chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Right upper arm where she received the vaccine was red; Right upper arm where she received the vaccine was swollen and puffy; Muscle aching; Right upper arm where she received the vaccine began to itch; Cramping in her feet and back of thighs; Mild soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping in her feet and back of thighs), PAIN (Mild soreness), VACCINATION SITE PRURITUS (Right upper arm where she received the vaccine began to itch), VACCINATION SITE ERYTHEMA (Right upper arm where she received the vaccine was red) and VACCINATION SITE SWELLING (Right upper arm where she received the vaccine was swollen and puffy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN (Mild soreness). On 05-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping in her feet and back of thighs). On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Right upper arm where she received the vaccine began to itch) and MYALGIA (Muscle aching). On 10-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Right upper arm where she received the vaccine was red) and VACCINATION SITE SWELLING (Right upper arm where she received the vaccine was swollen and puffy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 10-Jan-2021 at an unspecified dose and frequency. On 11-Jan-2021, MUSCLE SPASMS (Cramping in her feet and back of thighs) and PAIN (Mild soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Right upper arm where she received the vaccine began to itch), VACCINATION SITE ERYTHEMA (Right upper arm where she received the vaccine was red) and VACCINATION SITE SWELLING (Right upper arm where she received the vaccine was swollen and puffy) was resolving and MYALGIA (Muscle aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: No new information, denied further follow-up; Reporter'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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Right upper arm where she received the vaccine was red; Right upper arm where she received the vaccine was swollen and puffy; Muscle aching; Right upper arm where she received the vaccine began to itch; Cramping in her feet and back of thighs; Mild soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping in her feet and back of thighs), PAIN (Mild soreness), VACCINATION SITE PRURITUS (Right upper arm where she received the vaccine began to itch), VACCINATION SITE ERYTHEMA (Right upper arm where she received the vaccine was red) and VACCINATION SITE SWELLING (Right upper arm where she received the vaccine was swollen and puffy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN (Mild soreness). On 05-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping in her feet and back of thighs). On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Right upper arm where she received the vaccine began to itch) and MYALGIA (Muscle aching). On 10-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Right upper arm where she received the vaccine was red) and VACCINATION SITE SWELLING (Right upper arm where she received the vaccine was swollen and puffy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 10-Jan-2021 at an unspecified dose and frequency. On 11-Jan-2021, MUSCLE SPASMS (Cramping in her feet and back of thighs) and PAIN (Mild soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Right upper arm where she received the vaccine began to itch), VACCINATION SITE ERYTHEMA (Right upper arm where she received the vaccine was red) and VACCINATION SITE SWELLING (Right upper arm where she received the vaccine was swollen and puffy) was resolving and MYALGIA (Muscle aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: No new information, denied further follow-up; Reporter'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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: my arm got really itchy/Around injection site, it looks inflamed and it's super itchy; developed a big round red area about a 2inch in diameter around the injection site/red spot looks like cellulitis; Arm was sore/arm was mildy tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (my arm got really itchy/Around injection site, it looks inflamed and it's super itchy), VACCINATION SITE ERYTHEMA (developed a big round red area about a 2inch in diameter around the injection site/red spot looks like cellulitis) and VACCINATION SITE PAIN (Arm was sore/arm was mildy tender) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore/arm was mildy tender). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (my arm got really itchy/Around injection site, it looks inflamed and it's super itchy) and VACCINATION SITE ERYTHEMA (developed a big round red area about a 2inch in diameter around the injection site/red spot looks like cellulitis). At the time of the report, VACCINATION SITE PRURITUS (my arm got really itchy/Around injection site, it looks inflamed and it's super itchy), VACCINATION SITE ERYTHEMA (developed a big round red area about a 2inch in diameter around the injection site/red spot looks like cellulitis) and VACCINATION SITE PAIN (Arm was sore/arm was mildy tender) 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. Treatment medication included famotidine (pepcid).; 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria, Vaccination site vesicles, Vaccination site warmth
Clinical narrative: Itchiness at the injection site; welts at injection site; Red at the injection site; Bump at the injection site; Hot at injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE VESICLES (Bump at the injection site), VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE URTICARIA (welts at injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE VESICLES (Bump at the injection site), VACCINATION SITE WARMTH (Hot at injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE URTICARIA (welts at injection site). At the time of the report, VACCINATION SITE VESICLES (Bump at the injection site), VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE URTICARIA (welts at injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Reporter's Comments: This case concerns a 59-year-old female with a nonserious unexpected event of vaccination site vesicles, vaccination site warmth, and nonserious expected vaccination site urticaria, vaccination site pruritus, vaccination site erythema. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Mild pain; Axillar swelling (started 19 days ago) and residual swelling; A spontaneous report was received from physician concerning a 47 years old male patient who developed mild pain and  tenderness (Pain) , an adenopathy( Adenopathy), and axillary swelling (Swelling) 19 days after receiving Moderna vaccine mRNA-1273..   