chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: Appetite lost; Had a fever running for a little while; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost) and PYREXIA (Had a fever running for a little while) 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 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced DECREASED APPETITE (Appetite lost) and PYREXIA (Had a fever running for a little while). At the time of the report, DECREASED APPETITE (Appetite lost) and PYREXIA (Had a fever running for a little while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Swollen at lymph nodes in the neck and chest; Sore throat; A spontaneous report was received from a consumer concerning a 53-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen at lymph nodes in the neck and chest and sore throat.  The patient's medical history, is not provided by reporter.  On 14-jan-2021  the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21-jan-2021 the patient reported swollen at lymph nodes in the neck and chest ,and sore throat.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events, Swollen at lymph nodes in the neck and chest, and sore throat .  Based on comment, Sore throat and Swollen at lymph nodes in the neck and chest is Unlisted
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Vaccination site erythema
Clinical narrative: Left arm started to itch; Little red marks (dots) at the injection site; Left arm felt very warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Left arm felt very warm), PRURITUS (Left arm started to itch) and VACCINATION SITE ERYTHEMA (Little red marks (dots) at the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Feb-2021, the patient experienced FEELING HOT (Left arm felt very warm). On 15-Feb-2021, the patient experienced PRURITUS (Left arm started to itch) and VACCINATION SITE ERYTHEMA (Little red marks (dots) at the injection site). On 06-Feb-2021, FEELING HOT (Left arm felt very warm) had resolved. At the time of the report, PRURITUS (Left arm started to itch) and VACCINATION SITE ERYTHEMA (Little red marks (dots) at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: left arm was sore, red and swollen in a circular pattern around the injection site; left arm was sore, red and swollen in a circular pattern around the injection site; left arm was sore, red and swollen in a circular pattern around the injection site; sliced fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (sliced fever), HEADACHE (headache), INJECTION SITE SWELLING (left arm was sore, red and swollen in a circular pattern around the injection site), INJECTION SITE ERYTHEMA (left arm was sore, red and swollen in a circular pattern around the injection site) and INJECTION SITE PAIN (left arm was sore, red and swollen in a circular pattern around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013LZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (Since year 2000, no recent changes in status of condition) and Allergy to intravenous contrast media (IVF dye). Concomitant products included ROSUVASTATIN for Cholesterol high, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for Prophylaxis.   On 15-Jan-2021 at 7:24 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 7:24 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (sliced fever) and HEADACHE (headache). On 13-Feb-2021, the patient experienced INJECTION SITE SWELLING (left arm was sore, red and swollen in a circular pattern around the injection site), INJECTION SITE ERYTHEMA (left arm was sore, red and swollen in a circular pattern around the injection site) and INJECTION SITE PAIN (left arm was sore, red and swollen in a circular pattern around the injection site). The patient was treated with PARACETAMOL (TYLENOL) 12-Feb-2021 for Headache, at an unspecified dose and frequency. On 12-Feb-2021, HEADACHE (headache) had resolved. On 15-Feb-2021, INJECTION SITE SWELLING (left arm was sore, red and swollen in a circular pattern around the injection site), INJECTION SITE ERYTHEMA (left arm was sore, red and swollen in a circular pattern around the injection site) and INJECTION SITE PAIN (left arm was sore, red and swollen in a circular pattern around the injection site) had resolved. At the time of the report, PYREXIA (sliced fever) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Significant Follow up- information including patient demographics details, Concurrent conditions, Concomitant medications added, and additional events. On 07-Jul-2021: No new information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Pain has moved to the sternum (and almost to the spine) and sometimes hurts when she breathes; Pain has moved to the sternum (and almost to the spine) and sometimes hurts when she breathes; Sharp pain when she bends or moves; Aches throughout back and shoulder blades; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Headaches; Fatigue; Malaise; This spontaneous case was reported by a consumer  of 68 years female patient and experienced   FATIGUE , MALAISE , BACK PAIN , HEADACHE and VACCINATION SITE WARMTH who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event Concomitant products included vitamin b12 and Vitamin d Lab data was not reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273  via intramuscular route and  batch number (027L20A)  then  patient experienced FATIGUE  MALAISE and HEADACHE . On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH ,VACCINATION SITE PAIN , VACCINATION SITE PRURITUS  and VACCINATION SITE ERYTHEMA .  On 30-Jan-2021, the patient experienced BACK PAIN and PAIN  . On 14-Feb-2021, the patient experienced CHEST PAIN  and sometimes hurts when she breathes) and DYSPNOEA  . and the patient pain is still persisting     The action taken with mRNA-1273 was unknown.   The outcome of the event, was considered to be unknown at the time of this report.  Based on RA comment VACCINATION SITE PAIN, PAIN, VACCINATION SITE PRURITUS and VACCINATION SITE ERYTHEMA .
