chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Pruritus, Rash
Clinical narrative: Itching; Burning all over body; Rash started appearing first on my back, and spreads to entire body, kept spreading. It is on whole body including head and feet; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), BURNING SENSATION (Burning all over body) and RASH (Rash started appearing first on my back, and spreads to entire body, kept spreading. It is on whole body including head and feet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hepatitis B and Hepatitis C. Previously administered products included for Hepatitis C: Epclusa (Treatment for Hepatitis C). Concurrent medical conditions included Genital herpes.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced RASH (Rash started appearing first on my back, and spreads to entire body, kept spreading. It is on whole body including head and feet). On an unknown date, the patient experienced PRURITUS (Itching) and BURNING SENSATION (Burning all over body). The patient was treated with TRIAMCINOLONE for Rash, at a dose of injection; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency; HYDROCORTISONE for Rash, at a dose of cream; PREDNISONE for Rash, at an unspecified dose and frequency; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash, at an unspecified dose and frequency; HYDROXYZINE for Rash, at an unspecified dose and frequency; SULFAMETHOXAZOLE SODIUM;TRIMETHOPRIM for Rash, at an unspecified dose and frequency and BETAMETHASONE for Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and BURNING SENSATION (Burning all over body) outcome was unknown and RASH (Rash started appearing first on my back, and spreads to entire body, kept spreading. It is on whole body including head and feet) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal.         No concomitant medications reported.  It was reported, that the patient had already received shingles vaccine on 02FEB2021 and pneumonia vaccine on 05JAN2021.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Heart rate increased, Nasopharyngitis
Clinical narrative: Heart is racing a little, not much, 105 bpm; cold chills; cold chills; Fever of 100.8 ° F; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart is racing a little, not much, 105 bpm), NASOPHARYNGITIS (cold chills), CHILLS (cold chills) and PYREXIA (Fever of 100.8 ° F) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     The patient's past medical history included Stent placement.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced HEART RATE INCREASED (Heart is racing a little, not much, 105 bpm), NASOPHARYNGITIS (cold chills), CHILLS (cold chills) and PYREXIA (Fever of 100.8 ° F). At the time of the report, HEART RATE INCREASED (Heart is racing a little, not much, 105 bpm), NASOPHARYNGITIS (cold chills), CHILLS (cold chills) and PYREXIA (Fever of 100.8 ° F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Body temperature: 100.8 (High) fever of 100.8 ° F. On 30-Sep-2021, Heart rate: 105 (High) 105 bpm, not much.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was not having a history of COVID infection and myo/pericarditis.  No concomitant medication information was provided.  No treatment medication information was provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Heart is racing a little, not much, 105 bpm; cold chills; cold chills; Fever of 100.8 ° F; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart is racing a little, not much, 105 bpm), NASOPHARYNGITIS (cold chills), CHILLS (cold chills) and PYREXIA (Fever of 100.8 ° F) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     The patient's past medical history included Stent placement.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced HEART RATE INCREASED (Heart is racing a little, not much, 105 bpm), NASOPHARYNGITIS (cold chills), CHILLS (cold chills) and PYREXIA (Fever of 100.8 ° F). At the time of the report, HEART RATE INCREASED (Heart is racing a little, not much, 105 bpm), NASOPHARYNGITIS (cold chills), CHILLS (cold chills) and PYREXIA (Fever of 100.8 ° F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Body temperature: 100.8 (High) fever of 100.8 ° F. On 30-Sep-2021, Heart rate: 105 (High) 105 bpm, not much.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was not having a history of COVID infection and myo/pericarditis.  No concomitant medication information was provided.  No treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: not immunocompromised people received 3rd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (not immunocompromised people received 3rd dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (not immunocompromised people received 3rd dose). At the time of the report, OFF LABEL USE (not immunocompromised people received 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Malaise, Musculoskeletal chest pain