The patient's medical history included hypertension. Products known to have been used by the patient, within two weeks prior to the event, included Lisinopril and Vitamins.   The patient received his first of two planned doses of mRNA-1273 (Batch number: 011J2018 ) on 25 Dec 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 25 Dec 2020 the patient experienced axillary swelling which continues to the date of the report, pain and tenderness, and adenopathy The event adenopathy was assessed as medically significant. Treatment for the event included Ibuprofen and Acetaminophen.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) axillar swelling (started 19 days ago) and residual swelling, tenderness, mild pain and an adenopathy were  unknown.; Reporter'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: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site discolouration, Vaccination site warmth
Clinical narrative: warm to touch; color is red turning yellow; inches wide pretty severe bruise; Arm soreness; A spontaneous report was received from a non-healthcare professional concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness, inches wide pretty severe bruise, warm to touch and color is red turning yellow.  No medical history was reported.  No concomitant medications was reported.    On 10-Jan-2021, prior to the onset of the events swelling of the arm/arm was swollen, arm was swollen under the injection site like a ball, arm was really itchy and arm was hot to the touch, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via an unknown route in left arm for prophylaxis of COVID-19 infection.  On 05-Jan-2021, the patient experienced arm soreness, and on 08-Jan-2021 experienced inches wide pretty severe bruise, warm to touch and on an unknown dare experienced warm to touch and color is red turning yellow. Laboratory details were not provided.  No treatment medication included.  Action taken with mRNA-1273 in response to the events arm soreness, inches wide pretty severe bruise, warm to touch and color is red turning yellow was not provided.  The outcome of the events swelling of the arm/arm was swollen, arm was swollen under the injection site like a ball, arm was really itchy and arm was hot to the touch was not provided.  The reporter did not provide the assessment of the events arm soreness, inches wide pretty severe bruise, warm to touch and color is red turning yellow to study drug.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site redness and warm to touch; area as oval shaped measuring approximately two inches out; area as oval shaped measuring approximately two inches out and around site as well as some itching; swelling and soreness at the injection site; Redness, swelling and soreness at the injection site; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site redness and warm to touch), VACCINATION SITE MASS (area as oval shaped measuring approximately two inches out), VACCINATION SITE PRURITUS (area as oval shaped measuring approximately two inches out and around site as well as some itching), VACCINATION SITE SWELLING (swelling and soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness, swelling and soreness at the injection site) in a 66-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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling and soreness at the injection site), VACCINATION SITE ERYTHEMA (Redness, swelling and soreness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site redness and warm to touch), VACCINATION SITE MASS (area as oval shaped measuring approximately two inches out) and VACCINATION SITE PRURITUS (area as oval shaped measuring approximately two inches out and around site as well as some itching). At the time of the report, VACCINATION SITE WARMTH (injection site redness and warm to touch), VACCINATION SITE MASS (area as oval shaped measuring approximately two inches out) and VACCINATION SITE PRURITUS (area as oval shaped measuring approximately two inches out and around site as well as some itching) outcome was unknown and VACCINATION SITE SWELLING (swelling and soreness at the injection site), VACCINATION SITE ERYTHEMA (Redness, swelling and soreness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site redness and warm to touch; area as oval shaped measuring approximately two inches out; area as oval shaped measuring approximately two inches out and around site as well as some itching; swelling and soreness at the injection site; Redness, swelling and soreness at the injection site; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site redness and warm to touch), VACCINATION SITE MASS (area as oval shaped measuring approximately two inches out), VACCINATION SITE PRURITUS (area as oval shaped measuring approximately two inches out and around site as well as some itching), VACCINATION SITE SWELLING (swelling and soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness, swelling and soreness at the injection site) in a 66-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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling and soreness at the injection site), VACCINATION SITE ERYTHEMA (Redness, swelling and soreness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site redness and warm to touch), VACCINATION SITE MASS (area as oval shaped measuring approximately two inches out) and VACCINATION SITE PRURITUS (area as oval shaped measuring approximately two inches out and around site as well as some itching). At the time of the report, VACCINATION SITE WARMTH (injection site redness and warm to touch), VACCINATION SITE MASS (area as oval shaped measuring approximately two inches out) and VACCINATION SITE PRURITUS (area as oval shaped measuring approximately two inches out and around site as well as some itching) outcome was unknown and VACCINATION SITE SWELLING (swelling and soreness at the injection site), VACCINATION SITE ERYTHEMA (Redness, swelling and soreness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: only a little pain; A spontaneous report was received from a Consumer concerning a 72 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient experienced only a little pain. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   At the time of this report, the outcome of the event pain was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Paraesthesia, Paraesthesia oral
Clinical narrative: tingling in her mouth; tingling in her feet; elevated HR; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA ORAL (tingling in her mouth), PARAESTHESIA (tingling in her feet) and HEART RATE INCREASED (elevated HR) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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 PARAESTHESIA ORAL (tingling in her mouth), PARAESTHESIA (tingling in her feet) and HEART RATE INCREASED (elevated HR). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg and FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of 20 mg. At the time of the report, PARAESTHESIA ORAL (tingling in her mouth), PARAESTHESIA (tingling in her feet) and HEART RATE INCREASED (elevated HR) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Heart rate: Elevated.     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 medication was reported. Patient reports that the follow-up response to treatment was "good" and patient was stable to go home and follow up with PCP.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Nausea
Clinical narrative: Can't move my neck; Terrible headache; Nausea is bad; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Can't move my neck), HEADACHE (Terrible headache) and NAUSEA (Nausea is bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Had Last chemo treatment (Date was Unknown)).    On 11-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 HYPOKINESIA (Can't move my neck), HEADACHE (Terrible headache) and NAUSEA (Nausea is bad). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (Can't move my neck), HEADACHE (Terrible headache) and NAUSEA (Nausea is bad) 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 product use 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: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Hardness; Itching; Swelling; Redness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Rash) 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 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant mdications were reported.  No treatment information was provided.    Reporter did not allow further contact; 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: F
Vaccine: COVID19
Symptoms: Joint swelling, Joint warmth, Rash
Clinical narrative: full body rash that was on her chest and knees; joints were hot; joints were large and enflamed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (joints were large and enflamed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Polyethylene glycols (PEG)).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (joints were large and enflamed). The patient was treated with EPINEPHRINE (EPIPEN) for Rash, at an unspecified dose and frequency; PREDNISONE for Joint swelling, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (joints were large and enflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medication information provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm at the injection site) in a 57-year-old female patient 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 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore Arm at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Patient was treated with Tylenol   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms; Back was hurting; Achy all over-my skin hurts; Fever, temperature of 101.3; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back was hurting), PAIN (Achy all over-my skin hurts), PYREXIA (Fever, temperature of 101.3) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Medical history reported as COVID-19) in March 2020, Pneumonia (Medical history reported as Pneumonia) in March 2020 and Back injury (Patient stated thatshe had hurt her back and was on Medrol dose Pack which she finished it 2 days ago.). Concomitant products included METHYLPREDNISOLONE (MEDROL DOSEPAK) for Back injury, MULTIVITAMINS [VITAMINS NOS], ZINC, VITAMIN D3, CURCUMIN, PIPERINE (NANO CURCUMIN), ASCORBIC ACID (VITAMIN C ACID), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), ALBUTEROL [SALBUTAMOL], GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back was hurting), PAIN (Achy all over-my skin hurts), PYREXIA (Fever, temperature of 101.3), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back was hurting), PAIN (Achy all over-my skin hurts), PYREXIA (Fever, temperature of 101.3), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 101.3 101.3.     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.; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like symptoms; Back was hurting; Achy all over-my skin hurts; Fever, temperature of 101.3; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back was hurting), PAIN (Achy all over-my skin hurts), PYREXIA (Fever, temperature of 101.3) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Medical history reported as COVID-19) in March 2020, Pneumonia (Medical history reported as Pneumonia) in March 2020 and Back injury (Patient stated thatshe had hurt her back and was on Medrol dose Pack which she finished it 2 days ago.). Concomitant products included METHYLPREDNISOLONE (MEDROL DOSEPAK) for Back injury, MULTIVITAMINS [VITAMINS NOS], ZINC, VITAMIN D3, CURCUMIN, PIPERINE (NANO CURCUMIN), ASCORBIC ACID (VITAMIN C ACID), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), ALBUTEROL [SALBUTAMOL], GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back was hurting), PAIN (Achy all over-my skin hurts), PYREXIA (Fever, temperature of 101.3), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back was hurting), PAIN (Achy all over-my skin hurts), PYREXIA (Fever, temperature of 101.3), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 101.3 101.3.     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.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Heart rate, Myalgia
Clinical narrative: Joint pain worsening; chills; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (Joint pain worsening), CHILLS (chills) and MYALGIA (body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 02620A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since January 1995 and Osteoarthritis (increasingly worse after vaccination.) since November 2014. Concomitant products included DICLOFENAC (VOLTAREN [DICLOFENAC]) for Arthritis, METABOLIFE for Weight loss.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (Joint pain worsening), CHILLS (chills) and MYALGIA (body aches). On 07-Feb-2021, CHILLS (chills) and MYALGIA (body aches) had resolved. At the time of the report, ARTHRALGIA (Joint pain worsening) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Heart rate: increased (High) Increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided   This case was linked to MOD-2021-074674 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: no new information On 08-Jul-2021: Follow-up information received on 08 Jul 2021 contains significant information : Reporter Information, Other Relevant History and concomitant drug and events are added.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red and round like a circle at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Red and round like a circle at injection site) in a 58-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, VITAMINS NOS and MINERALS NOS, VITAMINS NOS (CENTRUM JR [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site). On 10-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red and round like a circle at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Red and round like a circle at injection site) was resolving. Unknown      The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.; 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: Oropharyngeal pain
Clinical narrative: throat ache that is worse in the morning; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (throat ache that is worse in the morning) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (throat ache that is worse in the morning).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: itching real bad injection site; soreness on the injection site; redness on the injection site; hardness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the injection site), VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE INDURATION (hardness on the injection site) and VACCINATION SITE PRURITUS (itching real bad injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SL20A) 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 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness on the injection site), VACCINATION SITE ERYTHEMA (redness on the injection site) and VACCINATION SITE INDURATION (hardness on the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching real bad injection site). At the time of the report, VACCINATION SITE PAIN (soreness on the injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE INDURATION (hardness on the injection site) and VACCINATION SITE PRURITUS (itching real bad injection site) 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 or concomitant medications 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swelling at the injection site (size of her palm); redness at injection site (around 1 inch in diameter); warmth and itchiness at the injection site; itchiness at the injection site; A spontaneous report was received from a other health care professional  concerning a 36-year's-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling (size of her palm), redness (around 1 inch in diameter), warmth and itchiness at the injection site.  As provided by the reporter the patient does not have medical history.  On 07 Jan 2021 at, the patient received their first of first planned dose of mRNA-1273 (Lot number: 025L20A) was administered on her L arm, at 0.5 ml with unknown route of administration for prophylaxis of COVID-19 infection.   On  07 Jan 2021, After  receiving mRNA-1273, the patient experienced On 14Jan2021 swelling (size of her palm), redness (around 1 inch in diameter),warmth and itchiness at the injection site.   Action taken with mRNA-1273 in response to the events was not 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: She felt her arm was warm to the touch; itchiness; Soreness in the arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm), VACCINATION SITE WARMTH (She felt her arm was warm to the touch) and VACCINATION SITE PRURITUS (itchiness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-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 PAIN IN EXTREMITY (Soreness in the arm). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (She felt her arm was warm to the touch) and VACCINATION SITE PRURITUS (itchiness). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm), VACCINATION SITE WARMTH (She felt her arm was warm to the touch) and VACCINATION SITE PRURITUS (itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.   Reporter did not allow further contact; 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: F
Vaccine: COVID19
Symptoms: Nausea, Rash
Clinical narrative: A little sick to my stomach; Rash on her back, abdomen area, under both arms (spreading lower); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her back, abdomen area, under both arms (spreading lower)) and NAUSEA (A little sick to my stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 11-Jan-2021, the patient experienced RASH (Rash on her back, abdomen area, under both arms (spreading lower)). On an unknown date, the patient experienced NAUSEA (A little sick to my stomach). At the time of the report, RASH (Rash on her back, abdomen area, under both arms (spreading lower)) and NAUSEA (A little sick to my stomach) 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 states she put on her lower back at first some Comet that she usually puts on her lips.Concomitant medication was not provided.; 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Hoarse voice; Mucus from out of the chest; Fatigue; 100.4 F; Cough; Tickle in the back of the throat; Sore arm; "runny nose"; Systemic body pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarse voice), THROAT IRRITATION (Tickle in the back of the throat), PRODUCTIVE COUGH (Mucus from out of the chest), PAIN IN EXTREMITY (Sore arm) and RHINORRHOEA ("runny nose") in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), RHINORRHOEA ("runny nose") and MYALGIA (Systemic body pain). On 13-Jan-2021, the patient experienced THROAT IRRITATION (Tickle in the back of the throat) and COUGH (Cough). On 14-Jan-2021, the patient experienced DYSPHONIA (Hoarse voice), PRODUCTIVE COUGH (Mucus from out of the chest), FATIGUE (Fatigue) and PYREXIA (100.4 F). At the time of the report, DYSPHONIA (Hoarse voice), THROAT IRRITATION (Tickle in the back of the throat), PRODUCTIVE COUGH (Mucus from out of the chest), PAIN IN EXTREMITY (Sore arm), RHINORRHOEA ("runny nose"), COUGH (Cough), MYALGIA (Systemic body pain), FATIGUE (Fatigue) and PYREXIA (100.4 F) 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.   Concomitant medication were not reported by the reporter. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: New events updated