chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Injection site inflammation, Pain, Pruritus
Clinical narrative: Itching all night long; it's red; It has Lumps; It's Itchy and i was not able to sleep because of itching; not able to sleep because of itching; It's red; Hard Lumps; Sometimes hurts; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It's red), INFLAMMATION (Hard Lumps), PAIN (Sometimes hurts), PRURITUS (Itching all night long) and ERYTHEMA (it's red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-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 ERYTHEMA (It's red), INFLAMMATION (Hard Lumps) and PAIN (Sometimes hurts). On 20-Jan-2021, the patient experienced PRURITUS (Itching all night long), ERYTHEMA (it's red), INJECTION SITE INFLAMMATION (It has Lumps), PRURITUS (It's Itchy and i was not able to sleep because of itching) and SLEEP DISORDER (not able to sleep because of itching). At the time of the report, ERYTHEMA (It's red), INFLAMMATION (Hard Lumps) and PAIN (Sometimes hurts) had resolved with sequelae and PRURITUS (Itching all night long), ERYTHEMA (it's red), INJECTION SITE INFLAMMATION (It has Lumps), PRURITUS (It's Itchy and i was not able to sleep because of itching) and SLEEP DISORDER (not able to sleep because of itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment medications were reported
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Itching all night long; it's red; It has Lumps; It's Itchy and i was not able to sleep because of itching; not able to sleep because of itching; It's red; Hard Lumps; Sometimes hurts; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It's red), INFLAMMATION (Hard Lumps), PAIN (Sometimes hurts), PRURITUS (Itching all night long) and ERYTHEMA (it's red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-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 ERYTHEMA (It's red), INFLAMMATION (Hard Lumps) and PAIN (Sometimes hurts). On 20-Jan-2021, the patient experienced PRURITUS (Itching all night long), ERYTHEMA (it's red), INJECTION SITE INFLAMMATION (It has Lumps), PRURITUS (It's Itchy and i was not able to sleep because of itching) and SLEEP DISORDER (not able to sleep because of itching). At the time of the report, ERYTHEMA (It's red), INFLAMMATION (Hard Lumps) and PAIN (Sometimes hurts) had resolved with sequelae and PRURITUS (Itching all night long), ERYTHEMA (it's red), INJECTION SITE INFLAMMATION (It has Lumps), PRURITUS (It's Itchy and i was not able to sleep because of itching) and SLEEP DISORDER (not able to sleep because of itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Itchy; A little warm at the touch; Rash at the injection site; Swelling; Pain in the arm on the first day; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm on the first day), PRURITUS (Itchy), VACCINATION SITE WARMTH (A little warm at the touch), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm on the first day). On 20-Jan-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE WARMTH (A little warm at the touch), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling). At the time of the report, PAIN IN EXTREMITY (Pain in the arm on the first day), PRURITUS (Itchy), VACCINATION SITE WARMTH (A little warm at the touch), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported Patient reported taking unknown medication to treat her symptoms
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness- intermittent; injection site pruritius; Swollen, like a mosquito bite - intermittent; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness- intermittent), VACCINATION SITE PRURITUS (injection site pruritius) and VACCINATION SITE SWELLING (Swollen, like a mosquito bite - intermittent) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021 at 4:00 AM, the patient experienced ERYTHEMA (redness- intermittent), VACCINATION SITE PRURITUS (injection site pruritius) and VACCINATION SITE SWELLING (Swollen, like a mosquito bite - intermittent). At the time of the report, ERYTHEMA (redness- intermittent), VACCINATION SITE PRURITUS (injection site pruritius) and VACCINATION SITE SWELLING (Swollen, like a mosquito bite - intermittent) 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.   Patient reported all symptoms appear to be intermittent in frequency No concomitant medications were reported No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) 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: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: PCR Covid test, results cam back positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (PCR Covid test, results cam back positive) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COVID-19 (PCR Covid test, results cam back positive). At the time of the report, COVID-19 (PCR Covid test, results cam back positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: confusion; fever of 104; injection site still sore; headache; body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (confusion), VACCINATION SITE PAIN (injection site still sore), HEADACHE (headache) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: BACTRIM (He was on Bactrim prior to the vaccine.He has been on Bactrim for two and a half days.). Concurrent medical conditions included Allergy (Allergic to Bactrim medication.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CONFUSIONAL STATE (confusion), VACCINATION SITE PAIN (injection site still sore), HEADACHE (headache) and MYALGIA (body aches). On 22-Jan-2021, CONFUSIONAL STATE (confusion), VACCINATION SITE PAIN (injection site still sore), HEADACHE (headache) and MYALGIA (body aches) 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.   Treatment information included discontinuing Bactrim.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: inflammation at injection site; rash at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (inflammation at injection site), INJECTION SITE RASH (rash at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE INFLAMMATION (inflammation at injection site), INJECTION SITE RASH (rash at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). At the time of the report, INJECTION SITE INFLAMMATION (inflammation at injection site), INJECTION SITE RASH (rash at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) 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: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and NAUSEA (Nausea) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included taking fluids.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Amoxicillin.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain, Vomiting