Clinical narrative: Today I'm not feeling well; Weakness; I have some headache; Little bit of chill that started yesterday afternoon; My ribs started feeling wrapped tight/compression on my ribs that got away; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Today I'm not feeling well), MUSCULOSKELETAL CHEST PAIN (My ribs started feeling wrapped tight/compression on my ribs that got away), ASTHENIA (Weakness), HEADACHE (I have some headache) and CHILLS (Little bit of chill that started yesterday afternoon) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included COLECALCIFEROL (VITAMIN D3) and FISH OIL for an unknown indication.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (My ribs started feeling wrapped tight/compression on my ribs that got away) and CHILLS (Little bit of chill that started yesterday afternoon). On 02-Oct-2021, the patient experienced MALAISE (Today I'm not feeling well), ASTHENIA (Weakness) and HEADACHE (I have some headache). The patient was treated with OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Adverse event, at a dose of 40 mg. At the time of the report, MALAISE (Today I'm not feeling well), ASTHENIA (Weakness), HEADACHE (I have some headache) and CHILLS (Little bit of chill that started yesterday afternoon) outcome was unknown and MUSCULOSKELETAL CHEST PAIN (My ribs started feeling wrapped tight/compression on my ribs that got away) had resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Fatigue, Feeling abnormal, Lymphadenopathy, Myalgia
Clinical narrative: weird feeling; felt high not thinking clearly; swollen lymph nodes; fatigued; achy arm/She woke up at 3AM feeling very achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (weird feeling), EUPHORIC MOOD (felt high not thinking clearly), LYMPHADENOPATHY (swollen lymph nodes), FATIGUE (fatigued) and MYALGIA (achy arm/She woke up at 3AM feeling very achy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced FEELING ABNORMAL (weird feeling), EUPHORIC MOOD (felt high not thinking clearly), LYMPHADENOPATHY (swollen lymph nodes), FATIGUE (fatigued) and MYALGIA (achy arm/She woke up at 3AM feeling very achy). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 05-May-2021, FEELING ABNORMAL (weird feeling), EUPHORIC MOOD (felt high not thinking clearly), FATIGUE (fatigued) and MYALGIA (achy arm/She woke up at 3AM feeling very achy) had resolved. On 05-Jun-2021, LYMPHADENOPATHY (swollen lymph nodes) had resolved.            No concomitant medication was reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient didn't receive the full dose, as some leaked out; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient didn't receive the full dose, as some leaked out) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient didn't receive the full dose, as some leaked out). On 02-Oct-2021, ACCIDENTAL UNDERDOSE (Patient didn't receive the full dose, as some leaked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. It was reported that second shot was scheduled for 31 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received on 04-oct-2021 included updated reporter's information.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: receiving 3rd dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (receiving 3rd dose without being immunocompromised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced OFF LABEL USE (receiving 3rd dose without being immunocompromised). On 26-Aug-2021, OFF LABEL USE (receiving 3rd dose without being immunocompromised) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 6 patients; 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients) 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.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients) 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 considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients) to be possibly related.    No concomitant medications were reported. No treatment medications were reported. Pharmacist was calling to report that 6 patients received the Moderna COVID-19 vaccine from 29SEP2021 to 30SEP2021. The Moderna Covid-19 vials administered to these 6 patients expired on 28SEP2021.   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus, Stress
Clinical narrative: tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body; numbness in her feet/tingling and numbness in her that rotates around her body; itchy feeling/worsen with stress. She describes it as an "itchy feeling; Stress; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (numbness in her feet/tingling and numbness in her that rotates around her body), PRURITUS (itchy feeling/worsen with stress. She describes it as an "itchy feeling) and STRESS (Stress) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Pericarditis (has a longstanding heart problem which she clarified as a pericardial episode.), Pregnancy and Surgery. Concurrent medical conditions included Chronic kidney disease stage 3 and Congestive heart failure (has a longstanding heart problem which she clarified as a pericardial episode and congestive heart failure during pregnancy years ago.).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (numbness in her feet/tingling and numbness in her that rotates around her body), PRURITUS (itchy feeling/worsen with stress. She describes it as an "itchy feeling) and STRESS (Stress). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (numbness in her feet/tingling and numbness in her that rotates around her body), PRURITUS (itchy feeling/worsen with stress. She describes it as an "itchy feeling) and STRESS (Stress) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient plan to see a neurologist. Concomitant medication was not provided.   