Woke up with severe muscular pain in my left shoulder going up the left side of my neck. This continued for 2 days and developed into a stiff neck on 9/7/21. The neck stiffness continued for over a week. 9/14/21 I experienced nerve pain in  a tooth in my upper left jaw. 9/20/21 My upper lip broke out in a fever blister.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen; Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) and INJECTION SITE SWELLING (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced INJECTION SITE ERYTHEMA (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) and INJECTION SITE SWELLING (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen). At the time of the report, INJECTION SITE ERYTHEMA (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) and INJECTION SITE SWELLING (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was underage for vaccine requirements. No adverse reaction occurred. Patient was seen by a medical provider the day of and the following day. No adverse outcome noted.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Pruritus, Sensitive skin, Skin lesion
Clinical narrative: Headaches started a little over one week post second shot. Not relieved with ibuprofen, Tylenol or water.  Increased skin sensitivity again with intense itching at times causing open sores on face.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired vaccine). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Dizziness, Feeling of despair, Hyperhidrosis, Paraesthesia
Clinical narrative: Ten minutes after injection patient started feeling faint/despondenet; Ten minutes after injection patient started feeling faint/despondenet; Cold to the touch, lips were blue; Cold to the touch, lips were blue; Sweating profusely; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Ten minutes after injection patient started feeling faint/despondenet), FEELING OF DESPAIR (Ten minutes after injection patient started feeling faint/despondenet), PARAESTHESIA (Cold to the touch, lips were blue), CYANOSIS (Cold to the touch, lips were blue) and HYPERHIDROSIS (Sweating profusely) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Ten minutes after injection patient started feeling faint/despondenet), FEELING OF DESPAIR (Ten minutes after injection patient started feeling faint/despondenet), PARAESTHESIA (Cold to the touch, lips were blue), CYANOSIS (Cold to the touch, lips were blue) and HYPERHIDROSIS (Sweating profusely). At the time of the report, DIZZINESS (Ten minutes after injection patient started feeling faint/despondenet), FEELING OF DESPAIR (Ten minutes after injection patient started feeling faint/despondenet), PARAESTHESIA (Cold to the touch, lips were blue), CYANOSIS (Cold to the touch, lips were blue) and HYPERHIDROSIS (Sweating profusely) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: not receiving 2nd dose in time; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose in time) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049c21a) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose in time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose in time) had resolved.            No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: pain which did hurt for few days; round red marks on their arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN and ERYTHEMA 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) at an unspecified dose. On an unknown date, the patient experienced PAIN and ERYTHEMA. At the time of the report, PAIN and ERYTHEMA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided. No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) 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 PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.    This case was linked to MOD-2021-316015 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial flutter, Dizziness, Electrocardiogram ambulatory, Erythema, Headache
Clinical narrative: Atrial flutter; Elevated heart rate (120-125); Whole left arm from shoulder to elbow became swollen; Whole left arm from shoulder to elbow became red; Dizziness; foggy headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FLUTTER (Atrial flutter), HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red) and DIZZINESS (Dizziness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tachycardia (was hospitalized for that but she was told that it was due to severe anemia (HR then reached 199)).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (foggy headache). On 15-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red) and DIZZINESS (Dizziness). On an unknown date, the patient experienced ATRIAL FLUTTER (Atrial flutter). The patient was treated with PARACETAMOL (TYLENOL) on 18-Jan-2021 for Tachycardia, at an unspecified dose and frequency; METOPROLOL for Adverse event, at a dose of 50 mg,1 1/2 tab AM 1 tab in the evening and WARFARIN SODIUM (COUMADIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ATRIAL FLUTTER (Atrial flutter) had not resolved and HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red), DIZZINESS (Dizziness) and HEADACHE (foggy headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Electrocardiogram ambulatory: abnormal (abnormal) atrial flutter. On an unknown date, Heart rate: 120-125 heart beats per minute (High) elevated heart rate (120-125).         No concomitant medication is provided On 2021, Patient had EKG, No results were provided  Patient was monitored for 14 days in Holter monitor and it was reported that she would be getting 2D Echocardiogram. She was monitored by an emergency doctor and the vaccine provider after she was given the 2nd dose.   This case was linked to MOD-2021-315374 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Peripheral swelling
Clinical narrative: Atrial flutter; Elevated heart rate (120-125); Whole left arm from shoulder to elbow became swollen; Whole left arm from shoulder to elbow became red; Dizziness; foggy headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FLUTTER (Atrial flutter), HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red) and DIZZINESS (Dizziness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tachycardia (was hospitalized for that but she was told that it was due to severe anemia (HR then reached 199)).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (foggy headache). On 15-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red) and DIZZINESS (Dizziness). On an unknown date, the patient experienced ATRIAL FLUTTER (Atrial flutter). The patient was treated with PARACETAMOL (TYLENOL) on 18-Jan-2021 for Tachycardia, at an unspecified dose and frequency; METOPROLOL for Adverse event, at a dose of 50 mg,1 1/2 tab AM 1 tab in the evening and WARFARIN SODIUM (COUMADIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ATRIAL FLUTTER (Atrial flutter) had not resolved and HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red), DIZZINESS (Dizziness) and HEADACHE (foggy headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Electrocardiogram ambulatory: abnormal (abnormal) atrial flutter. On an unknown date, Heart rate: 120-125 heart beats per minute (High) elevated heart rate (120-125).         