chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Inflammation, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: Experiencing like something in her throat / like a sore throat; inflammation on her throat; she had normal reaction; Allergic reaction; is in a lot of pain; rash in her throat; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat), VACCINATION COMPLICATION (she had normal reaction), ALLERGY TO VACCINE (Allergic reaction) and PAIN (is in a lot of pain) in a 67-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.     No Medical History information was reported.    In 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 OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat), VACCINATION COMPLICATION (she had normal reaction), ALLERGY TO VACCINE (Allergic reaction), PAIN (is in a lot of pain), RASH (rash in her throat), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat) and ALLERGY TO VACCINE (Allergic reaction) outcome was unknown, VACCINATION COMPLICATION (she had normal reaction), MYALGIA (body aches) and PYREXIA (fever) had resolved and PAIN (is in a lot of pain) and RASH (rash in her throat) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient was treated with antibiotics and steroids.   This case was linked to MOD-2021-339220 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination complication
Clinical narrative: Experiencing like something in her throat / like a sore throat; inflammation on her throat; she had normal reaction; Allergic reaction; is in a lot of pain; rash in her throat; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat), VACCINATION COMPLICATION (she had normal reaction), ALLERGY TO VACCINE (Allergic reaction) and PAIN (is in a lot of pain) in a 67-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.     No Medical History information was reported.    In 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 OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat), VACCINATION COMPLICATION (she had normal reaction), ALLERGY TO VACCINE (Allergic reaction), PAIN (is in a lot of pain), RASH (rash in her throat), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat) and ALLERGY TO VACCINE (Allergic reaction) outcome was unknown, VACCINATION COMPLICATION (she had normal reaction), MYALGIA (body aches) and PYREXIA (fever) had resolved and PAIN (is in a lot of pain) and RASH (rash in her throat) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient was treated with antibiotics and steroids.   This case was linked to MOD-2021-339220 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Translation received on 06-oct-2021 Event outcome updated.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-339291 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, M012M20A and M-13L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for an unreported indication: FLU on 08-Feb-2021. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, LISINOPRIL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Supplementation therapy, AMLODIPINE from 23-Aug-2021 to an unknown date for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.            No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant Follow-Up received on 5-Oct-2021.Updated concomitant medication, event start date and stop date, Updated event ADR term to Pain in Arm.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Vaccination complication
Clinical narrative: felt a little bit like "fluish"; stronger reaction; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt a little bit like "fluish"), VACCINATION COMPLICATION (stronger reaction) and PYREXIA (slight fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 INFLUENZA LIKE ILLNESS (felt a little bit like "fluish"), VACCINATION COMPLICATION (stronger reaction) and PYREXIA (slight fever). At the time of the report, INFLUENZA LIKE ILLNESS (felt a little bit like "fluish") and PYREXIA (slight fever) outcome was unknown and VACCINATION COMPLICATION (stronger reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-339322 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Vaccination site pain
Clinical narrative: The pain is only on the left side the same side as covid shot.; STIFF NECK; injection site soreness that lasted for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (STIFF NECK), PAIN (The pain is only on the left side the same side as covid shot.) and VACCINATION SITE PAIN (injection site soreness that lasted for 2 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included APIXABAN (ELIQUIS) from 01-Jan-1998 to an unknown date for Anticoagulant therapy, SIMVASTATIN for Cholesterol, METFORMIN from 01-Jan-1998 to an unknown date for Diabetes, METOPROLOL from 01-Jan-1998 to an unknown date for Hypertension, LISINOPRIL from 1998 to an unknown date for Stroke, ACETYLSALICYLIC ACID (ASPIRIN 81) from 01-Jan-1998 to an unknown date for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness that lasted for 2 days). On 28-Feb-2021 at 9:00 AM, the patient experienced MUSCULOSKELETAL STIFFNESS (STIFF NECK). On an unknown date, the patient experienced PAIN (The pain is only on the left side the same side as covid shot.). On 28-Feb-2021, VACCINATION SITE PAIN (injection site soreness that lasted for 2 days) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (STIFF NECK) had not resolved and PAIN (The pain is only on the left side the same side as covid shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Vitafusion men's multi vitamins, Equate low dose aspirin 81mg No treatment medications were reported. patient consulted his family doctor about Stiff neck and pain  at his regular appointment in June. Patient said it would probably  go away in about 3 months.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains  Reporter Information, , Patient Demographic details, Vaccine Facility Information,  Concomitant medication and event information updated
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-339498 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Body temperature, Fatigue, Headache, Migraine
