chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness; Swelling; Redness; A spontaneous report was received from a Consumer concerning a unknown age male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchiness, swelling, and redness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: denied) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events, itchiness. swelling, redness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events, itchiness, swelling, redness was not reported.   On an unknown date the outcome of events include, itchiness, swelling, redness was not reported.; Reporter'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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Pain in extremity, Peripheral swelling, Swelling face
Clinical narrative: left arm "swelled" and "hurt"; Left arm hurt; Face swollen; Eyes swollen; A spontaneous report was received from a Consumer concerning a 69-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, left arm swelled and hurt, face swollen, and eye swollen.  The patient's medical history was not provided. Concomitant medications reported were Wellbutrin, Zoloft, Ativan, Synthroid for drug use for unknown indication.  On 22 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 left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, left arm swelled and hurt, face swollen and eye swollen.  Treatment details included ketotifen fumarate antihistamine eye drops.  Action taken with mRNA-1273 in response to the events, left arm swelled and hurt, face swollen, eye swollen was not reported.   On an unknown date the outcome of events include, left arm swelled and hurt, face swollen, eye swollen was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: arm was red; arm was warm; arm was itchy; rash was 2 inches long and 1 inch wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE PRURITUS (arm was itchy) and RASH (rash was 2 inches long and 1 inch wide) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131.20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE PRURITUS (arm was itchy) and RASH (rash was 2 inches long and 1 inch wide). At the time of the report, VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE PRURITUS (arm was itchy) and RASH (rash was 2 inches long and 1 inch wide) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included unspecified lotion. No relevant concomitant medications were 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Round Pink Area; Warm to Touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Round Pink Area) and VACCINATION SITE WARMTH (Warm to Touch) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Round Pink Area) and VACCINATION SITE WARMTH (Warm to Touch). At the time of the report, VACCINATION SITE ERYTHEMA (Round Pink Area) and VACCINATION SITE WARMTH (Warm to Touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: NNI; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Flushing, Pain, Pain in extremity
Clinical narrative: dizziness; "it makes me feel unbalanced."; egg-size rash around the site of the injection; body aches; arm soreness; face flushing; heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), FLUSHING ( face flushing), PALPITATIONS (heart palpitations), DIZZINESS (dizziness) and BALANCE DISORDER ("it makes me feel unbalanced.") in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), FLUSHING ( face flushing), PALPITATIONS (heart palpitations) and PAIN (body aches). On 02-Feb-2021, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER ("it makes me feel unbalanced.") and VACCINATION SITE RASH (egg-size rash around the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), FLUSHING ( face flushing), PALPITATIONS (heart palpitations), DIZZINESS (dizziness), BALANCE DISORDER ("it makes me feel unbalanced."), PAIN (body aches) and VACCINATION SITE RASH (egg-size rash around the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. Patient has used Benadryl gel for her rash.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vaccination site rash
Clinical narrative: dizziness; "it makes me feel unbalanced."; egg-size rash around the site of the injection; body aches; arm soreness; face flushing; heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), FLUSHING ( face flushing), PALPITATIONS (heart palpitations), DIZZINESS (dizziness) and BALANCE DISORDER ("it makes me feel unbalanced.") in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), FLUSHING ( face flushing), PALPITATIONS (heart palpitations) and PAIN (body aches). On 02-Feb-2021, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER ("it makes me feel unbalanced.") and VACCINATION SITE RASH (egg-size rash around the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), FLUSHING ( face flushing), PALPITATIONS (heart palpitations), DIZZINESS (dizziness), BALANCE DISORDER ("it makes me feel unbalanced."), PAIN (body aches) and VACCINATION SITE RASH (egg-size rash around the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. Patient has used Benadryl gel for her rash.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: itching on the injection site; red blotch on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching on the injection site) and INJECTION SITE ERYTHEMA (red blotch on the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High Blood pressure). Concomitant products included LISINOPRIL for an unknown indication.    On 25-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 INJECTION SITE PRURITUS (itching on the injection site) and INJECTION SITE ERYTHEMA (red blotch on the injection site). At the time of the report, INJECTION SITE PRURITUS (itching on the injection site) and INJECTION SITE ERYTHEMA (red blotch on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: redness; lump on my lymph node; feels kind of hot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (lump on my lymph node) and FEELING HOT (feels kind of hot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included GLATIRAMER ACETATE (COPAXONE) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (redness), SWELLING (lump on my lymph node) and FEELING HOT (feels kind of hot). At the time of the report, ERYTHEMA (redness) and FEELING HOT (feels kind of hot) outcome was unknown and SWELLING (lump on my lymph node) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: redness around the injection site; injection site itches; injection site hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE PRURITUS (injection site itches) and VACCINATION SITE INDURATION (injection site hard) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE PRURITUS (injection site itches) and VACCINATION SITE INDURATION (injection site hard). At the time of the report, VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE PRURITUS (injection site itches) and VACCINATION SITE INDURATION (injection site hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included high blood pressure medication and thyroid medication.  