chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Colitis, Computerised tomogram, Diarrhoea, Nausea
Clinical narrative: Diarrhea; Colitis; Vomiting; Nausea; severe stomach pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021. The most recent information was received on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain), DIARRHOEA (Diarrhea), COLITIS (Colitis), VOMITING (Vomiting) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics, Allergic reaction to antibiotics, Allergic reaction to antibiotics, Diabetic, Asthma, Hypothyroidism and Angioma. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA), LEVOTHYROXINE SODIUM (SYNTHROID) and INSULIN GLARGINE (LANTUS) for an unknown indication.   On 31-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 01-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach pain), COLITIS (Colitis), VOMITING (Vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (severe stomach pain) and COLITIS (Colitis) had not resolved, DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown and VOMITING (Vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Colitis diagnosed.         Lab test include promethium test results negative. Treatment for the event include bacterium. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021. Allergic medications reported. Lab test reported. Concomitant medications were reported. outcome of the event and new event reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; Colitis; Vomiting; Nausea; severe stomach pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021. The most recent information was received on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain), DIARRHOEA (Diarrhea), COLITIS (Colitis), VOMITING (Vomiting) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics, Allergic reaction to antibiotics, Allergic reaction to antibiotics, Diabetic, Asthma, Hypothyroidism and Angioma. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA), LEVOTHYROXINE SODIUM (SYNTHROID) and INSULIN GLARGINE (LANTUS) for an unknown indication.   On 31-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 01-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach pain), COLITIS (Colitis), VOMITING (Vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (severe stomach pain) and COLITIS (Colitis) had not resolved, DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown and VOMITING (Vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Colitis diagnosed.         Lab test include promethium test results negative. Treatment for the event include bacterium. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021. Allergic medications reported. Lab test reported. Concomitant medications were reported. outcome of the event and new event reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Increased blood sugar level after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Increased blood sugar level after vaccination) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032020A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Increased blood sugar level after vaccination). At the time of the report, BLOOD GLUCOSE INCREASED (Increased blood sugar level after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nightmare, Vaccination site discolouration, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Stomach is squeezy.; I developed a "covid arm; I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch; It's like 3-and-a-half-inch medium pink spot that was itching; This was a nightmare getting my shot.; It's like 3-and-a-half-inch medium pink spot that was itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I developed a "covid arm), VACCINATION SITE MASS (I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch), VACCINATION SITE DISCOLOURATION (It's like 3-and-a-half-inch medium pink spot that was itching), ABDOMINAL PAIN UPPER (Stomach is squeezy.) and NIGHTMARE (This was a nightmare getting my shot.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included HRT.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch), VACCINATION SITE DISCOLOURATION (It's like 3-and-a-half-inch medium pink spot that was itching), NIGHTMARE (This was a nightmare getting my shot.) and VACCINATION SITE PRURITUS (It's like 3-and-a-half-inch medium pink spot that was itching). On 03-Apr-2021, the patient experienced VACCINATION SITE REACTION (I developed a "covid arm). On 04-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach is squeezy.). At the time of the report, VACCINATION SITE REACTION (I developed a "covid arm), VACCINATION SITE MASS (I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch), VACCINATION SITE DISCOLOURATION (It's like 3-and-a-half-inch medium pink spot that was itching), ABDOMINAL PAIN UPPER (Stomach is squeezy.), NIGHTMARE (This was a nightmare getting my shot.) and VACCINATION SITE PRURITUS (It's like 3-and-a-half-inch medium pink spot that was itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.Concomitant medication was on a low dose of Hormone replacement therapy (HRT) for 20 years.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Stomach is squeezy.; I developed a "covid arm; I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch; It's like 3-and-a-half-inch medium pink spot that was itching; This was a nightmare getting my shot.; It's like 3-and-a-half-inch medium pink spot that was itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I developed a "covid arm), VACCINATION SITE MASS (I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch), VACCINATION SITE DISCOLOURATION (It's like 3-and-a-half-inch medium pink spot that was itching), ABDOMINAL PAIN UPPER (Stomach is squeezy.) and NIGHTMARE (This was a nightmare getting my shot.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included HRT.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch), VACCINATION SITE DISCOLOURATION (It's like 3-and-a-half-inch medium pink spot that was itching), NIGHTMARE (This was a nightmare getting my shot.) and VACCINATION SITE PRURITUS (It's like 3-and-a-half-inch medium pink spot that was itching). On 03-Apr-2021, the patient experienced VACCINATION SITE REACTION (I developed a "covid arm). On 04-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach is squeezy.). At the time of the report, VACCINATION SITE REACTION (I developed a "covid arm), VACCINATION SITE MASS (I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch), VACCINATION SITE DISCOLOURATION (It's like 3-and-a-half-inch medium pink spot that was itching), ABDOMINAL PAIN UPPER (Stomach is squeezy.), NIGHTMARE (This was a nightmare getting my shot.) and VACCINATION SITE PRURITUS (It's like 3-and-a-half-inch medium pink spot that was itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.Concomitant medication was on a low dose of Hormone replacement therapy (HRT) for 20 years.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus, Vaccination site pain
Clinical narrative: Tinnitus got a lot louder on the left ear; Mild pain at the injection site; Short episode of fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of TINNITUS (Tinnitus got a lot louder on the left ear), VACCINATION SITE PAIN (Mild pain at the injection site) and FATIGUE (Short episode of fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CHOLECALCIFEROL for Vitamin supplementation, METOPROLOL TARTRATE and LEVOTHYROXINE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced TINNITUS (Tinnitus got a lot louder on the left ear), VACCINATION SITE PAIN (Mild pain at the injection site) and FATIGUE (Short episode of fatigue). At the time of the report, TINNITUS (Tinnitus got a lot louder on the left ear), VACCINATION SITE PAIN (Mild pain at the injection site) and FATIGUE (Short episode of fatigue) 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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Non-Significant follow up appended to AER
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. 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.   No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:Cross link
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itch; large red area about 2 inches below where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itch) and VACCINATION SITE ERYTHEMA (large red area about 2 inches below where the vaccine was given) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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 28-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itch) and VACCINATION SITE ERYTHEMA (large red area about 2 inches below where the vaccine was given). At the time of the report, VACCINATION SITE PRURITUS (itch) and VACCINATION SITE ERYTHEMA (large red area about 2 inches below where the vaccine was given) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.  Patient gave consent to safety for Follow-up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: body aches; muscle pain; headache; fever,; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), MYALGIA (muscle pain), HEADACHE (headache) and PYREXIA (fever,) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (In December) and Pneumonia.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (body aches), MYALGIA (muscle pain), HEADACHE (headache) and PYREXIA (fever,). At the time of the report, PAIN (body aches), MYALGIA (muscle pain), HEADACHE (headache) and PYREXIA (fever,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Antibody test
Clinical narrative: Severe side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Severe side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Severe side effects). At the time of the report, ADVERSE EVENT (Severe side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 79.37 (Inconclusive) Her physician sent her for antibody testing after two and a half weeks after her first shot and result was 79.37.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain
Clinical narrative: severe diarrhea; sick like nausea; pain/body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain/body aches), DIARRHOEA (severe diarrhea) and NAUSEA (sick like nausea) 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 27-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 27-Mar-2021, the patient experienced PAIN (pain/body aches) and NAUSEA (sick like nausea). On 29-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea). At the time of the report, PAIN (pain/body aches), DIARRHOEA (severe diarrhea) and NAUSEA (sick like nausea) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.  .   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received: reporter mailing address was updated
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had to reschedule second Moderna dose for 4-5-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had to reschedule second Moderna dose for 4-5-2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had to reschedule second Moderna dose for 4-5-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had to reschedule second Moderna dose for 4-5-2021) had resolved.            Concomitant product use included migraine medications and Birth control.  Treatment of this event was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up information was received on 15-Jun-2021 and contains no new information.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Inappropriate schedule of product administration, Nausea, Pain
Clinical narrative: associated with body aches and low-grade fever (99degrees F; Extreme headaches; these headaches are much worse/pain from headaches was severe; associated with body aches and low-grade fever (99degrees F; body aches decreased but then she had severe nausea for last day and half.; Received both doses in span of 20 days per the caller; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses in span of 20 days per the caller), PAIN (associated with body aches and low-grade fever (99degrees F), HEADACHE (Extreme headaches), HEADACHE (these headaches are much worse/pain from headaches was severe) and PYREXIA (associated with body aches and low-grade fever (99degrees F) in a 52-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.     The patient's past medical history included Migraine.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses in span of 20 days per the caller). On 31-Mar-2021, the patient experienced PAIN (associated with body aches and low-grade fever (99degrees F), HEADACHE (Extreme headaches), HEADACHE (these headaches are much worse/pain from headaches was severe), PYREXIA (associated with body aches and low-grade fever (99degrees F) and NAUSEA (body aches decreased but then she had severe nausea for last day and half.). On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses in span of 20 days per the caller) had resolved. At the time of the report, PAIN (associated with body aches and low-grade fever (99degrees F), HEADACHE (Extreme headaches), HEADACHE (these headaches are much worse/pain from headaches was severe), PYREXIA (associated with body aches and low-grade fever (99degrees F) and NAUSEA (body aches decreased but then she had severe nausea for last day and half.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 99 degrees F- low-grade fever.         There was no concomitant list.  She received treatment this morning, 02Apr2021, at 4am patient took Tylenol with codeine as pain from headaches was severe.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: associated with body aches and low-grade fever (99degrees F; Extreme headaches; these headaches are much worse/pain from headaches was severe; associated with body aches and low-grade fever (99degrees F; body aches decreased but then she had severe nausea for last day and half.; Received both doses in span of 20 days per the caller; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses in span of 20 days per the caller), PAIN (associated with body aches and low-grade fever (99degrees F), HEADACHE (Extreme headaches), HEADACHE (these headaches are much worse/pain from headaches was severe) and PYREXIA (associated with body aches and low-grade fever (99degrees F) in a 52-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.     The patient's past medical history included Migraine.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses in span of 20 days per the caller). On 31-Mar-2021, the patient experienced PAIN (associated with body aches and low-grade fever (99degrees F), HEADACHE (Extreme headaches), HEADACHE (these headaches are much worse/pain from headaches was severe), PYREXIA (associated with body aches and low-grade fever (99degrees F) and NAUSEA (body aches decreased but then she had severe nausea for last day and half.). On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses in span of 20 days per the caller) had resolved. At the time of the report, PAIN (associated with body aches and low-grade fever (99degrees F), HEADACHE (Extreme headaches), HEADACHE (these headaches are much worse/pain from headaches was severe), PYREXIA (associated with body aches and low-grade fever (99degrees F) and NAUSEA (body aches decreased but then she had severe nausea for last day and half.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 99 degrees F- low-grade fever.         There was no concomitant list.  She received treatment this morning, 02Apr2021, at 4am patient took Tylenol with codeine as pain from headaches was severe.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: tired; little soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and MYALGIA (little soreness in the arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (tired) and MYALGIA (little soreness in the arm). At the time of the report, FATIGUE (tired) and MYALGIA (little soreness in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Chest pain, Chills, Heart rate increased
Clinical narrative: Sore arm in the mornings; Chills; Palpitations; Anxiety; rapid pulse; elevated blood pressure; Jaw and chest pains; Jaw and chest pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm in the mornings), PALPITATIONS (Palpitations), ANXIETY (Anxiety), HEART RATE INCREASED (rapid pulse) and BLOOD PRESSURE INCREASED (elevated blood pressure) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 (She believed she had covid in Nov 2019, she was almost certain but they did not do any tests because at that time they did not know much about the disease.) in November 2019. Concurrent medical conditions included High cholesterol, Glaucoma and Blood pressure. Concomitant products included NIFEDIPINE for Blood pressure high, EZETIMIBE for High cholesterol, NETARSUDIL MESILATE (RHOPRESSA), LATANOPROST and TIMOLOL MALEATE (ISTALOL) for Ocular hypertension.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PALPITATIONS (Palpitations), ANXIETY (Anxiety), HEART RATE INCREASED (rapid pulse), BLOOD PRESSURE INCREASED (elevated blood pressure), PAIN IN JAW (Jaw and chest pains) and CHEST PAIN (Jaw and chest pains). On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm in the mornings) and CHILLS (Chills). On 04-Mar-2021, PALPITATIONS (Palpitations), ANXIETY (Anxiety), HEART RATE INCREASED (rapid pulse), BLOOD PRESSURE INCREASED (elevated blood pressure), PAIN IN JAW (Jaw and chest pains) and CHEST PAIN (Jaw and chest pains) had resolved. On 27-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm in the mornings) had not resolved.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-066403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 included reporter details, patient demographic, other relevant history, concomitant medications and new events added.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Palpitations
Clinical narrative: Sore arm in the mornings; Chills; Palpitations; Anxiety; rapid pulse; elevated blood pressure; Jaw and chest pains; Jaw and chest pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm in the mornings), PALPITATIONS (Palpitations), ANXIETY (Anxiety), HEART RATE INCREASED (rapid pulse) and BLOOD PRESSURE INCREASED (elevated blood pressure) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 (She believed she had covid in Nov 2019, she was almost certain but they did not do any tests because at that time they did not know much about the disease.) in November 2019. Concurrent medical conditions included High cholesterol, Glaucoma and Blood pressure. Concomitant products included NIFEDIPINE for Blood pressure high, EZETIMIBE for High cholesterol, NETARSUDIL MESILATE (RHOPRESSA), LATANOPROST and TIMOLOL MALEATE (ISTALOL) for Ocular hypertension.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PALPITATIONS (Palpitations), ANXIETY (Anxiety), HEART RATE INCREASED (rapid pulse), BLOOD PRESSURE INCREASED (elevated blood pressure), PAIN IN JAW (Jaw and chest pains) and CHEST PAIN (Jaw and chest pains). On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm in the mornings) and CHILLS (Chills). On 04-Mar-2021, PALPITATIONS (Palpitations), ANXIETY (Anxiety), HEART RATE INCREASED (rapid pulse), BLOOD PRESSURE INCREASED (elevated blood pressure), PAIN IN JAW (Jaw and chest pains) and CHEST PAIN (Jaw and chest pains) had resolved. On 27-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm in the mornings) had not resolved.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-066403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 included reporter details, patient demographic, other relevant history, concomitant medications and new events added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: very hot itchy throat inside and out; small hives on throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT IRRITATION (very hot itchy throat inside and out) and URTICARIA (small hives on throat) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (penicillin,), Allergy to insect sting (wasp allergic), Allergy to antibiotic (ciprofloxacin) and Blood pressure fluctuation. Concomitant products included LISINOPRIL for Blood pressure management, AMLODIPINE for an unknown indication.    On 02-Apr-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 8:00 PM, the patient experienced THROAT IRRITATION (very hot itchy throat inside and out) and URTICARIA (small hives on throat). At the time of the report, THROAT IRRITATION (very hot itchy throat inside and out) and URTICARIA (small hives on throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take any treatment.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL (ALYQ) and AMBRISENTAN (LETAIRIS) for an unknown indication.   On 18-Jun-2019, the patient started TREPROSTINIL SODIUM (Intravenous) .052 microgram/kilogram. 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, 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 experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No treatment drugs were reported
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Malaise, Musculoskeletal stiffness
Clinical narrative: very stiff body; feeling poor; injection site is red; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (very stiff body), MALAISE (feeling poor), INJECTION SITE ERYTHEMA (injection site is red) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 001A1A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (very stiff body), MALAISE (feeling poor), INJECTION SITE ERYTHEMA (injection site is red) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (very stiff body), MALAISE (feeling poor), INJECTION SITE ERYTHEMA (injection site is red) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No treatment medication details was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhoea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) and VOMITING (Vomiting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024M20A) for an unknown indication.     The patient's past medical history included No adverse event (No medical history reported.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhoea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhoea) and VOMITING (Vomiting) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event , included ezetimibe, losartan, metoprolol and levothyroxine. Treatment information included Pedialyte and Tylenol. Action taken with mRNA-1273 in response to the events was  not applicable.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pyrexia, Rash, Rash pruritic
Clinical narrative: itchy rash on his torso, arms and legs; bumpy raised rash on his torso, arms and legs; red rash on his torso, arms and legs; fever of 101.2F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on his torso, arms and legs), MASS (bumpy raised rash on his torso, arms and legs), RASH (red rash on his torso, arms and legs) and PYREXIA (fever of 101.2F) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (fever of 101.2F). On 28-Mar-2021, the patient experienced RASH PRURITIC (itchy rash on his torso, arms and legs), MASS (bumpy raised rash on his torso, arms and legs) and RASH (red rash on his torso, arms and legs). At the time of the report, RASH PRURITIC (itchy rash on his torso, arms and legs), MASS (bumpy raised rash on his torso, arms and legs), RASH (red rash on his torso, arms and legs) and PYREXIA (fever of 101.2F) outcome was unknown.            No concomitant information was reported. Treatment details include aspirin,Tylenol ,Benadryl, cortizone cream.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Body aches; fatigue/exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (fatigue/exhaustion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (He had COVID in Nov/Dec) from November 2020 to December 2020. Concomitant products included ATORVASTATIN, LISINOPRIL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (fatigue/exhaustion). At the time of the report, PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (fatigue/exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient want to know wants to know if the vaccine can produce a positive COVID test.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: fever; Chills; Arm pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (Arm pain at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (Arm pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (Arm pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site swelling (injection site swollen), injection site pruritus (injection site swollen, itching) and fatigue (felt tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 003B21A) for COVID-19 immunization. No medical history provided. Concomitant products included metformin for an unknown indication. On Apr 2, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 3, 2021, patient experienced injection site swelling (injection site swollen), injection site pruritus (injection site swollen, itching) and fatigue (felt tired). At the time of the report, injection site swelling (injection site swollen), injection site pruritus (injection site swollen, itching) and fatigue  (felt tired) outcome: unknown/not provided. Treatment provided included Tylenol for tiredness.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) 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.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Facial pain, Fatigue, Headache, Nervous system disorder
Clinical narrative: Face to hurt; Some type of nerve issue; Hot and cold sensation on the left side of her mouth; Which tooth was bothering her; Tired; Headache; Aching pain and sensitivity in teeth; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Aching pain and sensitivity in teeth), PAIN IN EXTREMITY (Sore arm), FACIAL PAIN (Face to hurt), NERVOUS SYSTEM DISORDER (Some type of nerve issue) and ORAL DISCOMFORT (Hot and cold sensation on the left side of her mouth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for Vitamin supplementation.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced TOOTHACHE (Aching pain and sensitivity in teeth), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and HEADACHE (Headache). On an unknown date, the patient experienced FACIAL PAIN (Face to hurt), NERVOUS SYSTEM DISORDER (Some type of nerve issue), ORAL DISCOMFORT (Hot and cold sensation on the left side of her mouth) and DENTAL DISCOMFORT (Which tooth was bothering her). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form; ACETYLSALICYLIC ACID (ASPIRIN 81) for Headache, at a dose of 1 dosage form; IBUPROFEN for Pain, at a dose of 1 dosage form and GABAPENTIN for Nerve pain, at a dose of 300 mg three times a day. At the time of the report, TOOTHACHE (Aching pain and sensitivity in teeth) had not resolved and PAIN IN EXTREMITY (Sore arm), FACIAL PAIN (Face to hurt), NERVOUS SYSTEM DISORDER (Some type of nerve issue), ORAL DISCOMFORT (Hot and cold sensation on the left side of her mouth), DENTAL DISCOMFORT (Which tooth was bothering her), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The other concomitant was cholesterol medication and blood pressure medication. The Patient went to the ENT for Nerve Pain and take her a CT scan. The patient treatment medications includes Antibiotics and steroids.   This case was linked to MOD-2021-067637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: The Significant follow up received in which treatment information is added.(Gabapentin).