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Pain has moved to the sternum (and almost to the spine) and sometimes hurts when she breathes; Pain has moved to the sternum (and almost to the spine) and sometimes hurts when she breathes; Sharp pain when she bends or moves; Aches throughout back and shoulder blades; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Headaches; Fatigue; Malaise; This spontaneous case was reported by a consumer  of 68 years female patient and experienced   FATIGUE , MALAISE , BACK PAIN , HEADACHE and VACCINATION SITE WARMTH who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event Concomitant products included vitamin b12 and Vitamin d Lab data was not reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273  via intramuscular route and  batch number (027L20A)  then  patient experienced FATIGUE  MALAISE and HEADACHE . On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH ,VACCINATION SITE PAIN , VACCINATION SITE PRURITUS  and VACCINATION SITE ERYTHEMA .  On 30-Jan-2021, the patient experienced BACK PAIN and PAIN  . On 14-Feb-2021, the patient experienced CHEST PAIN  and sometimes hurts when she breathes) and DYSPNOEA  . and the patient pain is still persisting     The action taken with mRNA-1273 was unknown.   The outcome of the event, was considered to be unknown at the time of this report.  Based on RA comment VACCINATION SITE PAIN, PAIN, VACCINATION SITE PRURITUS and VACCINATION SITE ERYTHEMA .
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Pain has moved to the sternum (and almost to the spine) and sometimes hurts when she breathes; Pain has moved to the sternum (and almost to the spine) and sometimes hurts when she breathes; Sharp pain when she bends or moves; Aches throughout back and shoulder blades; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Headaches; Fatigue; Malaise; This spontaneous case was reported by a consumer  of 68 years female patient and experienced   FATIGUE , MALAISE , BACK PAIN , HEADACHE and VACCINATION SITE WARMTH who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event Concomitant products included vitamin b12 and Vitamin d Lab data was not reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273  via intramuscular route and  batch number (027L20A)  then  patient experienced FATIGUE  MALAISE and HEADACHE . On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH ,VACCINATION SITE PAIN , VACCINATION SITE PRURITUS  and VACCINATION SITE ERYTHEMA .  On 30-Jan-2021, the patient experienced BACK PAIN and PAIN  . On 14-Feb-2021, the patient experienced CHEST PAIN  and sometimes hurts when she breathes) and DYSPNOEA  . and the patient pain is still persisting     The action taken with mRNA-1273 was unknown.   The outcome of the event, was considered to be unknown at the time of this report.  Based on RA comment VACCINATION SITE PAIN, PAIN, VACCINATION SITE PRURITUS and VACCINATION SITE ERYTHEMA .
