chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: altered taste; diarrhea; bad smelling farts; extremely tired; chills; joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (diarrhea), FLATULENCE (bad smelling farts), TASTE DISORDER (altered taste), FATIGUE (extremely tired) and CHILLS (chills) in a 43-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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 13-Jan-2021, the patient experienced ARTHRALGIA (joint pain). On 14-Jan-2021, the patient experienced FATIGUE (extremely tired) and CHILLS (chills). On 15-Jan-2021, the patient experienced DIARRHOEA (diarrhea) and FLATULENCE (bad smelling farts). On 17-Jan-2021, the patient experienced TASTE DISORDER (altered taste). At the time of the report, DIARRHOEA (diarrhea), FLATULENCE (bad smelling farts) and TASTE DISORDER (altered taste) outcome was unknown and FATIGUE (extremely tired), CHILLS (chills) and ARTHRALGIA (joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin lesion
Clinical narrative: Red raised lesion on the injection site; Lesion is itchy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Red raised lesion on the injection site) and PRURITUS (Lesion is itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced SKIN LESION (Red raised lesion on the injection site) and PRURITUS (Lesion is itchy). At the time of the report, SKIN LESION (Red raised lesion on the injection site) and PRURITUS (Lesion is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included alcohol application on the lesion.  No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood potassium, Chills, Headache, Pyrexia
Clinical narrative: Vomiting; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Dialysis (Patient has to regularly do dialysis.). Concurrent medical conditions included Blood pressure, High cholesterol and Potassium high.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol increased: High. On an unknown date, Blood potassium: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications for blood pressure, high cholesterol and high potassium was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Dialysis (Patient has to regularly do dialysis.). Concurrent medical conditions included Blood pressure, High cholesterol and Potassium high.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol increased: High. On an unknown date, Blood potassium: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications for blood pressure, high cholesterol and high potassium was reported.; 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site irritation
Clinical narrative: it was irritated where I got the shot; red 2" long x 1" across; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (it was irritated where I got the shot) and VACCINATION SITE ERYTHEMA (red 2" long x 1" across) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 10-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 IRRITATION (it was irritated where I got the shot) and VACCINATION SITE ERYTHEMA (red 2" long x 1" across). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE IRRITATION (it was irritated where I got the shot) and VACCINATION SITE ERYTHEMA (red 2" long x 1" across) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cold pack.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: started to become red again; injection had site reaction, a little itchy; grew to size half dollar, swollen; warm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (injection had site reaction, a little itchy), VACCINATION SITE SWELLING (grew to size half dollar, swollen), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (started to become red again) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LL20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-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 VACCINATION SITE PRURITUS (injection had site reaction, a little itchy), VACCINATION SITE SWELLING (grew to size half dollar, swollen) and VACCINATION SITE WARMTH (warm). On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (started to become red again). At the time of the report, VACCINATION SITE PRURITUS (injection had site reaction, a little itchy), VACCINATION SITE SWELLING (grew to size half dollar, swollen), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (started to become red again) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs provided. No treatment.
