chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Injection site pain
Clinical narrative: tremendous lower back pain shooting down to her toes; little soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (little soreness) and BACK PAIN (tremendous lower back pain shooting down to her toes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included GERD, Cholesterol and IVP. Concurrent medical conditions included Pollen allergy, Dust allergy, Allergy to animal dander, Penicillin allergy, Shellfish allergy and Blood pressure increased. Concomitant products included ROSUVASTATIN, LANSOPRAZOLE (PREVACID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCT), FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), AMLODIPINE BESILATE, PANTOPRAZOLE and GABAPENTIN.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (little soreness). On 07-Jan-2021, the patient experienced BACK PAIN (tremendous lower back pain shooting down to her toes). At the time of the report, INJECTION SITE PAIN (little soreness) and BACK PAIN (tremendous lower back pain shooting down to her toes) outcome was unknown.          ; 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: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Sore arm; A spontaneous report was received from a consumer, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced PAIN IN EXTREMITY/sore arm  The patient's medical history and concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of event, the patient received first dose of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  On an unspecified date, after the first dose of vaccine, the patient experienced a sore arm. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was considered to be unknown at the time of this report.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Fatigue, Feeling cold, Headache
Clinical narrative: Nose bleed; Feeling cold; Chills; Headache; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of EPISTAXIS (Nose bleed), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue) and FEELING COLD (Feeling cold) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KD3A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (Nose bleed), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue) and FEELING COLD (Feeling cold). At the time of the report, EPISTAXIS (Nose bleed) had not resolved and CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue) and FEELING COLD (Feeling cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; A spontaneous report was received from a consumer concerning himself, a 65-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness at the injection site (vaccination site pain).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 06 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) in the left deltoid for prophylaxis of COVID-19 infection.  On 06 Jan 2021, after the vaccination, the patient experienced soreness at the injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.    The outcome of the event, soreness at the injection site, was resolved on 06 Jan 2021.; 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus, Urticaria
Clinical narrative: Headache; itching at injection site; pretty big rash/hives started that went down to the leg from the same side, mid calf, then to the; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), INJECTION SITE PRURITUS (itching at injection site) and URTICARIA (pretty big rash/hives started that went down to the leg from the same side, mid calf, then to the) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O27V2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TAMSULOSIN, AMLODIPINE, POTASSIUM CHLORIDE (KLOR-CON), LISINOPRIL, APIXABAN (ELIQUIS), GABAPENTIN, ACETYLSALICYLIC ACID (ASPRIN), ATORVASTATIN, FUROSEMIDE, CARVEDILOL and SOFOSBUVIR for an unknown indication, Belpatra.    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 HEADACHE (Headache), INJECTION SITE PRURITUS (itching at injection site) and URTICARIA (pretty big rash/hives started that went down to the leg from the same side, mid calf, then to the). On 13-Jan-2021, INJECTION SITE PRURITUS (itching at injection site) had resolved. At the time of the report, HEADACHE (Headache) and URTICARIA (pretty big rash/hives started that went down to the leg from the same side, mid calf, then to the) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient applied alcohol on itchiness   This case was linked to US-MODERNATX, INC.-MOD-2021-006272 (Linked Report).; Sender'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. US-MODERNATX, INC.-MOD-2021-006272:Crosslinked with MOD21-05193
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm was a little tender; Arm was red; Arm was swollen-like; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little tender), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE SWELLING (Arm was swollen-like) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-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 (Arm was a little tender), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE SWELLING (Arm was swollen-like). At the time of the report, VACCINATION SITE PAIN (Arm was a little tender), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE SWELLING (Arm was swollen-like) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment 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.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: diagnosed with COVID; Itchy at site of injection; Redness which is now 2 inches at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with COVID ), VACCINATION SITE PRURITUS (Itchy at site of injection) and VACCINATION SITE ERYTHEMA (Redness which is now 2 inches at injection site) in a 64-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 Chemotherapy since an unknown date.    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 PRURITUS (Itchy at site of injection) and VACCINATION SITE ERYTHEMA (Redness which is now 2 inches at injection site). On 12-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (diagnosed with COVID ). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with COVID ), VACCINATION SITE PRURITUS (Itchy at site of injection) and VACCINATION SITE ERYTHEMA (Redness which is now 2 inches at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive (Positive) diagnosed with COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: asthmatic episodes- happening a lot more ofte; fever; fatigue; Shortness of breath; A spontaneous report was received from a patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, asthmatic episode-happening a lot more often, fever and fatigue.  The patient's medical history was not provided. No concomitant product use was reported.  On 06-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 06-Jan-2021, the patient had experienced shortness of breath. On an unspecified date, it was known that the patient had experienced asthmatic-happening a lot more often, fever and fatigue.  Treatment information included Prednisone.  Action taken with mRNA-1273 was unknown.  The outcome of the events, shortness of breath, asthmatic episode-happening a lot more often, fever and fatigue, was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose; Chills; Headache; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), CHILLS (Chills), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body aches) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027LZOA) 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) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced RHINORRHOEA (Runny nose), CHILLS (Chills), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny nose), CHILLS (Chills), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy
Clinical narrative: Headache; is 14 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (is 14 weeks pregnant) and HEADACHE (Headache) in a 33-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011120A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 25-Oct-2001, Pregnancy (Live, full-term birth) on 18-Apr-2006 and Pregnancy (Live, full-term birth) on 26-Jun-2012. Concurrent medical conditions included Arm injury and Dust allergy.    On 09-Jan-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Oct-2020 and the estimated date of delivery was 15-Jul-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (is 14 weeks pregnant). On 12-Jan-2021, the patient experienced HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (is 14 weeks pregnant) had resolved. On 13-Jan-2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant medication reported. On 25-OCT-2001, it was reported that 1st pregnancy ended with live, full-term birth. On 18-APR-2006, it was reported that 2st pregnancy ended with live, full-term birth. On 26-JUN-2012 was reported that 3t pregnancy ended with live, full-term birth. On an unknown date in Oct-2020, it was reported as the estimated date of conception. Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on current available information and the temporal association between product use and the start date of Headache, a causal relationship cannot be excluded, while the event was reported not vaccine related.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: Internal review on 20-Jul-2021 resulted in updates to the patient details, events, and narrative.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on current available information and the temporal association between product use and the start date of Headache, a causal relationship cannot be excluded, while the event was reported not vaccine related.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Pain
Clinical narrative: body pain; Headache; nausea; pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain), HEADACHE (Headache), NAUSEA (nausea) and INJECTION SITE PAIN (pain at the site of injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (body pain), HEADACHE (Headache), NAUSEA (nausea) and INJECTION SITE PAIN (pain at the site of injection). The patient was treated with ACETAMINOPHEN 500mg at an unknown frequency. At the time of the report, PAIN (body pain), HEADACHE (Headache), NAUSEA (nausea) and INJECTION SITE PAIN (pain at the site of injection) 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 temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 09-Jan-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was taken and symptoms have subsided. No relevant concomitant medications were reported.   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 these events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness on her R arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on her R arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Jan-2021 at 12:08 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021 at 12:38 PM, the patient experienced VACCINATION SITE PAIN (Soreness on her R arm). At the time of the report, VACCINATION SITE PAIN (Soreness on her R arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment 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 event, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (Rash) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Dec-2020, the patient experienced RASH (Rash). On 25-Dec-2020, RASH (Rash) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was 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 event, a causal relationship cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tunnel vision, Vision blurred
Clinical narrative: sensation of tunnel vision; blurred vision; Light headed; This spontaneous case was reported by a patient and describes the occurrence of TUNNEL VISION (sensation of tunnel vision), VISION BLURRED (blurred vision) and DIZZINESS (Light headed) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20/2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for Prevention.    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 TUNNEL VISION (sensation of tunnel vision), VISION BLURRED (blurred vision) and DIZZINESS (Light headed). On 13-Jan-2021, TUNNEL VISION (sensation of tunnel vision), VISION BLURRED (blurred vision) and DIZZINESS (Light headed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: A follow up received on 04 JUN 2021 has no new information; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Lymph node pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Left arm was sore; achy in her lymph nodes; deltoid was hot; deltoid was itchy; rash formed on deltoid, rash to be 102F on her arm; achy in her armpit; chills; Left arm was swollen; Left arm was very red; This spontaneous case was reported by a nurse and describes the occurrence of LYMPH NODE PAIN (achy in her lymph nodes), VACCINATION SITE WARMTH (deltoid was hot), VACCINATION SITE PRURITUS (deltoid was itchy), VACCINATION SITE RASH (rash formed on deltoid, rash to be 102F on her arm) and AXILLARY PAIN (achy in her armpit) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LYMPH NODE PAIN (achy in her lymph nodes), VACCINATION SITE WARMTH (deltoid was hot), VACCINATION SITE PRURITUS (deltoid was itchy), VACCINATION SITE RASH (rash formed on deltoid, rash to be 102F on her arm), AXILLARY PAIN (achy in her armpit) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and VACCINATION SITE ERYTHEMA (Left arm was very red). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPH NODE PAIN (achy in her lymph nodes), VACCINATION SITE WARMTH (deltoid was hot), VACCINATION SITE PRURITUS (deltoid was itchy), VACCINATION SITE RASH (rash formed on deltoid, rash to be 102F on her arm), AXILLARY PAIN (achy in her armpit), CHILLS (chills), VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and VACCINATION SITE ERYTHEMA (Left arm was very red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left arm was sore; achy in her lymph nodes; deltoid was hot; deltoid was itchy; rash formed on deltoid, rash to be 102F on her arm; achy in her armpit; chills; Left arm was swollen; Left arm was very red; This spontaneous case was reported by a nurse and describes the occurrence of LYMPH NODE PAIN (achy in her lymph nodes), VACCINATION SITE WARMTH (deltoid was hot), VACCINATION SITE PRURITUS (deltoid was itchy), VACCINATION SITE RASH (rash formed on deltoid, rash to be 102F on her arm) and AXILLARY PAIN (achy in her armpit) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LYMPH NODE PAIN (achy in her lymph nodes), VACCINATION SITE WARMTH (deltoid was hot), VACCINATION SITE PRURITUS (deltoid was itchy), VACCINATION SITE RASH (rash formed on deltoid, rash to be 102F on her arm), AXILLARY PAIN (achy in her armpit) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and VACCINATION SITE ERYTHEMA (Left arm was very red). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPH NODE PAIN (achy in her lymph nodes), VACCINATION SITE WARMTH (deltoid was hot), VACCINATION SITE PRURITUS (deltoid was itchy), VACCINATION SITE RASH (rash formed on deltoid, rash to be 102F on her arm), AXILLARY PAIN (achy in her armpit), CHILLS (chills), VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and VACCINATION SITE ERYTHEMA (Left arm was very red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were 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.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: red welt in the arm; pain in the arm; injection site was red a firm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (red welt in the arm), PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE ERYTHEMA (injection site was red a firm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (red welt in the arm), PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE ERYTHEMA (injection site was red a firm). At the time of the report, PERIPHERAL SWELLING (red welt in the arm), PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE ERYTHEMA (injection site was red a firm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced INSOMNIA (Insomnia). The patient was treated with MELATONIN ongoing since an unknown date at an unspecified dose and frequency and DOXYLAMINE SUCCINATE (UNISOM 2) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INSOMNIA (Insomnia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Photophobia
Clinical narrative: Left eye problem; Daylight affected me; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Left eye problem) and PHOTOPHOBIA (Daylight affected me) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, VALSARTAN and TIMOLOL for an unknown indication.    On 14-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 OCULAR DISCOMFORT (Left eye problem) and PHOTOPHOBIA (Daylight affected me). At the time of the report, OCULAR DISCOMFORT (Left eye problem) and PHOTOPHOBIA (Daylight affected me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Circular itchy rash around injection site; Circular itchy rash around injection site; Armpit soreness; Hardness at the injection site; Headache; lack of range of motion in the injected arm; Pain in arm; Fatigue/additional fatigue; Rapid Heart beat; light headed; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid Heart beat), DIZZINESS (light headed), VACCINATION SITE MOVEMENT IMPAIRMENT (lack of range of motion in the injected arm), AXILLARY PAIN (Armpit soreness) and VACCINATION SITE INDURATION (Hardness at the injection site) in a 30-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 reported.     On 23-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 23-Dec-2020, the patient experienced HEART RATE INCREASED (Rapid Heart beat) and DIZZINESS (light headed). On 24-Dec-2020, the patient experienced VACCINATION SITE PAIN (Pain in arm) and FATIGUE (Fatigue/additional fatigue). On 25-Dec-2020, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (lack of range of motion in the injected arm) and HEADACHE (Headache). On 31-Dec-2020, the patient experienced AXILLARY PAIN (Armpit soreness) and VACCINATION SITE INDURATION (Hardness at the injection site). On 01-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Circular itchy rash around injection site) and VACCINATION SITE RASH (Circular itchy rash around injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Dec-2020, FATIGUE (Fatigue/additional fatigue) outcome was unknown. On 02-Jan-2021, AXILLARY PAIN (Armpit soreness) and VACCINATION SITE INDURATION (Hardness at the injection site) had resolved. On 03-Jan-2021, VACCINATION SITE PRURITUS (Circular itchy rash around injection site) and VACCINATION SITE RASH (Circular itchy rash around injection site) had resolved. At the time of the report, HEART RATE INCREASED (Rapid Heart beat), DIZZINESS (light headed), VACCINATION SITE MOVEMENT IMPAIRMENT (lack of range of motion in the injected arm), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 dates of the events, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site movement impairment, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Circular itchy rash around injection site; Circular itchy rash around injection site; Armpit soreness; Hardness at the injection site; Headache; lack of range of motion in the injected arm; Pain in arm; Fatigue/additional fatigue; Rapid Heart beat; light headed; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid Heart beat), DIZZINESS (light headed), VACCINATION SITE MOVEMENT IMPAIRMENT (lack of range of motion in the injected arm), AXILLARY PAIN (Armpit soreness) and VACCINATION SITE INDURATION (Hardness at the injection site) in a 30-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 reported.     