chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: reaction of my whole arm going numb; reaction is growing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (reaction of my whole arm going numb) and CONDITION AGGRAVATED (reaction is growing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-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 HYPOAESTHESIA (reaction of my whole arm going numb) and CONDITION AGGRAVATED (reaction is growing). At the time of the report, HYPOAESTHESIA (reaction of my whole arm going numb) and CONDITION AGGRAVATED (reaction is growing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm red; Arm swollen; Arm a little tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm a little tender), VACCINATION SITE ERYTHEMA (Arm red) and VACCINATION SITE SWELLING (Arm swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALBUTAMOL SULFATE (INHALERIN) and Eye vitamins for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm a little tender). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm red) and VACCINATION SITE SWELLING (Arm swollen). At the time of the report, VACCINATION SITE PAIN (Arm a little tender), VACCINATION SITE ERYTHEMA (Arm red) and VACCINATION SITE SWELLING (Arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Benadryl at an unknown dose and frequency via an unknown route.   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Nausea, Oxygen saturation, Pain in extremity, Vaccination complication
Clinical narrative: Doesn't feel well; Feeling funny in the top of her stomach with lots of gases; Nauseated; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Doesn't feel well), FLATULENCE (Feeling funny in the top of her stomach with lots of gases) and NAUSEA (Nauseated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, AMLODIPINE, METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), INSULIN GLARGINE (LANTUS), VITAMINS NOS and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 22-Jan-2021, the patient experienced VACCINATION COMPLICATION (Doesn't feel well), FLATULENCE (Feeling funny in the top of her stomach with lots of gases) and NAUSEA (Nauseated). The patient was treated with ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Adverse event, at a dose of UNK dosage form. On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION COMPLICATION (Doesn't feel well), FLATULENCE (Feeling funny in the top of her stomach with lots of gases) and NAUSEA (Nauseated) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 98 % normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medical included glucoride (1mg, twice a day).  The patient received treatment with inhaler (indication unspecified).
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: have  precipitated a cervical radiculopathy that she had in the past ;really classic and really bad; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CONDITION AGGRAVATED (have  precipitated a cervical radiculopathy that she had in the past ;really classic and really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cervical radiculopathy (The patient had this event in the past).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (have  precipitated a cervical radiculopathy that she had in the past ;really classic and really bad). At the time of the report, CONDITION AGGRAVATED (have  precipitated a cervical radiculopathy that she had in the past ;really classic and really bad) outcome was unknown. Not Provided      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 was not reported. Treatment medication was not reported. Within hours of getting the vaccine, it seems to have precipitated a cervical radiculopathy that she had in the past, really classic and really bad.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Lymphadenopathy
Clinical narrative: Swelling glands at neck, chest, groin, and under arm; JOINT PAIN; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (JOINT PAIN) and LYMPHADENOPATHY (Swelling glands at neck, chest, groin, and under arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from March 2020 to April 2020.    On 10-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced ARTHRALGIA (JOINT PAIN). On 11-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling glands at neck, chest, groin, and under arm). At the time of the report, ARTHRALGIA (JOINT PAIN) and LYMPHADENOPATHY (Swelling glands at neck, chest, groin, and under arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood test: normal (normal) normal.     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 was not reported. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling around the injection site; arm soreness; Pain; redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), VACCINATION SITE PAIN (Pain), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (redness around the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling around the injection site). At the time of the report, PAIN IN EXTREMITY (arm soreness), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Felt soreness on his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    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 PAIN (Felt soreness on his arm). At the time of the report, VACCINATION SITE PAIN (Felt soreness on his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information provided. No treatment information 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: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: Arm pain; Tremors where a little stronger; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and TREMOR (Tremors where a little stronger) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease (He has tremors due to Parkinson's disease.