At the begging the patient had redness on her arm about the size of a 50 cent piece, it almost went away but then it came back bigger and it was red, about 4 by 4 inches in size. It also was itchy and was hard.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Myalgia, Neck pain, Vaccination site pain
Clinical narrative: neck sore; sore arm; generally sore; getting chills; really cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (really cold), NECK PAIN (neck sore), CHILLS (getting chills), VACCINATION SITE PAIN (sore arm) and MYALGIA (generally sore) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FEELING COLD (really cold) and CHILLS (getting chills). On 03-Feb-2021, the patient experienced NECK PAIN (neck sore), VACCINATION SITE PAIN (sore arm) and MYALGIA (generally sore). At the time of the report, FEELING COLD (really cold), NECK PAIN (neck sore), CHILLS (getting chills), VACCINATION SITE PAIN (sore arm) and MYALGIA (generally sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took cholesterol drugs as concomitant medication. The patient did not take any treatment.  The patient was fine all day (day of vaccination) but at 11:30 pm he had really cold, getting chills, he woke up 4 times and took a shower to get warm.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Within 10 - 15 minutes of receiving vaccine in left deltoid, a single hive (typical wheal & flare) developed on the left volar forearm approximately 10 cm proximal to the wrist crease. It was itchy. I also demonstrated dermatographism on the same volar forearm. No other hives elsewhere. No shortness of breath or wheezing. Two physicians, a nurse and a pharmacist examined me. We were all puzzled initially but decided it was a localized allergic reaction. I was treated with 50mg. Benadryl and observed an additional 30 minutes with no progression and was then released from the clinic. No further problems. Hive faded gradually over 36 - 48 hours.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain
Clinical narrative: On August 9th, I laid in bed with chest pain for maybe 30-45 minutes. On August 11 (today), I am at work. Around 5 AM, I started feeling pain in stomach. Possibly could be hunger pain. However, the pain migrated to my chest quickly. Chest pain has been consistent and is still occurring (6:33 am). My lower back is also hurting, and when I try to laugh it increases the pain in my chest. I have a history of heartburn, but my heartburn has not been an issue since last summer (after changing my diet).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest pain, Electrocardiogram, Full blood count, Myocarditis
Clinical narrative: Myocarditis , chest pain, admitted to ER on 5/30
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Troponin I increased
Clinical narrative: Myocarditis , chest pain, admitted to ER on 5/30
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dizziness, Dysphagia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Mouth swelling, Nausea, Pain, Paraesthesia, Pruritus
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Tachycardia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Hyperglycaemia, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Additional Details: hyperglycemia after covid shot. Fasting blood sugar above normal every day for 5 days consistently (above 200), patient reported to dr.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Tremor
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt started having severe tremors all over within 15 minutes of injection-Severe
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: reaction to the Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction to the Covid-19 vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction to the Covid-19 vaccine). At the time of the report, VACCINATION SITE REACTION (reaction to the Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site bruising, Paraesthesia
Clinical narrative: Injection site black and blue mark; Bruise; Something tickle down my arm when I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Injection site black and blue mark), CONTUSION (Bruise) and PARAESTHESIA (Something tickle down my arm when I got the vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 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 INJECTION SITE BRUISING (Injection site black and blue mark), CONTUSION (Bruise) and PARAESTHESIA (Something tickle down my arm when I got the vaccine). At the time of the report, INJECTION SITE BRUISING (Injection site black and blue mark) was resolving and CONTUSION (Bruise) and PARAESTHESIA (Something tickle down my arm when I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headed; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (light headed) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OCTREOTIDE ACETATE (SANDOSTATIN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (light headed). On 03-Feb-2021, DIZZINESS (light headed) had resolved. 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 treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: achy; headache; warm spot at the injection site; raised spot at the injection site; itchy spot at the injection site; red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm spot at the injection site), PAIN (achy), VACCINATION SITE INDURATION (raised spot at the injection site), VACCINATION SITE PRURITUS (itchy spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm spot at the injection site), VACCINATION SITE INDURATION (raised spot at the injection site), VACCINATION SITE PRURITUS (itchy spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site). On an unknown date, the patient experienced PAIN (achy) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm spot at the injection site), PAIN (achy), VACCINATION SITE INDURATION (raised spot at the injection site), VACCINATION SITE PRURITUS (itchy spot at the injection site), VACCINATION SITE ERYTHEMA (red spot at the injection site) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Patient stated that the spot was 2inches in diameter and then grew to 5 inches in diameter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-JUN-2021, contains no newinformation. On 10-Jun-2021: Follow-up information received on 10-JUN-2021, updated contact details(mail address).