chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: have side effects; 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 ADVERSE EVENT (have side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (have side effects). At the time of the report, ADVERSE EVENT (have side effects) outcome was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic kidney (Patient stated as adult domisal polycystic disease at stage -3.). Concomitant products included LOSARTAN, ALLOPURINOL SODIUM (ALLOPURINOL [ALLOPURINOL SODIUM]), DILTIAZEM, ROSUVASTATIN and VITAMIN D3 for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN (Abdominal pain). On 04-Jun-2021, ABDOMINAL PAIN (Abdominal pain) had resolved.            The patient stated that he was treated with intravenous antibiotic twice daily ,and continued until 26-MAY-2021, switched to oral antibiotic until finished 10 day prescription Patient done with lab tests CT, blood cultures, and echo cardiogram of heart Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable   This case was linked to MOD-2021-181749, MOD-2021-181749 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-jun-2021 contains significant information as the outcome of the event and lab data, concomitant medications is updated. On 24-Jul-2021: Follow up document received and contains No New Information
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Blood test, Feeling abnormal
Clinical narrative: felt bad; my stomach is not right; pains in the upper stomach; sore joints; ran fever; 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 FEELING ABNORMAL (felt bad), ABDOMINAL DISCOMFORT (my stomach is not right), ABDOMINAL PAIN UPPER (pains in the upper stomach), ARTHRALGIA (sore joints) and PYREXIA (ran fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 FEELING ABNORMAL (felt bad), ARTHRALGIA (sore joints) and PYREXIA (ran fever). an unknown date, the patient experienced ABDOMINAL DISCOMFORT (my stomach is not right) and ABDOMINAL PAIN UPPER (pains in the upper stomach). At the time of the report, FEELING ABNORMAL (felt bad), ABDOMINAL DISCOMFORT (my stomach is not right), ABDOMINAL PAIN UPPER (pains in the upper stomach), ARTHRALGIA (sore joints) and PYREXIA (ran fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: unknown Pyrexia.         Concomitant medications were not reported. Treatment details were not reported. Body temperature assessment was not given.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt bad; my stomach is not right; pains in the upper stomach; sore joints; ran fever; 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 FEELING ABNORMAL (felt bad), ABDOMINAL DISCOMFORT (my stomach is not right), ABDOMINAL PAIN UPPER (pains in the upper stomach), ARTHRALGIA (sore joints) and PYREXIA (ran fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 FEELING ABNORMAL (felt bad), ARTHRALGIA (sore joints) and PYREXIA (ran fever). an unknown date, the patient experienced ABDOMINAL DISCOMFORT (my stomach is not right) and ABDOMINAL PAIN UPPER (pains in the upper stomach). At the time of the report, FEELING ABNORMAL (felt bad), ABDOMINAL DISCOMFORT (my stomach is not right), ABDOMINAL PAIN UPPER (pains in the upper stomach), ARTHRALGIA (sore joints) and PYREXIA (ran fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: unknown Pyrexia.         Concomitant medications were not reported. Treatment details were not reported. Body temperature assessment was not given.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza
Clinical narrative: Flu; I have full body chills and headache and fatigue; I have full body chills and headache and fatigue; I have full body chills and headache and fatigue; 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 INFLUENZA (Flu), CHILLS (I have full body chills and headache and fatigue), HEADACHE (I have full body chills and headache and fatigue) and FATIGUE (I have full body chills and headache and fatigue) 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 INFLUENZA (Flu), CHILLS (I have full body chills and headache and fatigue), HEADACHE (I have full body chills and headache and fatigue) and FATIGUE (I have full body chills and headache and fatigue). At the time of the report, INFLUENZA (Flu), CHILLS (I have full body chills and headache and fatigue), HEADACHE (I have full body chills and headache and fatigue) and FATIGUE (I have full body chills and headache and fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Insomnia, Somnolence, Vaccination site pain
Clinical narrative: Can't sleep; Weak; Groggy; Site of injection was very sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't sleep), ASTHENIA (Weak), SOMNOLENCE (Groggy) and VACCINATION SITE PAIN (Site of injection was very sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced INSOMNIA (Can't sleep), ASTHENIA (Weak), SOMNOLENCE (Groggy) and VACCINATION SITE PAIN (Site of injection was very sore). At the time of the report, INSOMNIA (Can't sleep), ASTHENIA (Weak), SOMNOLENCE (Groggy) and VACCINATION SITE PAIN (Site of injection was very sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-181682 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throw up; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throw up) 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 VOMITING (Throw up). At the time of the report, VOMITING (Throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     no medical history information was reported.     On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: hasn't received the second dose in the series from Moderna's COVID-19 vaccine; 99 days have passed since first dose given in the series; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (hasn't received the second dose in the series from Moderna's COVID-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (99 days have passed since first dose given in the series) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]), APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL XL) and HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (hasn't received the second dose in the series from Moderna's COVID-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (99 days have passed since first dose given in the series). At the time of the report, PRODUCT DOSE OMISSION ISSUE (hasn't received the second dose in the series from Moderna's COVID-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (99 days have passed since first dose given in the series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Diarrhoea, Fatigue
