chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: An expired 2nd dose administered to a patient; An expired 2nd dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose administered to a patient) and PRODUCT STORAGE ERROR (An expired 2nd dose administered to a patient) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose administered to a patient) and PRODUCT STORAGE ERROR (An expired 2nd dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose administered to a patient) and PRODUCT STORAGE ERROR (An expired 2nd dose administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was opened and punctured on 18 Sep 2021 at 10 AM. The vial was at room temperature for 26 hours. A dose was administered on 19 Sep 2021 at around 11 AM. Patient had received 2nd dose. Pharmacist wants to know if the dose needs to be repeated. No Treatment medications were provided No  Concomitant medications were provided
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Erythema, Pemphigoid, Pruritus, Skin reaction
Clinical narrative: Pemphigoid Bullous; Itchy skin; Red skin; Broke out in blisters, the location of the reaction was torso, towards the back, legs, and arms; bilateral; Delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (Pemphigoid Bullous) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PRURITUS (Itchy skin), ERYTHEMA (Red skin), BLISTER (Broke out in blisters, the location of the reaction was torso, towards the back, legs, and arms; bilateral) and SKIN REACTION (Delayed reaction). On an unknown date, the patient experienced PEMPHIGOID (Pemphigoid Bullous) (seriousness criterion medically significant). The patient was treated with PREDNISONE (oral) for Pemphigoid, at a dose of 1 dosage form; DOXYCYCLINE ongoing since an unknown date for Pemphigoid, at a dose of 100 milligram twice a day; NIACINAMIDE ongoing since an unknown date for Pemphigoid, at a dose of 1 dosage form twice a day and CORTISONE (topical) ongoing since an unknown date for Pemphigoid, at a dose of 1 dosage form. At the time of the report, PEMPHIGOID (Pemphigoid Bullous), PRURITUS (Itchy skin), ERYTHEMA (Red skin), BLISTER (Broke out in blisters, the location of the reaction was torso, towards the back, legs, and arms; bilateral) and SKIN REACTION (Delayed reaction) had not resolved.            No concomitant medication details were provided. The reporter also stated that Consumer was prescribed medications for treatment, which included oral steroid, antibiotics, topical steroid, and vitamin.  Also Consumer had discontinued oral steroids.  company comment: This case concerns a  79-year-old, male patient with no relevant medical history, who experienced the unexpected event of pemphigoid bullous. The event occurred approximately 3 months after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the event as related to the product. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a  79-year-old, male patient with no relevant medical history, who experienced the unexpected event of pemphigoid bullous. The event occurred approximately 3 months after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the event as related to the product. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Illness, Myalgia, Nausea
Clinical narrative: we are still sick from that shot; I was nauseous last nigh; we had a real adverse reaction to it; fever, on and off; fatigue; joint pain; muscle pain is too much/muscle pain is terrible and too much; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (we had a real adverse reaction to it), ILLNESS (we are still sick from that shot), PYREXIA (fever, on and off), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 LISINOPRIL, PAROXETINE and OMEPRAZOLE for an unknown indication.    On 17-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced VACCINATION COMPLICATION (we had a real adverse reaction to it), PYREXIA (fever, on and off), FATIGUE (fatigue), ARTHRALGIA (joint pain) and MYALGIA (muscle pain is too much/muscle pain is terrible and too much). On 19-Sep-2021, the patient experienced NAUSEA (I was nauseous last nigh). On 20-Sep-2021, the patient experienced ILLNESS (we are still sick from that shot). At the time of the report, VACCINATION COMPLICATION (we had a real adverse reaction to it), PYREXIA (fever, on and off), FATIGUE (fatigue), ARTHRALGIA (joint pain), MYALGIA (muscle pain is too much/muscle pain is terrible and too much) and NAUSEA (I was nauseous last nigh) outcome was unknown and ILLNESS (we are still sick from that shot) had not resolved.            The concomitant medication also included pain medication.  No treatment medication were provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: we are still sick from that shot; I was nauseous last nigh; we had a real adverse reaction to it; fever, on and off; fatigue; joint pain; muscle pain is too much/muscle pain is terrible and too much; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (we had a real adverse reaction to it), ILLNESS (we are still sick from that shot), PYREXIA (fever, on and off), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 LISINOPRIL, PAROXETINE and OMEPRAZOLE for an unknown indication.    On 17-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced VACCINATION COMPLICATION (we had a real adverse reaction to it), PYREXIA (fever, on and off), FATIGUE (fatigue), ARTHRALGIA (joint pain) and MYALGIA (muscle pain is too much/muscle pain is terrible and too much). On 19-Sep-2021, the patient experienced NAUSEA (I was nauseous last nigh). On 20-Sep-2021, the patient experienced ILLNESS (we are still sick from that shot). At the time of the report, VACCINATION COMPLICATION (we had a real adverse reaction to it), PYREXIA (fever, on and off), FATIGUE (fatigue), ARTHRALGIA (joint pain), MYALGIA (muscle pain is too much/muscle pain is terrible and too much) and NAUSEA (I was nauseous last nigh) outcome was unknown and ILLNESS (we are still sick from that shot) had not resolved.            