Clinical narrative: Vomiting; nausea; Pain at injection (L); This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), NAUSEA (nausea) and VACCINATION SITE PAIN (Pain at injection (L)) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included MEPOLIZUMAB (NUCALA) from an unknown date to 11-Jan-2021 for Allergy, AMLODIPINE for Hypertension.    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 VACCINATION SITE PAIN (Pain at injection (L)). On 21-Jan-2021, the patient experienced VOMITING (Vomiting) and NAUSEA (nausea). On 21-Jan-2021, VACCINATION SITE PAIN (Pain at injection (L)) had resolved. At the time of the report, VOMITING (Vomiting) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included [ Amlodipine and Nucala Auto Injector]  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; Case reference number MOD-2021-012188 is a spontaneous case report sent by a Non-Health Professional on 22-JAN-2021 .   On 20-JAN-2021,  the patient received Moderna COVID-19 Vaccine for COVID-19 vaccination and developed headache. Also patient Patient asked if is there a difference on the Moderna COVID-19 Vaccine in patients who are on a blood thinner  No concomitant medicines were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: injection site itching; injection site rash; A spontaneous report was received from a other Health Professional who was 71-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site rash and injection site itching.  The patient's medical history included were allergic to dust, cats and contrast dye from an unknown date. Product known to have been used by the patient, within two weeks prior to the event, included was levothyroxine from an unknown date for an unknown indication.  On 15 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L207) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 21 JAN 2021, the patient developer a rash and itching in the left deltoid- injection site. Treatment information was not provided.  The Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, injection site rash and injection site itching were considered as unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site pain
Clinical narrative: Covid-19; arm was sore; Case reference number MOD-2021-012197 is a spontaneous case report sent by a Non-Health Professional on 22-JAN-2021  , which refers to a Male aged 43 Years .  The patients has not reported about his past medical history .  On  04-JAN-2021, the patient was participating in the mRNA-1273 Emergency Use program at the hospital and developed  sore arm on the same day. After a couple of days. on 06-JAN-2021  the patient was exposed tp covid 19. And then on 11-Jan-2021 he received monoclonal antibodies to treat that.   No details of concomitant medicines were provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: fever; slept a lot the next day; A spontaneous report was received from a reporter (consumer )  concerning an unknown year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight reaction to the vaccine, fever and slept a lot next day.  The patient's medical history was not provided. The relevant concomitant medications were also not provided.  On Jan-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route of administration  for prophylaxis of COVID-19 infection.   On Jan-2021, the patient experienced  slight reaction to the vaccine, fever and slept a lot next day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   the outcome of the event was unknown .
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort
Clinical narrative: Sore arm; Headache; This spontaneous case was reported by a nurse and describes the occurrence of LIMB DISCOMFORT (Sore arm) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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) 1 dosage form. On 04-Feb-2021, the patient experienced LIMB DISCOMFORT (Sore arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, HEADACHE (Headache) had resolved. On 06-Feb-2021, LIMB DISCOMFORT (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-011917 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a nurse and describes the occurrence of LIMB DISCOMFORT (Sore arm) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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) 1 dosage form. On 04-Feb-2021, the patient experienced LIMB DISCOMFORT (Sore arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, HEADACHE (Headache) had resolved. On 06-Feb-2021, LIMB DISCOMFORT (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-011917 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011917:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: itchy hives on the injection arm; itchy hives on the injection arm; Redness on the injection arm/Redness reappeared; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy hives on the injection arm), VACCINATION SITE URTICARIA (itchy hives on the injection arm) and VACCINATION SITE ERYTHEMA (Redness on the injection arm/Redness reappeared) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy hives on the injection arm), VACCINATION SITE URTICARIA (itchy hives on the injection arm) and VACCINATION SITE ERYTHEMA (Redness on the injection arm/Redness reappeared). At the time of the report, VACCINATION SITE PRURITUS (itchy hives on the injection arm) and VACCINATION SITE URTICARIA (itchy hives on the injection arm) had resolved and VACCINATION SITE ERYTHEMA (Redness on the injection arm/Redness reappeared) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site warmth, Pruritus, Rash
Clinical narrative: egg sized raised bump; hot to the touch; mild rash; redness; itchiness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness) and VACCINATION SITE MASS (egg sized raised bump) in a 44-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.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 21-Jan-2021, the patient experienced RASH (mild rash), ERYTHEMA (redness) and PRURITUS (itchiness). On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch). At the time of the report, INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness), VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information included Corticoid cream. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness) and VACCINATION SITE MASS (egg sized raised bump) in a 44-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.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 21-Jan-2021, the patient experienced RASH (mild rash), ERYTHEMA (redness) and PRURITUS (itchiness). On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch). At the time of the report, INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness), VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information included Corticoid cream.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: egg sized raised bump; hot to the touch; mild rash; redness; itchiness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness) and VACCINATION SITE MASS (egg sized raised bump) in a 44-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.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 21-Jan-2021, the patient experienced RASH (mild rash), ERYTHEMA (redness) and PRURITUS (itchiness). On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch). At the time of the report, INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness), VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information included Corticoid cream. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness) and VACCINATION SITE MASS (egg sized raised bump) in a 44-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.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 21-Jan-2021, the patient experienced RASH (mild rash), ERYTHEMA (redness) and PRURITUS (itchiness). On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch). At the time of the report, INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness), VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information included Corticoid cream.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Cardiac stress test, Carditis, Dyspnoea, Echocardiogram
