chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: about one-half hour later, she experienced a minimal sore arm; minimal soreness is off and on and ongoing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (about one-half hour later, she experienced a minimal sore arm) and PAIN (minimal soreness is off and on and ongoing) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (about one-half hour later, she experienced a minimal sore arm) and PAIN (minimal soreness is off and on and ongoing). At the time of the report, PAIN IN EXTREMITY (about one-half hour later, she experienced a minimal sore arm) and PAIN (minimal soreness is off and on and ongoing) had resolved.            No concomitant medications were reported.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: FU-1 is added and the outcome of events are updated.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Headache; Redness at injection site; Itching at the injection site; Chills; fever of 107; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever of 107), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever of 107). On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itching at the injection site). On 18-Jan-2021, the patient experienced HEADACHE (Headache). On 10-Jan-2021, CHILLS (Chills) and PYREXIA (fever of 107) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Nausea, Pain in extremity
Clinical narrative: nausea; hard time trying to eat; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DYSPHAGIA (hard time trying to eat) and PAIN IN EXTREMITY (sore arm) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 103L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced NAUSEA (nausea), DYSPHAGIA (hard time trying to eat) and PAIN IN EXTREMITY (sore arm). At the time of the report, NAUSEA (nausea), DYSPHAGIA (hard time trying to eat) and PAIN IN EXTREMITY (sore arm) 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: have redness around the injection site; it feels hot; little bit hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (have redness around the injection site), VACCINATION SITE WARMTH (it feels hot) and VACCINATION SITE INDURATION (little bit hard) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (have redness around the injection site), VACCINATION SITE WARMTH (it feels hot) and VACCINATION SITE INDURATION (little bit hard). At the time of the report, VACCINATION SITE ERYTHEMA (have redness around the injection site), VACCINATION SITE WARMTH (it feels hot) and VACCINATION SITE INDURATION (little bit hard) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache
Clinical narrative: headache; coughing at night; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and COUGH (coughing at night) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Headache and Coughing.    On 08-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 HEADACHE (headache) and COUGH (coughing at night). At the time of the report, HEADACHE (headache) and COUGH (coughing at night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swelling face
Clinical narrative: facial swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (facial swelling) and HEADACHE (headache). At the time of the report, SWELLING FACE (facial swelling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021 contains NNI On 26-Jul-2021: Follow up received on 26-Jul-2021 and contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Peripheral swelling
Clinical narrative: Arm was swollen; woke up with terrible chills that lasted 45-60 minutes; Her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Her arm was sore), PERIPHERAL SWELLING (Arm was swollen) and CHILLS (woke up with terrible chills that lasted 45-60 minutes) 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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced ARTHRALGIA (Her arm was sore). On 18-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen) and CHILLS (woke up with terrible chills that lasted 45-60 minutes). At the time of the report, ARTHRALGIA (Her arm was sore), PERIPHERAL SWELLING (Arm was swollen) and CHILLS (woke up with terrible chills that lasted 45-60 minutes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Vaccination site erythema
Clinical narrative: Redness at the injection site; Throat felt thick; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat felt thick) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 56-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 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PHARYNGEAL SWELLING (Throat felt thick). On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). On 18-Jan-2021, PHARYNGEAL SWELLING (Throat felt thick) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No new information received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Fatigue, Injection site pain, Lip swelling