The concomitant medication also included pain medication.  No treatment medication were provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: rash which looked like welts with blisters,size of the fingertip; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (rash which looked like welts with blisters,size of the fingertip) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E4A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced RASH VESICULAR (rash which looked like welts with blisters,size of the fingertip). The patient was treated with HYDROCORTISONE ongoing since an unknown date for Blistery rash, at a dose of 1 dosage form and ANTIHISTAMINES ongoing since an unknown date for Blistery rash, at a dose of 1 dosage form. At the time of the report, RASH VESICULAR (rash which looked like welts with blisters,size of the fingertip) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was mentioned by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Urinary incontinence
Clinical narrative: Diarrhea; uncontrollable urination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea) and URINARY INCONTINENCE (uncontrollable urination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DIARRHEA (Diarrhea) and URINARY INCONTINENCE (uncontrollable urination). At the time of the report, DIARRHEA (Diarrhea) and URINARY INCONTINENCE (uncontrollable urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Impaired work ability
Clinical narrative: I couldn't breath; coughing a lot; I can't do anything; feeling tired with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I couldn't breath), COUGH (coughing a lot), IMPAIRED WORK ABILITY (I can't do anything) and FATIGUE (feeling tired with fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included INSULIN for Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (I couldn't breath), COUGH (coughing a lot), IMPAIRED WORK ABILITY (I can't do anything) and FATIGUE (feeling tired with fatigue). At the time of the report, DYSPNOEA (I couldn't breath), COUGH (coughing a lot) and IMPAIRED WORK ABILITY (I can't do anything) outcome was unknown and FATIGUE (feeling tired with fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that the vaccine was administered 3 or 4 months ago. He could not breath and was sitting down for a month. He was coughing a lot. He had been feeling tired for about 4 months already, with fatigue. He cannot do anything. The symptoms started a week after the vaccination was given.   No treatment information was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Pyrexia, Vaccination complication
Clinical narrative: red patch on arm (1st dose); swollen glands on injection site; continued fever that doesn't go away/elevated body temperature/fever of 100 F at most/fever for 2.5 to 3 weeks (1st dose); COVID arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm (1st dose)), ERYTHEMA (red patch on arm (1st dose)), LYMPHADENOPATHY (swollen glands on injection site) and PYREXIA (continued fever that doesn't go away/elevated body temperature/fever of 100 F at most/fever for 2.5 to 3 weeks (1st dose)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (COVID arm (1st dose)). On an unknown date, the patient experienced ERYTHEMA (red patch on arm (1st dose)), LYMPHADENOPATHY (swollen glands on injection site) and PYREXIA (continued fever that doesn't go away/elevated body temperature/fever of 100 F at most/fever for 2.5 to 3 weeks (1st dose)).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided by the reporter.   This case was linked to MOD-2021-325347 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm; pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm; excruciating pain.; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm), PAIN IN EXTREMITY (pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm) and PAIN (excruciating pain.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021F and 024L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced LIMB DISCOMFORT (since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm), PAIN IN EXTREMITY (pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm) and PAIN (excruciating pain.). At the time of the report, LIMB DISCOMFORT (since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm), PAIN IN EXTREMITY (pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm) and PAIN (excruciating pain.) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-325319 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "Negligible side effects" after all the doses, except for her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Negligible side effects" after all the doses, except for her arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Immunocompromised), Blood pressure high (High Blood pressure) and Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("Negligible side effects" after all the doses, except for her arm). At the time of the report, VACCINATION COMPLICATION ("Negligible side effects" after all the doses, except for her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states that she used to take an immunosuppressant drug for a long time for her current conditions, but she stopped taking the drug after the pandemic started.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-325511, MOD-2021-325512 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria, Vaccination site pain
Clinical narrative: Started breaking out with hives/I still have them; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Started breaking out with hives/I still have them), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, COPD, Anxiety and Tremor.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm). In June 2021, the patient experienced URTICARIA (Started breaking out with hives/I still have them). At the time of the report, URTICARIA (Started breaking out with hives/I still have them) had not resolved and HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.            concomitant medications include High Blood Pressure medication,COPD Medication,Anxiety Medication,Medication for Tremors. patient  Went to an allergist and they took 11 vials of blood to check on allergies, etc. Nothing jumped out. patient also know someone that has gotten the 2nd shot and started in June with rashes, she just have the hives.Allergist said it could be possible side effect. Patient is also unsure if she will get a third dose.   This case was linked to MOD-2021-325579 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Feeling hot, Gait disturbance, Joint lock, Lip swelling
Clinical narrative: lot of pain all the time; they feel heat; it is hard to walk and their knees are locked; and their knees are locked  and it is all worse at night; Their eyes are very dry; their lips are tingling andpuffed and also their fingers, toes, legs, hands and face pinches like needles that make her scream and even in their vagina; everything is swollen and tight; lips are tingling and puffed; Patient states everything is swollen and tight.; soreness all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lot of pain all the time), FEELING HOT (they feel heat), GAIT DISTURBANCE (it is hard to walk and their knees are locked), JOINT LOCK (and their knees are locked  and it is all worse at night) and DRY EYE (Their eyes are very dry) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, the patient experienced PAIN (lot of pain all the time), FEELING HOT (they feel heat), GAIT DISTURBANCE (it is hard to walk and their knees are locked), JOINT LOCK (and their knees are locked  and it is all worse at night), DRY EYE (Their eyes are very dry), PARAESTHESIA (their lips are tingling andpuffed and also their fingers, toes, legs, hands and face pinches like needles that make her scream and even in their vagina), SWELLING (everything is swollen and tight), LIP SWELLING (lips are tingling and puffed), MUSCLE TIGHTNESS (Patient states everything is swollen and tight.) and MYALGIA (soreness all the time). At the time of the report, PAIN (lot of pain all the time), FEELING HOT (they feel heat), GAIT DISTURBANCE (it is hard to walk and their knees are locked), JOINT LOCK (and their knees are locked  and it is all worse at night), DRY EYE (Their eyes are very dry), PARAESTHESIA (their lips are tingling andpuffed and also their fingers, toes, legs, hands and face pinches like needles that make her scream and even in their vagina), SWELLING (everything is swollen and tight), LIP SWELLING (lips are tingling and puffed), MUSCLE TIGHTNESS (Patient states everything is swollen and tight.) and MYALGIA (soreness all the time) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Pain, Paraesthesia, Swelling
Clinical narrative: lot of pain all the time; they feel heat; it is hard to walk and their knees are locked; and their knees are locked  and it is all worse at night; Their eyes are very dry; their lips are tingling andpuffed and also their fingers, toes, legs, hands and face pinches like needles that make her scream and even in their vagina; everything is swollen and tight; lips are tingling and puffed; Patient states everything is swollen and tight.; soreness all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lot of pain all the time), FEELING HOT (they feel heat), GAIT DISTURBANCE (it is hard to walk and their knees are locked), JOINT LOCK (and their knees are locked  and it is all worse at night) and DRY EYE (Their eyes are very dry) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, the patient experienced PAIN (lot of pain all the time), FEELING HOT (they feel heat), GAIT DISTURBANCE (it is hard to walk and their knees are locked), JOINT LOCK (and their knees are locked  and it is all worse at night), DRY EYE (Their eyes are very dry), PARAESTHESIA (their lips are tingling andpuffed and also their fingers, toes, legs, hands and face pinches like needles that make her scream and even in their vagina), SWELLING (everything is swollen and tight), LIP SWELLING (lips are tingling and puffed), MUSCLE TIGHTNESS (Patient states everything is swollen and tight.) and MYALGIA (soreness all the time). At the time of the report, PAIN (lot of pain all the time), FEELING HOT (they feel heat), GAIT DISTURBANCE (it is hard to walk and their knees are locked), JOINT LOCK (and their knees are locked  and it is all worse at night), DRY EYE (Their eyes are very dry), PARAESTHESIA (their lips are tingling andpuffed and also their fingers, toes, legs, hands and face pinches like needles that make her scream and even in their vagina), SWELLING (everything is swollen and tight), LIP SWELLING (lips are tingling and puffed), MUSCLE TIGHTNESS (Patient states everything is swollen and tight.) and MYALGIA (soreness all the time) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had covid after vaccination/covid-19 symptoms not bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid after vaccination/covid-19 symptoms not bad) in a 52-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 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 COVID-19 (had covid after vaccination/covid-19 symptoms not bad). At the time of the report, COVID-19 (had covid after vaccination/covid-19 symptoms not bad) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.; Sender's Comments: This report concerns a 52 year old male patient with no relevant medical history who experienced an unexpected non-serious event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. It was reported that the patient was fully vaccinated with 2 doses of mRNA-1273 prior to onset of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Malaise, Myalgia, Somnolence
Clinical narrative: Sharp pains in lower back; Almost falling asleep in the afternoons; Sick feeling in the morning; Muscle pain; Fatigue/ very tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sharp pains in lower back), SOMNOLENCE (Almost falling asleep in the afternoons), MALAISE (Sick feeling in the morning), MYALGIA (Muscle pain) and FATIGUE (Fatigue/ very tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014S21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAMADOL HYDROCHLORIDE (TAMADOL) for Increased intraocular pressure.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-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 BACK PAIN (Sharp pains in lower back), SOMNOLENCE (Almost falling asleep in the afternoons), MALAISE (Sick feeling in the morning), MYALGIA (Muscle pain) and FATIGUE (Fatigue/ very tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Feeling sick, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Sharp pains in lower back), SOMNOLENCE (Almost falling asleep in the afternoons), MALAISE (Sick feeling in the morning), MYALGIA (Muscle pain) and FATIGUE (Fatigue/ very tired) outcome was unknown.            This case was linked to MOD-2021-325386 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got covid after vaccination; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid after vaccination) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In July 2021, the patient experienced COVID-19 (got covid after vaccination) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (got covid after vaccination) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive covid-19 test (Positive) Positive COVID-19 test.         No concomitant medications reported by reporter.  No treatment medications provided by the reporter.  Company comment: This case concerns an 83-year-old female patient who experienced the unexpected event of COVID-19 with seriousness criteria of hospitalization. The event occurred approximately 5 months after the first dose of mRNA-1273 and 4 months after the second dose of mRNA-1273. The rechallenge was not applicable. Because the event happened after the second dose of the vaccine after a 30 interval between 2 doses, lack of drug effect has also been captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns an 83-year-old female patient who experienced the unexpected event of COVID-19 with seriousness criteria of hospitalization. The event occurred approximately 5 months after the first dose of mRNA-1273 and 4 months after the second dose of mRNA-1273. The rechallenge was not applicable. Because the event happened after the second dose of the vaccine after a 30 interval between 2 doses, lack of drug effect has also been captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: headache; body aches - could barely walk; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (body aches - could barely walk) and VACCINATION SITE PAIN (injection site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced HEADACHE (headache), MYALGIA (body aches - could barely walk) and VACCINATION SITE PAIN (injection site pain). On 23-May-2021, HEADACHE (headache), MYALGIA (body aches - could barely walk) and VACCINATION SITE PAIN (injection site pain) had resolved.            No treatment informations were reported.   This case was linked to MOD-2021-325332 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The second dose was not as bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The second dose was not as bad) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The second dose was not as bad). At the time of the report, VACCINATION COMPLICATION (The second dose was not as bad) outcome was unknown. Not Provided          No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-319058 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 15-Apr-2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue
Clinical narrative: balance is off; really fatigued; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (balance is off) and FATIGUE (really fatigued) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced BALANCE DISORDER (balance is off) and FATIGUE (really fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (balance is off) had not resolved and FATIGUE (really fatigued) outcome was unknown.            no concomitant medications are provided.   This case was linked to MOD-2021-325524 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). In 2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 15-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. In 2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) 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 provided by reporter. No treatment medications were provided by reporter.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness would come and go after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness would come and go after the first shot) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Anemic.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS (Dizziness would come and go after the first shot). At the time of the report, DIZZINESS (Dizziness would come and go after the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-326086 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccines were applied to patients after being refrozen; shipment was thawed, and then it was refrozen again during transport; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (shipment was thawed, and then it was refrozen again during transport) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (shipment was thawed, and then it was refrozen again during transport). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (shipment was thawed, and then it was refrozen again during transport) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up document included no new information.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 15-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.