Clinical narrative: Heart inflammation  Heart Flutter Rapid Heart rate Shortness of breath
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart inflammation  Heart Flutter Rapid Heart rate Shortness of breath
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dry mouth, Headache, Influenza like illness
Clinical narrative: dry mouth; drinking a lot of water; achy; headache; flu like symptoms; felt sick in stomach; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.     On 11-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 MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea). On 21-Jan-2021, the patient experienced DRY MOUTH (dry mouth) and THIRST (drinking a lot of water). At the time of the report, MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach), DIARRHOEA (diarrhea), DRY MOUTH (dry mouth) and THIRST (drinking a lot of water) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication report was not provided.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.     On 11-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 MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea). On 21-Jan-2021, the patient experienced DRY MOUTH (dry mouth) and THIRST (drinking a lot of water). At the time of the report, MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach), DIARRHOEA (diarrhea), DRY MOUTH (dry mouth) and THIRST (drinking a lot of water) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication report was not provided.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Thirst
Clinical narrative: dry mouth; drinking a lot of water; achy; headache; flu like symptoms; felt sick in stomach; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.     On 11-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 MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea). On 21-Jan-2021, the patient experienced DRY MOUTH (dry mouth) and THIRST (drinking a lot of water). At the time of the report, MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach), DIARRHOEA (diarrhea), DRY MOUTH (dry mouth) and THIRST (drinking a lot of water) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication report was not provided.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.     On 11-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 MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea). On 21-Jan-2021, the patient experienced DRY MOUTH (dry mouth) and THIRST (drinking a lot of water). At the time of the report, MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach), DIARRHOEA (diarrhea), DRY MOUTH (dry mouth) and THIRST (drinking a lot of water) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication report was not provided.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: body ache; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  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 an unknown date, the patient experienced MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Reporter contact information was updated.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness; a little fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient shared that he had COVID last November) in November 2020, Hypertension since an unknown date and Cholesterol since an unknown date. Concomitant products included ATORVASTATIN for Cholesterol, LOSARTAN for Hypertension.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue). On 05-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient shared that he had COVID last November) in November 2020, Hypertension since an unknown date and Cholesterol since an unknown date. Concomitant products included ATORVASTATIN for Cholesterol, LOSARTAN for Hypertension.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue). On 05-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain
Clinical narrative: redness came out it's like a map.; arm redness, a bit sore and muscle pain..; arm redness, a bit sore and muscle pain..; arm redness, a bit sore and muscle pain..; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (arm redness, a bit sore and muscle pain..), PAIN (arm redness, a bit sore and muscle pain..), MYALGIA (arm redness, a bit sore and muscle pain..) and ERYTHEMA (redness came out it's like a map.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history information was reported.     On 28-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 ERYTHEMA (arm redness, a bit sore and muscle pain..), PAIN (arm redness, a bit sore and muscle pain..) and MYALGIA (arm redness, a bit sore and muscle pain..). On an unknown date, the patient experienced ERYTHEMA (redness came out it's like a map.). At the time of the report, ERYTHEMA (arm redness, a bit sore and muscle pain.), PAIN (arm redness, a bit sore and muscle pain.) and MYALGIA (arm redness, a bit sore and muscle pain.) had resolved and ERYTHEMA (redness came out it's like a map.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (arm redness, a bit sore and muscle pain..), PAIN (arm redness, a bit sore and muscle pain..), MYALGIA (arm redness, a bit sore and muscle pain..) and ERYTHEMA (redness came out it's like a map.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history information was reported.     On 28-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 ERYTHEMA (arm redness, a bit sore and muscle pain..), PAIN (arm redness, a bit sore and muscle pain..) and MYALGIA (arm redness, a bit sore and muscle pain..). On an unknown date, the patient experienced ERYTHEMA (redness came out it's like a map.). At the time of the report, ERYTHEMA (arm redness, a bit sore and muscle pain.), PAIN (arm redness, a bit sore and muscle pain.) and MYALGIA (arm redness, a bit sore and muscle pain.) had resolved and ERYTHEMA (redness came out it's like a map.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Vaccination site pain, Vaccination site rash
Clinical narrative: rash on my upper left arm where I received the vaccine.; fatigued; vaccinated arm sore; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, 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 RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching). At the time of the report, VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, 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 RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching). At the time of the report, VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: very red splotch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (very red splotch at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A.) for COVID-19 immunization.     NO medical history information was reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (very red splotch at injection site). At the time of the report, INJECTION SITE ERYTHEMA (very red splotch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (very red splotch at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A.) for COVID-19 immunization.     NO medical history information was reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (very red splotch at injection site). At the time of the report, INJECTION SITE ERYTHEMA (very red splotch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.