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and TREMOR (Tremors where a little stronger). At the time of the report, PAIN IN EXTREMITY (Arm pain) and TREMOR (Tremors where a little stronger) outcome was unknown.            No concomitant medications were provided No treatment information 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria, Vaccination site dysaesthesia, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: also a little bit on my right arm and big welts all over my back; felt like something was biting me; Itchy at injection site; these giant welts all over where I got the injection; arm was killing me for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was killing me for 2 days), VACCINATION SITE DYSAESTHESIA (felt like something was biting me), VACCINATION SITE URTICARIA (these giant welts all over where I got the injection), URTICARIA (also a little bit on my right arm and big welts all over my back) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS) (in remission). Concomitant products included PALBOCICLIB (IBRANCE), LETROZOLE and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was killing me for 2 days). On 19-Jan-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (felt like something was biting me), VACCINATION SITE URTICARIA (these giant welts all over where I got the injection), URTICARIA (also a little bit on my right arm and big welts all over my back) and VACCINATION SITE PRURITUS (Itchy at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 19-Jan-2021 for Adverse event, at a dose of UNK dosage form (for 2 days). On 12-Jan-2021, PAIN IN EXTREMITY (arm was killing me for 2 days) had resolved. On 22-Jan-2021, VACCINATION SITE URTICARIA (these giant welts all over where I got the injection) and URTICARIA (also a little bit on my right arm and big welts all over my back) had resolved. At the time of the report, VACCINATION SITE DYSAESTHESIA (felt like something was biting me) and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was due for her second dose on 07-Feb-2021. The patient took the first doe when she was on her off week of Ibrance. The patient took Ibrance on 18-Jan-2021 and on 19-Jan-2021, the patient developed giant welts all over where she got the injection and also a little bit on her right arm and big welts all over her back. The doctor asked her to stop Ibrance for the time.
Sex: U
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: Mouth sores (Ulcers)-area like circle and spots and spots were not bleeding; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Mouth sores (Ulcers)-area like circle and spots and spots were not bleeding) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOUTH ULCERATION (Mouth sores (Ulcers)-area like circle and spots and spots were not bleeding). At the time of the report, MOUTH ULCERATION (Mouth sores (Ulcers)-area like circle and spots and spots were not bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Updated Email address and address of reporter
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast discomfort, Skin discolouration
Clinical narrative: Palms looked like black blue tie dye; Twinge twice in left breast; shoulder pain above injection site; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder pain above injection site, twinge twice in left breast and palms looked like black blue tie dye.  The patient's medical history included lumpectomy and chemotherapy. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (029L20A) intramuscularly in the shoulder for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced shoulder pain above injection site, twinge twice in left breast and palms looked like black blue tie dye.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On an unknown date, the event palms looked like black blue tie dye was resolved. The outcome of the events shoulder pain above injection site and twinge twice in left breast 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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot; arm  was itching; arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot; arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot), VACCINATION SITE PRURITUS (arm  was itching), VACCINATION SITE SWELLING (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) and VACCINATION SITE ERYTHEMA (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Vitamin D deficiency and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT) for Blood pressure high, MONASCUS PURPUREUS, UBIDECARENONE (CHOLEAST) for Hypercholesterolaemia, COLECALCIFEROL (VIT D3) for Vitamin D3 deficiency.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot), VACCINATION SITE PRURITUS (arm  was itching), VACCINATION SITE SWELLING (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) and VACCINATION SITE ERYTHEMA (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 625 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE WARMTH (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot), VACCINATION SITE PRURITUS (arm  was itching), VACCINATION SITE SWELLING (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) and VACCINATION SITE ERYTHEMA (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-252963 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up received on 11JUL2021, included reporter's contact details, updated patient's demographics, medical history, 2nd dose was given 12FEB2021 Lot@039K20A and action taken with the drug was updated to no change, concomitant medications, treatment medication (Acetaminophen), events stop date and outcome was updated as recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Dyspnoea, Fatigue, Palpitations