Clinical narrative: large lump in his armpit with a size of a golf ball; light headache; slight fever 98.8F; feeling tired; bad migraine; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (large lump in his armpit with a size of a golf ball), MIGRAINE (bad migraine), HEADACHE (light headache), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, M012M20A and M-13L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Drug allergy (Niscon allergy.). Concomitant products included LISINOPRIL and AMLODIPINE for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation, FINASTERIDE and FENOFIBRATE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced MIGRAINE (bad migraine), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired). On 03-Oct-2021, the patient experienced AXILLARY MASS (large lump in his armpit with a size of a golf ball) and HEADACHE (light headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 03-Oct-2021, MIGRAINE (bad migraine), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired) had resolved. At the time of the report, AXILLARY MASS (large lump in his armpit with a size of a golf ball) and HEADACHE (light headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, Body temperature: 98.8 f (High) 98.8 F.    Indication for use of concomitant medication Finasteride was Prostate and for Fenofibrate was Cholesterol.  Patient's historical vaccine includes Flu shot on 05AUG2021.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received contains additional race, allergies and medical history  and concomitant therapy dates information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: large lump in his armpit with a size of a golf ball; light headache; slight fever 98.8F; feeling tired; bad migraine; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (large lump in his armpit with a size of a golf ball), MIGRAINE (bad migraine), HEADACHE (light headache), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, M012M20A and M-13L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Drug allergy (Niscon allergy.). Concomitant products included LISINOPRIL and AMLODIPINE for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation, FINASTERIDE and FENOFIBRATE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced MIGRAINE (bad migraine), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired). On 03-Oct-2021, the patient experienced AXILLARY MASS (large lump in his armpit with a size of a golf ball) and HEADACHE (light headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 03-Oct-2021, MIGRAINE (bad migraine), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired) had resolved. At the time of the report, AXILLARY MASS (large lump in his armpit with a size of a golf ball) and HEADACHE (light headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, Body temperature: 98.8 f (High) 98.8 F.    Indication for use of concomitant medication Finasteride was Prostate and for Fenofibrate was Cholesterol.  Patient's historical vaccine includes Flu shot on 05AUG2021.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received contains additional race, allergies and medical history  and concomitant therapy dates information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired 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 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Depressed mood, Headache, Pain
Clinical narrative: Headache; Does not have any energy; Lot of pain; No appetite; Depressed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ASTHENIA (Does not have any energy), PAIN (Lot of pain), DECREASED APPETITE (No appetite) and DEPRESSED MOOD (Depressed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), ASTHENIA (Does not have any energy), PAIN (Lot of pain), DECREASED APPETITE (No appetite) and DEPRESSED MOOD (Depressed). The patient was treated with OXYCODONE for Pain, at a dose of 5 milligram. At the time of the report, HEADACHE (Headache), ASTHENIA (Does not have any energy), PAIN (Lot of pain), DECREASED APPETITE (No appetite) and DEPRESSED MOOD (Depressed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Taking extra vitamins and an energy pack which didn't help Consumer advised she is on Oxycodone 5 mg 1 tab twice daily, but the vaccine intensified pain which is constant- 24/7.   This case was linked to MOD-2021-328765 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nausea, Tremor
Clinical narrative: Nausea; shakes; chills; joint ache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), CHILLS (chills), ARTHRALGIA (joint ache) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 012L20A and 939906) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included L-THYROXINE [LEVOTHYROXINE] and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021 at 8:00 PM, the patient experienced TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint ache). On 16-Sep-2021, the patient experienced NAUSEA (Nausea). On 08-Feb-2021, TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint ache) had resolved. On 17-Sep-2021, NAUSEA (Nausea) had resolved.            No treatment medications reported. Patient took Shingles vaccine in 8/20 and experienced same events.  This case involves a 73-year-old female subject with unknown medical history who experienced the unlisted non-serious adverse event of tremor and the listed non-serious adverse events of chills, arthralgia and nausea over her three vaccination doses. No re-challenge information was provided or is applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-339520, MOD-2021-322828 (Patient Link).; Sender's Comments: This case involves a 73-year-old female subject with unknown medical history who experienced the unlisted non-serious adverse event of tremor and the listed non-serious adverse events of chills, arthralgia and nausea over her three vaccination doses. No re-challenge information was provided or is applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Restlessness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of restlessness, feeling abnormal and pain in extremity (arm pain) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. In March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In March 2021, patient experienced  restlessness, feeling abnormal and pain in extremity (arm pain). At the time of the report, restlessness, feeling abnormal and pain in extremity (arm pain): resolved. Concomitant medication not reported. In the morning, of getting the first vaccine, patient did a prep: Sun gazing, gallons of water and an overdose of Vitamin D. On the evening of first dose, when the patient got back to home, he was so restless. He worked-out and felt like was a "mac truck driver on whites." By 9, patient took a shot of whiskey and needed to go to bed. The next day; no problems, no arm pain. No treatment information provided. This case linked to MOD-2021-339561 (patient link). Most recent follow-up information incorporated: On Oct 5, 2021: Follow-up information included no new information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Product availability issue