This case was linked to MOD-2021-339160 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: a patient received their 2nd dose of the Moderna Covid-19 Vaccine on 1Oct2021,from a previously opened (24Sep2021) vial that has been stored at room temperature since 24Sep2021; a patient received their 2nd dose of the Moderna Vaccine on 1Oct2021, from a previously opened (24Sep2021) vial that has been stored at room temperature since 24Sep2021; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received their 2nd dose of the Moderna Vaccine on 1Oct2021, from a previously opened (24Sep2021) vial that has been stored at room temperature since 24Sep2021) and PRODUCT STORAGE ERROR (a patient received their 2nd dose of the Moderna Covid-19 Vaccine on 1Oct2021,from a previously opened (24Sep2021) vial that has been stored at room temperature since 24Sep2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient received their 2nd dose of the Moderna Vaccine on 1Oct2021, from a previously opened (24Sep2021) vial that has been stored at room temperature since 24Sep2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (a patient received their 2nd dose of the Moderna Covid-19 Vaccine on 1Oct2021,from a previously opened (24Sep2021) vial that has been stored at room temperature since 24Sep2021). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (a patient received their 2nd dose of the Moderna Vaccine on 1Oct2021, from a previously opened (24Sep2021) vial that has been stored at room temperature since 24Sep2021) had resolved. At the time of the report, PRODUCT STORAGE ERROR (a patient received their 2nd dose of the Moderna Covid-19 Vaccine on 1Oct2021,from a previously opened (24Sep2021) vial that has been stored at room temperature since 24Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication were reported.  The patient was given accidentally a dose of vaccine that had been out of the fridge for multiple days   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received contains no new information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Pyrexia, Vaccination complication
Clinical narrative: it started itchin/itching is feeling now like she's breaking out in way ups all over her body/She states it started in her arm, then started in the lower part of legs, and her stomach; had itchy skin; The doctors stated it could be a reaction from the Covid vaccine; achy; ran a fever for like 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it started itchin/itching is feeling now like she's breaking out in way ups all over her body/She states it started in her arm, then started in the lower part of legs, and her stomach), PRURITUS (had itchy skin), VACCINATION COMPLICATION (The doctors stated it could be a reaction from the Covid vaccine), MYALGIA (achy) and PYREXIA (ran a fever for like 3 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03021A and 023M209) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-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 PRURITUS (it started itchin/itching is feeling now like she's breaking out in way ups all over her body/She states it started in her arm, then started in the lower part of legs, and her stomach), PRURITUS (had itchy skin), VACCINATION COMPLICATION (The doctors stated it could be a reaction from the Covid vaccine), MYALGIA (achy) and PYREXIA (ran a fever for like 3 days). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency and PREDNISONE for Itching, at a dose of 20 milligram. At the time of the report, PRURITUS (it started itchin/itching is feeling now like she's breaking out in way ups all over her body/She states it started in her arm, then started in the lower part of legs, and her stomach), PRURITUS (had itchy skin), VACCINATION COMPLICATION (The doctors stated it could be a reaction from the Covid vaccine), MYALGIA (achy) and PYREXIA (ran a fever for like 3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that itching started a week after vaccine and didn't stopped even after taking hydrocortisone and prednisone. No concomitant medication reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular
Clinical narrative: My menstrual cycle has been irregular for the first time in my life. I have always been regular and I track my periods in an app. I had two 2-week cycles and one delayed cycle in the 5 months following my second dose of the Pfizer shot.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus
Clinical narrative: Severe itch on scalp left side only toward base of skull in the back
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Burning sensation, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Muscle aches, skin sensitive to touch, feeling of burning throughout body, fatigue, upset stomach, flu like symptoms on 2nd day.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: Muscle aches, skin sensitive to touch, feeling of burning throughout body, fatigue, upset stomach, flu like symptoms on 2nd day.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: I?m about may my periods started getting a lot heavier, and today started the worst one so far I?m wearing both a tampon and a pad and bleeding through both every 21/2-3 hours
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Tendonitis in Left upper arm extending to elbow.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I believe we vaccinated an individual after the beyond use date of the vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I believe we vaccinated an individual after the beyond use date of the vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I believe we vaccinated an individual after the beyond use date of the vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I believe we vaccinated an individual after the beyond use date of the vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Lethargy, Myalgia, Pyrexia
Clinical narrative: Fever, Chills, Muscle Aches/Soreness, Profuse Sweating, Lethargy
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Gait disturbance, Hot flush, Hypersomnia
Clinical narrative: Sore lymph nodes in underarm area still on day 5, slept for 11 hours, cold/hot flashes, cold sore emerged in center left of lower lip. Haven't had a gold sore in over 25 years. Left foot is tender so a bit wobbly walking wise. No treatment for lymph nodes or tiredness. Just rest. Will pick up abreva for cold sore. possibly physical therapy for foot to be discussed with doctor.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Oral herpes, Pain in extremity
Clinical narrative: Sore lymph nodes in underarm area still on day 5, slept for 11 hours, cold/hot flashes, cold sore emerged in center left of lower lip. Haven't had a gold sore in over 25 years. Left foot is tender so a bit wobbly walking wise. No treatment for lymph nodes or tiredness. Just rest. Will pick up abreva for cold sore. possibly physical therapy for foot to be discussed with doctor.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Joint swelling
Clinical narrative: Swollen ankles and loss of menstrual cycle
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Rash, Rash pruritic, Urticaria
Clinical narrative: Rash that appears at different spots on body and last approximate 1-2 days itchy, bumps and sometimes whelps.  Taking Benadryl to help with the discomfort and itchiness Rash started approx 1 week after vaccine was administered on 9/5/21 and 9/28/21
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Systemic: Hypertension-Severe, Additional Details: reports hypertension persisting since her vaccine, reports systolic readings close to 200, went to emergency room 3 times since vaccine
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Malaise
Clinical narrative: Fever 99.7 F, chills, muscle pain, fatigue, malaise, headache, GI disturbance
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever 99.7 F, chills, muscle pain, fatigue, malaise, headache, GI disturbance
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: I received the 1st and 2nd doses of the COVID vaccine of Moderna. Went for the booster due to having cancer and receiving chemo and radiation and being immunocompromised. Filled it paperwork selected which vaccine I had gotten and present vaccination card to pharmacist. My daughter also got her 3rd dose and was with me. Pharmacist gave me injection then my daughter. He went to fill out our cards and saw mine then stated to my daughter ?Oops I didn?t see her card and realize that she got the Moderna vaccine, I saw your car and thought you both got the same vaccine.? ?Well I can?t take it back out of her?. This is a medication error and I don?t know how that?s gonna affect me or if I?ll build up antibodies and be protective for the next year until the next booster. Something needs done.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Sore Arm for 1 day as per mom and pt has taken ibuprofen for 24 hours.-Mild, Error: Patient Too Young for Vaccine Administered-, Additional Details: Sore Arm for 1 day as per mom and pt has taken ibuprofen for 24 hours. Pharmacist has requested the immunization team to contact the patients family regarding any further notice. patient has been waiting for the call from pharmacy in order to hear anything in details. The error could have been prevented if laptops were present during the clinic and woking. we could not type a prescription as system was automatically rejecting due to age limit.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: felt tired; injection site arm hurt.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired) and VACCINATION SITE PAIN (injection site arm hurt.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-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 FATIGUE (felt tired) and VACCINATION SITE PAIN (injection site arm hurt.). At the time of the report, FATIGUE (felt tired) and VACCINATION SITE PAIN (injection site arm hurt.) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.    This case was linked to MOD-2021-339171 (Patient Link).   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; Mild aching; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Mild aching) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Manic depression. Concurrent medical conditions included Lactose intolerant and Blood pressure high. Concomitant products included PAROXETINE, CHLORTALIDONE (CHLORTHALIDONE), IRBESARTAN, LEVOTHYROXINE, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), CARBAMAZEPINE, METFORMIN, METOPROLOL SUCCINATE, PREGABALIN, ATORVASTATIN CALCIUM, QUETIAPINE FUMARATE (SEROQUEL) and CLONAZEPAM (KLONOPIN) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-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 INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Mild aching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Mild aching) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications also included an Over the Counter Flu-Like Medicine "name not provided".
