chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: 100F temperature; chills; nausea; Headache; overall body ache; feels tired; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (100F temperature), CHILLS (chills), NAUSEA (nausea), HEADACHE (Headache) and MYALGIA (overall body ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (100F temperature), CHILLS (chills), NAUSEA (nausea), HEADACHE (Headache), MYALGIA (overall body ache) and FATIGUE (feels tired). At the time of the report, PYREXIA (100F temperature), CHILLS (chills), NAUSEA (nausea), HEADACHE (Headache), MYALGIA (overall body ache) and FATIGUE (feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.  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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 100F temperature; chills; nausea; Headache; overall body ache; feels tired; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (100F temperature), CHILLS (chills), NAUSEA (nausea), HEADACHE (Headache) and MYALGIA (overall body ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (100F temperature), CHILLS (chills), NAUSEA (nausea), HEADACHE (Headache), MYALGIA (overall body ache) and FATIGUE (feels tired). At the time of the report, PYREXIA (100F temperature), CHILLS (chills), NAUSEA (nausea), HEADACHE (Headache), MYALGIA (overall body ache) and FATIGUE (feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.  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.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pain
Clinical narrative: swelling on his ankle; felt a little achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt a little achy) and JOINT SWELLING (swelling on his ankle) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis.    On 27-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 PAIN (felt a little achy). On an unknown date, the patient experienced JOINT SWELLING (swelling on his ankle). At the time of the report, PAIN (felt a little achy) and JOINT SWELLING (swelling on his ankle) outcome was unknown. Not Provided      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 these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Epistaxis, Myalgia, Pain in extremity
Clinical narrative: some blood in nose, fever, and arm hurt; dizzy for a few days; some blood in nose, fever, and arm hurt; stomach pain and achy body; some blood in nose, fever, and arm hurt; stomach pain and achy body; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (some blood in nose, fever, and arm hurt), DIZZINESS (dizzy for a few days), PAIN IN EXTREMITY (some blood in nose, fever, and arm hurt), ABDOMINAL PAIN UPPER (stomach pain and achy body) and PYREXIA (some blood in nose, fever, and arm hurt) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Drug allergy (Flagyl, Levaquin, metronidazole, and pravastatin). Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), CETIRIZINE, LEVOTHYROXINE, EZETIMIBE (ZETIA), ACETYLSALICYLIC ACID (BAYER ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), APIXABAN (ELIQUIS) and LISINOPRIL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced EPISTAXIS (some blood in nose, fever, and arm hurt), DIZZINESS (dizzy for a few days), PAIN IN EXTREMITY (some blood in nose, fever, and arm hurt), ABDOMINAL PAIN UPPER (stomach pain and achy body), PYREXIA (some blood in nose, fever, and arm hurt) and MYALGIA (stomach pain and achy body). On 21-Jan-2021, DIZZINESS (dizzy for a few days) had resolved. At the time of the report, EPISTAXIS (some blood in nose, fever, and arm hurt), PAIN IN EXTREMITY (some blood in nose, fever, and arm hurt), ABDOMINAL PAIN UPPER (stomach pain and achy body), PYREXIA (some blood in nose, fever, and arm hurt) and MYALGIA (stomach pain and achy body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter states that HCP thinks epistaxis could be due to apixaban.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: some blood in nose, fever, and arm hurt; dizzy for a few days; some blood in nose, fever, and arm hurt; stomach pain and achy body; some blood in nose, fever, and arm hurt; stomach pain and achy body; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (some blood in nose, fever, and arm hurt), DIZZINESS (dizzy for a few days), PAIN IN EXTREMITY (some blood in nose, fever, and arm hurt), ABDOMINAL PAIN UPPER (stomach pain and achy body) and PYREXIA (some blood in nose, fever, and arm hurt) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Drug allergy (Flagyl, Levaquin, metronidazole, and pravastatin). Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), CETIRIZINE, LEVOTHYROXINE, EZETIMIBE (ZETIA), ACETYLSALICYLIC ACID (BAYER ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), APIXABAN (ELIQUIS) and LISINOPRIL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced EPISTAXIS (some blood in nose, fever, and arm hurt), DIZZINESS (dizzy for a few days), PAIN IN EXTREMITY (some blood in nose, fever, and arm hurt), ABDOMINAL PAIN UPPER (stomach pain and achy body), PYREXIA (some blood in nose, fever, and arm hurt) and MYALGIA (stomach pain and achy body). On 21-Jan-2021, DIZZINESS (dizzy for a few days) had resolved. At the time of the report, EPISTAXIS (some blood in nose, fever, and arm hurt), PAIN IN EXTREMITY (some blood in nose, fever, and arm hurt), ABDOMINAL PAIN UPPER (stomach pain and achy body), PYREXIA (some blood in nose, fever, and arm hurt) and MYALGIA (stomach pain and achy body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter states that HCP thinks epistaxis could be due to apixaban.