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site mass
Clinical narrative: Swelling bump below the injection site; Bruise at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Swelling bump below the injection site) and VACCINATION SITE BRUISING (Bruise at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Swelling bump below the injection site) and VACCINATION SITE BRUISING (Bruise at injection site). At the time of the report, VACCINATION SITE MASS (Swelling bump below the injection site) and VACCINATION SITE BRUISING (Bruise at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash maculo-papular, Vaccination site pain, Vaccination site rash
Clinical narrative: Pruritic maculopapular rash; Itching; vaccination site rash; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULO-PAPULAR (Pruritic maculopapular rash), PRURITUS (Itching), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PAIN (COVID arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012629A) for COVID-19 vaccination.     No Medical History information was reported.   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 13-Feb-2021, the patient experienced RASH MACULO-PAPULAR (Pruritic maculopapular rash), PRURITUS (Itching), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PAIN (COVID arm). On 26-Feb-2021, RASH MACULO-PAPULAR (Pruritic maculopapular rash), PRURITUS (Itching), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PAIN (COVID arm) had resolved. Not Provided          No concomitant drug information was provided. Treatment information included Benadryl and Tylenol. Action taken with Moderna COVID-19 Vaccine was not applicable    Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Email On 24-Apr-2021: Patient demographics added, vaccine dosage details added, event stop date added, outcome updated from unknown to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; A spontaneous report was received from  a HCP concerning a 66 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm.  the patient's medical history is provided as the patient have rheumatoid arthritis. relevant concomitant medications are also provided. The patient having Methotrexate Enbrel for rheumatoid arthritis.  On 28-JAN-2021,prior to the onset of the events, the patient received their second dose of two planned doses of mRNA-1273(Batch number unknown) for prophylaxis of COVID-19 infection.  On 29-JNA-2021,same date of vaccination the patient experienced the event of sore arm..  Laboratory details are not provided.  Treatment details are not provided.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the event in 28-JAN-2021 remain unknown at the time of this report.  Based on MSA comment, sore arm change to vaccination site pain and listed in all RSIs.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Having a cold; A spontaneous report was received from a consumer concerning herself, a 83-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cold.  The patient's medical history included high blood pressure. Concomitant medications reported included carvedilol for high blood pressure, iron, amlodipine, levothyroxine, aspirin, famotidine, losartan, metformin, biosil, multivitamin with minerals, calcium carbonate, vitamin D and magnesium.  On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 038K20A) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date the patient was having a cold.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; A spontaneous report was received from a reporter like consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event like  headache. The patient's medication history was not provided. Concomitant medications reported include5mg Levocetirizine daily. On 11th Feb 2021, prior to the onset of the events, the patient received the second of the two planned doses of mRNA-1273 (lot/batch unknown) in the anatomical location for prophylaxis of COVID-19 infection. On 15th Feb 2021, following vaccine administration the patient experienced events like headache. Laboratory details were not provided. Treatment details included Tylenol. Action taken with mRNA-1273 in response to the events were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site warmth
Clinical narrative: red warm area that occurred over a week; vaccination site warmth; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (red warm area that occurred over a week) and VACCINATION SITE WARMTH (vaccination site warmth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red warm area that occurred over a week) and VACCINATION SITE WARMTH (vaccination site warmth). At the time of the report, ERYTHEMA (red warm area that occurred over a week) and VACCINATION SITE WARMTH (vaccination site warmth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications as provided by reporter was unknown.    Treatment for the events was unknown
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Pain
Clinical narrative: Soreness; Muscle pain; Nausea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), MYALGIA (Muscle pain), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (Soreness), MYALGIA (Muscle pain), NAUSEA (Nausea) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Soreness), MYALGIA (Muscle pain), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: arm was swollen about 5-6 inches; rash around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm was swollen about 5-6 inches) and VACCINATION SITE RASH (rash around it) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Osteoporosis and Drug allergy (Allergy to Lyrica(Pregabalin)).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen about 5-6 inches) and VACCINATION SITE RASH (rash around it). At the time of the report, VACCINATION SITE SWELLING (arm was swollen about 5-6 inches) and VACCINATION SITE RASH (rash around it) 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Papule
Clinical narrative: circular red spot on the opposite arm of the injection; white dot on the opposite arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (circular red spot on the opposite arm of the injection) and PAPULE (white dot on the opposite arm of the injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical History was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ERYTHEMA (circular red spot on the opposite arm of the injection) and PAPULE (white dot on the opposite arm of the injection). At the time of the report, ERYTHEMA (circular red spot on the opposite arm of the injection) and PAPULE (white dot on the opposite arm of the injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site discomfort