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: achy; headache; warm spot at the injection site; raised spot at the injection site; itchy spot at the injection site; red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm spot at the injection site), PAIN (achy), VACCINATION SITE INDURATION (raised spot at the injection site), VACCINATION SITE PRURITUS (itchy spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm spot at the injection site), VACCINATION SITE INDURATION (raised spot at the injection site), VACCINATION SITE PRURITUS (itchy spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site). On an unknown date, the patient experienced PAIN (achy) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm spot at the injection site), PAIN (achy), VACCINATION SITE INDURATION (raised spot at the injection site), VACCINATION SITE PRURITUS (itchy spot at the injection site), VACCINATION SITE ERYTHEMA (red spot at the injection site) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Patient stated that the spot was 2inches in diameter and then grew to 5 inches in diameter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-JUN-2021, contains no newinformation. On 10-Jun-2021: Follow-up information received on 10-JUN-2021, updated contact details(mail address).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included OCTREOTIDE ACETATE (SANDOSTATIN) for an unknown indication.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (light headed). On 03-Feb-2021, DIZZINESS (light headed) had resolved.            The patient got her shot at 1.30 PM and the light head started 5.00 PM. It went away in the evening. The patient did not consume any medication to treat his symptom. The patient did not consume concomitant medication on the day of his vaccine.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: his armsand face were red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (his armsand face were red) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (his armsand face were red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (his armsand face were red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were 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: Lip swelling, Rash, Urticaria
Clinical narrative: Swollen lips; Hives; Welts on back; A spontaneous report was received from a Healthcare Professional concerning a 41 Years-old male patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events, swollen lips, welts on back and hives .  The patient's medical history is unknown. Concomitant medication levothyroxine were reported.  On 21- Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 032L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 22-Jan-2021, the patient experienced circular hives all the way from his neck down to his lower back. they were spread out all over and he also had swollen lips.   Laboratory details are not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events include swollen lips, welts on back, hives was not reported.   At the time of this report, the outcome of the events swollen lips, welts on back, hives was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Developed a 99.5°F fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Developed a 99.5°F fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), CARVEDILOL and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (Developed a 99.5°F fever). At the time of the report, PYREXIA (Developed a 99.5°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 99.5 (Inconclusive) 99.5 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient used other medications Tormcaide 20 mg, Glamoraite and yanubin 100mg. Treatment included Tylenol.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: vaccination area was blistery; vaccination area was bumpy; vaccination area was itchy; vaccination area was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (vaccination area was blistery), VACCINATION SITE MASS (vaccination area was bumpy), VACCINATION SITE PRURITUS (vaccination area was itchy) and VACCINATION SITE ERYTHEMA (vaccination area was red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder NOS.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE VESICLES (vaccination area was blistery), VACCINATION SITE MASS (vaccination area was bumpy), VACCINATION SITE PRURITUS (vaccination area was itchy) and VACCINATION SITE ERYTHEMA (vaccination area was red). At the time of the report, VACCINATION SITE VESICLES (vaccination area was blistery), VACCINATION SITE MASS (vaccination area was bumpy), VACCINATION SITE PRURITUS (vaccination area was itchy) and VACCINATION SITE ERYTHEMA (vaccination area was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant medication reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positve for covid-19 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positve for covid-19 after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 experienced COVID-19 (Tested positve for covid-19 after first dose). At the time of the report, COVID-19 (Tested positve for covid-19 after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested for Covid-19 positive after vaccination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment was not reported.  It was reported that the patient gets his second dose vaccination on 05-Feb-2021.