Clinical narrative: Difficulty breathing; Growling sensation in chest; Heart palpitations; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Growling sensation in chest) and PALPITATIONS (Heart palpitations) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Chemical injury (Toxic Injury from her previous employment) in 1999. Concurrent medical conditions included Sleep apnea (previous medical history). Concomitant products included VITAMIN E NOS and CALCIUM for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (Fatigue), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Growling sensation in chest) and PALPITATIONS (Heart palpitations). The patient was treated with VITAMIN D [VITAMIN D NOS] ongoing since an unknown date at a dose of UNK dosage form and CLONIDINE in February 2021 for Adverse event, at a dose of UNK dosage form. On 06-Feb-2021, FATIGUE (Fatigue), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Growling sensation in chest) and PALPITATIONS (Heart palpitations) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was using CPAPA machine. The patient reported that those symptoms caused her to go to the Emergency Room on 05-FEB-2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: develop rash at injection site; rash spread to chest and throat at 12 noon and then all over body including thigh; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash spread to chest and throat at 12 noon and then all over body including thigh) and VACCINATION SITE RASH (develop rash at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L30N) for COVID-19 vaccination.     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 22-Jan-2021, the patient experienced RASH (rash spread to chest and throat at 12 noon and then all over body including thigh). On 22-Jan-2021 at 10:15 AM, the patient experienced VACCINATION SITE RASH (develop rash at injection site). At the time of the report, RASH (rash spread to chest and throat at 12 noon and then all over body including thigh) and VACCINATION SITE RASH (develop rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching) in a 69-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 per source document.).    On 14-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) and VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications 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 events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Rash
Clinical narrative: itching; RASH; plushed face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching), RASH (RASH) and FLUSHING (plushed face) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism, GERD, Osteopenia, Vitamin D deficiency and Vitamin B12 deficiency. Concomitant products included OMEPRAZOLE for GERD, VITAMINS NOS and LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, IBUPROFEN from 25-Mar-2021 to an unknown date for Knee pain, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for Vitamin B12 deficiency.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (itching), RASH (RASH) and FLUSHING (plushed face). The patient was treated with CALCIUM ongoing since an unknown date for Osteopenia, at a dose of 500 UNK, qd. At the time of the report, PRURITUS (itching), RASH (RASH) and FLUSHING (plushed face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment provided
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: rash on injection site that was itchy and red; rash on injection site that was itchy and red; rash on injection site that was itchy and red; the infection site was warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on injection site that was itchy and red), VACCINATION SITE PRURITUS (rash on injection site that was itchy and red), VACCINATION SITE ERYTHEMA (rash on injection site that was itchy and red) and VACCINATION SITE WARMTH (the infection site was warm to touch) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L208) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) 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 24-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on injection site that was itchy and red), VACCINATION SITE PRURITUS (rash on injection site that was itchy and red), VACCINATION SITE ERYTHEMA (rash on injection site that was itchy and red) and VACCINATION SITE WARMTH (the infection site was warm to touch). At the time of the report, VACCINATION SITE RASH (rash on injection site that was itchy and red), VACCINATION SITE PRURITUS (rash on injection site that was itchy and red), VACCINATION SITE ERYTHEMA (rash on injection site that was itchy and red) and VACCINATION SITE WARMTH (the infection site was warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment was given   This case was linked to MOD-2021-081188 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: General achiness; Pain at Injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General achiness), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (General achiness), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Headache). At the time of the report, PAIN (General achiness), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant medication details has provided as patient was receiving migraine tablets and allergic medication not specially mentioned the class of drugs; 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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K209) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.            