Clinical narrative: discomfort at injection site; little arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort at injection site) and PAIN IN EXTREMITY (little arm soreness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (little arm soreness). On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (discomfort at injection site). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort at injection site) outcome was unknown and PAIN IN EXTREMITY (little arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy
Clinical narrative: lethargic; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), LETHARGY (lethargic) and FATIGUE (Tired) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (Headache). On 21-Jan-2021, the patient experienced LETHARGY (lethargic) and FATIGUE (Tired). At the time of the report, HEADACHE (Headache), LETHARGY (lethargic) and FATIGUE (Tired) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm is tight; Hot; Dull throbbing; Itchy; Red area as big as a baseball; Arm was sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm is tight), VACCINATION SITE WARMTH (Hot), PAIN (Dull throbbing), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (Arm was sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 16-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm is tight), VACCINATION SITE WARMTH (Hot), PAIN (Dull throbbing), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red area as big as a baseball). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 07-Feb-2021, VACCINATION SITE PAIN (Arm was sore) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm is tight), VACCINATION SITE WARMTH (Hot), PAIN (Dull throbbing), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red area as big as a baseball) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 contains No New Information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Arm is tight; Hot; Dull throbbing; Itchy; Red area as big as a baseball; Arm was sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm is tight), VACCINATION SITE WARMTH (Hot), PAIN (Dull throbbing), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (Arm was sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 16-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm is tight), VACCINATION SITE WARMTH (Hot), PAIN (Dull throbbing), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red area as big as a baseball). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 07-Feb-2021, VACCINATION SITE PAIN (Arm was sore) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm is tight), VACCINATION SITE WARMTH (Hot), PAIN (Dull throbbing), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red area as big as a baseball) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 contains No New Information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash erythematous, Skin discolouration, Skin warm
Clinical narrative: warm; about 3 inches by 2 inches pink area; redness; red bumps; itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red bumps), PRURITUS (itching), SKIN WARM (warm), SKIN DISCOLOURATION (about 3 inches by 2 inches pink area) and ERYTHEMA (redness) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red bumps), PRURITUS (itching) and ERYTHEMA (redness). On 15-Feb-2021, the patient experienced SKIN WARM (warm) and SKIN DISCOLOURATION (about 3 inches by 2 inches pink area). On 14-Feb-2021, RASH ERYTHEMATOUS (red bumps) and ERYTHEMA (redness) had resolved. At the time of the report, PRURITUS (itching) had not resolved and SKIN WARM (warm) and SKIN DISCOLOURATION (about 3 inches by 2 inches pink area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pruritus, Rash
Clinical narrative: itchy rashes all over her body which started on her left arm; rash; headache; muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy rashes all over her body which started on her left arm), RASH (rash), HEADACHE (headache) and MYALGIA (muscle pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PRURITUS (itchy rashes all over her body which started on her left arm), RASH (rash), HEADACHE (headache) and MYALGIA (muscle pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency; CALAMINE for Itching, at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and HYDROXYZINE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy rashes all over her body which started on her left arm), RASH (rash), HEADACHE (headache) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LOSARTAN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (tested positive for COVID). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of Covid-19 test positive after vaccination, this event is assessed as unlikely related to mRNA-1273.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on hands and legs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on hands and legs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced URTICARIA (hives on hands and legs). At the time of the report, URTICARIA (hives on hands and legs) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.  On an unknown date. the patient went ahead and was administered with the second dose of vaccination and was fine. The patient requested a call back from safety to provide contact information.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information was received on 13-Jul-2021: Contact information updated. Patient got second dose of Moderna vaccine.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Arm was red (the size of a silver dollar about 2); Injection site was itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Arm was red (the size of a silver dollar about 2)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itching). On 14-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm was red (the size of a silver dollar about 2)). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Arm was red (the size of a silver dollar about 2)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Vaccination site pain
