chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Vaccination site pain
Clinical narrative: little soreness on left arm; stomach pain; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness on left arm), ABDOMINAL PAIN UPPER (stomach pain) and DIZZINESS (dizziness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALFUZOSIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and DIZZINESS (dizziness). On an unknown date, the patient experienced VACCINATION SITE PAIN (little soreness on left arm). At the time of the report, VACCINATION SITE PAIN (little soreness on left arm), ABDOMINAL PAIN UPPER (stomach pain) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: No energy; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy) and FATIGUE (Exhaustion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced ASTHENIA (No energy) and FATIGUE (Exhaustion). At the time of the report, ASTHENIA (No energy) and FATIGUE (Exhaustion) had not resolved.            No concomitant medications were given  No treatment information was provided  Action taken with mRNA-1273 in response to the events was not applicable.       Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Tenderness, Vaccination site erythema, Vaccination site pain
Clinical narrative: tiny red spot at the injection site; It's still a little sore; little tender; arm started with a little itching; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (little tender), INJECTION SITE PRURITUS (arm started with a little itching), VACCINATION SITE ERYTHEMA (tiny red spot at the injection site) and VACCINATION SITE PAIN (It's still a little sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and MANITOL for an unknown indication.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced TENDERNESS (little tender), INJECTION SITE PRURITUS (arm started with a little itching) and VACCINATION SITE PAIN (It's still a little sore).   On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (tiny red spot at the injection site). At the time of the report, TENDERNESS (little tender), INJECTION SITE PRURITUS (arm started with a little itching), VACCINATION SITE ERYTHEMA (tiny red spot at the injection site) and VACCINATION SITE PAIN (It's still a little sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Rash, Vaccination site warmth
Clinical narrative: it was hot; Break out a little bit; Arm began to itch, it itched so bad; It was a little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it was hot), RASH (Break out a little bit), INJECTION SITE PRURITUS (Arm began to itch, it itched so bad) and INJECTION SITE ERYTHEMA (It was a little red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (it was hot), RASH (Break out a little bit), INJECTION SITE PRURITUS (Arm began to itch, it itched so bad) and INJECTION SITE ERYTHEMA (It was a little red). At the time of the report, VACCINATION SITE WARMTH (it was hot), RASH (Break out a little bit), INJECTION SITE PRURITUS (Arm began to itch, it itched so bad) and INJECTION SITE ERYTHEMA (It was a little red) 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 product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-020870 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mass, Pain in extremity, Rash macular, Skin depigmentation
Clinical narrative: 8th day after vaccine, had a large, red, raised hot spot, just 2 inches below where injection was; Arm pit had a lump, was sore; 9th day, red raised spots got larger and redder, soreness got worse; 9th day, red raised spots got larger and redder, soreness got worse; Feels like a bruise or ligament is pulling; Arm pit had a lump, was sore; Then soreness continued and lump under arm got larger on day 10; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DEPIGMENTATION (8th day after vaccine, had a large, red, raised hot spot, just 2 inches below where injection was), MASS (Arm pit had a lump, was sore), RASH MACULAR (9th day, red raised spots got larger and redder, soreness got worse), PAIN IN EXTREMITY (9th day, red raised spots got larger and redder, soreness got worse) and CONTUSION (Feels like a bruise or ligament is pulling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 28-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 SKIN DEPIGMENTATION (8th day after vaccine, had a large, red, raised hot spot, just 2 inches below where injection was), MASS (Arm pit had a lump, was sore), RASH MACULAR (9th day, red raised spots got larger and redder, soreness got worse), PAIN IN EXTREMITY (9th day, red raised spots got larger and redder, soreness got worse), CONTUSION (Feels like a bruise or ligament is pulling), PAIN IN EXTREMITY (Arm pit had a lump, was sore) and MASS (Then soreness continued and lump under arm got larger on day 10). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800 mg. At the time of the report, SKIN DEPIGMENTATION (8th day after vaccine, had a large, red, raised hot spot, just 2 inches below where injection was), MASS (Arm pit had a lump, was sore), RASH MACULAR (9th day, red raised spots got larger and redder, soreness got worse), PAIN IN EXTREMITY (9th day, red raised spots got larger and redder, soreness got worse), CONTUSION (Feels like a bruise or ligament is pulling), PAIN IN EXTREMITY (Arm pit had a lump, was sore) and MASS (Then soreness continued and lump under arm got larger on day 10) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received and contain no new information.The reporter declined further follow-up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy at time of vaccination; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L206) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Nov-2020 and the estimated date of delivery was 28-Aug-2021. On 17-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: Swelling at the injection site; Stomach ache; felt severe fatigue; Flu like symptoms; Diarrhea; Fever; Fatigue; Dull headache; Pain in arm; A spontaneous/solicited report was received from a consumer concerning a 88 years old, female patient who developed fatigue , dull head ache , pain in arm ,felt severe fatigue , flue like symptoms ,diarrhea , fever , stomach ache ,swelling at injection site  The patient's medical history included [HISTORICAL CONDITION] diagnosed with irritable bowel syndrome.Concomitant product use was not provided/unknown by the reporter.  