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Deathly Ill; Sore Throat; Headache; Nausea; fever; couldn't talk because he hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Deathly Ill), OROPHARYNGEAL PAIN (Sore Throat), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (fever) in a 49-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 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Deathly Ill), OROPHARYNGEAL PAIN (Sore Throat), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (fever) and MYALGIA (couldn't talk because he hurts). At the time of the report, VACCINATION COMPLICATION (Deathly Ill), OROPHARYNGEAL PAIN (Sore Throat), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (fever) and MYALGIA (couldn't talk because he hurts) outcome was unknown. Not applicable          No concomitant and treatment drugs were reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Deathly Ill; Sore Throat; Headache; Nausea; fever; couldn't talk because he hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Deathly Ill), OROPHARYNGEAL PAIN (Sore Throat), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (fever) in a 49-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 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Deathly Ill), OROPHARYNGEAL PAIN (Sore Throat), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (fever) and MYALGIA (couldn't talk because he hurts). At the time of the report, VACCINATION COMPLICATION (Deathly Ill), OROPHARYNGEAL PAIN (Sore Throat), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (fever) and MYALGIA (couldn't talk because he hurts) outcome was unknown. Not applicable          No concomitant and treatment drugs were reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positve for covid after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positve for covid after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for an unknown indication.     No Medical History information was reported.   On 08-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. 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 COVID-19 (Tested positve for covid after first dose). At the time of the report, COVID-19 (Tested positve for covid after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaccination site swelling
Clinical narrative: sore; swelling; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sore) and VACCINATION SITE SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 28L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced NECK PAIN (sore) and VACCINATION SITE SWELLING (swelling). At the time of the report, NECK PAIN (sore) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: sore and itching around the site; after the shot arm turned red like a rash; sore and itching around the site; after the shot arm turned red like a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (sore and itching around the site), VACCINATION SITE RASH (after the shot arm turned red like a rash), VACCINATION SITE PAIN (sore and itching around the site) and VACCINATION SITE ERYTHEMA (after the shot arm turned red like a rash) in a 72-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 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (sore and itching around the site), VACCINATION SITE RASH (after the shot arm turned red like a rash), VACCINATION SITE PAIN (sore and itching around the site) and VACCINATION SITE ERYTHEMA (after the shot arm turned red like a rash). At the time of the report, VACCINATION SITE PRURITUS (sore and itching around the site), VACCINATION SITE RASH (after the shot arm turned red like a rash), VACCINATION SITE PAIN (sore and itching around the site) and VACCINATION SITE ERYTHEMA (after the shot arm turned red like a rash) outcome was unknown.            No concomitant medications provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Urticaria
Clinical narrative: stinging around the chest; whelps/hives around the chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest). At the time of the report, PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest). At the time of the report, PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; A spontaneous report was received from a wife concerning a a male patient of unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed sore arm.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported..  On 21Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient developed sore arm. Treatment received for the event was not reported..    Action taken with mRNA-1273 in response to the event was not reported.     The outcome of the event reported  were considered unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced NS unexpected event of pain of extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included ibuprofen. Event outcome known. 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.; Sender's Comments:  MOD-2021-022491:Wife case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pruritus
Clinical narrative: Body aches; Severe itchiness at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and VACCINATION SITE PRURITUS (Severe itchiness at the injection arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN (Body aches) and VACCINATION SITE PRURITUS (Severe itchiness at the injection arm). At the time of the report, PAIN (Body aches) and VACCINATION SITE PRURITUS (Severe itchiness at the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Headache, Loss of personal independence in daily activities
Clinical narrative: she is shaking so bad; Was very hard to get up and shower today; shivering,chills; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she is shaking so bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Was very hard to get up and shower today), CHILLS (shivering,chills), HEADACHE (headache) and PYREXIA (fever) 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 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TREMOR (she is shaking so bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Was very hard to get up and shower today), CHILLS (shivering,chills), HEADACHE (headache) and PYREXIA (fever). The patient was treated with IBUPROFEN on 01-Feb-2021 for Prophylaxis NOS, at a dose of UNK dosage form. At the time of the report, TREMOR (she is shaking so bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Was very hard to get up and shower today), CHILLS (shivering,chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Blood pressure measurement: 102/63 (Inconclusive) 102/63. On 02-Feb-2021, Body temperature: 100.5 (High) 100.5. On an unknown date, Blood pressure measurement: 130/80 (normal) normal blood pressure.         Concomitant was not reported.