Clinical narrative: Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available; Received 2nd shot 3 months after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Received 2nd shot 3 months after the first shot) and PRODUCT AVAILABILITY ISSUE (Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Received 2nd shot 3 months after the first shot). On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available). In June 2021, PRODUCT ADMINISTRATION INTERRUPTED (Received 2nd shot 3 months after the first shot) and PRODUCT AVAILABILITY ISSUE (Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available) had resolved.            No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-339758 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Moderna vaccine given to patient who had J&J; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine given to patient who had J&J) 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 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine given to patient who had J&J). On 14-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine given to patient who had J&J) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient received Johnson and Johnson vaccine on 27-May-2021. Then returned on 14-Sep-2021 and was asked if patient was vaccinated, patient said no and was given a dose of the Moderna vaccine.  No treatment information was provided by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Illness
Clinical narrative: dizziness; patient states being constantly Ill every sense; soreness in arm; Diarrhea; Nausea; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (dizziness), ILLNESS (patient states being constantly Ill every sense), NAUSEA (Nausea) and CHILLS (chills) in a 34-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.     The patient's past medical history included COVID-19 (and had to be hospitalized and received the same medication  took) in October 2020 and Hospitalization. Concurrent medical conditions included Chest pain.    On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced DIZZINESS (dizziness), ILLNESS (patient states being constantly Ill every sense) and MYALGIA (soreness in arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (dizziness), ILLNESS (patient states being constantly Ill every sense), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache) and MYALGIA (soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Tylenol was taken for extra strength.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received: Added events, patient details
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: dizziness; patient states being constantly Ill every sense; soreness in arm; Diarrhea; Nausea; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (dizziness), ILLNESS (patient states being constantly Ill every sense), NAUSEA (Nausea) and CHILLS (chills) in a 34-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.     The patient's past medical history included COVID-19 (and had to be hospitalized and received the same medication  took) in October 2020 and Hospitalization. Concurrent medical conditions included Chest pain.    On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced DIZZINESS (dizziness), ILLNESS (patient states being constantly Ill every sense) and MYALGIA (soreness in arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (dizziness), ILLNESS (patient states being constantly Ill every sense), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache) and MYALGIA (soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Tylenol was taken for extra strength.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received: Added events, patient details
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Feeling abnormal, Feeling of body temperature change, Myalgia
Clinical narrative: being hot/cold; anxiety symptoms; Heart palitation; feeling bad; Pressure headache; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (being hot/cold), ANXIETY (anxiety symptoms), PALPITATIONS (Heart palitation), FEELING ABNORMAL (feeling bad) and TENSION HEADACHE (Pressure headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (being hot/cold), ANXIETY (anxiety symptoms), PALPITATIONS (Heart palitation), FEELING ABNORMAL (feeling bad), TENSION HEADACHE (Pressure headache), MYALGIA (body aches) and CHILLS (chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (being hot/cold), ANXIETY (anxiety symptoms), PALPITATIONS (Heart palitation), FEELING ABNORMAL (feeling bad), TENSION HEADACHE (Pressure headache), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-053194, MOD-2021-053183 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tension headache
Clinical narrative: being hot/cold; anxiety symptoms; Heart palitation; feeling bad; Pressure headache; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (being hot/cold), ANXIETY (anxiety symptoms), PALPITATIONS (Heart palitation), FEELING ABNORMAL (feeling bad) and TENSION HEADACHE (Pressure headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (being hot/cold), ANXIETY (anxiety symptoms), PALPITATIONS (Heart palitation), FEELING ABNORMAL (feeling bad), TENSION HEADACHE (Pressure headache), MYALGIA (body aches) and CHILLS (chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (being hot/cold), ANXIETY (anxiety symptoms), PALPITATIONS (Heart palitation), FEELING ABNORMAL (feeling bad), TENSION HEADACHE (Pressure headache), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-053194, MOD-2021-053183 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site urticaria
