chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Feeling hot, Middle insomnia, Palpitations, Panic attack
Clinical narrative: panic attacks at night; will wake up at night/ wake up disoriented/ symptoms wakes her up and she has to cool down before going back to sleep; feel over heated; heart was racing like she was running for a period of time; wake up disoriented; mind racing; Patient has not received the second dose and it is more than 36 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (panic attacks at night), MIDDLE INSOMNIA (will wake up at night/ wake up disoriented/ symptoms wakes her up and she has to cool down before going back to sleep), FEELING HOT (feel over heated), PALPITATIONS (heart was racing like she was running for a period of time) and DISORIENTATION (wake up disoriented) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia and Panic attack (when patient was pregnant and her child was 10 pounds and child's feet were in her lungs). Concurrent medical conditions included Lung scarring (Scar tissue in lungs from having pneumonia too many times).    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (panic attacks at night), MIDDLE INSOMNIA (will wake up at night/ wake up disoriented/ symptoms wakes her up and she has to cool down before going back to sleep), FEELING HOT (feel over heated), PALPITATIONS (heart was racing like she was running for a period of time), DISORIENTATION (wake up disoriented), TACHYPHRENIA (mind racing) and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose and it is more than 36 days from the first dose). In July 2021, PANIC ATTACK (panic attacks at night), MIDDLE INSOMNIA (will wake up at night/ wake up disoriented/ symptoms wakes her up and she has to cool down before going back to sleep), FEELING HOT (feel over heated), PALPITATIONS (heart was racing like she was running for a period of time), DISORIENTATION (wake up disoriented) and TACHYPHRENIA (mind racing) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose and it is more than 36 days from the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the symptoms occurred 2 to 3 times a week for 3 weeks and it went down to once a week and it stopped around 6 weeks after receiving the vaccine. Concomitant medications were not provided. Treatment information was not reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tachyphrenia
Clinical narrative: panic attacks at night; will wake up at night/ wake up disoriented/ symptoms wakes her up and she has to cool down before going back to sleep; feel over heated; heart was racing like she was running for a period of time; wake up disoriented; mind racing; Patient has not received the second dose and it is more than 36 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (panic attacks at night), MIDDLE INSOMNIA (will wake up at night/ wake up disoriented/ symptoms wakes her up and she has to cool down before going back to sleep), FEELING HOT (feel over heated), PALPITATIONS (heart was racing like she was running for a period of time) and DISORIENTATION (wake up disoriented) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia and Panic attack (when patient was pregnant and her child was 10 pounds and child's feet were in her lungs). Concurrent medical conditions included Lung scarring (Scar tissue in lungs from having pneumonia too many times).    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (panic attacks at night), MIDDLE INSOMNIA (will wake up at night/ wake up disoriented/ symptoms wakes her up and she has to cool down before going back to sleep), FEELING HOT (feel over heated), PALPITATIONS (heart was racing like she was running for a period of time), DISORIENTATION (wake up disoriented), TACHYPHRENIA (mind racing) and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose and it is more than 36 days from the first dose). In July 2021, PANIC ATTACK (panic attacks at night), MIDDLE INSOMNIA (will wake up at night/ wake up disoriented/ symptoms wakes her up and she has to cool down before going back to sleep), FEELING HOT (feel over heated), PALPITATIONS (heart was racing like she was running for a period of time), DISORIENTATION (wake up disoriented) and TACHYPHRENIA (mind racing) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose and it is more than 36 days from the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the symptoms occurred 2 to 3 times a week for 3 weeks and it went down to once a week and it stopped around 6 weeks after receiving the vaccine. Concomitant medications were not provided. Treatment information was not reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: two red dots,can feel them at touch; sore arm; Fever; injection site hurts  when moving or doing; Has 2 red dots for both shots in upper arm; can feel them at touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (two red dots,can feel them at touch), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), VACCINATION SITE PAIN (injection site hurts  when moving or doing) and VACCINATION SITE SWELLING (Has 2 red dots for both shots in upper arm; can feel them at touch) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (two red dots,can feel them at touch), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), VACCINATION SITE PAIN (injection site hurts  when moving or doing) and VACCINATION SITE SWELLING (Has 2 red dots for both shots in upper arm; can feel them at touch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ERYTHEMA (two red dots,can feel them at touch), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), VACCINATION SITE PAIN (injection site hurts  when moving or doing) and VACCINATION SITE SWELLING (Has 2 red dots for both shots in upper arm; can feel them at touch) outcome was unknown.      Concomitant medications included unspecified supplements.   This case was linked to MOD-2021-263681 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red mark at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red mark at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 008D21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red mark at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red mark at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No information about treatment medication was provided by reporter.   This case was linked to MOD-2021-263826 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination complication