No concomitant medication is provided On 2021, Patient had EKG, No results were provided  Patient was monitored for 14 days in Holter monitor and it was reported that she would be getting 2D Echocardiogram. She was monitored by an emergency doctor and the vaccine provider after she was given the 2nd dose.   This case was linked to MOD-2021-315374 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: tingling in my left arm/tingling in my left hand; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my left arm/tingling in my left hand) and VACCINATION SITE PAIN (pain at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced PARAESTHESIA (tingling in my left arm/tingling in my left hand) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, PARAESTHESIA (tingling in my left arm/tingling in my left hand) and VACCINATION SITE PAIN (pain at the injection site) 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 provided.  No treatment medication provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Redness in the area of injection; Very hard to the touch in the area of the injection; Swelling at the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Very hard to the touch in the area of the injection), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041l20a and 041l20a) for COVID-19 vaccination.     Concurrent medical conditions included Sclerosis multiple. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALINE [SERTRALINE HYDROCHLORIDE]), NORTRIPTYLINE, SUMATRIPTAN, OCRELIZUMAB, HYDROXOCOBALAMIN ACETATE (V12) and ZOLPIDEM for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PYREXIA (Fever). On 10-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE INDURATION (Very hard to the touch in the area of the injection). 10-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Swelling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; MORINDA CITRIFOLIA (MORIN [MORINDA CITRIFOLIA]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Very hard to the touch in the area of the injection), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Myalgia, Pain
Clinical narrative: Nose dripping immediately after first shot; Radiating pain after first shot; Felt warm  after first shot; Felt  achy  after first shot; Fever 102F after first shot; Feeling wearied in her body immediately after first shot; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Nose dripping immediately after first shot), PAIN (Radiating pain after first shot), FEELING HOT (Felt warm  after first shot), MYALGIA (Felt  achy  after first shot) and PYREXIA (Fever 102F after first shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heartbeats irregular and COVID-19 in January 2021. Concurrent medical conditions included Immunocompromised and Asthma. Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Asthma.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (Nose dripping immediately after first shot), PAIN (Radiating pain after first shot), FEELING HOT (Felt warm  after first shot), MYALGIA (Felt  achy  after first shot), PYREXIA (Fever 102F after first shot) and FATIGUE (Feeling wearied in her body immediately after first shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK mg. On 05-Mar-2021, RHINORRHOEA (Nose dripping immediately after first shot), FEELING HOT (Felt warm  after first shot), MYALGIA (Felt  achy  after first shot), PYREXIA (Fever 102F after first shot) and FATIGUE (Feeling wearied in her body immediately after first shot) had resolved. On 06-Mar-2021, PAIN (Radiating pain after first shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Body temperature: high (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-315707, MOD-2021-315706 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Nose dripping immediately after first shot; Radiating pain after first shot; Felt warm  after first shot; Felt  achy  after first shot; Fever 102F after first shot; Feeling wearied in her body immediately after first shot; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Nose dripping immediately after first shot), PAIN (Radiating pain after first shot), FEELING HOT (Felt warm  after first shot), MYALGIA (Felt  achy  after first shot) and PYREXIA (Fever 102F after first shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heartbeats irregular and COVID-19 in January 2021. Concurrent medical conditions included Immunocompromised and Asthma. Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Asthma.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (Nose dripping immediately after first shot), PAIN (Radiating pain after first shot), FEELING HOT (Felt warm  after first shot), MYALGIA (Felt  achy  after first shot), PYREXIA (Fever 102F after first shot) and FATIGUE (Feeling wearied in her body immediately after first shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK mg. On 05-Mar-2021, RHINORRHOEA (Nose dripping immediately after first shot), FEELING HOT (Felt warm  after first shot), MYALGIA (Felt  achy  after first shot), PYREXIA (Fever 102F after first shot) and FATIGUE (Feeling wearied in her body immediately after first shot) had resolved. On 06-Mar-2021, PAIN (Radiating pain after first shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Body temperature: high (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-315707, MOD-2021-315706 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Fatigue
Clinical narrative: Afib; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant) and FATIGUE (Tired). At the time of the report, ATRIAL FIBRILLATION (Afib) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (abnormal) Abnormal.         Concomitant product details were not provided by the reporter.  Treatment details were not provided by the reporter.  action taken was not applicable.  Company comment: This case concerns an 81-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date after an unknown dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns an 81-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date after an unknown dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: Fever returned; Headache/having headaches mostly when i lay down; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (Fever returned) and HEADACHE (Headache/having headaches mostly when i lay down) 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 08-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 09-Sep-2021, the patient experienced PYREXIA (Fever returned) and HEADACHE (Headache/having headaches mostly when i lay down). On 08-Sep-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. On 10-Sep-2021, PYREXIA (Fever returned) had resolved. At the time of the report, HEADACHE (Headache/having headaches mostly when i lay down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment drugs were reported   This case was linked to MOD-2021-293439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow-up information received on 12-09-2021 contains non-significant information.