Clinical narrative: Moderna arm; people are getting urticaria on injection site and it spreads; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE URTICARIA (people are getting urticaria on injection site and it spreads) 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 VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE URTICARIA (people are getting urticaria on injection site and it spreads). At the time of the report, VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE URTICARIA (people are getting urticaria on injection site and it spreads) 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.   Reporter stated that she read about the Moderna arm, where people were getting urticaria on injection site and it spreads.   No concomitant medications were reported.  No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Right injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Right injection site arm was sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Right injection site arm was sore). At the time of the report, VACCINATION SITE PAIN (Right injection site arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.) 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 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy after vaccine; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy after vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy after vaccine) (seriousness criteria disability and medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy after vaccine) 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 considered NEUROPATHY PERIPHERAL (Neuropathy after vaccine) to be possibly related.    No concomitant medication was reported.  No treatment medication use was reported.  Company comment: This case concerns a female subject of unknown age with a history of autoimmune disorder, who experienced the unexpected event of neuropathy peripheral. The event occurred on an unknown date, patient also received the Moderna Covid-19 vaccine on an unknown date. The rechallenge is not applicable since no other data is provided. The event was considered possibly related to the study drug per the reporter's assessment. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a female subject of unknown age with a history of autoimmune disorder, who experienced the unexpected event of neuropathy peripheral. The event occurred on an unknown date, patient also received the Moderna Covid-19 vaccine on an unknown date. The rechallenge is not applicable since no other data is provided. The event was considered possibly related to the study drug per the reporter's assessment.The benefit-risk relationship of the vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: I got sick after the 2nd shot; it was one day of feeling uncomfortable; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (I got sick after the 2nd shot) and FEELING ABNORMAL (it was one day of feeling uncomfortable) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included CELECOXIB (CELEBREX) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for Rheumatoid arthritis.    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 ILLNESS (I got sick after the 2nd shot) and FEELING ABNORMAL (it was one day of feeling uncomfortable). At the time of the report, ILLNESS (I got sick after the 2nd shot) and FEELING ABNORMAL (it was one day of feeling uncomfortable) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient was an ophthalmologist. She was  now at the 8 month point since her 2nd Moderna dose. She was in the high risk category and says that it is scary to go back to work and not have a booster dose yet. She said that her colleagues who received the Pfizer are being protected by the booster shot, but not the Moderna consumers.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-340460 (Patient Link).   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Coma, Haemorrhagic stroke
Clinical narrative: hemorrhaging stroke/ brain bleed; in a coma for nine days; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (hemorrhaging stroke/ brain bleed) and COMA (in a coma for nine days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Heart disorder (Heart problems). Concomitant products included LISINOPRIL for an unknown indication.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced HAEMORRHAGIC STROKE (hemorrhaging stroke/ brain bleed) (seriousness criteria death, hospitalization prolonged and medically significant) and COMA (in a coma for nine days) (seriousness criteria death, hospitalization prolonged and medically significant). The patient was hospitalized on 28-Aug-2021 due to COMA and HAEMORRHAGIC STROKE. The patient died on 08-Sep-2021. The reported cause of death was hemorrhaging stroke. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient found her husband lying on the floor. Reporter was unsure that whether patient was taking concomitant drug daily. No treatment information were provided.  Company Comment: This case concerns a 66-year-old, male patient with relevant medical history of Blood pressure high and Heart disorder, who experienced, serious unlisted AESI of hemorrhagic stroke and serious unlisted event of coma, both had a fatal oucome. The event occurred after unspecified duration from  second dose of Moderna COVID-19 Vaccine.  The rechallenge was not applicable as the events occurred after second dose of Moderna COVID-19 Vaccine. The exact cause of death was not provided. However, the medical history of Blood pressure high and Heart disorder remains as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 66-year-old, male patient with relevant medical history of Blood pressure high and Heart disorder, who experienced, serious unlisted AESI of hemorrhagic stroke and serious unlisted event of coma, both had a fatal oucome. The event occurred after unspecified duration from  second dose of Moderna COVID-19 Vaccine.  The rechallenge was not applicable as the events occurred after second dose of Moderna COVID-19 Vaccine. The exact cause of death was not provided. However, the medical history of Blood pressure high and Heart disorder remains as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reported Cause(s) of Death: Hemorrhaging stroke