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.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information received on 30-JUN-2021. No new information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Itching at the injection site; Injection site swelling; The injection site had huge amount of redness; Injection site was hot/ the localized reaction warm to touch; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (The injection site had huge amount of redness), VACCINATION SITE WARMTH (Injection site was hot/ the localized reaction warm to touch) and VACCINATION SITE PRURITUS (Itching at the injection site) in a 63-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 No adverse event (no medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 06-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (The injection site had huge amount of redness) and VACCINATION SITE WARMTH (Injection site was hot/ the localized reaction warm to touch). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). The patient was treated with LORATADINE for Itching, Swelling and Rash, at an unspecified dose and frequency and IBUPROFEN for Redness and Swelling, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (The injection site had huge amount of redness), VACCINATION SITE WARMTH (Injection site was hot/ the localized reaction warm to touch) and VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication patient used ice packs as his arm was hot at injection site
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site induration, Lymphadenopathy, Paraesthesia, Vaccination site erythema
Clinical narrative: injection site is swollen, red, and warm to the touch; the lymph node on the same side where I had the injection is swollen; hands and arm were tingling; hands and arms were numb; injection site is swollen, red, and warm to the touch; injection site is swollen; hard knot in my arm that has been here for over a week now; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site is swollen, red, and warm to the touch), LYMPHADENOPATHY (the lymph node on the same side where I had the injection is swollen), PARAESTHESIA (hands and arm were tingling), HYPOAESTHESIA (hands and arms were numb) and VACCINATION SITE ERYTHEMA (injection site is swollen, red, and warm to the touch) in a 42-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.     The patient's past medical history included No adverse event (no medical history).    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 WARMTH (injection site is swollen, red, and warm to the touch), LYMPHADENOPATHY (the lymph node on the same side where I had the injection is swollen), PARAESTHESIA (hands and arm were tingling), HYPOAESTHESIA (hands and arms were numb), VACCINATION SITE ERYTHEMA (injection site is swollen, red, and warm to the touch), VACCINATION SITE SWELLING (injection site is swollen) and INJECTION SITE INDURATION (hard knot in my arm that has been here for over a week now). At the time of the report, VACCINATION SITE WARMTH (injection site is swollen, red, and warm to the touch), LYMPHADENOPATHY (the lymph node on the same side where I had the injection is swollen), PARAESTHESIA (hands and arm were tingling), HYPOAESTHESIA (hands and arms were numb), VACCINATION SITE ERYTHEMA (injection site is swollen, red, and warm to the touch), VACCINATION SITE SWELLING (injection site is swollen) and INJECTION SITE INDURATION (hard knot in my arm that has been here for over a week now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Additional events were provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site is swollen, red, and warm to the touch; the lymph node on the same side where I had the injection is swollen; hands and arm were tingling; hands and arms were numb; injection site is swollen, red, and warm to the touch; injection site is swollen; hard knot in my arm that has been here for over a week now; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site is swollen, red, and warm to the touch), LYMPHADENOPATHY (the lymph node on the same side where I had the injection is swollen), PARAESTHESIA (hands and arm were tingling), HYPOAESTHESIA (hands and arms were numb) and VACCINATION SITE ERYTHEMA (injection site is swollen, red, and warm to the touch) in a 42-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.     The patient's past medical history included No adverse event (no medical history).    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 WARMTH (injection site is swollen, red, and warm to the touch), LYMPHADENOPATHY (the lymph node on the same side where I had the injection is swollen), PARAESTHESIA (hands and arm were tingling), HYPOAESTHESIA (hands and arms were numb), VACCINATION SITE ERYTHEMA (injection site is swollen, red, and warm to the touch), VACCINATION SITE SWELLING (injection site is swollen) and INJECTION SITE INDURATION (hard knot in my arm that has been here for over a week now). At the time of the report, VACCINATION SITE WARMTH (injection site is swollen, red, and warm to the touch), LYMPHADENOPATHY (the lymph node on the same side where I had the injection is swollen), PARAESTHESIA (hands and arm were tingling), HYPOAESTHESIA (hands and arms were numb), VACCINATION SITE ERYTHEMA (injection site is swollen, red, and warm to the touch), VACCINATION SITE SWELLING (injection site is swollen) and INJECTION SITE INDURATION (hard knot in my arm that has been here for over a week now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Additional events were provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: Exhaustion; Fever 101.8 Fahrenheit; body aches; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Exhaustion), PYREXIA (Fever 101.8 Fahrenheit) and MYALGIA (body aches) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021 at 7:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (Exhaustion), PYREXIA (Fever 101.8 Fahrenheit) and MYALGIA (body aches). At the time of the report, FATIGUE (Exhaustion), PYREXIA (Fever 101.8 Fahrenheit) and MYALGIA (body aches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 101.8 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. 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 events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: Tingling on the left side of my face; slight tightness in my throat; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on the left side of my face) and THROAT TIGHTNESS (slight tightness in my throat) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced PARAESTHESIA (Tingling on the left side of my face) and THROAT TIGHTNESS (slight tightness in my throat). At the time of the report, PARAESTHESIA (Tingling on the left side of my face) and THROAT TIGHTNESS (slight tightness in my throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. no treatment taken
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Night sweats, Pain in extremity, Vaccination complication
Clinical narrative: Sore arm; Night sweats; Local reactions; Other side effects; Fatigue; Chills/Shaking chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night sweats), VACCINATION SITE REACTION (Local reactions), VACCINATION COMPLICATION (Other side effects) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night sweats), VACCINATION SITE REACTION (Local reactions), VACCINATION COMPLICATION (Other side effects), FATIGUE (Fatigue) and CHILLS (Chills/Shaking chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night sweats), VACCINATION SITE REACTION (Local reactions), VACCINATION COMPLICATION (Other side effects), FATIGUE (Fatigue) and CHILLS (Chills/Shaking chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Sore arm; Night sweats; Local reactions; Other side effects; Fatigue; Chills/Shaking chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night sweats), VACCINATION SITE REACTION (Local reactions), VACCINATION COMPLICATION (Other side effects) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night sweats), VACCINATION SITE REACTION (Local reactions), VACCINATION COMPLICATION (Other side effects), FATIGUE (Fatigue) and CHILLS (Chills/Shaking chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night sweats), VACCINATION SITE REACTION (Local reactions), VACCINATION COMPLICATION (Other side effects), FATIGUE (Fatigue) and CHILLS (Chills/Shaking chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Halo pink sore; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Halo pink sore) 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 ERYTHEMA (Halo pink sore). At the time of the report, VACCINATION SITE ERYTHEMA (Halo pink sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient took Benadryl as treatment for their symptoms.    This case was linked to MOD-2021-013030 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Diarrhoea, Pyrexia
Clinical narrative: Felt Weak; Diarrhea; Back ache; Shivers; Fever; Injection site pain; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Felt Weak), DIARRHOEA (Diarrhea), BACK PAIN (Back ache), CHILLS (Shivers) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (Felt Weak), DIARRHOEA (Diarrhea), BACK PAIN (Back ache), CHILLS (Shivers), PYREXIA (Fever), VACCINATION SITE PAIN (Injection site pain) and VOMITING (Vomiting). On 22-Jan-2021, ASTHENIA (Felt Weak), DIARRHOEA (Diarrhea), BACK PAIN (Back ache), CHILLS (Shivers), PYREXIA (Fever), VACCINATION SITE PAIN (Injection site pain) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient took Aspirin on 21-JAN-2021 for treatment of the symptoms.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Felt Weak; Diarrhea; Back ache; Shivers; Fever; Injection site pain; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Felt Weak), DIARRHOEA (Diarrhea), BACK PAIN (Back ache), CHILLS (Shivers) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (Felt Weak), DIARRHOEA (Diarrhea), BACK PAIN (Back ache), CHILLS (Shivers), PYREXIA (Fever), VACCINATION SITE PAIN (Injection site pain) and VOMITING (Vomiting). On 22-Jan-2021, ASTHENIA (Felt Weak), DIARRHOEA (Diarrhea), BACK PAIN (Back ache), CHILLS (Shivers), PYREXIA (Fever), VACCINATION SITE PAIN (Injection site pain) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient took Aspirin on 21-JAN-2021 for treatment of the symptoms.