Clinical narrative: big fat lip; light bloody nose; bad dizziness; muscle ache; fatigue; pain and sore over the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache), FATIGUE (fatigue), LIP SWELLING (big fat lip), EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness) in a female patient of an unknown age 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 05-Jan-2021 at 5:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (pain and sore over the injection site). On 06-Jan-2021, the patient experienced MYALGIA (muscle ache) and FATIGUE (fatigue). On 07-Jan-2021, the patient experienced LIP SWELLING (big fat lip), EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Jan-2021 for Lip swelling, at an unspecified dose and frequency. On 07-Jan-2021, MYALGIA (muscle ache) had resolved. On 08-Jan-2021, EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness) had resolved. At the time of the report, FATIGUE (fatigue), LIP SWELLING (big fat lip) and INJECTION SITE PAIN (pain and sore over the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: big fat lip; light bloody nose; bad dizziness; muscle ache; fatigue; pain and sore over the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache), FATIGUE (fatigue), LIP SWELLING (big fat lip), EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness) in a female patient of an unknown age 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 05-Jan-2021 at 5:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (pain and sore over the injection site). On 06-Jan-2021, the patient experienced MYALGIA (muscle ache) and FATIGUE (fatigue). On 07-Jan-2021, the patient experienced LIP SWELLING (big fat lip), EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Jan-2021 for Lip swelling, at an unspecified dose and frequency. On 07-Jan-2021, MYALGIA (muscle ache) had resolved. On 08-Jan-2021, EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness) had resolved. At the time of the report, FATIGUE (fatigue), LIP SWELLING (big fat lip) and INJECTION SITE PAIN (pain and sore over the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medication was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Vaccination site pain
Clinical narrative: sense of smells vastly enhanced; pain at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Loss of smell in 2019, Hearing loss in 2019 and Taste loss in 2019.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications used were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: widwly spread reaction in the arm up to the elbow; wide spread reaction at the injection site, redness and itching of the arm; wide spread reaction at the injection site, redness and itching of the arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (wide spread reaction at the injection site, redness and itching of the arm), VACCINATION SITE PRURITUS (wide spread reaction at the injection site, redness and itching of the arm) and ADVERSE REACTION (widwly spread reaction in the arm up to the elbow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Low blood pressure. Concomitant products included LISINOPRIL for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (wide spread reaction at the injection site, redness and itching of the arm) and VACCINATION SITE PRURITUS (wide spread reaction at the injection site, redness and itching of the arm). On 17-Jan-2021, the patient experienced ADVERSE REACTION (widwly spread reaction in the arm up to the elbow). At the time of the report, VACCINATION SITE ERYTHEMA (wide spread reaction at the injection site, redness and itching of the arm), VACCINATION SITE PRURITUS (wide spread reaction at the injection site, redness and itching of the arm) and ADVERSE REACTION (widwly spread reaction in the arm up to the elbow) outcome was unknown. Not Provided      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.   Treatment drug included Tylenol and benadryl; 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Genitals enlarged, Headache, Myalgia
Clinical narrative: a lot of headache; fever; nausea; vomit; dilation of the genitals; tingling on her arms and legs; pain in the abdominal area; pain in the legs; a lot of muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a lot of headache), PYREXIA (fever), CHILLS (chills), ABDOMINAL PAIN (pain in the abdominal area) and PAIN IN EXTREMITY (pain in the legs) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Type 2 diabetes mellitus, Hypertension and High cholesterol. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN, GEMFIBROZIL, ROSUVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills) and MYALGIA (a lot of muscle pain). On 17-Jan-2021, the patient experienced ABDOMINAL PAIN (pain in the abdominal area), PAIN IN EXTREMITY (pain in the legs), GENITALS ENLARGED (dilation of the genitals) and PARAESTHESIA (tingling on her arms and legs). On 18-Jan-2021, the patient experienced HEADACHE (a lot of headache), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomit). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. On 18-Jan-2021, CHILLS (chills), ABDOMINAL PAIN (pain in the abdominal area), PAIN IN EXTREMITY (pain in the legs), MYALGIA (a lot of muscle pain), GENITALS ENLARGED (dilation of the genitals) and PARAESTHESIA (tingling on her arms and legs) had resolved. At the time of the report, HEADACHE (a lot of headache), NAUSEA (nausea) and VOMITING (vomit) outcome was unknown and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided was Ibuprofen and Acetaminophen.; 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: a lot of headache; fever; nausea; vomit; dilation of the genitals; tingling on her arms and legs; pain in the abdominal area; pain in the legs; a lot of muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a lot of headache), PYREXIA (fever), CHILLS (chills), ABDOMINAL PAIN (pain in the abdominal area) and PAIN IN EXTREMITY (pain in the legs) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Type 2 diabetes mellitus, Hypertension and High cholesterol. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN, GEMFIBROZIL, ROSUVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills) and MYALGIA (a lot of muscle pain). On 17-Jan-2021, the patient experienced ABDOMINAL PAIN (pain in the abdominal area), PAIN IN EXTREMITY (pain in the legs), GENITALS ENLARGED (dilation of the genitals) and PARAESTHESIA (tingling on her arms and legs). On 18-Jan-2021, the patient experienced HEADACHE (a lot of headache), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomit). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. On 18-Jan-2021, CHILLS (chills), ABDOMINAL PAIN (pain in the abdominal area), PAIN IN EXTREMITY (pain in the legs), MYALGIA (a lot of muscle pain), GENITALS ENLARGED (dilation of the genitals) and PARAESTHESIA (tingling on her arms and legs) had resolved. At the time of the report, HEADACHE (a lot of headache), NAUSEA (nausea) and VOMITING (vomit) outcome was unknown and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided was Ibuprofen and Acetaminophen.; 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 pruritus, Vaccination site swelling
Clinical narrative: itchy; swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. No treatment details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis
Clinical narrative: sweat; Chills; Headache; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (sweat), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chills (No reported medical history), Headache, Joint pain and Nausea.    On 16-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 HYPERHIDROSIS (sweat), CHILLS (Chills) and HEADACHE (Headache). On 17-Jan-2021, HYPERHIDROSIS (sweat), CHILLS (Chills) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed with Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (diagnosed with Shingles) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HERPES ZOSTER (diagnosed with Shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (diagnosed with Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and RHINORRHOEA (Runny nose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and RHINORRHOEA (Runny nose). At the time of the report, VACCINATION SITE PAIN (Sore arm) and RHINORRHOEA (Runny nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on her arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash on her arm at the injection site). At the time of the report, VACCINATION SITE RASH (Rash on her arm at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Vaccination site pruritus
Clinical narrative: localized reaction at the injection site, 23cm x 29cm; itching and extending towords elbow; 5cm, typical local redness at the site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION (localized reaction at the injection site, 23cm x 29cm), VACCINATION SITE PRURITUS (itching and extending towords elbow) and INJECTION SITE ERYTHEMA (5cm, typical local redness at the site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching and extending towords elbow) and INJECTION SITE ERYTHEMA (5cm, typical local redness at the site). On an unknown date, the patient experienced INJECTION SITE REACTION (localized reaction at the injection site, 23cm x 29cm). The patient was treated with DOXYCYCLINE HYDROCHLORIDE (DOXY [DOXYCYCLINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency; PREDNISOLONE for Itching, at a dose of 5 milligram three times a day; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Scratch and Local reaction, at a dose of UNK, qd and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Local reaction and Scratch, at an unspecified dose and frequency. At the time of the report, INJECTION SITE REACTION (localized reaction at the injection site, 23cm x 29cm), VACCINATION SITE PRURITUS (itching and extending towords elbow) and INJECTION SITE ERYTHEMA (5cm, typical local redness at the site) had not 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 did not provide any causality assessments.   No concomitant medication provided
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Big and itchy at injection site; Redness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Big and itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unkwown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 09-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 VACCINATION SITE PRURITUS (Big and itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, Swelling and Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Big and itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: small bumps developed with itchiness and redness; rash/Bumps developed all over the; This spontaneous case was reported by a health care professional and describes the occurrence of RASH ERYTHEMATOUS (small bumps developed with itchiness and redness), RASH PRURITIC (small bumps developed with itchiness and redness) and RASH (rash/Bumps developed all over the) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.  No medical history was provided by the reporter. Concomitant products included OMEPRAZOLE.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced RASH (rash/Bumps developed all over the). On 15-Jan-2021, the patient experienced RASH ERYTHEMATOUS (small bumps developed with itchiness and redness) and RASH PRURITIC (small bumps developed with itchiness and redness). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency; PROBIOTICS NOS at an unspecified dose and frequency and VITAMINS NOS at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (small bumps developed with itchiness and redness), RASH PRURITIC (small bumps developed with itchiness and redness) and RASH (rash/Bumps developed all over the) 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.  