chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ZINC, Black elderberry, VITAMINS NOS, TERBINAFINE and LANSOPRAZOLE for an unknown indication.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up received on 09-APR-2021 contains significant information include Reporter's details.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Jun-2021. On 16-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. No concomitant medications and treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Internal review on 20 Jul 2021 resulted in the update of event verbatim, outcome and pregnancy information (birth type and fetal outcome). On 27-Apr-2021: Added email address of the reporter. Expected delivery date was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-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 ASTHMA (asthma). At the time of the report, ASTHMA (asthma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment using  budesonide-formoterol combination  (160/4.5mg), montelukast and inhaler (name Unknown) was reported   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Not significant- Patient declined further contact.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Peripheral swelling, Stomatitis, Tenderness
Clinical narrative: sores in her mouth; absolutely no energy; Feels very fatigued; arm is swollen; arm was swollen and tender; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), TENDERNESS (arm was swollen and tender), STOMATITIS (sores in her mouth), ASTHENIA (absolutely no energy) and FATIGUE (Feels very fatigued) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PERIPHERAL SWELLING (arm is swollen) and TENDERNESS (arm was swollen and tender). On 02-Feb-2021, the patient experienced STOMATITIS (sores in her mouth), ASTHENIA (absolutely no energy) and FATIGUE (Feels very fatigued). At the time of the report, PERIPHERAL SWELLING (arm is swollen), TENDERNESS (arm was swollen and tender), STOMATITIS (sores in her mouth), ASTHENIA (absolutely no energy) and FATIGUE (Feels very fatigued) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included allergy pill and arrhythmia medication (not specified)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Soreness at the injection arm; Knot above her clavicle that is very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection arm) and LYMPHADENOPATHY (Knot above her clavicle that is very painful) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection arm) and LYMPHADENOPATHY (Knot above her clavicle that is very painful). The patient was treated with IBUPROFEN for Pain, at a dose of 600 mg. At the time of the report, VACCINATION SITE PAIN (Soreness at the injection arm) and LYMPHADENOPATHY (Knot above her clavicle that is very painful) had not resolved.            No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow-up received on 06-Apr-2021 included no new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: redness; Itching; Heat; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness), INJECTION SITE PRURITUS (Itching) and INJECTION SITE WARMTH (Heat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness), INJECTION SITE PRURITUS (Itching) and INJECTION SITE WARMTH (Heat). At the time of the report, INJECTION SITE ERYTHEMA (redness), INJECTION SITE PRURITUS (Itching) and INJECTION SITE WARMTH (Heat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Coronavirus test positive
Clinical narrative: Tested positive for covid after getting first dose; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CORONAVIRUS TEST POSITIVE (Tested positive for covid after getting first dose) 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.    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 CORONAVIRUS TEST POSITIVE (Tested positive for covid after getting first dose). At the time of the report, CORONAVIRUS TEST POSITIVE (Tested positive for covid after getting first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coronavirus test: positive.     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.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 10-MAY-2021 contains no significant information. On 10-May-2021: Follow-up information received on 10-MAY-2021 contains no significant information.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Melanocytic naevus, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain for 3 days; Skin little darker; Like a little mole around the neck, arm and low part oh her leg; Very painful; Rash around her lip; Rash in some portions; Muscle pain, muscle area very painful; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain for 3 days), SKIN DISCOLOURATION (Skin little darker), MELANOCYTIC NAEVUS (Like a little mole around the neck, arm and low part oh her leg), PAIN IN EXTREMITY (Very painful) and CHEILITIS (Rash around her lip) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN (Pain for 3 days), SKIN DISCOLOURATION (Skin little darker), MELANOCYTIC NAEVUS (Like a little mole around the neck, arm and low part oh her leg), PAIN IN EXTREMITY (Very painful), CHEILITIS (Rash around her lip), RASH (Rash in some portions), MYALGIA (Muscle pain, muscle area very painful) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, PAIN (Pain for 3 days), SKIN DISCOLOURATION (Skin little darker), MELANOCYTIC NAEVUS (Like a little mole around the neck, arm and low part oh her leg), PAIN IN EXTREMITY (Very painful), CHEILITIS (Rash around her lip), RASH (Rash in some portions), MYALGIA (Muscle pain, muscle area very painful) and VACCINATION SITE SWELLING (Swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure pills.   Patient mentioned she went into the shower to put on warm water to make her feel better.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin discolouration, Vaccination site swelling