Clinical narrative: Blood pressure increased; Injection site is sore; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure increased) and VACCINATION SITE PAIN (Injection site is sore) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025220A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation since 10-Dec-2018, Prediabetes since 2001, Hypertension since 2017, Enlarged prostate since 2009, Glaucoma (Glaucoma suspect) since 2005, Penicillin allergy, Allergy to antibiotic (Some quinolone antibiotics), Allergy to plants (Cedar), Pollen allergy (Elm pollen) and Fragrance sensitivity. Concomitant products included SOTALOL and ASPIRIN [ACETYLSALICYLIC ACID] for Atrial fibrillation, ALFUZOSIN for Enlarged prostate, VALSARTAN (DIOVAN) for Hypertension.    On 08-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased) and VACCINATION SITE PAIN (Injection site is sore). On 09-Jan-2021, BLOOD PRESSURE INCREASED (Blood pressure increased) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site is sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 149/71 (High) Higher than normal 130/70 and 162/78 (High) Highest blood pressure ever recorded on OMRON Model: BP786 sleeve type blood pressure monitor.. On 09-Jan-2021, Blood pressure measurement: 137/72 (Inconclusive) Inconclusive and 120/64 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Consumer email address added. On 19-Apr-2021: Added primary reporter information (address, email), HCP contact details, patient demographics, relevant medical history (Allergies: penicillin, some quinolone antibiotics, cedar, elm pollen, fragrances; Current conditions: atrial fibrillation, prediabetes, borderline high blood pressure, enlarged prostate, glaucoma suspect), batch number and site of administration of 1st dose, concomitant medications (sotalol, Alfuzosin, Finasteride, Aspirin, Diovan). Event outcome changed (from unknown to recovered).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Vomiting
Clinical narrative: Dizzy; vomitted; Sick; A spontaneous report was received from consumer, concerning a female patient of unspecified age, who received Moderna's covid-19 vaccine (mRNA-1273) and vomited during night, dizzy this morning and was sick.  The patient's medical history and concomitant medication was not provided.  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of covid-19 infection.  On 11 Feb 2021 the patient was sick. On 14 Feb 2021 the patient vomited during night. On 15 eb 2021, this morning, the patient felt dizzy.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the events vomited, dizzy and sick were considered unknown.; Reporter's Comments: Based on the information provide which includes a strong temporal association, a causal association between the reported event and the administration of the mRNA-1273 vaccine cannot be excluded. Vomiting is  consistent with the known safety profile of vaccine and hence, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced TOOTH INFECTION (Tooth infection). At the time of the report, TOOTH INFECTION (Tooth infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.  No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Swelling
Clinical narrative: neck is swelling between the collar bone and going up her neck; Headache; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (neck is swelling between the collar bone and going up her neck), HEADACHE (Headache), PYREXIA (fever) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced SWELLING (neck is swelling between the collar bone and going up her neck), HEADACHE (Headache), PYREXIA (fever) and FATIGUE (tired). At the time of the report, SWELLING (neck is swelling between the collar bone and going up her neck), HEADACHE (Headache), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Headache, Insomnia
Clinical narrative: Couldn't sleep; Burning up; Fever; Chills; Muscle pain; Headache; In so much pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), BURNING SENSATION (Burning up), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), BURNING SENSATION (Burning up), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PAIN (In so much pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldn't sleep), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PAIN (In so much pain) and FATIGUE (Fatigue) had not resolved and BURNING SENSATION (Burning up) outcome was unknown.            No concomitant medications were reported.  Treatment medication also included cold compress.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Couldn't sleep; Burning up; Fever; Chills; Muscle pain; Headache; In so much pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), BURNING SENSATION (Burning up), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), BURNING SENSATION (Burning up), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PAIN (In so much pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldn't sleep), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PAIN (In so much pain) and FATIGUE (Fatigue) had not resolved and BURNING SENSATION (Burning up) outcome was unknown.            No concomitant medications were reported.  Treatment medication also included cold compress.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives on trunk; Itching everywhere; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives on trunk) and PRURITUS (Itching everywhere) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Mild Hypertension) since 2015, Anxiety (Mild Anxiety) since 2015, Arthritis since 2000 and Drug allergy (Sulfa drugs). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, DICLOFENAC for Arthritis, ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol, AMLODIPINE and HYDROCHLOORTHIAZIDE for Hypertension, VITAMIN D3 and BIOTIN for an unknown indication.    On 03-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced URTICARIA (hives on trunk) and PRURITUS (Itching everywhere). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 17-Feb-2021, URTICARIA (hives on trunk) and PRURITUS (Itching everywhere) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-072157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2021: Follow up received on 04-Feb-2021 included patient's height and weight, other medical history and event start date and stop dates.; Reporter's Comments: Based on reporter's causality and onset of urticaria 2 weeks after the dose the event is assessed as unlikely related to mRNA-1273.