Concomitant medications Omeprazole. Treatment medications Allegra, Probiotic, Vitamins.  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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: welt on the injection site the size of a silver dollar which was itchy; Itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (welt on the injection site the size of a silver dollar which was itchy) and INJECTION SITE PRURITUS (Itching at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE URTICARIA (welt on the injection site the size of a silver dollar which was itchy) and INJECTION SITE PRURITUS (Itching at injection site). The patient was treated with STEROIDS CREAM (topical) on 07-Jan-2021 for Itching, at a dose of 1 dosage form. On 10-Jan-2021, INJECTION SITE URTICARIA (welt on the injection site the size of a silver dollar which was itchy) and INJECTION SITE PRURITUS (Itching at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Non significant follow up received. On 14-Apr-2021: Non-significant Follow-up appended: updated contact information, last name correction.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by an other and describes the occurrence of COVID-19 (tested positive for COVID-19) 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 COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitants or treatment medications were reported.  Sender's Comments: Based on biological implausibility the event of COVID-19 test positive is assessed as unlikely related to mRNA-1273. Very limited information regarding this event/s has been provided at this time. Further information has been requested
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Faeces discoloured, Fatigue, Frequent bowel movements, Haematochezia
Clinical narrative: Hi. I am registered nurse. I got my vaccine 08/10/21 at pharmacy at 09:15 am. I felt fatigue and and pain/soreness on my left arm. It feel heavy too. I had my bowel movement today four times already. First three times of my BM, the stool?s consistency was semi-formed. My latest bowel movement which was around 11:45 pm - 08/10/21. It was a bright red bloody stool. I am worried and still watching out for my symptoms. I don?t have a primacy care physician right now because I don?t have insurance. Can you help me with this?
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Hi. I am registered nurse. I got my vaccine 08/10/21 at pharmacy at 09:15 am. I felt fatigue and and pain/soreness on my left arm. It feel heavy too. I had my bowel movement today four times already. First three times of my BM, the stool?s consistency was semi-formed. My latest bowel movement which was around 11:45 pm - 08/10/21. It was a bright red bloody stool. I am worried and still watching out for my symptoms. I don?t have a primacy care physician right now because I don?t have insurance. Can you help me with this?
Age: 66.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Hypotension
Clinical narrative: SEVERE HYPOTENSION WITH CARDIAC ARREST
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: site of injection hard; site of injection swollen; Arm hurt and  site of injection spread all over the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Arm hurt and  site of injection spread all over the arm), VACCINATION SITE SWELLING (site of injection swollen) and VACCINATION SITE INDURATION (site of injection hard) in a 63-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 provided).    On 09-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 VACCINATION SITE PAIN (Arm hurt and  site of injection spread all over the arm). On 17-Jan-2021, the patient experienced VACCINATION SITE SWELLING (site of injection swollen). On an unknown date, the patient experienced VACCINATION SITE INDURATION (site of injection hard). The patient was treated with AMOXICILLIN (oral) for Pain and Swelling, at a dose of 500 mg. At the time of the report, VACCINATION SITE PAIN (Arm hurt and  site of injection spread all over the arm) had not resolved and VACCINATION SITE SWELLING (site of injection swollen) and VACCINATION SITE INDURATION (site of injection hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Acute coronary syndrome
Clinical narrative: ACUTE CORONARY SYNDROM
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Gait inability, Mobility decreased, Parkinson's disease
Clinical narrative: Two days after having received the vaccine and being practically normal in life with the medications that I was taking for Parkinson's, all the symptoms I had worsened, and I had to spend more than 8 hours laying down because I could not walk or move. Recovering little by little and I can already spend more than 6 hours started doing things normally. I am afraid to get the second dose because I do not know how I will react even though my doctor tells me she does not think it was the vaccine but I know myself and I feel that it was the vaccine. I would like them to communicate with me to explain in more details because here I do not have the space to check it in the way and I could explain.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: At 11:12am pt c/o increase heart rate due to anxiety and tingling numbness in last 2 fingers of left arm. Vital taken at 11:12am - BP: 159/116. HR: 75. SpO2: 100% Vital taken at 11:30am - BP: 160/112. HR 75. SpO2: 100% Nurse practitioner on site did the assessment on pt and did not call EMS. Advise pt to see PCP for high blood pressure.  Pt left site in stable condition.
Age: 90.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: CARDIAC ARREST
Age: 69.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Sudden cardiac death
Clinical narrative: SUDDEN CARDIAC DEATH
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: CARDIAC ARREST
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Cardiac flutter, Chest X-ray, Chest discomfort
Clinical narrative: Beginning on August 4th I started feeling a heavy chest with pressure. That continued until the 6th of August when I developed shortness of breath as well. Extreme fatigue, the feeling of a fluttering heart, and skipping beats developed on the 7th as well as the extreme chest pressure still being present. I have been seen at the hospital twice now due to these very worrisome and scary symptoms.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Extrasystoles, Fatigue, Fear
Clinical narrative: Beginning on August 4th I started feeling a heavy chest with pressure. That continued until the 6th of August when I developed shortness of breath as well. Extreme fatigue, the feeling of a fluttering heart, and skipping beats developed on the 7th as well as the extreme chest pressure still being present. I have been seen at the hospital twice now due to these very worrisome and scary symptoms.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Cerebrovascular accident, Condition aggravated
Clinical narrative: Stroke
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest pain, Diarrhoea, Headache
Clinical narrative: chest pain; racing heart; muscle ache; really shaking up; bad lower back pain; headache; nausea; diarrhea; she feels weak; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), PALPITATIONS (racing heart), MYALGIA (muscle ache), NERVOUSNESS (really shaking up) and BACK PAIN (bad lower back pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHEST PAIN (chest pain), PALPITATIONS (racing heart), MYALGIA (muscle ache), NERVOUSNESS (really shaking up), BACK PAIN (bad lower back pain), HEADACHE (headache), NAUSEA (nausea), DIARRHOEA (diarrhea) and ASTHENIA (she feels weak). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, Muscle ache and Back pain, at an unspecified dose and frequency and CELASTRUS PANICULATUS, CENTELLA ASIATICA, VALERIANA JATAMANSI (SLEEP TEA) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain), PALPITATIONS (racing heart), MYALGIA (muscle ache), NERVOUSNESS (really shaking up), BACK PAIN (bad lower back pain), HEADACHE (headache), NAUSEA (nausea), DIARRHOEA (diarrhea) and ASTHENIA (she feels weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Nervousness, Palpitations
Clinical narrative: chest pain; racing heart; muscle ache; really shaking up; bad lower back pain; headache; nausea; diarrhea; she feels weak; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), PALPITATIONS (racing heart), MYALGIA (muscle ache), NERVOUSNESS (really shaking up) and BACK PAIN (bad lower back pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHEST PAIN (chest pain), PALPITATIONS (racing heart), MYALGIA (muscle ache), NERVOUSNESS (really shaking up), BACK PAIN (bad lower back pain), HEADACHE (headache), NAUSEA (nausea), DIARRHOEA (diarrhea) and ASTHENIA (she feels weak). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, Muscle ache and Back pain, at an unspecified dose and frequency and CELASTRUS PANICULATUS, CENTELLA ASIATICA, VALERIANA JATAMANSI (SLEEP TEA) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain), PALPITATIONS (racing heart), MYALGIA (muscle ache), NERVOUSNESS (really shaking up), BACK PAIN (bad lower back pain), HEADACHE (headache), NAUSEA (nausea), DIARRHOEA (diarrhea) and ASTHENIA (she feels weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Significant arm pain at the site of the injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (Significant arm pain at the site of the injection) 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 reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Significant arm pain at the site of the injection). At the time of the report, VACCINATION SITE PAIN (Significant arm pain at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided. no treatment information provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (headache) in a 54-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 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) 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 event, a causal relationship cannot be excluded.