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: some numbness on her tongue, right side of her tongue and lips became numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (some numbness on her tongue, right side of her tongue and lips became numb) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (some numbness on her tongue, right side of her tongue and lips became numb). At the time of the report, HYPOAESTHESIA ORAL (some numbness on her tongue, right side of her tongue and lips became numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: itching on his chest up to his hair and said it lasted for 20-25minutes.; sore arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on his chest up to his hair and said it lasted for 20-25minutes.) and PAIN IN EXTREMITY (sore arms) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (itching on his chest up to his hair and said it lasted for 20-25minutes.) and PAIN IN EXTREMITY (sore arms). On 28-Jan-2021, PRURITUS (itching on his chest up to his hair and said it lasted for 20-25minutes.) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Shingles (About 10-12 days after receiving the vaccine, her shingles reactivated and she got the shingles infection. She originally had shingles when she was 32 years old.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided; The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product used was unknown. Treatment information was not provided. Reporter did not allow further contact; Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient demographics were updated. The reporter stated the patient is not themselves. The patient is an unknown patient with unknown details and no way to contact them.
Sex: U
Vaccine: COVID19
Symptoms: Product packaging issue
Clinical narrative: Product packaging issue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT PACKAGING ISSUE (Product packaging issue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced PRODUCT PACKAGING ISSUE (Product packaging issue). At the time of the report, PRODUCT PACKAGING ISSUE (Product packaging issue) had resolved.        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.   Additional information: 1 vial short 1 dose, 1 vial short 2 doses, stated patients received all other doses in either vial.  Concomitant and treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: email received
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bleeding after injection; A spontaneous report  was received from a Consumer concerning a 89 Years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeding after injection.  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 their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced bleeding after injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymphadenopathy, Musculoskeletal discomfort
Clinical narrative: discomfort in the elbow; swelling on the outside and inside of her elbow; swollen lymph node; A spontaneous report was received from a consumer concerning herself, of unknown age, female patient who experienced discomfort in the elbow/musculoskeletal discomfort, musculoskeletal discomfort/joint swelling, swollen lymph node/lymphadenopathy.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) on 25 Jan 2021 at unknown injection site for prophylaxis of COVID-19 infection.    On 25 Jan 2021 the patient discomfort in the elbow of the arm where she got the injection. Later that evening, she noticed a swelling on the outside and inside of her elbow. It was larger and harder but did go down a bit and was still swollen. She thought it was a swollen lymph node and wanted to make sure this was normal. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events discomfort in the elbow, musculoskeletal discomfort, swollen lymph node was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: really sick; leg really hurt bad; HIGH FEVER; feeling exhausted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really sick), PAIN IN EXTREMITY (leg really hurt bad), PYREXIA (HIGH FEVER) and FATIGUE (feeling exhausted) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 07-Dec-2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION COMPLICATION (really sick), PAIN IN EXTREMITY (leg really hurt bad), PYREXIA (HIGH FEVER) and FATIGUE (feeling exhausted). At the time of the report, VACCINATION COMPLICATION (really sick), PAIN IN EXTREMITY (leg really hurt bad), PYREXIA (HIGH FEVER) and FATIGUE (feeling exhausted) 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.  Treatment details included Ibuprofen and Tylenol.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at the injection site; swollen lymph nodes;  A spontaneous report was received from a Healthcare Professional concerning a 38 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, redness at the injection site, swollen lymph nodes. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events, redness at the injection site . On an unknown date, the patient experienced the events, swollen lymph nodes. Treatment details included Benadryl and Tylenol Action taken with mRNA-1273 in response to the events, redness at the injection site, swollen lymph nodes was not reported.   On an unknown date the outcome of events include, redness at the injection site, swollen lymph nodes was not reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick feeling stomach), DIZZINESS (really dizzy had to lay down), HEADACHE (light headache) and DIZZINESS (lightheaded) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LORATADINE (CLARITIN [LORATADINE]) and VITAMINS NOS for an unknown indication. On 28-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 ILLNESS (sick feeling stomach), DIZZINESS (really dizzy had to lay down), HEADACHE (light headache) and DIZZINESS (lightheaded). The patient was treated with IBUPROFEN (ADVIL 12HOUR) ongoing since an unknown date at an unspecified dose and frequency. On 28-Jan-2021, ILLNESS (sick feeling stomach), DIZZINESS (really dizzy had to lay down), HEADACHE (light headache) and DIZZINESS (lightheaded) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. corrective treatment included 2 IBUPROFEN and drank water. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Event outcome updated.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache
Clinical narrative: stomachache; small headche; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), HEADACHE (small headche) and CHILLS (chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012120A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomachache), HEADACHE (small headche) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN UPPER (stomachache), HEADACHE (small headche) and CHILLS (chills) had resolved.            No concomitant medication reported   No treatment medication reported   This case was linked to MOD-2021-019373 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR added on 25-MAY-2021 and outcome of the events are updated and contact details updated
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: SIGNIFICANT SIDE EFFECTS; A spontaneous report was received from a Consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events significant side effects.  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 their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number)  for prophylaxis of COVID-19 infection.   on an unknown date, patient experienced significant side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the outcome of event, significant side effects was not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and GLIPIZIDE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Decreased activity, Feeling abnormal, Injection site induration, Injection site reaction
Clinical narrative: felt pretty horrible; unable to work; developed induration at the site of injection.; developed allergic sort of reaction at the site of injection.; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (felt pretty horrible), DECREASED ACTIVITY (unable to work), INJECTION SITE INDURATION (developed induration at the site of injection.) and INJECTION SITE REACTION (developed allergic sort of reaction at the site of injection.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 INDURATION (developed induration at the site of injection.) and INJECTION SITE REACTION (developed allergic sort of reaction at the site of injection.). On an unknown date, the patient experienced FEELING ABNORMAL (felt pretty horrible) and DECREASED ACTIVITY (unable to work). At the time of the report, FEELING ABNORMAL (felt pretty horrible), DECREASED ACTIVITY (unable to work), INJECTION SITE INDURATION (developed induration at the site of injection.) and INJECTION SITE REACTION (developed allergic sort of reaction at the site of injection.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter.  No treatment information was provided.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Fear, Feeling abnormal, Hypoaesthesia
Clinical narrative: red patch a few inches away from the injection site; got bigger; Itchier; whole left side of the body was feeling weird; was feeling numb Even under her armpit by her nodes; anxiety; Scared; sore arm; tired; A spontaneous report () was received from a Consumer concerning a 49 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, sore arm, tired, red patch a few inches away from the injection site, got bigger, itchier, whole left side of the body was feeling weird, was feeling numb, under her armpit by her nodes, anxiety, scared. The patient's medical history was not provided. Concomitant medications reported were Asmanex, Nasonex, allergy eye drops, vitamins for drug use for unknown indication. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced the events, sore arm. tired. On 30 Jan 2021, the patient experienced the events, red patch a few inches away from the injection site. got bigger, itchier, whole left side of the body was feeling weird, was feeling numb, under her armpit by her nodes, anxiety, scared. Treatment details included Benadryl Action taken with mRNA-1273 in response to the events, sore arm, tired, red patch a few inches away from the injection site, got bigger, itchier, whole left side of the body was feeling weird, was feeling numb, under her armpit by her nodes, anxiety, scared was not reported.   On an unknown date the outcome of events include, sore arm, tired, red patch a few inches away from the injection site, got bigger, itchier, whole left side of the body was feeling weird was feeling numb, under her armpit by her nodes, anxiety, scared was not reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Pain in extremity, Vaccination site pruritus
Clinical narrative: red patch a few inches away from the injection site; got bigger; Itchier; whole left side of the body was feeling weird; was feeling numb Even under her armpit by her nodes; anxiety; Scared; sore arm; tired; A spontaneous report () was received from a Consumer concerning a 49 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, sore arm, tired, red patch a few inches away from the injection site, got bigger, itchier, whole left side of the body was feeling weird, was feeling numb, under her armpit by her nodes, anxiety, scared. The patient's medical history was not provided. Concomitant medications reported were Asmanex, Nasonex, allergy eye drops, vitamins for drug use for unknown indication. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced the events, sore arm. tired. On 30 Jan 2021, the patient experienced the events, red patch a few inches away from the injection site. got bigger, itchier, whole left side of the body was feeling weird, was feeling numb, under her armpit by her nodes, anxiety, scared. Treatment details included Benadryl Action taken with mRNA-1273 in response to the events, sore arm, tired, red patch a few inches away from the injection site, got bigger, itchier, whole left side of the body was feeling weird, was feeling numb, under her armpit by her nodes, anxiety, scared was not reported.   On an unknown date the outcome of events include, sore arm, tired, red patch a few inches away from the injection site, got bigger, itchier, whole left side of the body was feeling weird was feeling numb, under her armpit by her nodes, anxiety, scared was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Generalized body itch; Bumps around neck; Rashes all over the body; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (Generalized body itch), RASH PAPULAR (Bumps around neck) and RASH (Rashes all over the body) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (Generalized body itch), RASH PAPULAR (Bumps around neck) and RASH (Rashes all over the body). At the time of the report, PRURITUS (Generalized body itch), RASH PAPULAR (Bumps around neck) and RASH (Rashes all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events of itching, skin papule and generalized rash, a causal relationship cannot be excluded.; 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 of itching, skin papule and generalized rash, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Chills; Headache; Dizziness; Nausea; Low graded fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (Low graded fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (Low graded fever). At the time of the report, CHILLS (Chills), HEADACHE (Headache), DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (Low graded fever) had resolved.            No concomitant medications were reported.  The patient used Acetaminophen to alleviate the symptoms  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Red - Near Injection Site; Swollen - Near Injection Site; Itchy Sensation - Near Injection Site; Sore Arm; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, red near injection site, swollen near injection site, itchy sensation near injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the events sore arm .  On 31 Jan 2021, the patient experienced the events red near injection site, swollen near injection site, itchy sensation near injection site.  Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events was not reported.  On 1 Feb 2021 the outcome of events sore arm was resolved. On 1 Feb 2021 the outcome of events red near injection site, swollen near injection site, itchy sensation near injection site was not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: little nauseated; arm hurting; 99.4°F fever; A spontaneous report was received from a Consumer concerning a 80 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, arm hurting, 99.4â°f fever, little nauseated, just doesn't felt good, the side effects didn't lasted more than a day. The patient's medical history was not provided. Concomitant medications reported were Cintroid, Climara, Hemotoplin, Baby aspirin every night, TRN Hydroxine anxiety for drug use for unknown indication. On 7 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 8 Jan 2021, the patient experienced the events, arm hurting. 99.4â°f fever, little nauseated, just doesn't felt good. On an unknown date, the patient experienced the events, the side effects didn't lasted more than a day. Treatment details included Tylenol after the vaccine for the pain. When started with the fever took tylenol. Action taken with mRNA-1273 in response to the events, arm hurting, 99.4â°f fever, little nauseated, just doesn't felt good, the side effects didn't lasted more than a day was not reported.  On 9 Jan 2021 the outcome of events, arm hurting was resolved., 99.4â°f fever was resolved., little nauseated was resolved., just doesn't felt good was resolved. On an unknown date the outcome of events include, the side effects didn't lasted more than a day was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Pain in extremity
Clinical narrative: severe quaking chills; severe pain in leg bone; severe pain in shin; severe pain in knees; severe pain in hip joint; A spontaneous report (United States) was received from a Consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe quaking chills, severe pain in leg bone, severe pain in shin, severe pain in knees, severe pain in hip joint.   The patient's medical history reported included Seasonal allergies and history of Lung cancer.  Concomitant medications reported were Protonix, Eliquis, Lasix, Aldactone for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the events severe quaking chills, severe pain in leg bone, severe pain in shin, severe pain in knees, severe pain in hip joint and also mentioned that the pain was similar to the pain she had during chemotherapy.  Treatment details included Tylenol, topical ointment and Tramadol  Action taken with mRNA-1273 in response to the events was not reported.   On 1 Feb 2021, the outcome of events include, severe quaking chills, severe pain in leg bone, severe pain in shin, severe pain in knees, severe pain in hip joint, the pain was similar to the pain she had during chemotherapy was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Myalgia, Pyrexia