Clinical narrative: Pain for 3 days; Skin little darker; Like a little mole around the neck, arm and low part oh her leg; Very painful; Rash around her lip; Rash in some portions; Muscle pain, muscle area very painful; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain for 3 days), SKIN DISCOLOURATION (Skin little darker), MELANOCYTIC NAEVUS (Like a little mole around the neck, arm and low part oh her leg), PAIN IN EXTREMITY (Very painful) and CHEILITIS (Rash around her lip) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN (Pain for 3 days), SKIN DISCOLOURATION (Skin little darker), MELANOCYTIC NAEVUS (Like a little mole around the neck, arm and low part oh her leg), PAIN IN EXTREMITY (Very painful), CHEILITIS (Rash around her lip), RASH (Rash in some portions), MYALGIA (Muscle pain, muscle area very painful) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, PAIN (Pain for 3 days), SKIN DISCOLOURATION (Skin little darker), MELANOCYTIC NAEVUS (Like a little mole around the neck, arm and low part oh her leg), PAIN IN EXTREMITY (Very painful), CHEILITIS (Rash around her lip), RASH (Rash in some portions), MYALGIA (Muscle pain, muscle area very painful) and VACCINATION SITE SWELLING (Swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure pills.   Patient mentioned she went into the shower to put on warm water to make her feel better.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: sore throat; he couldn't talk because he hurts.; fever; nausea; got deathly ill with headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PAIN (he couldn't talk because he hurts.), HEADACHE (got deathly ill with headache), PYREXIA (fever) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced HEADACHE (got deathly ill with headache) and NAUSEA (nausea). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (he couldn't talk because he hurts.) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), PAIN (he couldn't talk because he hurts.), HEADACHE (got deathly ill with headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: significant pain and the injection site; swelling in her lymph nodes; rash at the injection site; injection site that is red; injection site that is itchy; weepy (rash); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (significant pain and the injection site), LYMPHADENOPATHY (swelling in her lymph nodes), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (injection site that is red) and VACCINATION SITE PRURITUS (injection site that is itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Radical mastectomy. Concurrent medical conditions included Cancer. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (significant pain and the injection site), LYMPHADENOPATHY (swelling in her lymph nodes), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (injection site that is red), VACCINATION SITE PRURITUS (injection site that is itchy) and RASH (weepy (rash)). At the time of the report, VACCINATION SITE PAIN (significant pain and the injection site), LYMPHADENOPATHY (swelling in her lymph nodes), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (injection site that is red), VACCINATION SITE PRURITUS (injection site that is itchy) and RASH (weepy (rash)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: significant pain and the injection site; swelling in her lymph nodes; rash at the injection site; injection site that is red; injection site that is itchy; weepy (rash); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (significant pain and the injection site), LYMPHADENOPATHY (swelling in her lymph nodes), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (injection site that is red) and VACCINATION SITE PRURITUS (injection site that is itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Radical mastectomy. Concurrent medical conditions included Cancer. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (significant pain and the injection site), LYMPHADENOPATHY (swelling in her lymph nodes), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (injection site that is red), VACCINATION SITE PRURITUS (injection site that is itchy) and RASH (weepy (rash)). At the time of the report, VACCINATION SITE PAIN (significant pain and the injection site), LYMPHADENOPATHY (swelling in her lymph nodes), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (injection site that is red), VACCINATION SITE PRURITUS (injection site that is itchy) and RASH (weepy (rash)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Nausea, Pyrexia, Vaccination site lymphadenopathy