On 22-JAN-2021 ,prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:[032L20A] intramuscularly in the unknown site for prophylaxis of COVID-19 infection.  On 19-FEB-2021 ,prior to onset of events ,the  .patient received second of two planned doses of mRNA (Batch number:013M20A)intramuscularly in the unknown site for prophylaxis of COVID-19 infection  On 22-JAN-2021 ,the patient experienced event(s) fatigue , dull head ache ,pain in arm. On 19-FEB-2021,the patient experienced events felt severe fatigue ,flue like symptoms ,diarrhea ,fever. On 21-FEB-2021 ,experienced event stomach ache. On 22 FEB-2021 ,patient experienced event swelling at the site of infection.   Treatment details included NONE.  Action taken with response to events were unknown.  On 23-JAN-2021 ,the outcome of events developed fatigue ,dull head ache ,pain in arm were recovered. On an unknown date the outcome of events felt severe fatigue, flue like symptoms ,diarrhea ,fever , stomach ache swelling at the injection site was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Swelling at the injection site; Stomach ache; felt severe fatigue; Flu like symptoms; Diarrhea; Fever; Fatigue; Dull headache; Pain in arm; A spontaneous/solicited report was received from a consumer concerning a 88 years old, female patient who developed fatigue , dull head ache , pain in arm ,felt severe fatigue , flue like symptoms ,diarrhea , fever , stomach ache ,swelling at injection site  The patient's medical history included [HISTORICAL CONDITION] diagnosed with irritable bowel syndrome.Concomitant product use was not provided/unknown by the reporter.  On 22-JAN-2021 ,prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:[032L20A] intramuscularly in the unknown site for prophylaxis of COVID-19 infection.  On 19-FEB-2021 ,prior to onset of events ,the  .patient received second of two planned doses of mRNA (Batch number:013M20A)intramuscularly in the unknown site for prophylaxis of COVID-19 infection  On 22-JAN-2021 ,the patient experienced event(s) fatigue , dull head ache ,pain in arm. On 19-FEB-2021,the patient experienced events felt severe fatigue ,flue like symptoms ,diarrhea ,fever. On 21-FEB-2021 ,experienced event stomach ache. On 22 FEB-2021 ,patient experienced event swelling at the site of infection.   Treatment details included NONE.  Action taken with response to events were unknown.  On 23-JAN-2021 ,the outcome of events developed fatigue ,dull head ache ,pain in arm were recovered. On an unknown date the outcome of events felt severe fatigue, flue like symptoms ,diarrhea ,fever , stomach ache swelling at the injection site was not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia, Vaccination site rash, Vaccination site swelling
Clinical narrative: Vaccination site rash; Peripheral swelling; Fever; headache; dizzy; vertigo; A spontaneous report was received from a consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  fever/pyrexia, headache, dizzy/dizziness, vertigo.  The patient's medical history was not provided. Concomitant medications reported were Levothyroxine, Cholesterol medicine for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13Jan2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced fever/pyrexia, headache, dizzy/dizziness, vertigo.  Treatment details included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   On 10 Feb 2021 the outcome of  fever/pyrexia, headache was resolved. On an unknown date the outcome of dizzy/dizziness, vertigo was unknown.  Based on MSA comment, Rash coded to Vaccination site rash and Peripheral swelling coded to Vaccination site swelling
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vaccination site rash; Peripheral swelling; Fever; headache; dizzy; vertigo; A spontaneous report was received from a consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  fever/pyrexia, headache, dizzy/dizziness, vertigo.  The patient's medical history was not provided. Concomitant medications reported were Levothyroxine, Cholesterol medicine for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13Jan2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced fever/pyrexia, headache, dizzy/dizziness, vertigo.  Treatment details included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   On 10 Feb 2021 the outcome of  fever/pyrexia, headache was resolved. On an unknown date the outcome of dizzy/dizziness, vertigo was unknown.  Based on MSA comment, Rash coded to Vaccination site rash and Peripheral swelling coded to Vaccination site swelling
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site warmth
Clinical narrative: Feeling hot; Tenderness and swelling of the lymph nodes; Tenderness and swelling of the lymph nodes; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness/ vaccination site tenderness and swelling of the lymph nodes in the Same arm of the injection/ Vaccination site lymphadenopathy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the events tenderness and swelling of the lymph nodes in the Same arm of the injection.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events tenderness and swelling of the lymph nodes in the Same arm of the injection was unknown.  Based on MSA comment Feeling hot coded as Vaccination site warmth