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: period is now going on over 7 days; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (period is now going on over 7 days) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     The patient's past medical history included Menstrual cramps.    On 13-Sep-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 HEAVY MENSTRUAL BLEEDING (period is now going on over 7 days). At the time of the report, HEAVY MENSTRUAL BLEEDING (period is now going on over 7 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Normally they are 3 days long, and the longest one ever that she can remember lasted 5 days.  She also said that she had cramps bad when she was young.  The concomitant medications information was not reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Ear infection, Product dose omission issue
Clinical narrative: ear infection; got first dose on spring of 2021 and still has not received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (ear infection) and PRODUCT DOSE OMISSION ISSUE (got first dose on spring of 2021 and still has not received 2nd dose) 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.    In 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 EAR INFECTION (ear infection) and PRODUCT DOSE OMISSION ISSUE (got first dose on spring of 2021 and still has not received 2nd dose). At the time of the report, EAR INFECTION (ear infection) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (got first dose on spring of 2021 and still has not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As reported patient was taking antibiotics.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient was vaccinated on Wednesday 29Sept2021 with a Moderna dose from a vial the pharmacist believes was opened on Monday 27Sep2021/ Patient was administered a dose that was stored for over 30 days t; patient administered a dose from an excursed vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was vaccinated on Wednesday 29Sept2021 with a Moderna dose from a vial the pharmacist believes was opened on Monday 27Sep2021/ Patient was administered a dose that was stored for over 30 days t) and PRODUCT STORAGE ERROR (patient administered a dose from an excursed vial) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was vaccinated on Wednesday 29Sept2021 with a Moderna dose from a vial the pharmacist believes was opened on Monday 27Sep2021/ Patient was administered a dose that was stored for over 30 days t) and PRODUCT STORAGE ERROR (patient administered a dose from an excursed vial). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patient was vaccinated on Wednesday 29Sept2021 with a Moderna dose from a vial the pharmacist believes was opened on Monday 27Sep2021/ Patient was administered a dose that was stored for over 30 days t) and PRODUCT STORAGE ERROR (patient administered a dose from an excursed vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist believed was opened on Monday 27-Sep-2021 (but he was not sure). Pharmacist was unsure if it was the patient's first or second dose and unsure which arm vaccine was administered in. It was also reported that administered a dose that was stored for over 30 days to a patient. No other adverse events have been experienced.  Concomitant medications were not reported.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Follow up received on 02 OCT 2021 contains : Reporter information updated, patient demographics added and lot number updated. On 05-Oct-2021: Folow up received on 05 oct 2021 contains No New Information.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Herpes zoster, Nipple swelling, Pruritus, Skin mass
Clinical narrative: Diagnosed with shingles/Shingles under the left breast and left leg; Swollen nipple & left Breast; Breast swelling; Scratchy under her left breast.; Bumps under her left breast; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagnosed with shingles/Shingles under the left breast and left leg), PRURITUS (Scratchy under her left breast.), SKIN MASS (Bumps under her left breast), NIPPLE SWELLING (Swollen nipple & left Breast) and BREAST SWELLING (Breast swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain since 27-Sep-2021, Leg pain since 27-Sep-2021 and UTI since 27-Sep-2021.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PRURITUS (Scratchy under her left breast.) and SKIN MASS (Bumps under her left breast). On 30-Sep-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles/Shingles under the left breast and left leg), NIPPLE SWELLING (Swollen nipple & left Breast) and BREAST SWELLING (Breast swelling). At the time of the report, HERPES ZOSTER (Diagnosed with shingles/Shingles under the left breast and left leg) had not resolved and PRURITUS (Scratchy under her left breast.), SKIN MASS (Bumps under her left breast), NIPPLE SWELLING (Swollen nipple & left Breast) and BREAST SWELLING (Breast swelling) 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 Concomitant medication was reported.  Patient said that she had shingles under the left breast and on the left leg, which was spreading.  No treatment medication was reported.  