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraines). At the time of the report, MIGRAINE (Migraines) outcome was unknown.            No concomitant drugs are provided. No treatment.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Diarrhoea, Fatigue, Hypoaesthesia
Clinical narrative: having some adverse reactions; numbness and tingling in arm; tingling in arm; fever 102.3; chills; fatigue; myalgia; nausea; vomiting; diarrhea; A spontaneous report was received from a nurse concerning Unknown patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  experienced sme adverse reactions.   The patient's medical history, is npt provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 19JAN2021.The patient received their first of two planned doses of mRNA-1273 in(Lot number: Unknown) for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events were unknown.   The reporter did not provide an assessment for the events.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: having some adverse reactions; numbness and tingling in arm; tingling in arm; fever 102.3; chills; fatigue; myalgia; nausea; vomiting; diarrhea; A spontaneous report was received from a nurse concerning Unknown patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  experienced sme adverse reactions.   The patient's medical history, is npt provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 19JAN2021.The patient received their first of two planned doses of mRNA-1273 in(Lot number: Unknown) for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events were unknown.   The reporter did not provide an assessment for the events.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Myalgia
Clinical narrative: tested positive for covid-19; headache; muscle ache; fatigue; A spontaneous report was received from a (HCP) concerning a  Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 16JAN2021, The patient experienced the events list An Orthopedic surgeon calls and states his parents got the Moderna Covid-19 vaccine on 09JAN2021, started having symptoms of coivd ( Headache, muscle ache, fatigue) on 16JAN2021 and tested positive for covid on 18JAN2021. They are both scheduled to get an antibody infusion on 23JAN2021. He wants to know if they should still get the second dose of the vaccine. if they don't, what do they do Consent for safety to follow-up was received and also to have this call documented. Action taken with mRNA-1273 in response to the events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Soreness; Round area of redness in arm; Itchy; round hard area; A spontaneous report was received from a (Consumer) concerning a  77 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 11/Jan/2021, The patient experienced the events list (verbatims).  Warm Transferred from Moderna Customer Care-Case Number:00031631 She experienced soreness/tenderness, round area of redness, hard, itchy in her arm after receiving vaccine on 11JAN2021. Received it in left arm. Medical history includes allergic to PCN and Bactrim. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Limb discomfort, Myalgia
Clinical narrative: soreness on arm; chills; feeling tired; joint pain; arm hurting; A spontaneous report was received from a consumer concerning a 68 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myalgia, chills, fatigue, arthralgia and limb discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient was diagnosed with COVID-19 in June 2020. On 20 JAN 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 JAN 2021, The patient said that his arm was hurting, had soreness on arm, had chills, (no chills since that noon) was feeling tired, had slight joint pain.  No laboratory details were provided.  Patient took Tylenol one in the morning and the other in the evening to relieve the symptoms.   Action taken with mRNA-1273 in response to the events was not reported.   On 21 JAN 2021, the outcome of the event Chills was resolved. At the time of this report, the outcome of the events like myalgia, fatigue, arthralgia and limb discomfort was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness; A spontaneous report was received from a consumer concerning a 72 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event vaccination site pain.  ~ The patient's medical history was not provided. No relevant concomitant medications were reported.   On Date 19-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) in the left for prophylaxis of COVID-19 infection.   On date 19-Jan-2021, the patient experienced the event Soreness at the injection site which stopped on 22-Jan-2021.   Laboratory details was not provided.   No treatment information was none.   Action taken with mRNA-1273 in response to the events was not reported.   On date 22-Jan-2021, the outcome of the event soreness at the injection site was resolved/ recovered.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hard; a swelling in her arm; warm; bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (hard) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concomitant products included PRAVASTATIN and VITAMINS NOS 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 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE WARMTH (warm) and VACCINATION SITE MASS (bump). On 22-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard). On 21-Jan-2021, VACCINATION SITE WARMTH (warm) had resolved. At the time of the report, VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (hard) had not resolved.        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 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 VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (hard) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concomitant products included PRAVASTATIN and VITAMINS NOS 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 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE WARMTH (warm) and VACCINATION SITE MASS (bump). On 22-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard). On 21-Jan-2021, VACCINATION SITE WARMTH (warm) had resolved. At the time of the report, VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (hard) had not resolved.        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: U
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: pain; inflammation; swelling; bruising; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising). At the time of the report, INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising). At the time of the report, INJECTION SITE PAIN (pain), INJECTION SITE INFLAMMATION (inflammation), INJECTION SITE SWELLING (swelling) and INJECTION SITE BRUISING (bruising) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site warmth, Limb discomfort
Clinical narrative: Arm is a little warm; Allergic reaction; Injection site redness; hot; Arm was sore the first few days after the infjection; painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), LIMB DISCOMFORT (Arm was sore the first few days after the infjection), SKIN WARM (Arm is a little warm), INJECTION SITE PAIN (painful) and INJECTION SITE ERYTHEMA (Injection site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product LEVOTHYROXINE for Hypothyroidism.    Concurrent medical conditions included Hypothyroidism and Allergy to arthropod sting (Allergic to bee sting.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE (unknown route) dosage form. On 08-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm was sore the first few days after the infjection) and INJECTION SITE PAIN (painful). On 15-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE WARMTH (hot). On 22-Jan-2021, the patient experienced SKIN WARM (Arm is a little warm). At the time of the report, HYPERSENSITIVITY (Allergic reaction), SKIN WARM (Arm is a little warm), INJECTION SITE PAIN (painful), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE WARMTH (hot) outcome was unknown and LIMB DISCOMFORT (Arm was sore the first few days after the infjection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin warm
Clinical narrative: Arm is a little warm; Allergic reaction; Injection site redness; hot; Arm was sore the first few days after the infjection; painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), LIMB DISCOMFORT (Arm was sore the first few days after the infjection), SKIN WARM (Arm is a little warm), INJECTION SITE PAIN (painful) and INJECTION SITE ERYTHEMA (Injection site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product LEVOTHYROXINE for Hypothyroidism.    Concurrent medical conditions included Hypothyroidism and Allergy to arthropod sting (Allergic to bee sting.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE (unknown route) dosage form. On 08-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm was sore the first few days after the infjection) and INJECTION SITE PAIN (painful). On 15-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE WARMTH (hot). On 22-Jan-2021, the patient experienced SKIN WARM (Arm is a little warm). At the time of the report, HYPERSENSITIVITY (Allergic reaction), SKIN WARM (Arm is a little warm), INJECTION SITE PAIN (painful), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE WARMTH (hot) outcome was unknown and LIMB DISCOMFORT (Arm was sore the first few days after the infjection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site rash
Clinical narrative: horrible rash at the injection site; looked like she was burned; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (horrible rash at the injection site) and INJECTION SITE PAIN (looked like she was burned) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (horrible rash at the injection site) and INJECTION SITE PAIN (looked like she was burned). At the time of the report, VACCINATION SITE RASH (horrible rash at the injection site) and INJECTION SITE PAIN (looked like she was burned) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: arm sore; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm sore) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm sore). At the time of the report, LIMB DISCOMFORT (arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided.  Treatment actions was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on my face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my face) 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 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 RASH (rash on my face). At the time of the report, RASH (rash on my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The relevant concomitant medications were also not provided.  No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (injection site hurt), vaccination site pruritus (site started to itch) and vaccination site erythema (it was red (1.5")) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025J202A) for COVID-19 immunization. No medical history reported. On Jan 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 10, 2021, patient experienced vaccination site pain (injection site hurt). On Jan 13, 2021, patient experienced vaccination site pruritus (site started to itch) and vaccination site erythema (it was red (1.5")). The patient treated with Advil (ibuprofen) on Jan 11, 2021 for vaccination site pain, at an unspecified dose and frequency. On Jan 11, 2021, vaccination site pain (injection site hurt) resolved. On Jan 15, 2021, vaccination site pruritus (site started to itch) and vaccination site erythema (it was red (1.5")) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications not provided.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Injection site swelling, Injection site warmth
Clinical narrative: warmness to the touch; cough; swelling at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warmness to the touch), COUGH (cough), INJECTION SITE SWELLING (swelling at the injection site) and 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INJECTION SITE WARMTH (warmness to the touch), COUGH (cough), INJECTION SITE SWELLING (swelling at the injection site) and HEADACHE (headache). On 19-Jan-2021, COUGH (cough) and HEADACHE (headache) had resolved. At the time of the report, INJECTION SITE WARMTH (warmness to the touch) and INJECTION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Mild headache). At the time of the report, HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye swelling, Nausea