Clinical narrative: felt very cold/shakes; muscle and joint pains; muscle and joint pains; Fever; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (felt very cold/shakes), MYALGIA (muscle and joint pains), ARTHRALGIA (muscle and joint pains) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING COLD (felt very cold/shakes), MYALGIA (muscle and joint pains), ARTHRALGIA (muscle and joint pains) and PYREXIA (Fever). At the time of the report, FEELING COLD (felt very cold/shakes), MYALGIA (muscle and joint pains), ARTHRALGIA (muscle and joint pains) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: had a little bit of discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (had a little bit of discomfort) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced DISCOMFORT (had a little bit of discomfort). At the time of the report, DISCOMFORT (had a little bit of discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Swelling; Itchiness; Redness 4 inches/redness was 8x6inches which extended from shoulder towards elbow; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness 4 inches/redness was 8x6inches which extended from shoulder towards elbow), FEELING HOT (Warm to touch) and SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness 4 inches/redness was 8x6inches which extended from shoulder towards elbow) and FEELING HOT (Warm to touch). On 03-Feb-2021, the patient experienced SWELLING (Swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Redness 4 inches/redness was 8x6inches which extended from shoulder towards elbow), FEELING HOT (Warm to touch) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Ice. Concomitant information not provided
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effect after first COVID vaccine; A spontaneous report was received from a Consumer concerning a 2021- Years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, side effect after first covid vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced the events, side effect after first covid vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events, side effect after first covid vaccine was not reported.   On an unknown date the outcome of events include, side effect after first covid vaccine was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: The lymph nodes of her arm and neck became really swollen and hard to the touch which she; A spontaneous report was received from a Consumer concerning a 22 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lymphadenopathy.  The patient's medical history was not provided. Vitamins were reported as the concomitant medications.  On 12-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027l20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16-JAN-2021, after 4/5 days receiving the first dose of vaccine, the lymph nodes of her arm and neck became really swollen and hard to the touch which she described as very painful. The symptoms lasted for a week and thus the patient visited  a healthcare professional who advised her to take Tylenol. But the patient did not take the medicine.  Action taken with mRNA-1273 in response to the events was not reported.   On 23-JAN-2021, the outcome of the event was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Tenderness
Clinical narrative: Redness around injection site; Redness was warm to touch; Tenderness; 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, redness around injection site, redness was warm to touch, tenderness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced the events, redness around injection site. redness was warm to touch, tenderness. Treatment details included None Action taken with mRNA-1273 in response to the events, redness around injection site, redness was warm to touch, tenderness was not reported.   On an unknown date the outcome of events include, redness around injection site, redness was warm to touch, tenderness was not reported.  Based on comment, (redness around injection site) causality assessment is missing. Possibly related would likely be entered in this field
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot injection site; Itchy injection site; Red injection site; Swollen injection site; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red injection site, hot injection site, swollen injection site, itchy injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced red and swollen injection site.   On 30 Jan 2021, the patient experienced hot injection site and itchy injection site.  No treatment information was provided.  Laboratory investigation details were not provided.  Action taken with mRNA-1273 in response to the events was unknown.   On 20 Jan 2021 the outcome of red injection site and swollen injection site were resolved. On 30 Jan 2021 the outcome of hot injection site, itchy injection site were resolved. .
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness at the injection site; Swelling at the injection site; A spontaneous report was received from a Consumer concerning a 75-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at the injection site and swelling at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced the events redness at the injection site and swelling at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   the outcome of events redness at the injection site and swelling at the injection site was resolved on 23 Jan 2021. .
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: warm to the touch at the injection site; itchy at the injection site; red knot at the injection site; Arm soreness; pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE PAIN (pain at the site of the injection) and VACCINATION SITE ERYTHEMA (red knot at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PAIN (pain at the site of the injection). On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red knot at the injection site). At the time of the report, PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE PAIN (pain at the site of the injection) and VACCINATION SITE ERYTHEMA (red knot at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment taken and symptoms have subsided.