No lab data was provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received a dose of the Moderna vaccine when he already had 2 doses of Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a dose of the Moderna vaccine when he already had 2 doses of Pfizer) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (dose2) in May 2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 1).    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a dose of the Moderna vaccine when he already had 2 doses of Pfizer). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a dose of the Moderna vaccine when he already had 2 doses of Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date , patient received first dose of Pfizer COVID-19 vaccine. On MAy2021, patient received second dose of Pfizer COVID-19 vaccine.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of polymenorrhea (my sister got the Moderna COVID-19 shot & it has shortened her menstrual cycle) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 1, 2021, patient experienced polymenorrhea (my sister got the Moderna COVID-19 shot & it has shortened her menstrual cycle). At the time of the report, polymenorrhea (my sister got the Moderna COVID-19 shot & it has shortened her menstrual cycle) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Allergic to vaccine; Injection site really hot; Injection site hard; Injection site swollen/swelling to my fingers and up under my armpit; Injection site was bright red; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Allergic reaction), VACCINATION SITE WARMTH (Injection site really hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE SWELLING (Injection site swollen/swelling to my fingers and up under my armpit) and VACCINATION SITE ERYTHEMA (Injection site was bright red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.   No Medical History information was reported.  On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site really hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE SWELLING (Injection site swollen/swelling to my fingers and up under my armpit) and VACCINATION SITE ERYTHEMA (Injection site was bright red). On an unknown date, the patient experienced VACCINATION COMPLICATION (Allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse reaction, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Allergic reaction), VACCINATION SITE WARMTH (Injection site really hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE SWELLING (Injection site swollen/swelling to my fingers and up under my armpit) and VACCINATION SITE ERYTHEMA (Injection site was bright red) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medication were reported.  Treatment details included antibiotics.  After experiencing the events patient went to urgent care and they said the swelling might be due to cellulitis and prescribed antibiotics. After taking high dose of prednisone, they said that it was not a cellulitis but instead an allergic reaction.   This case was linked to MOD-2021-339248 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up was received and contains significant details: primary source reporter, patient information, suspect information, event details, treatment drugs were updated. On 01-Oct-2021: Follow-up was received and contain significant details: vaccination dates were updated.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received shot from a vial punctured more than 12 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received shot from a vial punctured more than 12 hours ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040D21A and 017E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), COLECALCIFEROL (VITAMIN D3), OMEPRAZOLE and NAPROXEN for an unknown indication.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-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 EXPIRED PRODUCT ADMINISTERED (patient received shot from a vial punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received shot from a vial punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant naproxen from April. HCP did not know if patient still takes it.  Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received Moderna COVID-19 vaccine after Beyond Use Date; A Moderna COVID-19 vaccine vial was removed from the refrigerator yesterday; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine after Beyond Use Date) and PRODUCT STORAGE ERROR (A Moderna COVID-19 vaccine vial was removed from the refrigerator yesterday) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021 at 8:45 AM, the patient experienced PRODUCT STORAGE ERROR (A Moderna COVID-19 vaccine vial was removed from the refrigerator yesterday). On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine after Beyond Use Date). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine after Beyond Use Date) and PRODUCT STORAGE ERROR (A Moderna COVID-19 vaccine vial was removed from the refrigerator yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant was not reported.  No treatment medication was reported.  The vial was left out at room temperature until 01OCT2021 when a dose was given at 8:33AM.