Clinical narrative: Dizziness; Left eye swelling; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), EYE SWELLING (Left eye swelling) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010W20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Dizziness), EYE SWELLING (Left eye swelling) and NAUSEA (nausea). At the time of the report, DIZZINESS (Dizziness) had resolved and EYE SWELLING (Left eye swelling) and NAUSEA (nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication included Tylenol. No concomitant medications were provided by reporter.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: rash, hardness and swollen and it was warm at the touch at the injection site; rash, hardness and swollen and it was warm at the touch at the injection site; rash, hardness and swollen and it was warm at the touch at the injection site; rash, hardness and swollen and it was warm at the touch at the injection site; rash, hardness and swollen and it was warm at the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash, hardness and swollen and it was warm at the touch at the injection site), VACCINATION SITE ERYTHEMA (rash, hardness and swollen and it was warm at the touch at the injection site), VACCINATION SITE SWELLING (rash, hardness and swollen and it was warm at the touch at the injection site), VACCINATION SITE INDURATION (rash, hardness and swollen and it was warm at the touch at the injection site) and VACCINATION SITE WARMTH (rash, hardness and swollen and it was warm at the touch at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8077727399) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included Medicine for blood pressure (ANTIHYPERTENSIVES) for Hypertension.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash, hardness and swollen and it was warm at the touch at the injection site), VACCINATION SITE ERYTHEMA (rash, hardness and swollen and it was warm at the touch at the injection site), VACCINATION SITE SWELLING (rash, hardness and swollen and it was warm at the touch at the injection site), VACCINATION SITE INDURATION (rash, hardness and swollen and it was warm at the touch at the injection site) and VACCINATION SITE WARMTH (rash, hardness and swollen and it was warm at the touch at the injection site). At the time of the report, VACCINATION SITE RASH (rash, hardness and swollen and it was warm at the touch at the injection site), VACCINATION SITE ERYTHEMA (rash, hardness and swollen and it was warm at the touch at the injection site), VACCINATION SITE INDURATION (rash, hardness and swollen and it was warm at the touch at the injection site) and VACCINATION SITE WARMTH (rash, hardness and swollen and it was warm at the touch at the injection site) outcome was unknown and VACCINATION SITE SWELLING (rash, hardness and swollen and it was warm at the touch at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Paraesthesia, Vaccination site pain
Clinical narrative: Soreness at injection site; Stiff neck; Shoulder soreness; Tingling sensation; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site), MUSCULOSKELETAL STIFFNESS (Stiff neck), ARTHRALGIA (Shoulder soreness) and PARAESTHESIA (Tingling sensation) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site), MUSCULOSKELETAL STIFFNESS (Stiff neck), ARTHRALGIA (Shoulder soreness) and PARAESTHESIA (Tingling sensation). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site), MUSCULOSKELETAL STIFFNESS (Stiff neck), ARTHRALGIA (Shoulder soreness) and PARAESTHESIA (Tingling sensation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication  provided was ibuprofen OTC . No concomitant medications were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: headache; body aches; she has chills; she can´t get up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (body aches), CHILLS (she has chills) and FATIGUE (she can´t get up) 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, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), PAIN (body aches), CHILLS (she has chills) and FATIGUE (she can´t get up). At the time of the report, HEADACHE (headache), PAIN (body aches), CHILLS (she has chills) and FATIGUE (she can´t get up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information and concomitant medications were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Itch in the injection site; A spontaneous report was received from a consumer concerning an 87-years-old, female patient who experienced itch in the injection site.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient experienced itchiness around the injection site after vaccination. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event itch in the injection site was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot, red rash; Hot, red rash; Swelling; A spontaneous report was received on 26-Jan-2021 from a non healthcare professional concerning a 52 years old female patient who received Moderna's COVID-19(mRNA-1273) vaccine and experienced hot, red rash, swelling.  The Patient medical history was  not provided. No concomitant medications was reported.  On 14-Jan-2021, 9 days prior to the onset of events, patient received her first dose  of mRNA-1273(Batch:012L20A) intramuscularly on her left arm for the prophylaxis of covid-19 infection.  On 22-Jan-2021, patient experienced hot, red rash, swelling.  No laboratory information was provided.   Treatment information includes benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were recovering/resolving.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: feeling weak; dizziness; diarrhea; heart rate raising; site of injection tiny warm; feeling sick since friday; Redness; fever; chills; fatigue; light headache; nausea; This spontaneous report was received from consumer on 25-JAN-2021, concerning a 58 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced redness, fever, chills, fatigue, diarrhea, headache, nausea, dizziness, heart rate raising, feeling sick, weak , site of injection tiny warm  The patient's medical history was provided she has asthma and Concomitant  medication was  albuterol hfa, spironolactone, losartan,   Carvedilol, benzonatate , fluoxetine           The patient received suspect product  mRNA-1273 on 21/Jan/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:unknown) expiry  intramuscularly on the left arm for prophylaxis of COVID-19 infection  the patient received the first shot of the Moderna vaccine. She has done the antibody test and the results are that she has antibodies against COVID-19. Action taken with the second dose of mRNA-1273  in response to the event was not reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Illness, Nausea, Pyrexia
Clinical narrative: feeling weak; dizziness; diarrhea; heart rate raising; site of injection tiny warm; feeling sick since friday; Redness; fever; chills; fatigue; light headache; nausea; This spontaneous report was received from consumer on 25-JAN-2021, concerning a 58 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced redness, fever, chills, fatigue, diarrhea, headache, nausea, dizziness, heart rate raising, feeling sick, weak , site of injection tiny warm  The patient's medical history was provided she has asthma and Concomitant  medication was  albuterol hfa, spironolactone, losartan,   Carvedilol, benzonatate , fluoxetine           The patient received suspect product  mRNA-1273 on 21/Jan/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:unknown) expiry  intramuscularly on the left arm for prophylaxis of COVID-19 infection  the patient received the first shot of the Moderna vaccine. She has done the antibody test and the results are that she has antibodies against COVID-19. Action taken with the second dose of mRNA-1273  in response to the event was not reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: feeling weak; dizziness; diarrhea; heart rate raising; site of injection tiny warm; feeling sick since friday; Redness; fever; chills; fatigue; light headache; nausea; This spontaneous report was received from consumer on 25-JAN-2021, concerning a 58 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced redness, fever, chills, fatigue, diarrhea, headache, nausea, dizziness, heart rate raising, feeling sick, weak , site of injection tiny warm  The patient's medical history was provided she has asthma and Concomitant  medication was  albuterol hfa, spironolactone, losartan,   Carvedilol, benzonatate , fluoxetine           The patient received suspect product  mRNA-1273 on 21/Jan/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:unknown) expiry  intramuscularly on the left arm for prophylaxis of COVID-19 infection  the patient received the first shot of the Moderna vaccine. She has done the antibody test and the results are that she has antibodies against COVID-19. Action taken with the second dose of mRNA-1273  in response to the event was not reported
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: severe muscle pain; very bad headache; A spontaneous case report received from a consumer concerning a 82 years old, female patient  received the 2nd Dose of the Moderna Vaccine Patient on 4th of Feb 2021. The patient is now experiencing Myalgia aggravated, and Headache. Patient received the injection in the Right Dominant arm.  What medication can she take to treat symptoms?  Is this normal to experience these symptoms?  Report Source- Other,  Age- 82 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- severe muscle pain - Unknown,very bad headache - Unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash
Clinical narrative: Little lumps at site of injection; It is also red; site on injection has rash; itchiness at the site of injection; This spontaneous report was received from consumer on 25-JAN-2021, concerning a 58 year old male patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced some itchiness at the site of injection, the site on injection has rash and little lumps and it is also red. The patient's medical history was not provided and Concomitant  medication was not provided. The patient received suspect product  mRNA-1273 on 17/Jan/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:026L20A)  intramuscularly  for prophylaxis of COVID-19 infection  Patient stated that she received her 1st dose of the Moderna COVID 19 on Jan. 17, 2020 through the local department of health. On Jan 24, she started experiencing some itchiness at the site of injection. Today Jan. 25, the site on injection has rash and little lumps and it is also red. She called her healthcare provider and she was told it is expected. She has not taken anything to alleviate the symptoms. Action taken with the second dose of mRNA-1273  in response to the event was not reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site urticaria
Clinical narrative: it stopped and broke out again; red wheals broke out 3 inches below the injection site; A spontaneous report was received from a healthcare professional concerning a female patient of 76 years of age who was  his wife ,administered with Moderna's covid-19 vaccine and experienced red wheals broke out 3 inches below the injection site.  Patient's medical history was not provided.Concomitant medication included Pravastatin.  On 13-JAN-2021,prior to the onset of events,the patient received their first of two planned doses of mRNA-1273(Lot number:028L20A) for prophylaxis of covid-19 infection.  On 13-JAN-2021,the patient received Moderna's covid-19 vaccine on the left arm.Next day red wheals broke out 3 inches below the injection site.Then it stopped and broke out again on 22-JAN-2021  in the same place.Treatment  for the event included Benadryl.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events were unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the arm; A spontaneous report was received on 25-Jan-2021 from a consumer concerning a 70 years old female patient who received Moderna's COVID-19(mRNA-1273) vaccine and experienced pain on the arm .  The Patient medical history includes arthritic pain. No concomitant medications was reported.  On 19-Jan-2021, one day prior to the onset of events, patient received her first dose of mRNA-1273(Batch:029K20A) intramuscularly for the prophylaxis of covid-19 infection.  On 20-Jan-2021, patient experienced pain on the arm.  No laboratory information was provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was recovering/resolving.