Clinical narrative: Lymph nodes painful to the touch; Swollen lymph nodes on the arm where the vaccine was administered; Febrile; Fatigued; Nausea; Vomits; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPH NODE PAIN (Lymph nodes painful to the touch), NAUSEA (Nausea), VOMITING (Vomits), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes on the arm where the vaccine was administered) and PYREXIA (Febrile) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LANSOPRAZOLE and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) for an unknown indication.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomits). On 26-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes painful to the touch), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes on the arm where the vaccine was administered), PYREXIA (Febrile) and FATIGUE (Fatigued). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 09-Jan-2021, NAUSEA (Nausea) and VOMITING (Vomits) had resolved. On 26-Jan-2021, PYREXIA (Febrile) had resolved. At the time of the report, LYMPH NODE PAIN (Lymph nodes painful to the touch), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes on the arm where the vaccine was administered) and FATIGUE (Fatigued) 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.; 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Lymph nodes painful to the touch; Swollen lymph nodes on the arm where the vaccine was administered; Febrile; Fatigued; Nausea; Vomits; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPH NODE PAIN (Lymph nodes painful to the touch), NAUSEA (Nausea), VOMITING (Vomits), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes on the arm where the vaccine was administered) and PYREXIA (Febrile) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LANSOPRAZOLE and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) for an unknown indication.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomits). On 26-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes painful to the touch), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes on the arm where the vaccine was administered), PYREXIA (Febrile) and FATIGUE (Fatigued). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 09-Jan-2021, NAUSEA (Nausea) and VOMITING (Vomits) had resolved. On 26-Jan-2021, PYREXIA (Febrile) had resolved. At the time of the report, LYMPH NODE PAIN (Lymph nodes painful to the touch), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes on the arm where the vaccine was administered) and FATIGUE (Fatigued) 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.; 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: Nausea, Vomiting
Clinical narrative: Nauseated and throwing up; Had been throwing up; A spontaneous report was received from a Consumer concerning a 69-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling nauseated/ nausea and had been throwing up/ vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 032l70A) in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced feeling nauseated and had been throwing up.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, feeling nauseated and had been throwing up was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness leg; tingling; A spontaneous report  was received from a healthcare professional concerning a 35-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoesthesia (numbness leg) and paresthesia ( tingling).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced numbness in leg and tingling.  Treatment details included No.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events  was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (swollen lymph node above collar bone) and VACCINATION SITE PAIN (arm was sore and tender just above the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore and tender just above the injection site). On 29-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node above collar bone). At the time of the report, LYMPHADENOPATHY (swollen lymph node above collar bone) and VACCINATION SITE PAIN (arm was sore and tender just above the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Lethargy
Clinical narrative: red; sore; itchy arm at the injection site; headachy; nauseous; lethargic; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (sore), INJECTION SITE PRURITUS (itchy arm at the injection site), HEADACHE (headachy) and NAUSEA (nauseous) 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.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (sore), INJECTION SITE PRURITUS (itchy arm at the injection site), HEADACHE (headachy), NAUSEA (nauseous) and LETHARGY (lethargic). At the time of the report, INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (sore), INJECTION SITE PRURITUS (itchy arm at the injection site), HEADACHE (headachy), NAUSEA (nauseous) and LETHARGY (lethargic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: red; sore; itchy arm at the injection site; headachy; nauseous; lethargic; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (sore), INJECTION SITE PRURITUS (itchy arm at the injection site), HEADACHE (headachy) and NAUSEA (nauseous) 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.