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: I developed on my arm at the site a rash; Erythema; Hypersensitivity; Pruritus; A spontaneous report was received from a Non-Health Professional on 25-JAN-2021 00:00:00, which refers to a Female aged 74 Years who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypersensitivity, pruritus, rash and erythema. The patients past medical history included: No adverse event. No concomitant drugs taken. On 14-JAN-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot/batch: 012LZOA) on her left arm for prophylaxis of COVID-19 infection and experienced hypersensitivity, pruritus, rash and erythema. On 22-JAN-2021, the patient experienced a delayed type of reaction, her arm was itchy and red, there was a circle about 4 inches around and there was a little raised area of rash. On 23-JAN-2021, the patient experienced that her arm was red and developed a rash at the injection site. No treatments were taken. Action taken with mRNA-1273 in response to the events was not reported. Diagnosis\Outcome- I developed on my arm at the site a rash - Unknown, red - Unknown, arm was itchy and red - Recovered/Resolved, delayed type of reaction - Recovered/Resolved.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Eye disorder, Fatigue, Limb discomfort
Clinical narrative: A white ring between the colored part of my eye and the white part; Cholesterol build up; Sore arm; Fatigue; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), EYE DISORDER (A white ring between the colored part of my eye and the white part), EYE DISORDER (Cholesterol build up), LIMB DISCOMFORT (Sore arm) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DIZZINESS (Dizziness). On 10-Feb-2021, the patient experienced EYE DISORDER (A white ring between the colored part of my eye and the white part), EYE DISORDER (Cholesterol build up), LIMB DISCOMFORT (Sore arm) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), EYE DISORDER (A white ring between the colored part of my eye and the white part), EYE DISORDER (Cholesterol build up), LIMB DISCOMFORT (Sore arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cough, Insomnia
Clinical narrative: couldn't sleep and felt like a zombie. It made her weird; not knowing what caused the cough has taken her anxiety to another level; dry cough that feels like a tickle in her throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough that feels like a tickle in her throat), INSOMNIA (couldn't sleep and felt like a zombie. It made her weird) and ANXIETY (not knowing what caused the cough has taken her anxiety to another level) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Drug-induced cough. Concurrent medical conditions included Granuloma (Granuloma in lungs). Concomitant products included GUAIFENESIN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced COUGH (dry cough that feels like a tickle in her throat). On an unknown date, the patient experienced INSOMNIA (couldn't sleep and felt like a zombie. It made her weird) and ANXIETY (not knowing what caused the cough has taken her anxiety to another level). At the time of the report, COUGH (dry cough that feels like a tickle in her throat), INSOMNIA (couldn't sleep and felt like a zombie. It made her weird) and ANXIETY (not knowing what caused the cough has taken her anxiety to another level) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported on 23Feb2021 that she received the first dose of the Moderna vaccine on 17Feb2021 in her arm. On 20Feb2021 she developed a dry cough that felt like a tickle in her throat. She got the vaccine at the same time that she started a new medication, Guanfacine, and doesn't know if the cough is caused by the new medication, side effects from the vaccine, allergies or that she has developed COVID. She stopped taking the Guanfacine because she couldn't sleep and felt like a zombie. It made her weird. The not knowing what caused the cough has taken her anxiety to another level. She has a history of developing a cough with new medications and does have granulomas in her lungs.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness around the injection site; swelling; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling) 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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling). At the time of the report, PAIN IN EXTREMITY (arm hurt), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site discolouration, Vaccination site erythema, Vaccination site rash
Clinical narrative: Ring around the redness in the injection site, the edges are like a board of dark red; Arm got really big; (Injection site) had a red rash; Ring around the redness in the injection site, the edges are like a board of dark red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Ring around the redness in the injection site, the edges are like a board of dark red), PERIPHERAL SWELLING (Arm got really big), VACCINATION SITE RASH ((Injection site) had a red rash) and VACCINATION SITE ERYTHEMA (Ring around the redness in the injection site, the edges are like a board of dark red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Ring around the redness in the injection site, the edges are like a board of dark red), PERIPHERAL SWELLING (Arm got really big), VACCINATION SITE RASH ((Injection site) had a red rash) and VACCINATION SITE ERYTHEMA (Ring around the redness in the injection site, the edges are like a board of dark red). At the time of the report, VACCINATION SITE DISCOLOURATION (Ring around the redness in the injection site, the edges are like a board of dark red), PERIPHERAL SWELLING (Arm got really big), VACCINATION SITE RASH ((Injection site) had a red rash) and VACCINATION SITE ERYTHEMA (Ring around the redness in the injection site, the edges are like a board of dark red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   No treatment medication reported Caller called asking if her side effects are normal: She received the 1st dose of the Moderna Covid19 Vaccine on 2February2021 . She said that the last 2 days her arm got really big, had a red rash, and a ring around where she got the injection. Says she read about the covid arm, similar to what happened to her as around where it is red, the edges are like a board of dark red. States symptoms are still ongoing.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR Received: Patient feeling fine and requested no further followup.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: left knee hurts; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (left knee hurts) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No concomitant medications provided.  The patient's past medical history included Knee replacement.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ARTHRALGIA (left knee hurts). At the time of the report, ARTHRALGIA (left knee hurts) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR Received: Consent to follow up denied
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Muscle rigidity, Pruritus, Skin warm
Clinical narrative: has redness of 3 inches in diameter; inflammation; itches a lot; warm comes and go; gets hard; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (has redness of 3 inches in diameter), INFLAMMATION (inflammation), PRURITUS (itches a lot), SKIN WARM (warm comes and go) and MUSCLE RIGIDITY (gets hard) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (has redness of 3 inches in diameter), INFLAMMATION (inflammation), PRURITUS (itches a lot), SKIN WARM (warm comes and go) and MUSCLE RIGIDITY (gets hard). At the time of the report, ERYTHEMA (has redness of 3 inches in diameter), INFLAMMATION (inflammation), PRURITUS (itches a lot), SKIN WARM (warm comes and go) and MUSCLE RIGIDITY (gets hard) 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling
Clinical narrative: lips started swelling up; eyes started swelling up; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips started swelling up) and EYE SWELLING (eyes started swelling up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (she fell and broke her ankle. Six days later she needed surgery and was itching all over from the medication they gave her.) in January 2021. Concomitant products included LOSARTAN 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 08-Feb-2021, the patient experienced LIP SWELLING (lips started swelling up) and EYE SWELLING (eyes started swelling up). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 08-Feb-2021, LIP SWELLING (lips started swelling up) and EYE SWELLING (eyes started swelling up) 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.   Patient's primary care physician who took her off of Losartan just incase the reaction was induced from this medication.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dysgeusia, Headache, Influenza like illness
Clinical narrative: feeling like having the flue; a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything; disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight; slight cough; pain in their legs, and on every bone on their body; chills; headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like having the flue), DYSGEUSIA (a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything), WEIGHT DECREASED (disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight), COUGH (slight cough) and PAIN (pain in their legs, and on every bone on their body) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye operation NOS (Eye surgery).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (feeling like having the flue), DYSGEUSIA (a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything), WEIGHT DECREASED (disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight), COUGH (slight cough), PAIN (pain in their legs, and on every bone on their body), CHILLS (chills), HEADACHE (headaches) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 2 dosage form every four hours. At the time of the report, INFLUENZA LIKE ILLNESS (feeling like having the flue), COUGH (slight cough), PAIN (pain in their legs, and on every bone on their body), CHILLS (chills) and HEADACHE (headaches) had resolved and DYSGEUSIA (a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything), WEIGHT DECREASED (disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was concomitantly taking eye drops medication, cholesterol and triglycerol medication.  The patient treated nausea with an unknown medication.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Weight decreased
Clinical narrative: feeling like having the flue; a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything; disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight; slight cough; pain in their legs, and on every bone on their body; chills; headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like having the flue), DYSGEUSIA (a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything), WEIGHT DECREASED (disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight), COUGH (slight cough) and PAIN (pain in their legs, and on every bone on their body) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye operation NOS (Eye surgery).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (feeling like having the flue), DYSGEUSIA (a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything), WEIGHT DECREASED (disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight), COUGH (slight cough), PAIN (pain in their legs, and on every bone on their body), CHILLS (chills), HEADACHE (headaches) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 2 dosage form every four hours. At the time of the report, INFLUENZA LIKE ILLNESS (feeling like having the flue), COUGH (slight cough), PAIN (pain in their legs, and on every bone on their body), CHILLS (chills) and HEADACHE (headaches) had resolved and DYSGEUSIA (a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything), WEIGHT DECREASED (disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was concomitantly taking eye drops medication, cholesterol and triglycerol medication.  The patient treated nausea with an unknown medication.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: hives on the chest, neck, and both arms; no longer itching but the marks are still there; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hives on both arms, hives on chest, hives on neck, no longer itching but the marks are still there.  The patient's medical history was not provided. Concomitant medications reported were Amlodipine, Carvedilol, Triamterene Hydrochlorothiazide, Pravastatin, Gabapentin, Trelegy Inhaler for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 01120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Hives on both arms, Hives on chest, Hives on neck, no longer itching but the marks are still there.  Treatment details included Benadryl for the hives.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hives on both arms, hives on chest, hives on neck, no longer itching but the marks are still there was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic, Vaccination site erythema
Clinical narrative: ITCHY; RED; RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM; itchy, rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (ITCHY), VACCINATION SITE ERYTHEMA (RED), RASH (RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM) and RASH PRURITIC (itchy, rash) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 18-Feb-2021, the patient experienced PRURITUS (ITCHY), VACCINATION SITE ERYTHEMA (RED), RASH (RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM) and RASH PRURITIC (itchy, rash).   The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, PRURITUS (ITCHY), VACCINATION SITE ERYTHEMA (RED), RASH (RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM) and RASH PRURITIC (itchy, rash) outcome was unknown.      Concomitant product use was not provided by the reporter.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm hurts a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm hurts a little bit) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm hurts a little bit). At the time of the report, VACCINATION SITE PAIN (left arm hurts a little bit) 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 relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm at the site of injection; Itchy at the site of injection; Red at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection). At the time of the report, VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Red at injection site(4in. diameter); Itching at injection site; Swelling at injection site; Arm muscle feels hard; Burning at injection site; Tingling in scalp; Arm hurt for a couple of days; Arm very sore; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in scalp), VACCINATION SITE INDURATION (Arm muscle feels hard), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE PAIN (Arm hurt for a couple of days) and VACCINATION SITE ERYTHEMA (Red at injection site(4in. diameter)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt for a couple of days) and VACCINATION SITE PAIN (Arm very sore). On 02-Feb-2021, the patient experienced PARAESTHESIA (Tingling in scalp). On 06-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Arm muscle feels hard), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE ERYTHEMA (Red at injection site(4in. diameter)), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in scalp), VACCINATION SITE INDURATION (Arm muscle feels hard), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE PAIN (Arm hurt for a couple of days), VACCINATION SITE ERYTHEMA (Red at injection site(4in. diameter)), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Arm very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Red at injection site(4in. diameter); Itching at injection site; Swelling at injection site; Arm muscle feels hard; Burning at injection site; Tingling in scalp; Arm hurt for a couple of days; Arm very sore; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in scalp), VACCINATION SITE INDURATION (Arm muscle feels hard), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE PAIN (Arm hurt for a couple of days) and VACCINATION SITE ERYTHEMA (Red at injection site(4in. diameter)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt for a couple of days) and VACCINATION SITE PAIN (Arm very sore). On 02-Feb-2021, the patient experienced PARAESTHESIA (Tingling in scalp). On 06-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Arm muscle feels hard), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE ERYTHEMA (Red at injection site(4in. diameter)), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in scalp), VACCINATION SITE INDURATION (Arm muscle feels hard), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE PAIN (Arm hurt for a couple of days), VACCINATION SITE ERYTHEMA (Red at injection site(4in. diameter)), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Arm very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), HCTZ, LISINOPRIL, SERTRALINE, SIMVASTATIN, BIMATOPROST (LUMIGAN) and DORZOLAMIDE 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 INJECTION SITE PAIN (sore arm). On 17-Jan-2021, INJECTION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-024349 (Patient Link).