Clinical narrative: cramping; bloating; some diarrhea; GI symptoms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (cramping), ABDOMINAL DISTENSION (bloating), DIARRHOEA (some diarrhea), ABDOMINAL DISCOMFORT (GI symptoms) and FATIGUE (fatigue) 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 ABDOMINAL PAIN (cramping), ABDOMINAL DISTENSION (bloating), DIARRHOEA (some diarrhea), ABDOMINAL DISCOMFORT (GI symptoms) and FATIGUE (fatigue). At the time of the report, ABDOMINAL PAIN (cramping), ABDOMINAL DISTENSION (bloating), DIARRHOEA (some diarrhea), ABDOMINAL DISCOMFORT (GI symptoms) and FATIGUE (fatigue) had not resolved.            No concomitant and treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site reaction
Clinical narrative: vaccination site pruritus; vaccination site rash; Vaccination site reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash) had not resolved.            No concomitant medication were provided.   Patient also reported using itch cream  as treatment medication for this third episode of COVID arm. (vaccination site reaction). She reported diphenhydramine (Benadryl) and the itch cream did not help.   The patient reported she started to have Covid arm  for a third time on the same area of vaccination on 10-May-2021. The patient reported that her Covid arm  took a month each time to (go) away after her vaccinations. The Covid arm  she got was of nice size and itchy when it started and she stated that it was weird that she was getting another event after two months. The patient reported she received an unknown shot (injection in arm) for an unknown indication 17 days prior to her 1st dose of Moderna Covid-10 vaccine in the same arm .  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: double vision when head turns to the left; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (double vision when head turns to the left) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIPLOPIA (double vision when head turns to the left). At the time of the report, DIPLOPIA (double vision when head turns to the left) outcome was unknown.            No concomitant and treatment medications were provided  Reporter said that he was going to eye doctor.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Headache
Clinical narrative: Headache on one side of the head; Anxiety; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache on one side of the head) and ANXIETY (Anxiety) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Anxiety.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 HEADACHE (Headache on one side of the head) and ANXIETY (Anxiety). At the time of the report, HEADACHE (Headache on one side of the head) and ANXIETY (Anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 189/90 (High) high.         Concomitant medications taken were blood pressure medications and anxiety medications. No treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Tongue discomfort
Clinical narrative: Everything tastes metallic after the 2nd dose; Tongue feels like weird; 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 DYSGEUSIA (Everything tastes metallic after the 2nd dose) and TONGUE DISCOMFORT (Tongue feels like weird) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 DYSGEUSIA (Everything tastes metallic after the 2nd dose) and TONGUE DISCOMFORT (Tongue feels like weird). At the time of the report, DYSGEUSIA (Everything tastes metallic after the 2nd dose) and TONGUE DISCOMFORT (Tongue feels like weird) outcome was unknown.            No Concomitant Medication was provided. No treatment  was provided. The action taken with mRNA-1273 in response to the event was not applicable.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: extreme swelling in both hands, swelling is extremely bad; extreme pain in both hands; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (extreme swelling in both hands, swelling is extremely bad) and PAIN IN EXTREMITY (extreme pain in both hands) in a 73-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (extreme swelling in both hands, swelling is extremely bad) and PAIN IN EXTREMITY (extreme pain in both hands). At the time of the report, PERIPHERAL SWELLING (extreme swelling in both hands, swelling is extremely bad) and PAIN IN EXTREMITY (extreme pain in both hands) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.  A patient called in to report that after receiving the 2nd dose of the Moderna COVID 19 Vaccine he experienced severe swelling and pain in both of his hands. The swelling is extremely bad to the point where he is not able to use his arms. Patient received the 2nd dose the end of February. Additionally, after receiving the 1st dose he completely lost control of his bladder and urinated on himself daily for about 2 1/2 days.   This case was linked to MOD-2021-181925 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (Rash ) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ATORVASTATIN, AMLODIPINE and TRAMADOL for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced RASH (Rash ). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH (Rash ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cold symptoms; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), PYREXIA (Fever) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history is provided by reporter.     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 NASOPHARYNGITIS (Cold symptoms), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, NASOPHARYNGITIS (Cold symptoms), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Peripheral swelling
Clinical narrative: I have noticed my right leg swe; got "covid arm"; felt like I got hit by a bus; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like I got hit by a bus), PERIPHERAL SWELLING (I have noticed my right leg swe) and MYALGIA (got "covid arm") in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like I got hit by a bus), PERIPHERAL SWELLING (I have noticed my right leg swe) and MYALGIA (got "covid arm"). At the time of the report, FEELING ABNORMAL (felt like I got hit by a bus) had resolved and PERIPHERAL SWELLING (I have noticed my right leg swe) and MYALGIA (got "covid arm") outcome was unknown.            No treatment medication provided. No concomitant medication provided. The report stated that the patient had COVID arm  after the fist dose. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable, reporter didn't provide any causality assessment.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Shaking; Chills; Fatigue; Muscle pain; Fever of 102.4 degrees; 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 TREMOR (Shaking), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Fever of 102.4 degrees) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Fever of 102.4 degrees). At the time of the report, TREMOR (Shaking), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Fever of 102.4 degrees) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.4 (High) fever of 102.4.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking; Chills; Fatigue; Muscle pain; Fever of 102.4 degrees; 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 TREMOR (Shaking), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Fever of 102.4 degrees) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Fever of 102.4 degrees). At the time of the report, TREMOR (Shaking), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Fever of 102.4 degrees) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.4 (High) fever of 102.4.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Concomitant medications were not reported.  The treatment information was not provided.  The action taken mRNA 1273 with the events was considered as not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: The follow-up document was received on 10-JUN-2021 and has no new information.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: arm hurting really bad (soreness); redness at site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting really bad (soreness)) and VACCINATION SITE ERYTHEMA (redness at site) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurting really bad (soreness)) and VACCINATION SITE ERYTHEMA (redness at site). At the time of the report, PAIN IN EXTREMITY (arm hurting really bad (soreness)) and VACCINATION SITE ERYTHEMA (redness at site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Unspecified medication for Acid reflux . No treatment medications taken   This case was linked to MOD-2021-181959, MOD-2021-181959 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: lost control of his bladder, urinated on himself; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (lost control of his bladder, urinated on himself) in a 73-year-old male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY INCONTINENCE (lost control of his bladder, urinated on himself). At the time of the report, URINARY INCONTINENCE (lost control of his bladder, urinated on himself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no medical history and concomitant medications were provided.   This case was linked to MOD-2021-181894 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: My sons arm really hurts; He can barely move it; 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 PAIN IN EXTREMITY (my sons arm really hurts) and LIMB DISCOMFORT (he can barely move it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my sons arm really hurts) and LIMB DISCOMFORT (he can barely move it). At the time of the report, PAIN IN EXTREMITY (my sons arm really hurts) and LIMB DISCOMFORT (he can barely move it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: I had my 2nd vaccine yesterday and today experience chills; vomiting; and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I had my 2nd vaccine yesterday and today experience chills), VOMITING (vomiting) and DIARRHOEA (and diarrhea) 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 CHILLS (I had my 2nd vaccine yesterday and today experience chills), VOMITING (vomiting) and DIARRHOEA (and diarrhea). At the time of the report, CHILLS (I had my 2nd vaccine yesterday and today experience chills), VOMITING (vomiting) and DIARRHOEA (and diarrhea) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Im just really cold about 12 hours after vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Im just really cold about 12 hours after vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Im just really cold about 12 hours after vaccine). At the time of the report, FEELING COLD (Im just really cold about 12 hours after vaccine) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I took the first Moderna dose on 3/18, the second dose was scheduled to 4/15 ( Patient missed the second dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I took the first Moderna dose on 3/18, the second dose was scheduled to 4/15 ( Patient missed the second dose)) in a female patient of an unknown age who received  .     The patient's past medical history included No adverse event.     On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I took the first Moderna dose on 3/18, the second dose was scheduled to 4/15 ( Patient missed the second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I took the first Moderna dose on 3/18, the second dose was scheduled to 4/15 ( Patient missed the second dose)) had resolved.            This case was linked to MOD-2021-182590 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received on 27-MAY-2021. Updated reporter's address and contact information
Sex: F
Vaccine: COVID19
Symptoms: Headache, Occipital neuralgia
Clinical narrative: Pain at base of skull/ Feeling of a hook pulling at the base of skull; Intense Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of OCCIPITAL NEURALGIA (Pain at base of skull/ Feeling of a hook pulling at the base of skull) and HEADACHE (Intense Headache) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 OCCIPITAL NEURALGIA (Pain at base of skull/ Feeling of a hook pulling at the base of skull) and HEADACHE (Intense Headache). At the time of the report, OCCIPITAL NEURALGIA (Pain at base of skull/ Feeling of a hook pulling at the base of skull) and HEADACHE (Intense Headache) outcome was unknown.            No concomitant medications provided No treatment medications provided
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: vertigo; headaches; 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 VERTIGO (vertigo) and HEADACHE (headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo) and HEADACHE (headaches). At the time of the report, VERTIGO (vertigo) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Muscle contractions involuntary, Musculoskeletal stiffness
Clinical narrative: Muscle reactions on left side of face; Left eye ball was noticeably different on camera; top of head was tingling; arm was sore, stiff; Dizzy; sore arm; Weird headache; Fatigue; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE CONTRACTIONS INVOLUNTARY (Muscle reactions on left side of face), OCULAR DISCOMFORT (Left eye ball was noticeably different on camera), PARAESTHESIA (top of head was tingling), MUSCULOSKELETAL STIFFNESS (arm was sore, stiff) and DIZZINESS (Dizzy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 29-Apr-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 MUSCLE CONTRACTIONS INVOLUNTARY (Muscle reactions on left side of face), OCULAR DISCOMFORT (Left eye ball was noticeably different on camera), PARAESTHESIA (top of head was tingling), MUSCULOSKELETAL STIFFNESS (arm was sore, stiff), DIZZINESS (Dizzy), PAIN IN EXTREMITY (sore arm), HEADACHE (Weird headache), FATIGUE (Fatigue) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MUSCLE CONTRACTIONS INVOLUNTARY (Muscle reactions on left side of face), OCULAR DISCOMFORT (Left eye ball was noticeably different on camera), PARAESTHESIA (top of head was tingling), MUSCULOSKELETAL STIFFNESS (arm was sore, stiff), DIZZINESS (Dizzy), PAIN IN EXTREMITY (sore arm), HEADACHE (Weird headache), FATIGUE (Fatigue) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Patient second dose was not received due to side effects.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Muscle reactions on left side of face; Left eye ball was noticeably different on camera; top of head was tingling; arm was sore, stiff; Dizzy; sore arm; Weird headache; Fatigue; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE CONTRACTIONS INVOLUNTARY (Muscle reactions on left side of face), OCULAR DISCOMFORT (Left eye ball was noticeably different on camera), PARAESTHESIA (top of head was tingling), MUSCULOSKELETAL STIFFNESS (arm was sore, stiff) and DIZZINESS (Dizzy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 29-Apr-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 MUSCLE CONTRACTIONS INVOLUNTARY (Muscle reactions on left side of face), OCULAR DISCOMFORT (Left eye ball was noticeably different on camera), PARAESTHESIA (top of head was tingling), MUSCULOSKELETAL STIFFNESS (arm was sore, stiff), DIZZINESS (Dizzy), PAIN IN EXTREMITY (sore arm), HEADACHE (Weird headache), FATIGUE (Fatigue) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MUSCLE CONTRACTIONS INVOLUNTARY (Muscle reactions on left side of face), OCULAR DISCOMFORT (Left eye ball was noticeably different on camera), PARAESTHESIA (top of head was tingling), MUSCULOSKELETAL STIFFNESS (arm was sore, stiff), DIZZINESS (Dizzy), PAIN IN EXTREMITY (sore arm), HEADACHE (Weird headache), FATIGUE (Fatigue) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Patient second dose was not received due to side effects.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever after the vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after the vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after the vaccination). At the time of the report, PYREXIA (Fever after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: needing to take naps during the day, never had the problem before; arm was sore, but stated it was normal (after second vaccine); Three days following the second vaccine he started feeling extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (needing to take naps during the day, never had the problem before), PAIN IN EXTREMITY (arm was sore, but stated it was normal (after second vaccine)) and FATIGUE (Three days following the second vaccine he started feeling extremely fatigued) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-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 SOMNOLENCE (needing to take naps during the day, never had the problem before), PAIN IN EXTREMITY (arm was sore, but stated it was normal (after second vaccine)) and FATIGUE (Three days following the second vaccine he started feeling extremely fatigued). At the time of the report, SOMNOLENCE (needing to take naps during the day, never had the problem before), PAIN IN EXTREMITY (arm was sore, but stated it was normal (after second vaccine)) and FATIGUE (Three days following the second vaccine he started feeling extremely fatigued) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.    This case was linked to MOD-2021-181920 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Symptom; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Symptom) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Symptom). At the time of the report, ADVERSE EVENT (Symptom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long before side effects; 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 VACCINATION COMPLICATION (How long before side effects) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long before side effects). At the time of the report, VACCINATION COMPLICATION (How long before side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.