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (sore), INJECTION SITE PRURITUS (itchy arm at the injection site), HEADACHE (headachy), NAUSEA (nauseous) and LETHARGY (lethargic). At the time of the report, INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (sore), INJECTION SITE PRURITUS (itchy arm at the injection site), HEADACHE (headachy), NAUSEA (nauseous) and LETHARGY (lethargic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: Can't Walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can't Walk) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Can't Walk). At the time of the report, GAIT DISTURBANCE (Can't Walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: legs hurt so bad she cant walk; PAIN; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurt so bad she cant walk) and PAIN (PAIN) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    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 PAIN IN EXTREMITY (legs hurt so bad she cant walk) and PAIN (PAIN). At the time of the report, PAIN IN EXTREMITY (legs hurt so bad she cant walk) and PAIN (PAIN) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included non-specific diabetic medications. The patient thinks that the side effects were due to other medicines and she has reported to the other company.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: AE outcome, 2nd dose fine, no further follow up needed, other medical history updated
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pruritus
Clinical narrative: Itchiness; General body pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), PAIN (General body pain) and CHILLS (chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 20-Jul-1990.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (Itchiness), PAIN (General body pain) and CHILLS (chills). On 20-Feb-2021, PAIN (General body pain) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (Itchiness) had not resolved.            Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-102185, MOD-2021-102185 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Updated Patient details, demographics,Medical History, 2nd dose details, updated outcome of the event chills from Not recovered to Recovered. new event Body Pains added. updated action taken from Unknown to Not applicable and Reporter casualty to Possible
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Illness, Malaise, Nausea, Night sweats
Clinical narrative: nausea/feel like vomiting; he went straight to bed; he started to feel sick; sweated all night; havenot eaten; body shaking; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he started to feel sick), NIGHT SWEATS (sweated all night), DECREASED APPETITE (havenot eaten), TREMOR (body shaking) and NAUSEA (nausea/feel like vomiting) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TAMSULOSIN and LISINOPRIL for an unknown indication.    On 18-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 ILLNESS (he started to feel sick), NIGHT SWEATS (sweated all night), DECREASED APPETITE (havenot eaten), TREMOR (body shaking) and MALAISE (he went straight to bed). On an unknown date, the patient experienced NAUSEA (nausea/feel like vomiting). At the time of the report, ILLNESS (he started to feel sick), NIGHT SWEATS (sweated all night), DECREASED APPETITE (havenot eaten), TREMOR (body shaking), NAUSEA (nausea/feel like vomiting) and MALAISE (he went straight to bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment details was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: nausea/feel like vomiting; he went straight to bed; he started to feel sick; sweated all night; havenot eaten; body shaking; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he started to feel sick), NIGHT SWEATS (sweated all night), DECREASED APPETITE (havenot eaten), TREMOR (body shaking) and NAUSEA (nausea/feel like vomiting) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TAMSULOSIN and LISINOPRIL for an unknown indication.    On 18-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 ILLNESS (he started to feel sick), NIGHT SWEATS (sweated all night), DECREASED APPETITE (havenot eaten), TREMOR (body shaking) and MALAISE (he went straight to bed). On an unknown date, the patient experienced NAUSEA (nausea/feel like vomiting). At the time of the report, ILLNESS (he started to feel sick), NIGHT SWEATS (sweated all night), DECREASED APPETITE (havenot eaten), TREMOR (body shaking), NAUSEA (nausea/feel like vomiting) and MALAISE (he went straight to bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment details was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site induration, Pain, Swelling
Clinical narrative: Soreness; redness; swelling; reaction site was hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling) and INJECTION SITE INDURATION (reaction site was hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling) and INJECTION SITE INDURATION (reaction site was hard). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling) and INJECTION SITE INDURATION (reaction site was hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Broke out on arms; Arms were red; itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broke out on arms), ERYTHEMA (Arms were red) and PRURITUS (itching) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 11-Mar-2021, the patient experienced RASH (Broke out on arms), ERYTHEMA (Arms were red) and PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form twice a day. At the time of the report, RASH (Broke out on arms), ERYTHEMA (Arms were red) and PRURITUS (itching) outcome was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Local reaction, Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: delayed local reactions; itching (at injection