On 23-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 23-Dec-2020, the patient experienced HEART RATE INCREASED (Rapid Heart beat) and DIZZINESS (light headed). On 24-Dec-2020, the patient experienced VACCINATION SITE PAIN (Pain in arm) and FATIGUE (Fatigue/additional fatigue). On 25-Dec-2020, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (lack of range of motion in the injected arm) and HEADACHE (Headache). On 31-Dec-2020, the patient experienced AXILLARY PAIN (Armpit soreness) and VACCINATION SITE INDURATION (Hardness at the injection site). On 01-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Circular itchy rash around injection site) and VACCINATION SITE RASH (Circular itchy rash around injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Dec-2020, FATIGUE (Fatigue/additional fatigue) outcome was unknown. On 02-Jan-2021, AXILLARY PAIN (Armpit soreness) and VACCINATION SITE INDURATION (Hardness at the injection site) had resolved. On 03-Jan-2021, VACCINATION SITE PRURITUS (Circular itchy rash around injection site) and VACCINATION SITE RASH (Circular itchy rash around injection site) had resolved. At the time of the report, HEART RATE INCREASED (Rapid Heart beat), DIZZINESS (light headed), VACCINATION SITE MOVEMENT IMPAIRMENT (lack of range of motion in the injected arm), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Flat Rash at the injection arm; Redness at the injection site; Chills; Low grade Fever; Flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Flat Rash at the injection arm), INJECTION SITE ERYTHEMA (Redness at the injection site) and CHILLS (Chills) in a 38-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 03-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 INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills) and PYREXIA (Low grade Fever). On 15-Jan-2021, the patient experienced RASH (Flat Rash at the injection arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Flat Rash at the injection arm), INJECTION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills) and PYREXIA (Low grade Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Sore arm; Flat Rash at the injection arm; Redness at the injection site; Chills; Low grade Fever; Flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Flat Rash at the injection arm), INJECTION SITE ERYTHEMA (Redness at the injection site) and CHILLS (Chills) in a 38-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 03-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 INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills) and PYREXIA (Low grade Fever). On 15-Jan-2021, the patient experienced RASH (Flat Rash at the injection arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Flat Rash at the injection arm), INJECTION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills) and PYREXIA (Low grade Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: He felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (He felt tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 FATIGUE (He felt tired). At the time of the report, FATIGUE (He felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.; 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: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Very itchy; Rash at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE RASH (Rash at the injection site) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Very itchy) outcome was unknown and VACCINATION SITE RASH (Rash at the 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 concomitant medication reported.  Treatment medication 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Rash
Clinical narrative: Rash; Lymph nodes are swollen; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes are swollen), RASH (Rash) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Celiac disease and Graves' disease. Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CONTRACEPTIVE HD) for an unknown indication.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes are swollen), RASH (Rash) and CHILLS (Chills). At the time of the report, LYMPHADENOPATHY (Lymph nodes are swollen), RASH (Rash) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.; Sender'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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site rash
Clinical narrative: Sore arm; itching; 2-3 inch rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRURITUS (itching) and VACCINATION SITE RASH (2-3 inch rash around the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032LZ0A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease, CIPROFLOXACIN and DENOSUMAB (PROLIA) for an unknown indication, MULTIVITAMIN [VITAMINS NOS].   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE RASH (2-3 inch rash around the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PRURITUS (itching). On 12-Jan-2021, VACCINATION SITE RASH (2-3 inch rash around the injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and PRURITUS (itching) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that the first vaccine and second vaccines had the exact same rash on each arm from the shoulder to elbow. Concomitant medications also included Probiotic, Caltrate and Milk Thistle. She also stated that her dermatologist had suggested to apply Hydrocortisone to lessen the itching and oral Benadryl.   This case was linked to MOD-2021-208080.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received (New event 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: urticaria, hives; Erythema, redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (urticaria, hives), VACCINATION SITE ERYTHEMA (Erythema, redness) and VACCINATION SITE SWELLING (Swelling) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (urticaria, hives), VACCINATION SITE ERYTHEMA (Erythema, redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE URTICARIA (urticaria, hives), VACCINATION SITE ERYTHEMA (Erythema, redness) 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 information 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.