Clinical narrative: Adverse events from the vaccine; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse events from the vaccine), FATIGUE (Tired) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Transplant (Patient had Kidney Pancreas Transplant from type 1 diabetes). Concurrent medical conditions included Kidney failure, Blood pressure (High blood pressure), Cholesterol, Glaucoma, Neuropathy, Anxiety, Back pain (Lower Back Pain), Arthritis, Type 1 diabetes mellitus and Migraine. Concomitant products included TACROLIMUS, MYCOPHENOLIC ACID, PREDNISONE, OMEPRAZOLE, METOPROLOL TARTRATE, SIMVASTATIN, GABAPENTIN, SERTRALINE HYDROCHLORIDE (ZOLOFT), ONDANSETRON, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), METOCLOPRAMIDE, LORAZEPAM and LATANOPROST for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse events from the vaccine), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Adverse events from the vaccine), FATIGUE (Tired) and HEADACHE (Headache) had resolved.            Patient stated that she is a transplant patient who takes immunosuppressants.  Concomitant medication including Vitamins was reported.  No  treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Had the first vaccine shot on 1/8/21,  never had the second one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had the first vaccine shot on 1/8/21,  never had the second one) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Had the first vaccine shot on 1/8/21,  never had the second one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had the first vaccine shot on 1/8/21,  never had the second one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-263697, MOD-2021-263735 (Patient Link).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Patient had COVID-19 after first dose; More than 36 days passed since the first dose and patient has not got the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient had COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose and patient has not got the second dose) in a 19-year-old female patient 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 COVID-19 (Patient had COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose and patient has not got the second dose). At the time of the report, COVID-19 (Patient had COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose and patient has not got the second dose) 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.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information include No New Information
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 7 days too early; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (7 days too early) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (7 days too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (7 days too early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273,
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache, Pain
Clinical narrative: Red area below the injection site that is about 6 inches across; Swollen and raised area below the injection site that is about 6 inches across; Site is painful and sore; dull headache; stomach issues; Chills; Achineess; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (dull headache), ABDOMINAL DISCOMFORT (stomach issues), CHILLS (Chills), PAIN (Achineess) and ARTHRALGIA (Joint Pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008D21A and 20210622) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced HEADACHE (dull headache), ABDOMINAL DISCOMFORT (stomach issues) and PAIN (Achineess). 20-Jul-2021, the patient experienced CHILLS (Chills) and ARTHRALGIA (Joint Pain). On 21-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red area below the injection site that is about 6 inches across), VACCINATION SITE SWELLING (Swollen and raised area below the injection site that is about 6 inches across) and VACCINATION SITE PAIN (Site is painful and sore). At the time of the report, HEADACHE (dull headache), ABDOMINAL DISCOMFORT (stomach issues), CHILLS (Chills), PAIN (Achineess), ARTHRALGIA (Joint Pain), VACCINATION SITE ERYTHEMA (Red area below the injection site that is about 6 inches across), VACCINATION SITE SWELLING (Swollen and raised area below the injection site that is about 6 inches across) and VACCINATION SITE PAIN (Site is painful and sore) outcome was unknown.            No treatment information were reported by the reporter.   This case was linked to MOD-2021-263796 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Red area below the injection site that is about 6 inches across; Swollen and raised area below the injection site that is about 6 inches across; Site is painful and sore; dull headache; stomach issues; Chills; Achineess; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (dull headache), ABDOMINAL DISCOMFORT (stomach issues), CHILLS (Chills), PAIN (Achineess) and ARTHRALGIA (Joint Pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008D21A and 20210622) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced HEADACHE (dull headache), ABDOMINAL DISCOMFORT (stomach issues) and PAIN (Achineess). 