site); Red (at injection site); swollen (at injection site); Aching; This spontaneous case was reported by a consumer and describes the occurrence of LOCAL REACTION (delayed local reactions), VACCINATION SITE PRURITUS (itching (at injection site)), MYALGIA (Aching), VACCINATION SITE ERYTHEMA (Red (at injection site)) and VACCINATION SITE SWELLING (swollen (at injection site)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE BESILATE (NORVASC) and QUINAPRIL for Hypertension, CELECOXIB (CELEBREX) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MYALGIA (Aching). On 31-Jan-2021, the patient experienced LOCAL REACTION (delayed local reactions), VACCINATION SITE PRURITUS (itching (at injection site)), VACCINATION SITE ERYTHEMA (Red (at injection site)) and VACCINATION SITE SWELLING (swollen (at injection site)). On 26-Jan-2021, MYALGIA (Aching) had resolved. On 02-Feb-2021, LOCAL REACTION (delayed local reactions), VACCINATION SITE PRURITUS (itching (at injection site)), VACCINATION SITE ERYTHEMA (Red (at injection site)) and VACCINATION SITE SWELLING (swollen (at injection site)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take anything to treat the symptoms.   This case was linked to MOD-2021-205797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Additional information received On 03-Jun-2021: Duplicate Email, NNI
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red) and PRURITUS (itchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 ERYTHEMA (Red) and PRURITUS (itchy). At the time of the report, ERYTHEMA (Red) and PRURITUS (itchy) outcome was unknown. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reported. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Warmth of left upper arm including injection site; Redness covered most of the Left Upper arm including injection site; Swelling eventually covered most of the upper arm including Injection site; Mild itching eventually covered most of the Left Upper arm including the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Warmth of left upper arm including injection site), ERYTHEMA (Redness covered most of the Left Upper arm including injection site), PERIPHERAL SWELLING (Swelling eventually covered most of the upper arm including Injection site) and PRURITUS (Mild itching eventually covered most of the Left Upper arm including the injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FEELING HOT (Warmth of left upper arm including injection site), ERYTHEMA (Redness covered most of the Left Upper arm including injection site), PERIPHERAL SWELLING (Swelling eventually covered most of the upper arm including Injection site) and PRURITUS (Mild itching eventually covered most of the Left Upper arm including the injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 09-Feb-2021, FEELING HOT (Warmth of left upper arm including injection site), ERYTHEMA (Redness covered most of the Left Upper arm including injection site), PERIPHERAL SWELLING (Swelling eventually covered most of the upper arm including Injection site) and PRURITUS (Mild itching eventually covered most of the Left Upper arm including the injection site) had resolved. 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 considered FEELING HOT (Warmth of left upper arm including injection site), ERYTHEMA (Redness covered most of the Left Upper arm including injection site), PERIPHERAL SWELLING (Swelling eventually covered most of the upper arm including Injection site) and PRURITUS (Mild itching eventually covered most of the Left Upper arm including the injection site) to be possibly related.    Concomitant product information was no reported.  Treatment information also included icepack.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received: Patient's race and ethnicity updated, treatment information and event related information was updated.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (it's driving her crazy) and VACCINATION SITE PRURITUS (the injection site got very itchy/it's 4 inches wide and 5 long) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. On 12-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 FEELING ABNORMAL (it's driving her crazy) and VACCINATION SITE PRURITUS (the injection site got very itchy/it's 4 inches wide and 5 long). The patient was treated with HYDROGEN PEROXIDE ongoing since an unknown date at an unspecified dose and frequency and HAMAMELIS VIRGINIANA LEAF (WITCH HAZEL LEAVES) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (it's driving her crazy) and VACCINATION SITE PRURITUS (the injection site got very itchy/it's 4 inches wide and 5 long) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications details included thyroid medication. Treatment included aloe gel.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: adverse reaction; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's covid-19 vaccine (mRNA-1273) and experienced adverse reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received unknown dose of mRNA-1273 (lot/batch: Unknown) unknown route and in unknown site of administration for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was experiencing some adverse reaction after taking the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of event, adverse reaction was not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested