chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Productive cough, Rash, Rash macular
Clinical narrative: huge blotchy rash going up her neck and across top of chest, abdomen and side of cheek; rash is still blotchy but pink in color; felt like a Mack truck ran over her body; difficulty breathing; felt like her throat was on fire; coughing up stuff; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like a Mack truck ran over her body), DYSPNOEA (difficulty breathing), THROAT IRRITATION (felt like her throat was on fire), PRODUCTIVE COUGH (coughing up stuff) and RASH MACULAR (huge blotchy rash going up her neck and across top of chest, abdomen and side of cheek) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (Patient on 05mar2021-06mar2021 was experiencing some seasonal allergies symptoms(running nose, cough and sore throat)) since 05-Mar-2021.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING ABNORMAL (felt like a Mack truck ran over her body), DYSPNOEA (difficulty breathing), THROAT IRRITATION (felt like her throat was on fire) and PRODUCTIVE COUGH (coughing up stuff). On 09-Mar-2021, the patient experienced RASH MACULAR (huge blotchy rash going up her neck and across top of chest, abdomen and side of cheek) and RASH (rash is still blotchy but pink in color). At the time of the report, FEELING ABNORMAL (felt like a Mack truck ran over her body), DYSPNOEA (difficulty breathing), THROAT IRRITATION (felt like her throat was on fire), PRODUCTIVE COUGH (coughing up stuff) and RASH MACULAR (huge blotchy rash going up her neck and across top of chest, abdomen and side of cheek) outcome was unknown and RASH (rash is still blotchy but pink in color) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant information was reported.  Patient was advised to take 2 Benadryl.    Patient was suggested that her daughter may have had a rhino virus and may have given it to her and since she received the vaccine it may have caused her reaction from the vaccine
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat irritation
Clinical narrative: huge blotchy rash going up her neck and across top of chest, abdomen and side of cheek; rash is still blotchy but pink in color; felt like a Mack truck ran over her body; difficulty breathing; felt like her throat was on fire; coughing up stuff; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like a Mack truck ran over her body), DYSPNOEA (difficulty breathing), THROAT IRRITATION (felt like her throat was on fire), PRODUCTIVE COUGH (coughing up stuff) and RASH MACULAR (huge blotchy rash going up her neck and across top of chest, abdomen and side of cheek) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (Patient on 05mar2021-06mar2021 was experiencing some seasonal allergies symptoms(running nose, cough and sore throat)) since 05-Mar-2021.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING ABNORMAL (felt like a Mack truck ran over her body), DYSPNOEA (difficulty breathing), THROAT IRRITATION (felt like her throat was on fire) and PRODUCTIVE COUGH (coughing up stuff). On 09-Mar-2021, the patient experienced RASH MACULAR (huge blotchy rash going up her neck and across top of chest, abdomen and side of cheek) and RASH (rash is still blotchy but pink in color). At the time of the report, FEELING ABNORMAL (felt like a Mack truck ran over her body), DYSPNOEA (difficulty breathing), THROAT IRRITATION (felt like her throat was on fire), PRODUCTIVE COUGH (coughing up stuff) and RASH MACULAR (huge blotchy rash going up her neck and across top of chest, abdomen and side of cheek) outcome was unknown and RASH (rash is still blotchy but pink in color) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant information was reported.  Patient was advised to take 2 Benadryl.    Patient was suggested that her daughter may have had a rhino virus and may have given it to her and since she received the vaccine it may have caused her reaction from the vaccine
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Left arm pain; Heavy head; Fever ( do not know how); Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm pain), HEAD DISCOMFORT (Heavy head), PYREXIA (Fever ( do not know how)) and MYALGIA (Body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had Covid by the end of the past year and the beginning of this year). Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm pain), HEAD DISCOMFORT (Heavy head), PYREXIA (Fever ( do not know how)) and MYALGIA (Body aches). At the time of the report, PAIN IN EXTREMITY (Left arm pain), HEAD DISCOMFORT (Heavy head), PYREXIA (Fever ( do not know how)) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter asked could patient took some Tylenol or ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-041424 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-041424:husband crosslinked case
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: half or might be less than of the dose administered; might be due to equipment failure that the needle/hub got separated and some fell on the arm; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (half or might be less than of the dose administered) and DEVICE CONNECTION ISSUE (might be due to equipment failure that the needle/hub got separated and some fell on the arm) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced UNDERDOSE (half or might be less than of the dose administered) and DEVICE CONNECTION ISSUE (might be due to equipment failure that the needle/hub got separated and some fell on the arm). On 07-Mar-2021, UNDERDOSE (half or might be less than of the dose administered) and DEVICE CONNECTION ISSUE (might be due to equipment failure that the needle/hub got separated and some fell on the arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. The patient had no adverse reactions. The patient received both doses of mRNA-1273 (Moderna COVID-19 Vaccine); therefore, the action in response to the events was not applicable.; Sender's Comments: This report refers to a case of underdose, and device connection team for mRNA-1273, lot # 029A21A with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Unevaluable event
Clinical narrative: experiencing COVID-19 symptoms; tested positive for COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19 infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19 infection) with UNEVALUABLE EVENT (experiencing COVID-19 symptoms). At the time of the report, COVID-19 (tested positive for COVID-19 infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to touch; Side of the arm swollen; left side of the arm swollen,itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Side of the arm swollen) and VACCINATION SITE PRURITUS (left side of the arm swollen,itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Side of the arm swollen) and VACCINATION SITE PRURITUS (left side of the arm swollen,itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Side of the arm swollen) and VACCINATION SITE PRURITUS (left side of the arm swollen,itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had a fever). At the time of the report, PYREXIA (Had a fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine leaked out while administering the shot; Vaccine leaked out while administering the shot; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Vaccine leaked out while administering the shot) and DEVICE CONNECTION ISSUE (Vaccine leaked out while administering the shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced UNDERDOSE (Vaccine leaked out while administering the shot) and DEVICE CONNECTION ISSUE (Vaccine leaked out while administering the shot). On 11-Mar-2021, UNDERDOSE (Vaccine leaked out while administering the shot) and DEVICE CONNECTION ISSUE (Vaccine leaked out while administering the shot) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered from a vial punctured more than 18 hours ago; A spontaneous report was received from a (Pharmacist) concerning a  55 Years-old Female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced  vaccine administered from a vial punctured more than 18 hours ago / Expired product administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient experienced Expired product administered.    Action taken with mRNA-1273 in response to the events was not reported.   On 11 Mar 2021, the outcome of the event was considered as resolved.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, lot # 027A21A with no associated AEs.; Sender's Comments:  MOD-2021-041075:cross link MOD21-051431 MOD21-051527:cross link MOD-2021-027628:cross link MOD21-051523 MOD21-051528:cross link
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Stomach Ache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and ABDOMINAL PAIN UPPER (Stomach Ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and ABDOMINAL PAIN UPPER (Stomach Ache). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and ABDOMINAL PAIN UPPER (Stomach Ache) outcome was unknown. Not Provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red  at the injection site; welt at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red  at the injection site) and INJECTION SITE SWELLING (welt at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, ANTIHISTAMINES and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE SWELLING (welt at injection site). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Red  at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (Red  at the injection site) and INJECTION SITE SWELLING (welt at injection site) outcome was unknown.            This case was linked to MOD-2021-015139, MOD-2021-015139 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Has not felt good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Has not felt good) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MALAISE (Has not felt good). At the time of the report, MALAISE (Has not felt good) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: sever reaction; headache; fatigue; feverish; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ADVERSE REACTION (sever reaction), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (feverish) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Feb-2021, the patient experienced ADVERSE REACTION (sever reaction), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (feverish). On 27-Feb-2021, PAIN IN EXTREMITY (sore arm), ADVERSE REACTION (sever reaction), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (feverish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient used Tylenol and unspecified pain killer to treat the events.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itches slightly; Pale rash in a circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itches slightly) and VACCINATION SITE RASH (Pale rash in a circle around the injection site) in a 75-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 reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itches slightly) and VACCINATION SITE RASH (Pale rash in a circle around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itches slightly) and VACCINATION SITE RASH (Pale rash in a circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received 2 doses of Moderna COVID-19 vaccine one after another one; A spontaneous report was received from a nurse concerning a 59-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced: received two doses of Moderna COVID-19 vaccine, one after another one by mistake (extra dose administered).   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter   On 11 Mar 2021, the patient presented to receive her first dose of two planned doses of the Moderna COVID-19 Vaccine (mRNA-1273, lot number: 029A21A, expiration: 22 May 2021). The patient ended up receiving two doses of the vaccine (one after another one) by mistake via intramuscular injection into the right arm.  At the time of the report, the reporter stated the patient was currently in an ambulance on site being monitored.   No treatment information was provided/was unknown by the reporter.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, received two doses of Moderna COVID-19 vaccine one after another one by mistake  (extra dose administered), was considered resolved.  Causality was not provided by the reporter.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273, lot # 029A21A with no associated AEs
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Sciatic Pain in both legs; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatic Pain in both legs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sciatica.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SCIATICA (Sciatic Pain in both legs). At the time of the report, SCIATICA (Sciatic Pain in both legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site induration, Vaccination site pain, Vaccination site rash, Vaccination site reaction