20-Jul-2021, the patient experienced CHILLS (Chills) and ARTHRALGIA (Joint Pain). On 21-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red area below the injection site that is about 6 inches across), VACCINATION SITE SWELLING (Swollen and raised area below the injection site that is about 6 inches across) and VACCINATION SITE PAIN (Site is painful and sore). At the time of the report, HEADACHE (dull headache), ABDOMINAL DISCOMFORT (stomach issues), CHILLS (Chills), PAIN (Achineess), ARTHRALGIA (Joint Pain), VACCINATION SITE ERYTHEMA (Red area below the injection site that is about 6 inches across), VACCINATION SITE SWELLING (Swollen and raised area below the injection site that is about 6 inches across) and VACCINATION SITE PAIN (Site is painful and sore) outcome was unknown.            No treatment information were reported by the reporter.   This case was linked to MOD-2021-263796 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Skin reaction, Vaccination site discolouration
Clinical narrative: Big halo in the arm; It was described as a skin reaction.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Big halo in the arm) and SKIN REACTION (It was described as a skin reaction.) in a 40-year-old male patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Big halo in the arm) and SKIN REACTION (It was described as a skin reaction.). At the time of the report, VACCINATION SITE DISCOLOURATION (Big halo in the arm) and SKIN REACTION (It was described as a skin reaction.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got the first dose of the Moderna vaccine on 19Feb2021 and did not get the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 19Feb2021 and did not get the second dose yet) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B16H20T) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-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 PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 19Feb2021 and did not get the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 19Feb2021 and did not get the second dose yet) had resolved.            Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: both of us were deathley sick for; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (both of us were deathley sick for   ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    In June 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 ILLNESS (both of us were deathley sick for   ). At the time of the report, ILLNESS (both of us were deathley sick for   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment medications was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-263744 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received contains No new information,; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-263744:husband's case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: slight fever; body aches; soreness of the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever), MYALGIA (body aches) and INJECTION SITE PAIN (soreness of the arm of the injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Non-Hodgkin's lymphoma (spleen and gallbladder removed in 2000), Chemotherapy, Monoclonal antibody unconjugated therapy, Nerve injury (Patient also has a pudendal nerve injury that causes them a lot of pain specially when sitting) and Kidney stones (that need to be removed every few years).   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced PYREXIA (slight fever), MYALGIA (body aches) and INJECTION SITE PAIN (soreness of the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (slight fever), MYALGIA (body aches) and INJECTION SITE PAIN (soreness of the arm of the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medication information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Injection site pain, Injection site warmth, Rotator cuff syndrome
Clinical narrative: The only symptom I have is chronic tenderness of both injection sites.  Sometimes it feels very warm, sometimes it throbs. Unrelated in my opinion is the fact that I have been diagnosed with a torn rotator cuff on this same shoulder.  However, the discomfort is completely different.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Increased Tinnitus
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pain, Vaccine positive rechallenge
Clinical narrative: Soreness (local), myalgia, malaise, headaches
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Magnetic resonance imaging, Pain in extremity, Swelling
Clinical narrative: Left arm pain, weakness, constant swelling, and numbness at times.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Laboratory test
Clinical narrative: I went the health clinic had 2 shot and waited for 15 mins. After waiting went home and was feeling ok. Later the same evening I had a elevated heart rate for several days. I followed up with my PCP and did test and lab work. It resolved on its own after a couple of days.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Is abdominal Pain normal; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Is abdominal Pain normal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Is abdominal Pain normal). At the time of the report, ABDOMINAL PAIN (Is abdominal Pain normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow- up received, patient's demographics were added.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: 2nd of the Moderna Covid-19 vaccine given to 3 patients after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (2nd of the Moderna Covid-19 vaccine given to 3 patients after excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (2nd of the Moderna Covid-19 vaccine given to 3 patients after excursion). On 22-Jul-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (2nd of the Moderna Covid-19 vaccine given to 3 patients after excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  No treatment medications were reported by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Every bone in his body aches; Aches everywhere, but specifically mentioned hands, knees and legs; Elbow that hasn't hurt in 25 years is hurting/Aches everywhere, but specifically mentioned hands, knees and legs; muscle pain/can't work because body aches; Tired and Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Every bone in his body aches), PAIN IN EXTREMITY (Aches everywhere, but specifically mentioned hands, knees and legs), ARTHRALGIA (Elbow that hasn't hurt in 25 years is hurting/Aches everywhere, but specifically mentioned hands, knees and legs), MYALGIA (muscle pain/can't work because body aches) and FATIGUE (Tired and Fatigued) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Every bone in his body aches), PAIN IN EXTREMITY (Aches everywhere, but specifically mentioned hands, knees and legs), ARTHRALGIA (Elbow that hasn't hurt in 25 years is hurting/Aches everywhere, but specifically mentioned hands, knees and legs), MYALGIA (muscle pain/can't work because body aches) and FATIGUE (Tired and Fatigued). At the time of the report, BONE PAIN (Every bone in his body aches), PAIN IN EXTREMITY (Aches everywhere, but specifically mentioned hands, knees and legs), ARTHRALGIA (Elbow that hasn't hurt in 25 years is hurting/Aches everywhere, but specifically mentioned hands, knees and legs), MYALGIA (muscle pain/can't work because body aches) and FATIGUE (Tired and Fatigued) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Somnolence
Clinical narrative: all she wanted to do was sleep; she was totally exhausted; after 2nd dose, headache; she is currently feeling a little tired, but thinks it might be related to something else; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (all she wanted to do was sleep), FATIGUE (she was totally exhausted), HEADACHE (after 2nd dose, headache) and FATIGUE (she is currently feeling a little tired, but thinks it might be related to something else) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Mastocytosis (Patient had a health issue where she has too many mast cells that can cause a lot of itching.). Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (all she wanted to do was sleep), FATIGUE (she was totally exhausted), HEADACHE (after 2nd dose, headache) and FATIGUE (she is currently feeling a little tired, but thinks it might be related to something else). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (all she wanted to do was sleep), FATIGUE (she was totally exhausted), HEADACHE (after 2nd dose, headache) and FATIGUE (she is currently feeling a little tired, but thinks it might be related to something else) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-046016 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received the first dose of the Moderna COVID-19 vaccine on 05Apr2021 and now wants to get the second dose today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID-19 vaccine on 05Apr2021 and now wants to get the second dose today) 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 05-Apr-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 PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID-19 vaccine on 05Apr2021 and now wants to get the second dose today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID-19 vaccine on 05Apr2021 and now wants to get the second dose today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination complication
Clinical narrative: Why do i have fatigue; How long does the second dose side effects last?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long does the second dose side effects last?) and FATIGUE (Why do i have fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 VACCINATION COMPLICATION (How long does the second dose side effects last?) and FATIGUE (Why do i have fatigue). At the time of the report, VACCINATION COMPLICATION (How long does the second dose side effects last?) and FATIGUE (Why do i have fatigue) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administration error, Product storage error
Clinical narrative: 1 dose administered to 1 patient from vial greater then 24 hours at room temperature; Thus receiving two doses of the vaccine within a short period of time.; product administration error; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (1 dose administered to 1 patient from vial greater then 24 hours at room temperature), INCORRECT DOSE ADMINISTERED (Thus receiving two doses of the vaccine within a short period of time.) and PRODUCT ADMINISTRATION ERROR (product administration error) 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 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (1 dose administered to 1 patient from vial greater then 24 hours at room temperature), INCORRECT DOSE ADMINISTERED (Thus receiving two doses of the vaccine within a short period of time.) and PRODUCT ADMINISTRATION ERROR (product administration error). At the time of the report, PRODUCT STORAGE ERROR (1 dose administered to 1 patient from vial greater then 24 hours at room temperature), INCORRECT DOSE ADMINISTERED (Thus receiving two doses of the vaccine within a short period of time.) and PRODUCT ADMINISTRATION ERROR (product administration error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received contains significant information- receiving two doses of the vaccine within a short period of time.; Sender's Comments: This report refers to a case of Product storage error temperature too high, Inappropriate dose of vaccine administered and product administration error, for mRNA-1273 with no associated AEs reported.
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Illness, Weight decreased
Clinical narrative: short of breath; losing weight; very ill; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to 5 antibiotics) and Disability NOS.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill). At the time of the report, DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. The patient reported receiving the vaccine 16 months ago. No treatment details were reported.   This case was linked to MOD-2021-264021 (Patient Link). This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to 5 antibiotics) and Disability NOS.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill). At the time of the report, DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. The patient reported receiving the vaccine 16 months ago. No treatment details were reported.   This case was linked to MOD-2021-264021 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient delayed receiving the second dose of the Moderna COVID-19 vaccine for more than 35 days; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient delayed receiving the second dose of the Moderna COVID-19 vaccine for more than 35 days) 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient delayed receiving the second dose of the Moderna COVID-19 vaccine for more than 35 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient delayed receiving the second dose of the Moderna COVID-19 vaccine for more than 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort
Clinical narrative: I got vaccinated 5 days before and my arm get irritated with heat; face getting numb; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I got vaccinated 5 days before and my arm get irritated with heat) and HYPOAESTHESIA (face getting numb) 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 16-Jul-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 LIMB DISCOMFORT (I got vaccinated 5 days before and my arm get irritated with heat) and HYPOAESTHESIA (face getting numb). At the time of the report, LIMB DISCOMFORT (I got vaccinated 5 days before and my arm get irritated with heat) and HYPOAESTHESIA (face getting numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Severe muscle cramps after second shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Severe muscle cramps after second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Severe muscle cramps after second shot). At the time of the report, MUSCLE SPASMS (Severe muscle cramps after second shot) outcome was unknown.            No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose outside of the window of Moderna vaccine schedule; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of the window of Moderna vaccine schedule) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of the window of Moderna vaccine schedule). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of the window of Moderna vaccine schedule) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient has not received her 2nd dose of the Moderna vaccine almost 5 months later; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd dose of the Moderna vaccine almost 5 months later) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 17-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 PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd dose of the Moderna vaccine almost 5 months later). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd dose of the Moderna vaccine almost 5 months later) 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 medication information was not provided. Concomitant medication information was not provided.   This case was linked to MOD-2021-051942 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral discomfort
Clinical narrative: Swollen bottom lip; Burning bottom lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen bottom lip) and ORAL DISCOMFORT (Burning bottom lip) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced LIP SWELLING (Swollen bottom lip) and ORAL DISCOMFORT (Burning bottom lip). At the time of the report, LIP SWELLING (Swollen bottom lip) and ORAL DISCOMFORT (Burning bottom lip) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included Blood pressure medicines.  Treatment information was not provided. Patient reported that after 30 to 45 minutes of vaccination, adverse events started and felt like it was still getting bigger.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow- up  received contains non significant information. Outcome of the events and onset time updated in narrative from the initial source.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.