Clinical narrative: left arm blew up; COVID arm; it was hard to the touch; painful to the touch; had a big red spot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm blew up), VACCINATION SITE INDURATION (it was hard to the touch), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PAIN (painful to the touch) and VACCINATION SITE RASH (had a big red spot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (left arm blew up), VACCINATION SITE INDURATION (it was hard to the touch), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PAIN (painful to the touch) and VACCINATION SITE RASH (had a big red spot). On 27-Jan-2021, PERIPHERAL SWELLING (left arm blew up), VACCINATION SITE INDURATION (it was hard to the touch), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PAIN (painful to the touch) and VACCINATION SITE RASH (had a big red spot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD21-023517 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site). At the time of the report, INJECTION SITE PAIN (Soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported.  No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Blood pressure went up to 130/74 mmHg; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure went up to 130/74 mmHg) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure went up to 130/74 mmHg). On 01-Feb-2021, BLOOD PRESSURE INCREASED (Blood pressure went up to 130/74 mmHg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       TTreatment medications includes Amlodipine, Crestor and Metoprolol.   This case was linked to US-MODERNATX, INC.-MOD-2021-060208 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060208:1st Dose
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: In bed not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (In bed not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (In bed not feeling well). At the time of the report, MALAISE (In bed not feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE RASH (rash around the injection site). At the time of the report, VACCINATION SITE RASH (rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided/unknown. Treatment medication were not reported/unknown.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This spontaneous case was reported by an other and describes the occurrence of NASOPHARYNGITIS (Cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for covid-19 vaccination.     No Medical History Information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) had resolved.            Concomitant medications was  not reported.  Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by an other and describes the occurrence of NASOPHARYNGITIS (Cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for covid-19 vaccination.     No Medical History Information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) had resolved.            Concomitant medications was  not reported.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Chills, Fatigue, Feeling abnormal
Clinical narrative: burning sensation; not normal for me; body ache; headaches; fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out; chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation), FEELING ABNORMAL (not normal for me), MYALGIA (body ache), HEADACHE (headaches) and FATIGUE (fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Drug allergy (codeine, omeprazole, Bactrim) and Basal cell carcinoma. Concomitant products included ESTRADIOL and PROGESTERON for Hormone replacement therapy, THYROID COMPLEX, CHLORTHALIDONE and GABAPENTIN for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (headaches), FATIGUE (fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out) and CHILLS (chills). On an unknown date, the patient experienced BURNING SENSATION (burning sensation), FEELING ABNORMAL (not normal for me) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning sensation) and FEELING ABNORMAL (not normal for me) outcome was unknown, MYALGIA (body ache) and FATIGUE (fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out) had not resolved and HEADACHE (headaches) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) unknown blood work done. On an unknown date, SARS-CoV-2 test: no (Negative) negative.         Concomitant products included thyroid supplement, CHLORTHALIDONE, estrogen/progesterone, GABAPENTIN and Imiquimod cream,for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: The patient demographics, medical history, concomitant medications and events details were updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, SARS-CoV-2 test
Clinical narrative: burning sensation; not normal for me; body ache; headaches; fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out; chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation), FEELING ABNORMAL (not normal for me), MYALGIA (body ache), HEADACHE (headaches) and FATIGUE (fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Drug allergy (codeine, omeprazole, Bactrim) and Basal cell carcinoma. Concomitant products included ESTRADIOL and PROGESTERON for Hormone replacement therapy, THYROID COMPLEX, CHLORTHALIDONE and GABAPENTIN for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (headaches), FATIGUE (fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out) and CHILLS (chills). On an unknown date, the patient experienced BURNING SENSATION (burning sensation), FEELING ABNORMAL (not normal for me) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning sensation) and FEELING ABNORMAL (not normal for me) outcome was unknown, MYALGIA (body ache) and FATIGUE (fatigue/ profound fatigue/ mononucleosis level fatigue/ was present for 4 weeks/ fatigue upon exertion/ went on into may/ wiped out) had not resolved and HEADACHE (headaches) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) unknown blood work done. On an unknown date, SARS-CoV-2 test: no (Negative) negative.         Concomitant products included thyroid supplement, CHLORTHALIDONE, estrogen/progesterone, GABAPENTIN and Imiquimod cream,for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: The patient demographics, medical history, concomitant medications and events details were updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Has her 2nd dose appointment on 05March2021, it would be 45 days after the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has her 2nd dose appointment on 05March2021, it would be 45 days after the 1st shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has her 2nd dose appointment on 05March2021, it would be 45 days after the 1st shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has her 2nd dose appointment on 05March2021, it would be 45 days after the 1st shot) outcome was unknown.            This case was linked to MOD-2021-027923, MOD-2021-041951 (Patient Link).   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash on chest and stomach; Rash on right deltoid (injection site); This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash on chest and stomach) and VACCINATION SITE RASH (Rash on right deltoid (injection site)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity, Allergy to antibiotic (Patient is allergic to Amoxicillin.) and Drug allergy (Patient is allergic to Decadron.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rash on chest and stomach) and VACCINATION SITE RASH (Rash on right deltoid (injection site)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) 09-Mar-2021 at a dose of 25 milligram once a day. At the time of the report, RASH (Rash on chest and stomach) and VACCINATION SITE RASH (Rash on right deltoid (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.   Concomitant medications were not reported   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-May-2021 included HCP information,Patient's Initials "SS", Date of Birth, Medical history, Vaccine dose no and route of administration and Vaccine facility.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; Injection site redness; Injection site swelling; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site swelling) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A.) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site swelling). The patient was treated with BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] for Injection site pain, Redness and Swelling, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site swelling) 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.   Patient visit to the onsite nurse for reaction taken place.  No concomitant medication provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Daughter came by and said several other friends who have had Rash from the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Daughter came by and said several other friends who have had Rash from the vaccine) 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 02-Mar-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 RASH (Daughter came by and said several other friends who have had Rash from the vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Daughter came by and said several other friends who have had Rash from the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling arm; Redness and swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and swelling arm) and VACCINATION SITE SWELLING (Redness and swelling arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness and swelling arm) and VACCINATION SITE SWELLING (Redness and swelling arm). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and swelling arm) and VACCINATION SITE SWELLING (Redness and swelling arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Vaccine from Prefilled Syringe which was in Temp Excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Vaccine from Prefilled Syringe which was in Temp Excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Vaccine from Prefilled Syringe which was in Temp Excursion). On 01-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received Vaccine from Prefilled Syringe which was in Temp Excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist states that 2 persons were administered with prefilled syringes. and he doesn't know whether they got any AE..  Contacts and date of birth of both patient's were given moderna.  No concomitant medication nor treatment provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Drug ineffective, Feeling abnormal
Clinical narrative: lack of efficacy; weird feeling; chills; fever; Vaccination site pain; runny nose; cough; dizziness; A spontaneous report was received from a consumer, concerning a male patient of 84 years age, who received Moderna's COVID-19 vaccine and experienced adverse events such as pain at injection, runny nose, weird feeling, chills, cough, fever, lack of efficacy and dizziness.   The patient's medical history was provided that seasonal allergies. Concomitant product use was provided by the reporter. Lab data was reported, on 2-MAR-2021, that the patient tested COVID positive.  On 27-FEB-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 031M20A) via IM route for COVID-19 infection prophylaxis.   On 2-MAR-2021, the patient tested positive for SARS-CoV-2.  Treatment medication was reported that diphenhydramine and Corcidin was taken.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, pain at injection, runny nose, weird feeling, chills, cough, fever, lack of efficacy and dizziness, were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: lack of efficacy; weird feeling; chills; fever; Vaccination site pain; runny nose; cough; dizziness; A spontaneous report was received from a consumer, concerning a male patient of 84 years age, who received Moderna's COVID-19 vaccine and experienced adverse events such as pain at injection, runny nose, weird feeling, chills, cough, fever, lack of efficacy and dizziness.   The patient's medical history was provided that seasonal allergies. Concomitant product use was provided by the reporter. Lab data was reported, on 2-MAR-2021, that the patient tested COVID positive.  On 27-FEB-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 031M20A) via IM route for COVID-19 infection prophylaxis.   On 2-MAR-2021, the patient tested positive for SARS-CoV-2.  Treatment medication was reported that diphenhydramine and Corcidin was taken.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, pain at injection, runny nose, weird feeling, chills, cough, fever, lack of efficacy and dizziness, were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: His arm was tender and sore; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (His arm was tender and sore) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (His arm was tender and sore). At the time of the report, VACCINATION SITE PAIN (His arm was tender and sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-027447 (Patient Link).